Revocation Of Patents According To Indian Patent Act, 1970

1 What is revocation of a patent?

When a patent has been sealed or granted, it is not always the case that the patent shall stay
unhindered by any third party till the life of the patent. The patent can be challenged by
certain people on different grounds, and a method to cause the same is by filing a revocation
petition/ post-grant opposition proceedings. This article focuses on the revocation
proceedings.

2 Why does one file a revocation petition?

As the Patent Act does not presume Patents granted to be valid, rights granted on such
Patents cannot be absolute. Third parties which are required to seek permission from Patentee
for practicing any of the exclusive rights bestowed upon him are also given a chance to
challenge the validity of the Patents. This challenge can be instituted on own as well as on
Patentee asserting infringement of Patent rights.

3 Who can file a revocation petition?

As per Section 64 of the Patent Act, 1970, the following persons can file the petition in the
High Court:

 any person interested1;

 the Central Government
 the person making the counter-claim in a suit for the infringement of a patent

4 Where can a revocation petition be filed?

Thus, a revocation petition can be filed in the Intellectual Property Appellate Board by the
interested person or the Central Government, or it can be filed as a counter-claim in a suit for
infringement at the High Court.
To bring in the aspect about jurisdiction of suits of infringement and the corresponding
revocation petitions, Section 104 of the Patents Act, 1970 states that no suit of infringement
can be brought before a court inferior to the District Court having jurisdiction to try the suit
and in the event of a counter-claim for revocation of the patent made by the defendant, such
suit for infringement and the said counter-claim must be transferred to the High Court.

5 What are the grounds under which a revocation petition can be brought?

Under Section 64, the following are the said grounds:

1. the invention, so far as claimed in any claim of the complete specification, was
claimed in a valid claim of earlier priority date contained in the complete specification
of another patent granted in India;
2. the patent was granted on the application of a person not entitled to apply therefor;
3. the patent was obtained wrongfully in contravention of the rights or the petitioner or
any person under or through whom he claims;
4. the subject of any claim of the complete specification is not an invention;
5. the invention so far as claimed in any claim of the complete specification is not new,
having regard to what was publicly known to publicly used in India before the priority
date of the claim or to what was published in India or elsewhere in any of the
documents referred to in Section 13;
6. the invention so far as claimed in any claim of the complete specification is obvious
or does not involve any inventive step, having regard to what was publicly known or
publicly used in India or what was published in India or elsewhere before the priority
date of the claim;
7. the invention, so far as claimed in any claim of the complete specification, is not
useful;
8. the complete specification does not sufficiently and fairly describe the invention and
the method by which it is to be performed, that is to say, that the description of the
method or the instructions for the working of the invention as contained in the
complete specification are not by themselves sufficient to enable a person in India
possessing average skill in, and average knowledge of the art to which the invention
relates, to work the invention, or that it does not disclose the best method of
performing it which was known to the applicant for the patent and for which he was
entitled to claim protection;
 9. that the scope of any claim of the complete specification is not sufficiently and clearly
defined or that any claim of the complete specification is not fairly based on the
matter disclosed in the specification;
10. that the patent was obtained on a false suggestion or representation;
11. that the subject of any claim of the complete specification is not patentable under this
Act;
12. that the invention so far as claimed in any claim of the complete specification was
secretly used in India, otherwise than as mentioned in sub-section (3), before the
priority date of the claim;
13. that the applicant for the patent has failed to disclose to the Controller the information
required by section 8 or has furnished information which in any material particular
was false to his knowledge;
14. that the applicant contravened any direction for secrecy passed under section 35
15. that leave to amend the complete specification under section 57 or section 58 was
obtained by fraud.
16. that the complete specification does not disclose or wrongly mentions the source or
geographical origin of biological material used for the invention;
17. that the invention so far as claimed in any claim of the complete specification was
anticipated having regard to the knowledge, oral or otherwise, available within any
local or indigenous community in India or elsewhere.

6 Does revocation restrict itself to Section 64?

It is important to note that section 64 does not restrict grounds to be used in revocation to
only those provided in section 64 whereas section 25 (2) setting out grounds used in post-
grant opposition proceedings is restrictive in nature.

7 What are the other provisions concerning revocation?

Under Section 65, if a patent is claimed to be related to atomic energy, a revocation petition
can be filed against it. Such patent shall not be granted under the Atomic Energy Act, 1962
and shall be revoked. Under Section 66, if the Central Government is of the opinion that a
patent or the mode in which it is exercised was mischievous to the State or prejudicial to the
public, after giving an opportunity to the patentee to be heard, it may make such declaration
in the Official Gazette and the patent shall stand revoked.
Moreover in the Enercon (India) Ltd and Ors. v Enercon Gmbh (2014) 5 SCC 1 , it was laid
down by the Supreme Court that when post grant opposition proceedings are instituted by a
party, he cannot institute a revocation petition or counter-claim of revocation proceeding
against the same patent.

Footnotes

1 'Person interested' under Section 64 would mean a person who has a direct, present and
tangible commercial interest which is injured or affected by the continuance of the patent on
the register. (Ajay Industrial Corporation v Shiro Kanao of Ibaraki City AIR 1983 Del 496)"

IPAB dismisses a patentee’s plea to surrender his

patent
Section 63 of the Patents Act entitles a patentee to surrender a patent at any time after the
grant of a patent. This post deals with the situation where an offer to surrender a patent was
made during pending revocation proceedings (No.29 of 2016). The IPAB dismissed the
patentee’s plea to surrender the patent; and further directed the Controller to revoke the
patent. While the Act does not categorically state/forbid patentee from surrendering a patent
through opposition/revocation proceedings, the IPAB’s ruling in the present case clearly
established that a surrender is possible only when there are no proceedings pending with
respect to the patent. If, however, any such proceedings are pending at the time of surrender,
then the applicant should contest the proceeding before bailing out by surrendering the patent.
Alternatively, all the parties involved in the opposition/revocation proceeding must be
amenable to the patentee’s decision to surrender the patent.
Facts of the case:
ICOS Corporation of Eli Lily and Company was granted a patent, IN224314, on free β-
carboline drug, and its method of preparation thereof. Mylan laboratories, herein referred to
as the Applicant, has filed for revocation of the impugned patent on grounds of lack of
inventive step, failure to disclose other foreign applications, among other grounds, listed
under section 64 of the Act, before the Intellectual Property Appellate Board (IPAB).

ICOS corporation, herein referred to as the respondent, has neither disputed nor contradicted
the grounds raised by the Applicant, but instead communicated to the IPAB, and to the
Controller general of Patents, that they no longer have any business interest in maintaining
the patent due to the presence of many generic products in the market. The respondents
further stated that they do not intend to maintain the impugned patent for this reason, and
offered to surrender the patent in accordance with section 63 of the Act.

The offer to surrender and the revocation action were evaluated in the same form, i.e., the
IPAB,to ascertain if the Controller can accept the patentee plea to surrender his patent, while
a revocation suit is pending before the IPAB.
Relevant provisions:
Section 63 of the Act provides provisions for surrender of a patent. Under this provision, a
patentee may offer to surrender his patent by giving a notice in the prescribed manner to the
Controller. On receipt of such an offer the Controller publishes the offer in the Official
Journal and also notifies every person (other than the patentee) whose name appears in the
register as having an interest in the patent. An opposition against the offer to surrender the
patent may be filed by any person interested in Form 14 within 3 months from the date of
publication of such offer in the Official Journal. The Controller shall inform the patentee on
receipt of such notice. If the Controller is satisfied after hearing the patentee and any
opponent, if desirous of being heard, that the patent may properly be surrendered, he may
accept the offer and, by order, revoke the patent.
Ruling:
At the IPAB, the Applicant’s arguments were hinged on the following:

Firstly, the Applicant’s argued that the respondents have not contested the grounds for
revocation by either denying or resisting the grounds raised in the application for revocation.
In the absence of any such counter statement, the Applicant’s contented that they have
established the case, and as a result the impugned patent would become invalid.

Secondly, the Applicant contended that the respondents chose to bring a closure to the patent
by making an offer to surrender the patent. However, such an offer to surrender is
clearly contingent on Controller’s acceptance, whereby the Controller has to follow the
procedure contemplated under section 63 of the Patents Act, 1970. The Applicant further
relied on two decisions of UK Patents Court and UK Patents Office reported in [1999]
F.S.R.284, where it was held that the patent remained in existence until the Controller
decided to accept that offer for surrender. Till such a time, the patent was open for challenge
by way of opposition/revocation. In light of the above arguments, the Applicants requested
the IPAB to revoke the patent.
The decision of the IPAB was in favour of the Applicant. The board directed the Controller to
revoke the patent within a period of six weeks from the date of receipt of the order.

Surrender of a patent is an option that rarely exercised by the patentee to avoid a litigation
suit, among other reasons. With a sparse case history available, the present case can be used
as a precedent, where it is clearly established that surrender cannot be used as a route to
circumvent a potential revocation suit. Any contention that challenges the patent at the time
of surrender must be disposed of before the patent can be surrendered

Patent Infringement in India

INFRINGEMENT-MEANING THEREOF

Unlike the design law, the Patents law does not specify as to what would constitute
infringement of a patented product or process. Generally speaking, the following acts when
committed without the consent of the patentee shall amount to infringement:

 making, using, offering for sale, selling, importing the patented product
 using the patented process, or using, offering for sale, selling or importing the product
directly obtained by that process

Exclusions from infringement

The law however enumerates certain exceptions to infringement:

a. Experimental and Research: Any patented article or process can be used for the following
purposes:

 Experiment

 Research

 Instructing the pupils

It is also permitted to make, construct, use, sell or import a patented invention solely for the
uses reasonably related to the development and submission of information required under any
law for the time being in force, in India, or in a country other than India, that regulates the
manufacture, construction, use, sale or import of any product. All such acts, if within the
bounds as created above, cannot be challenged as infringing the rights of the patentee.

b. Parallel Importation under certain conditions: patented article or article made by usingthe
patented process can be imported by government for its own use. Also a patented process can
be used by the government solely for its own use. Moreover the government can import any
patented medicine or drug for the purposes of its own use or for distribution in any
dispensary, hospital or other medical institution maintained by the government or any other
dispensary, hospital or medical institution notified by the government.

Jurisdiction

For filing a suit for infringement, the Court of first instance in India is the District Court.
Now, where in such a suit the defendant pleads invalidity of the patent and makes a counter
claim for revocation of the patent, the suit of infringement along with the counter claim is
necessarily transferred to the High Court having the Jurisdiction. As a matter of practice, in
almost all the suits of infringement the defendant challenges the validity of the patent and
makes a counter-claim for revocation. The effect of this is that infringement suits are
generally decided by the High courts. In Low Heat Driers (P) Ltd. v. Biju George [2001 (21)
PTC 775 (Ker)] it was held that once the defendants file a counter claim seeking revocation
of patent, the District Court will lose jurisdiction to proceed with the matter any further. That
deprivation of power will necessarily include the power to deal with all interlocutory
applications pending as on that day.

Like any other civil suit the jurisdiction shall be determined in accordance with the rules of
Code of civil Procedure. The appropriate forum would be:

(a) Principal place where the plaintiff carries on his business; or

(b) Principal place where the defendant carries on his business; or

(c) Place where the infringing articles are manufactured/ sold or infringing process is being
applied or where the articles manufactured by the infringing process is being sold;
Burden of Proof

The traditional rule of burden of proof is adhered to with respect to patented product and
accordingly in case of alleged infringement of a patented product the ‘onus of proof’ rests on
the plaintiff. However, TRIPS-prompted amendment has resulted in ‘reversal of burden of
proof’ in case of infringement of patented process. Under the current law, the Court can at its
discretion shift the burden of proof on the defendant, in respect of process patent if either of
the two conditions are met: 1) the process results in ‘new’ product or 2) there is substantial
likelihood that an identical product is made by the process and plaintiff has made reasonable
efforts to determine the process but has failed.

Declaration as to non-infringement

Infringement suits are dilatory, may hamper the flow of business and involve considerable
costs. To keep them at bay, a suit for declaration as to non-infringement can be instituted. For
this the plaintiff must show that following: (a) he plaintiff applied in writing to the patentee
or his exclusive licensee for a written acknowledgement to the effect that the process used or
the article produced by him does not infringe the patent and (b) patentee or the licensee
refused or neglected to give such an acknowledgement. It is not necessary that the plaintiff
must anticipate an infringement suit.

Relief in suit for Infringement

When speaking of any legal proceeding, probably the most important concern in the nature
and scope of relief available to the ‘aggrieved party’. It is seen that like any other civil
proceedings, the infringement suits are often protracted and if the aggrieved party were made
to wait till the end, the damage inflicted would be irreparable.

1. Interlocutory Orders

In such cases the plaintiff can obtain interlocutory order in form of ‘temporary injunction’
from the court by proving the existence of the following facts:

(a) A prima facie case of infringement

(b) Balance of convenience is tilting in his/her favour

(c) If injunction is not granted he/she shall suffer irreparable damage

In Hindustan Lever Limited v. Godrej Soaps Limited [AIR 1996 Cal 367], the Court held that
the plaintiff in a patent case must show a prima facie case of infringement and further that the
balance of convenience and inconvenience is in his favour. Where the alleged infringement is
not novel and the patent has not yet been exploited there is no question of loss of employment
or fall in revenue and the damages if suffered could be provisionally quantified it could not
be said that the balance of convenience was definitely in favour of a interlocutory injunction.

The Courts may refuse to consider the question of validity while deciding on interlocutory
order. As in Schneider Electric Industries SA V. Telemecanique & Controls (I) Ltd. [2000
(20) PTC 620 (Del)], Delhi High Court held that an interlocutory application in a suit for
infringement of a registered patent, defendant’s plea that patents are invalid as patented
features are in the nature of obvious improvements cannot be considered at this stage in the
light of conflicting expert evidence.

On the other hand in a recent case Novartis AG and Anr V. Mehar Pharma and Anr, 2005(30)
PTC (Bom) the Court refused to grant temporary injunction on the ground that the validity of
a recent patent was challenged.

2. Anton Pillar Order

The Court can also order for the search of the premises of the defendant. The infringing
goods, materials and implements which are used for the creation of the infringing goods can
be seized, forfeited or destroyed on the order of the Court

3. Damages and Accounts for Profits

Once the suit is decided in favour of the plaintiff, the Court can either award damages or
direct the defendant to render an account of profits. The two remedies are alternative and not
concurrent in nature. Some express limitations have been imposed on the grant of this relief.
The Court shall not grant damages or account of profits in the following cases:

(a) Where the defendant proves that at the date of the infringement he was not aware and had
no reasonable grounds for believing that the patent existed.
(b) Where an amendment of a specification had been allowed after the publication of the
specification, and the infringement action is in respect of the specification before the date of
publication unless the Court is satisfied original specification was made in god faith and with
reasonable skill and knowledge.

Groundless threats of infringement proceedings

There may be situations where a person makes groundless threats of infringement of patent.
The person aggrieved by such threats may bring a suit for the following relief

(a) A declaration to the effect that the threats are unjustifiable

(b) An injunction against the continuance of such threats

(c) Such damages if any a he has sustained thereby

DEFENCES WHICH THE DEFENDANT MAY SET UP IN THE SUIT –

The defendant against whom a suit is filed for infringement may set up one or more of the
following defences:-

1. That the plaintiff is not entitled to sue for infringement. (The right to sue can be exercised
only by a registered proprietor of a patent or a registered assignee or an exclusive licensee.
Any alleged assignment which is not registered will not confer the right to sue on the
assignee.)

2. That there has been no infringement or any threat or intention to infringe. (This defence
can be set up only when no actual tangible evidence of infringed article or process has been
produced by the plaintiff. The defendant may also plead that there has been no infringement
by stating that he has the licence or implied permission to use the patent, but in such a case
the onus is on the defendant to prove the existence of licence or implied permission to use the
invention.)

3. That there was a leave and licence, express or implied, to use the invention.

4. Estoppel or Res Judicata.

5. That the claims alleged to be infringed are invalid on grounds: a. that the invention was
subject matter of a valid claim of earlier priority date or a prior grant. b. that the patent was
granted on the application of a person not entitled to apply. c. that the patent was obtained
wrongfully. d. that the subject of any claim of the complete specification is not an invention
within the meaning of this Act. e. that the invention so far as claimed in any claim is not new
since it was publicly known or publicly used in India before the priority date of the claim.

6. At the time of infringement there existed a contract relating to the patent containing a
condition which is unlawful.

7. Act complained of falls within the scope of innocent infringement, that is, the defendant
was unaware of the existence of the patent when the alleged act of the infringement occurred
or was done after failure to pay renewal fee or was dopne before the date of amendment of
specification. However this defence is 23 available only against a claim for damages or
account of profits and not where the relief sought is an injunction.

8. Acts complained of are in accordance with the conditions which provide that in
circumstances the invention can be used by the Government.

9. That the alleged use is for research or instruction of pupils. However, convincing evidence
of such use has to be furnished by the defendant.

10. Counter-claim for revocation of the patent by the defendant.

CASE STUDIES ON LAW SUITS ON PATENT INFRINGEMENTS AND

PHARMACEUTICAL PATENTS IN INDIA

Gleevec case of Novartis case

 In this case, Novartis , a swizz based pharma company applied for patent right of
its beta crystalline form of Imatinib mesylate( Gleevec). The patent claim was
objected by CIPLA and other generic drug producers. The patent claim was
rejected by Indian patent office and a writ petition was filed in Hon.
 Madras high court. Novartis has questioned the constitutional validity of 3(d)
section of the patent act. Novartis contended that the term ‘efficacy’ in section
3(d) is vague and ambiguous and against article 14 of the Constitution of India.
 However, Hon. Madras High court dismissed writ petition and upheld the
constitutional validity of section 3(d).
 Second appeal was filed by Novartis in Intellectual Property Appellate Board
(IPAB) and IPAB has upheld the novel and invention aspect of Novartis claim, but
rejected the claim of patentability under section 3(d). This order of IPAB was
challenged in the Hon. Supreme court of India by filing an SLP.
 However, in 2013, the Hon. Supreme court of India has dismissed SLP and upheld
that the Novartis claim was failing on both the test of invention and patentability
as per the provisions of section 2(j), (ja ) (l) and section 3(d) of the patent act.
 The landmark judgement in patent litigation is epitome of patent jurisprudence in
India. Because, the judgement of the Hon. Supreme court of India is illustration of
balancing between the patent holder right and public right. It was clearly stated
that evergreening of patent by patent holder and exploitation of general public and
prohibition of competition of rivals are not the intention of the patent act.
 Indeed, the Hon. Supreme court upheld in paragraph 191 of the said judgement
clearly stated that section 3(d) is valid and it does not disallow any right to patent
on incremental innovation provided that the said incremental innovation fits into
test of patentability.

Ericsson vs. Xiaomi case

 In this law suit, Ericsson filed a suit against Xiaomi in India in December 2014 to
protect its patent right on the 8 standard-essential patents. An ex-parte injunction
on the sale, manufacture, advertisement and import of Xiaomi’s devices was
imposed by the Hon. Delhi High court.
 The Hon. Delhi high court injunction order was challenged by Xiaomi before a
Division Bench of the Delhi High Court. A temporary order was issued by
division bench to allow Xiaomi to resume the sale, import, manufacture, and
advertisement of its mobile devices subject to the condition that Xiaomi would
only sell devices having Qualcomm chips and royalty of Rs 100 per device would
be deposited by Xiaomi.
 In this case, patent right infringement is averted by issuing injunction order against
Xiomi to exploit patent rights of Ericcson and also remedies are provided to
balance the right of patent holder as well as the user of patent.
Merck vs. Glenmark case

In this case, the Hon. Delhi High court passed injunction against Glenmark for manufacturing
the generic drug Sitagliptin and using patented product of Merck Sharp. In this case, the Hon.
Delhi High court upheld that there was Prima facie infringement of patent rights of Merck
over its patented product sitagliptin and irreparable injury was also found to be caused to
patent holder. Hence, balance of convenience is in favour of patent holder ie. Merck. and
therefore the Hon. Delhi High court passed injunction order against Glenmark from
manufacturing and selling of Zita and Zitamet. There by, patent rights of Merck was
protected and enforced.

Novartis vs. Cipla case

In another patent suit, Novartis filed suit against Indian generic drug maker Cipla from
making or selling generic copy of Novartis’s “Onbrez”. In this case, temporary injunction
was issued by Hon. Delhi High court against Cipla to protect the patent right of Novartis. The
Hon. Delhi High court has cited Roche vs Cipla case, and observed that a strong prima facia
case was established and validity of the patent of Novartis was not strongly disputed by
Cipla. Further, Cipla’s counter arguments on the basis of “epidemic” or a “public health
crisis”, unable to manufacture the same in India by Patentee and high cost of patented drug
were not accepted by the Hon. Delhi High court. Therefore, claim of “urgent unmet need” for
the drug in India was rejected by Hon. Delhi High court. Hence, the court granted injunction
against Cipla to prevent patent infringement of Novartis.

This case is a classic illustration of patent jurisprudence in India to enforce the patent rights
in a fair manner and to prevent inappropriate application of exemption clauses under patent
act with a vested interest to infringe the patent rights of patentee. Further, the apprehension
about the possibility of discrimination between MNC and Indian company in Indian patent
regime was proved to be wrong.
SYMED Labs vs. Glenmark Pharmaceuticals case

In another case of SYMED Labs vs. Glenmark Pharmaceuticals, Glenmark Pharmaceuticals

Laboratories was allegedly infringing two of SYMED patents: IN213062 & 213063. SYMED
filed suit against Glenmerck in Delhi high court.

The court observed that there was a prima facie case in favour of SYMED. Further, the court
also observed that protection to the patent processes ought to be granted to the SYMED as
damages will not be an effective remedy. Thus, there will be irreparable loss and injury due
to the misuse of patents by Glenmerck. Further, the balance of convenience was also found to
be in favour of SYMED. Thus the court granted an ad interim injunction restraining
Glenmark from manufacturing, selling, offering for sale, advertising or directly or indirectly
dealing in the production of Linezolid. Thus, infringement of the SYMED’s registered
Patents was effectively remedied by the court.

Vringo vs. ZTE case

 In this case, Vringo and Vringo Infrastructure alleged that ZTE has infringed
patent rights of Vringo patent IN200572. A suit was filed by Vringo against ZTE
against infringement of patent in the Hon.
 Delhi High court in 2014. In this case an ad interim ex-parte injunction was
granted to restrain ZTE from importing, selling, and advertising, installing or
operating devices that comprise the infringing components of Vringo. However,
ZTE has contested innovativeness of Vringo patent and Hon. High court has
appointed commission to look into the technical aspects of patent.
 This case is illustration that the post grant patent objection is also being considered
by the Indian patent jurisprudence during the hearing of patent infringement cases.
Therefore, patentability and innovativeness of patent may also be tested after grant
of patent. This ensures that patent is not only under scrutiny during grant of patent,
but also during its enforcement.
Maj. (Retd.) Sukesh Behl & Anr. vs Koninklijke Phillips case

In this case counterclaim for revocation of the suit under Section 64(1)(m) of the Patents Act,
1970 (for short “the Patents Act”) for non-compliance of the provisions of Section 8 was
made by Sukesh Behl. In the original suit Koninklijke Phillips has sued for permanent
injunction restraining Sukesh Behl from infringing its patent and for other incidental reliefs.
However, the court examined counterclaim for revocation and observed that the failure to
comply with the requirement of Section 8 of the Patents Act would invariably lead to the
revocation of the suit patent under Section 64(1)(m) of the Patents Act. This is significant
judgement in a complex patent jurisprudence to revocation of the suit on patent infringement.

Patent Revocation in Roche case

 In this case, a patent granted to Roche for Valganciclovir was revoked by

controller of patents. The patent for Valganciclovir was granted to Roche in 2007
in India. The grant of the patent in India also looked as restrictions or a threat to
cheaper generic versions of the drug that cannot enter the market. The principle
ground for revocation of the patent was non patentability under section 3 (d) of the
Indian Patent Act, 1970.
 Further, the drug formulation was alleged to exist before grant of patent and
“efficacy” of patented drug over old drug was also questioned. The arguments
were made stating that the drug was having improved bioavailability where
whether the improvement of oral bioavailability constitutes enhancement of the
known efficacy of that substance was discussed.
 By considering the thorough arguments The Controller ruled that the present
patent was a ‘mere use of a known process’ which was not patentable under
Section 3(d), Patents Act as well as known by the prior arts. Therefore on
consideration of all the above arguments and evidences the patent granted to
Valganciclovir was revoked. Thus, this case illustrates the evolution of Indian
patent jurisprudence to revoke the patent claim during patent litigation.
Natco and Bristol Meyers Squibb case

 NATCO and BMS has made a settlement in the matter of drug named “Entecavir”.
The drug is used in the treatment of hepatitis B infections and the dispute of the
patent concerned the use of “Entecavir” oral composition once in a day. Prior to
1995, Indian Patent Act was not granting product patents and hence the drug did
not process an Indian patent. Hence, many pharmaceutical companies infringed
patent rights of patentee and launched their own generic product.
 Therefore, injunction was granted against Ranbaxy when they had launched the
generic version of the same drug. When, the issue was raised against NATCO
when they had launched their independent drug, X-Vir and challenged BMS in
IPAB and settlement was entered with BMS. Thus, the alternative ways to
protection of patent right through settlement among disputed patentee is an
innovation of Indian patent jurisprudence.

Delhi High Court Awards Damages Worth 10 Lakhs For Patent Infringement

The Hon'ble Delhi High Court in a recent judgement in the case of, Vior (International) Ltd.
& Anr. v. Maxycon Health Care Private Ltd., held that the acts of the Defendants for
unauthorized manufacturing and selling of patented product amounts to infringement of
Plaintiffs rights granted under Section 48 of the Patents Act, 1970. Further, the act of the
Defendants of blatantly copying the content of Plaintiffs website is in violation of the
copyright vested with the Plaintiffs and amount to infringement as per Section 51 read with
Section 14 of the Copyright Act, 1957.

The Case

Facts

Vior (International) Ltd. (hereinafter referred to as 'the Plaintiff No. 1'), a Switzerland based
company, are exclusive owners of registered Indian Patent no. 221536, a product by process
patent on Ferric Carboxymaltose, a novel water-soluble iron carbohydrate complex prepared
by a novel process. The patented product is useful in the intravenous treatment of iron
deficiency when oral iron preparations are ineffective or cannot be used. The Plaintiff 1 has
granted a licensee to Plaintiff 2, a company incorporated under the Companies Act, 1956, for
the manufacture and commercialization of above patented product, in India. Further, Plaintiff
2 is the owner of the copyright with respect to literary work on website the
www.emcure.co.in.

The Plaintiffs filed a suit for restraining the Defendants from infringement of Indian Patent
No.221536; infringement of copyright in the literary work; dilution & tarnishment of brand
image of the Plaintiffs; malicious falsehood; delivery up; rendition of accounts; damages etc.
against the Defendants.

Further, the Plaintiffs pleaded that the Defendants are manufacturing and selling the
impugned patented product and falsely represented on their website that the Plaintiff no.1 has
given an IP license to the Defendant no. 1 to manufacture and commercialize the impugned
patented product.

Still, further, the Plaintiffs pleaded that Defendant no. 1 has blatantly copied the literary
write-up/content of the Plaintiff No.2s website www.emcure.co.in, thereby amounting to
infringement of the copyright of Plaintiff No.2. Such activities of the Defendant no.1 also
amounts to dilution of the brand image of the Plaintiffs thereby resulting in unlawful
enrichment.

Furthermore, the Plaintiffs pleaded that the Defendant No.1, despite the operation of an ad-
interim injunction against it, continued its infringing activities through the Defendant No.3
and under the able guidance of the Defendant No.2.

As none appeared on behalf of the Defendants despite service of notices hence the
proceedings are treated ex-parte.

Issue:

1. Whether the acts of the Defendants for unauthorized manufacture and sale of patented
product amounts to infringement of Plaintiffs' patent rights?
2. Whether the act of the Defendant no. 1 for misrepresenting on the website as being an
IP license holder of impugned patent amounts to infringement of Plaintiffs' patent
rights?
3. Whether the act of the Defendant no. 1 for blatantly copying the content of the
Plaintiff no. 2 website, amounts to infringement of Plaintiff no. 2's copyright?
Plaintiff's Contentions

The Plaintiffs relying upon the evidence of sole witness, Shri Pankaj Pahuja (PW1) and the
documents Ex. PW1/1 to Ex.PW1/23, Ex PW1/B, Ex.PW1/A1 to Ex.PW1/A5 as well as
Mark E to Mark H, argued that the act of the Defendants are nothing short of oppressive,
arbitrary and unconstitutional.

The Plaintiffs' relying upon the decision by the Division Bench of Delhi High Court in
paragraph number 69 and 70 of Hindustan Unilever Limited v. Reckitt Benckiser India
Limited, 2014 (57) PTC 495 [Del] [DB] claimed for damages to the tune of INR 1,00,01,000
(USD 142861 approx.). The Plaintiffs have claimed the rendition of accounts of profit
illegally earned by Defendants or in the alternate damages to the extent of INR 1,00,01,000
(USD 142861 approx.).

Further, for claiming the punitive damages, the Plaintiffs relied upon the case of Jockey
International Inc & Anr. vs. R. Chandra Mohan & Ors. CS(OS) 253/2012, wherein it was
held that one who chooses to stay away from the proceedings of the Court, should not be
permitted to enjoy the benefits of evasion of Court proceedings. The damages in such case
must be awarded.

Analysis by the Court on unauthorized manufacture and sale of patented product under
misrepresentation as IP license holder

The Court while determining whether a patent has been infringed, took into consideration
Section 48 of the Patents Act, 1970, and held that the act of the Defendants to deal with the
impugned API clearly relates to the product Ferric Carboxymaltose as has been claimed by
the Plaintiff No.1 in its independent claim 1. Further, such a product cannot be clinically
effaceable without using the process as claimed. The Court agreed with the Plaintiffs that the
acts of the Defendants amount to infringement of the Plaintiffs' rights.

Analysis by the Court on blatant copying of literary work

The Court while examining the issue of copying of literary work, took into consideration
Section 51 read with Section 14 of the Copyright Act, 1957, and held that the act of the
Defendant No. 1 of blatantly copying the content of the Plaintiff No.2's website is in violation
of the copyright vested with the Plaintiff No.2 and amounts to infringement of copyright by
 the Defendant No.1. The Court relied on the case of R.G Anand vs M/S. Delux Films & Ors.
and held that the literary work of Defendant No.1 in its website is substantially similar to the
content of the Plaintiff No.2, thus, such an adoption is mala fide and is with a clear intention
on the part of the Defendant to save himself of the labour. Moreover, the acts of the
Defendant No.1 in publication of a statement indicating a false association with the Plaintiff
No.1 amounts to a tort of malicious falsehood.

The Court also relied on the decision of Rookes v. Barnard (1964) and awarded damages that
is not merely to compensate the Plaintiffs for the loss that has been sustained by reasons of
the Defendants' wrongful act, but also to punish the Defendants in an exemplary manner and
vindicate the distinction between a willful and innocent wrongdoer.

Decision of the Court

The Court held that the act of the Defendants amounts to infringement of patent and
copyright of the Plaintiffs. In view thereof, damages for a sum of INR 10,00,000 (USD 14284
approx.) in favour of the Plaintiffs and against the Defendants, is passed on account of
infringing the registered marks, trade dress and violating interim order.

Conclusions

Traditionally in India the number of trademark and copyright litigations outnumbered the
patent litigations. The reversal of situation was being speculated in India due to the
introduction of product patent protection for technologies like pharmaceuticals and chemicals
on January 1 2005. However even after the passage of ten months, this situation has not come
about. Once the mailbox applications are processed and patents are granted, there would be a
deluge of litigations between pioneer and generic industry.

Patenting of microorganisms
Abstract

The Government of India permitted patenting of microorganisms in India under the Patents
(Second Amendment) Bill, 2002, which was passed by the Parliament on 14 May 2002.
The Government has so far granted very few patents for microorganisms, mainly on
directives from courts. With the law permitting patenting of microorganisms, several
private sector pharmaceutical companies and research institutions have filed applications
for patenting microorganisms including fungi, bacteria and viruses. But there is still much
debate on the advisability of allowing patenting of microorganisms in India. While the
existing provisions in the patents bill permit patenting of certain life forms in line with the
Trade-related Intellectual Property Rights Agreement, there is still sufficient controversy
regarding the term ‘microorganism’, which has not been clearly defined. This article
discusses the evolution of the patenting systems in relation to microorganisms. The article
also explores the feasibility of offering statutory protection to microorganisms that are
genetically altered with significant human intervention on harmonized global patent
systems and also elaborating on the need for a well-accepted definition of the term
‘microorganism’

INTRODUCTION
A patent is an intellectual property right relating to inventions and is the grant of
exclusive rights, for limited period, provided by the Government to the patentee, in
exchange of full disclosure of his invention, for excluding others, from making,
using, selling, importing the patented product or process producing that product for
those purpose. 1

A patent is a bunch of exclusive rights granted by the state to an inventor or his assignee on
satisfying certain conditions. The inventor is given a monopoly right over the product for a
fixed number of years in exchange for the public disclosure of certain details of a machine,
method or the composition of matter. The objective of patent law is to encourage inventions
by promoting their protection and utilization for the development of industries, promotion of
technological innovation, and transfer and dissemination of technology. It stimulates new
inventions of commercial utility. The patent is granted for a limited period to the inventor and
after the period of expiry of the patent, the monopoly goes into public domain. Patent right is
territorial in nature and patent obtained in one country cannot be enforced in other country.

The premise of intellectual property (IP) law is that by recognizing and rewarding the
innovator, it fosters industrial and technical progress paving way for a vibrant socio-
economic structure. Since invention is the life breath of growth and development, it is
pertinent that the same must be protected against unnecessary encroachment. This has
become more evident in context of huge strides being made in the field of biotechnology and
information technology. With advancements in biotechnological research and pharmaceutical
industry, pressure started mounting on policymakers to allow patenting of basic life forms so
as to encourage research and development initiatives, which can contribute to exploring the
unrecognized commercial utility of such life forms. New techniques have been developed to
create novel life forms like genetically modified plants and animal species, genes, cell lines
and so on, which can be patented as ‘bio-patents’. 2 But, the laws regulating and protecting
these experiments and their subsequent innovations continue, however, to sputter at an
inchoate stage. One reason for the situation can be the different economical and ethical
standings of the nations, which are being brought under the umbrella provisions of the World
Trade Organization (WTO).

However, the debate revolves around the limits of such protection. One strand of this mystery
is the patentability of microorganisms, which requires a critical analysis of the present
position of law and a further rumination with regard to its future prospects. Section 27 of
TRIPS recognizes microorganisms as a patentable subject matter and therefore many nations
have now started patenting of microorganism through their domestic patent laws.

BASIC PATENTABILITY CRITERIA

A patent is an exclusive privilege in the form of a monopoly right, granted by the State to the
inventor or an assignee for a certain period of time in return of the full disclosure of the
invention. A patent is thus a right to exclude others from making, using, selling, offering for
sale or importing the patented invention for the term of the patent, which is usually 20 years
from the filing date. As it is a monopoly right, the grant of a patent must fulfill the essential
criteria of novelty, non-obviousness and usefulness.

The threefold requirements of patentability are set out in the European Patent Convention
(EPC) in Article 52: 3

That the invention must be new; that it must involve an inventive step; and that it must be
capable of industrial application. The same three requirements are met with in one form or
another in the USA, Japan, and indeed in practically all the countries that have a patent
system.

The Trade-related Aspects of Intellectual Property Rights (TRIPS) agreement aims at

reducing the distortions and impediments in the international trade by an efficacious
protection of IP rights. It specifies certain minimum standards to be followed by the member
countries. Article 27 of the TRIPS stipulates that patents shall be available for any invention,
whether products or processes, in all fields of technology, provided that they are new, involve
an inventive step and are capable of industrial application. TRIPS do not define the terms
‘new’, ‘inventive step’ or ‘capable of industrial application’. In patent terms, ‘novel’ means
not previously ‘made available to the public’. 4

Members can exclude from patentability, commercial exploitation that is necessary to protect
human, animal or plant life, or health or to avoid serious prejudice to the environment.
Patents shall be available and patent rights can be made enjoyable without discrimination as
to the place of invention, the field of technology and whether products are imported or locally
produced. Therefore, this provision is resonant of the triple criteria of novelty, non-
obviousness and usefulness. However, the essence lies in non-discrimination, as patents shall
be available for any invention, unrestrained by the field of technology.

Focusing on the general patentability criteria in the United States, the provision of the US
Patent Act determines as to what is patentable subject matter. ‘Whoever invents or discovers
any new and useful process, machine, manufacture or composition of matter, or any new and
useful improvement’ may obtain a patent. 5 By perforating through the various International
Treaties and legal provisions in major jurisdictions, it becomes amply clear that the triple test
for patentability is the basic and immutable standard.

PATENTABILITY OF MICROORGANISMS

Bacteria, fungi and viruses constitute the major group of microorganisms that have been
exploited extensively by biotechnologists. The genetic material of these microorganisms
serving as raw materials are tailored by the biotechnologists with the scissors of restriction
endonucleases, stitched with ligases and converted into desirable form using sophisticated
techniques of genetic engineering. The field of application of genetic engineering is broad
and covers vast areas, for example, the use of fungi in bakery, wine and antibiotic industry,
bacteria for the manufacture of vaccines, modification of plants/insects genome (transgenic
plants) and the like. For over 200 years living organisms have been excluded from patent
laws; life forms were considered a ‘product of nature’ and not a human invention.
Before 1980, Patents were given for inventions based on microbiological processes. No
patent was given for the living entities per se, which were considered to be the products of
nature. Although patent laws were originally framed for mechanical and chemical inventions
the patenting of life forms was also included. 6 First patent based on microorganisms was
made by Louis Pasteur on 28 January 1873, for the process of fermenting beer. 7 The claim
made by him was: … invention produces a better quality and greater quantity of beer from
the same quantity and quality of wort (the boiled extract of malt or other material) … the
yeast or pure ferment is added to provoke or induce fermentation.

In countries across the world the so-called products of nature doctrine excluded living matter
from patentability. The products of nature doctrine prohibited patentability of materials
existing in nature, including living matter. Under this doctrine, one could secure patents for
fermentation processes and purification of naturally occurring chemical or biological
compounds as well as patents for microorganisms as a culture or in combination with a
carrier. The product claims for the microorganisms, however, were not patentable because
they comprised of living materials – microorganisms. The non-patentable status of living
organisms changed with the landmark decision of the Supreme Court, USA, in Diamond v.
Chakraborty in 1980, when the genetically modified bacterium was granted a patent.

BUDAPEST TREATY: DEPOSITION OF MICROORGANISMS

The Budapest Treaty on the International Recognition of the Deposit of Microorganisms for
the Purposes of Patent Procedure, or Budapest Treaty, is an international treaty signed in
Budapest, Hungary, on 28 April 1977. It was enforced on 9 August 1980, and was later
amended on 26 September 1980. The treaty is administered by the World Intellectual
Property Organization. 8 As of December 2008, 72 countries were party to the Budapest
Treaty. The accession to the Treaty is open to States party to the Paris Convention for the
Protection of Industrial Property of 1883. The African Regional Industrial Property
Organization, 9 the Eurasian Patent Organization (EAPO) 10 and the European Patent
Organization (EPO) have filed a declaration of acceptance under Article 9(1)(a) of the
Treaty. 11

The treaty allows ‘deposits of microorganisms at an international depositary authority to be

recognized for the purposes of patent procedure’. 12 Usually, in order to meet the legal
requirement of sufficiency of disclosure, patent applications and patents must disclose in their
description the subject-matter of the invention in a manner sufficiently clear and complete to
be carried out by the person skilled in the art. Regarding any invention involving a
microorganism, it is impossible to describe it completely. This is why, in the particular case
of inventions involving microorganisms, a deposit of biological material must be made in a
recognized institution. The Budapest Treaty ensures that an applicant, that is a person who
applies for a patent, need not deposit the biological material in all countries where he/she
wants to obtain a patent. The applicant needs to only deposit the biological material at one
recognized institution and this deposit will be recognized in all countries party to the
Budapest Treaty.

INTERNATIONAL DEPOSITARY AUTHORITY (IDA)

The deposition of patents of microorganisms in a culture collection recognized as an IDA

might be necessary in the realm of IP rights. It is likely that IDAs will transform into
‘biological resource centers’ and further into ‘global common genetic resources’, with an
internationally agreed legal basis for benefit sharing. 13 The deposits are made at an IDA in
accordance with the rules of the Treaty on or before the filing date of the complete patent
application. Article 7 of the Budapest Treaty outlines the requirements for a facility to
become an IDA. 12 As of 1 March 2008, there were 37 IDAs in approximately 20 countries
worldwide.

DEPOSITABLE MATTER TO THE IDA

IDAs have accepted deposits for biological materials, which do not fall within a literal
interpretation of ‘microorganism’. The Treaty does not define what is meant
by microorganism. It is not necessary for the entity being deposited to be a microorganism –
it should only be required for the purposes of disclosure and must be acceptable to the IDA.

The range of materials able to be deposited under the Budapest Treaty includes: cells, for
example, bacteria, fungi, eucaryotic cell lines, spores; genetic vectors (such as plasmids or
bacteriophage vectors or viruses) containing a gene or DNA fragments; 14 organisms used for
expression of a gene (making the protein from the DNA).
TRIPS AGREEMENT: PATENTING MICROORGANISMS

The agreement on TRIPS is an international agreement administered by the WTO, 15 which

sets down minimum standards for many forms of IP regulation as applied to other WTO
members. It was negotiated at the end of the Uruguay Round of the General Agreement on
Tariffs and Trade 16 in 1994. Apart from setting the basic minimum standard for patentability,
TRIPS obliges member states to patent microorganisms. 17 Therefore, an understanding as to
what constitutes a microorganism is essential. However, the term lacks a precise scientific
definition because of which there are inherent anomalies in patenting these life forms.
Although the TRIPS agreement is mandatory for patent production of microorganisms, yet it
does not define microorganisms; thus there is no yardstick definition for member nations to
follow in this regard. There is no clarity whether the term would include only genetically
modified organisms or naturally occurring substances also.

However, the term microorganism will be understood in its widest sense to include any
biological material that is self-replicable or replicable via a host organism. Sub-cellular
material like genes, gene sequences, plasmids, replicons and so on will come under the
definition of a microorganism. Some of the patentable micro-biological inventions according
to the TRIPS agreement are: (i) process of producing a new microorganism; (ii) new
microorganism as produced by the defined process; (iii) new microorganism per se; and (iv)
process of cultivation or otherwise using a known or new microorganism to: (a) a form of
multiplied microorganism itself, for example vaccine or edible biomass, and (b) a by-product
of microbial growth, for example an antibiotic, enzyme, toxin or an otherwise useful
industrial product. However, it becomes obligatory to provide patents for ‘microorganism’
and ‘micro-biological’ processes. Neither microorganism is defined in the TRIPS agreement
nor does the agreement specify any parameters concerning the scope of its protection. 18

MICROORGANISMS: MEANING AND DEFINITION

A general definition of a microorganism is an organism that is microscopic (too small to be

seen by the naked human eye) and which can be seen only under a microscope, usually, an
ordinary light microscope. Microorganisms are incredibly diverse and include bacteria, fungi,
archaea and protists as well as some microscopic plants such as planktons and organisms
such as amoeba. Thus, it may consist of a single cell or a cell cluster.
 The European Commission (EC)19, 20 directives on microorganisms define it as any
microbiological entity, cellular or non-cellular, capable of replication or transferring genetic
material. EC directives have also defined biological material as any material containing
genetic information and capable of reproducing itself or being reproduced in a biological
system. Various definitions of microorganisms could be quoted as follows:

 Any of various microscopic organisms, including algae, bacteria, fungi, protozoa and viruses
(The Concise Oxford Dictionary).
 Any organism, such as a virus, of microscopic size (Collins English Dictionary).
 Microorganisms are microscopic life forms including microscopic fungi, protista, prokaryotes
and viruses. 21
 A microscopic organism consisting of a single cell or cell cluster, including the viruses. 22

Hence a quotation from an English dictionary would not be sufficient to provide a definition
of the term ‘microorganism’. A more precise and scientific definition is required for the
purposes of providing a clear definition of the scope of exceptions to patentability set out in
Article 27.3(b) of TRIPS agreement. Hence TRIPS agreement produces an ambiguity in
defining microorganisms. The more authentic decisions regarding the patentability of
microorganisms were made by the US Supreme Court in 1980 (Diamond v. Chakrabarty
case), when the genetically modified bacterium was granted a patent. 31

CRITERIA OF NOVELTY FOR PATENTING MICROORGANISMS

A microorganism exists as a part of the Nature; hence its discovery is NOT an invention. If it
is an invention, logic of treating scientific theories and principles as non-patentable
inventions gets defeated. If microorganisms isolated from the nature for the first time are
considered patentable, then minerals and ores discovered from the interior of earth and deep
seabed would qualify for patenting. Thus, microorganisms can be considered as an invention
only if the microorganism has not been described in the literature and there is an element of
human intervention with the discovery. 23

The general notion is that the patent system encourages the creation of new, previously
unforeseen inventions. Therefore, even though Chakrabarty simply shuffled genes, changing
bacteria that already existed, the widest interpretation by the court lent the broadest amplitude
to patentability to the living subject matter. Thus, the US position could be summarized as:
once the basic patentability criteria are met, as for any other technological invention, living
matter can be patented. The relation between invention and products of nature does not
correspond to the relation between living and non-living things, but between products of
nature and man-made inventions. 24 There is a wide spread controversy regarding the
consideration of microorganisms as ‘invention’ or ‘discovery’. 25

Extensively interpreted, therefore, the invention concept would also encompass the kinds of
subject matter that require human intervention in order to make them available in a useful
form by way of isolating or purifying naturally occurring products. The TRIPS agreement
nowhere defines the term microorganism, and the lack of a commonly accepted scientific
definition poses the risk of inherently chaotic interpretations by different jurisdictions. As far
as the question of compliance with TRIPS is concerned, most patent laws do not deal
specifically with the question of whether or not a new living strain of microorganism is itself
patentable, but the EPC 26 does not exclude the possibility. 27 The EPO does grant patents for
microorganisms, as the patentability is not explicitly excluded. The present position is thus:
microorganisms are patentable not only in the United States, but also Europe, Japan and all
major jurisdictions under the TRIPS obligation.

DIAMOND v. CHAKRABARTY: OPENING A NEW AVENUE FOR PATENTING

SYSTEMS

The patenting of inventions per se seems to be interwoven with the doctrine of product of
nature. This doctrine specifies that potentially patentable subject matter must be created
through human intervention. Patents are not available for the handiwork of nature. Thus a
newly discovered mineral or plant found in the wild is not patentable subject matter under 35
U.S.C S.101.28, 29, 30 In contrast, the so-called purified forms of natural products may be
patentable if they are sufficiently different from the non-purified (natural) forms so as to be
novel and non-obvious. The non-patentable status of living organisms changed with the
landmark decision of the Supreme Court, USA, in Diamond v. Chakrabarty in 1980, when the
genetically modified bacterium was granted a patent. 31 In 1972, Ananda Mohan Chakrabarty,
a genetic engineer and a researcher of the General Electric Company, filed a patent
application in relation to a bacterium that was intended to consume petroleum (oil) spills
(superbug). Chakrabarty claimed that: A bacterium from the genus Pseudomonas containing
therein at least two stable energy-generating plasmids, each of said plasmids providing a
separate hydrocarbon degradative pathway: Salicylate – an aromatic hydrocarbon, and,
Naphthalene – a polynuclear aromatic hydrocarbon, was a human-made, genetically
 engineered bacterium capable of breaking down multiple components of crude oil. It was
asserted that because of this property, which is not possessed by any naturally occurring
bacteria, the invention could treat oil spills. The versatility of these ‘novel’ microorganisms
was demonstrated by the substantial extent to which degradation of complex hydrocarbons –
such as crude oil – was achieved. Hence Chakrabarty requested a patent for the bacterium in
the United States but was turned down by a patent examiner, because the law dictated that
living things were not patentable.

The Board of Patent Appeals and Interferences agreed with the original decision; however,
the United States Court of Customs and Patent Appeals overturned the case in Chakrabarty's
favor, writing that ‘the fact that microorganisms are alive is without legal significance for
purposes of the patent law’. Sidney A. Diamond, Commissioner of Patents and Trademarks,
appealed to the Supreme Court. In the Supreme Court the case was argued on 17 March 1980
and decided on 16 June 1980. 32

CHAKRABARTY’S PATENT CLAIMS

The patent claims made by Chakrabarthy were of three types:

 First, process claims for the method of producing the bacteria.

 Second, claims for an inoculum comprised of a carrier material floating on water, such as
straw, and the new bacteria.
 Third, claims to the bacteria themselves.
The patent examiner allowed the claims falling into the first two categories, but rejected
claims for the bacteria. The decision rested on two grounds:

1. 1
that microorganisms are products of nature, and

2. 2
that as living things they are not patentable subject matter under 35 U. S. C. 101. 33

The Patent Office Board of Appeals reiterated the examiners decision on the ground that
microorganisms do not fall within the ambit of 35 U. S. C. 101, as they are living things.
DECISION AND RULING

In a 5–4 ruling, the court ruled in favor of Chakrabarty, and upheld the patent, holding that: A
live, human-made microorganism is patentable subject matter under [Title 35 U.S.C.] 101.
Respondent's microorganism constitutes a ‘manufacture’ or ‘composition of matter’ within
that statute.

Chief Justice Warren E. Burger wrote the decision, and was joined by Potter Stewart, Harry
Blackmun, William Rehnquist and John Paul Stevens. Burger wrote the interpretation of 35
U.S.C. 101, which says:

Whoever invents or discovers any new and useful process, machine, manufacture, or
composition of matter, or any new and useful improvement thereof, may obtain a
patent therefore, subject to the conditions and requirements of this title.
SUPERBUG: DISCOVERY OR INVENTION

The Court of Customs and Patent Appeals emphasized that the issue was not whether the
claimed bacterium was living or inanimate, but whether it constituted an invention made by
human intervention. In the court's view, the fact that Chakrabarty's bacterium was alive was
without legal significance. On the question as to in which category would the invention fall,
the Supreme Court held that the genetically engineered petroleum-consuming bacterium
could be categorized either as a composition of matter or a manufacture. The court read the
term manufacture in S.101 in accordance with its dictionary definition to mean the production
of articles for use from raw or prepared materials by giving to these materials new forms,
qualities, properties or combinations, whether by hand labor or by machinery. In a landmark
decision, the US Supreme Court reaffirmed that the bacterium was not a handiwork of nature;
rather it was Chakrabarty's own invention, hence satisfies the criteria for being patented.

PATENTING MICROORGANISMS: POSITION IN INDIA

Patent Act of India, 1970, Section 2(1)(j) 34 defines an invention as a new and useful manner
of manufacture or a substance produced by manufacture. No definitions of manner of
manufacture or substances were given in the Act. Hence the Patent Office adopted the
practice of interpreting a manner of manufacture as a patentable subject matter only if it
results in a tangible nonliving substance.
The Section 3(j) of the Act stated that plants and animals in whole, or in part thereof
including seeds, varieties and essentially biological process for the production of plants and
animals, are excluded. India joined the Budapest Treaty on 17 December 2001, and Microbial
Type Culture Collection (MTCC) and Gene Bank of the Institute of Microbial Technology,
Chandigarh (IMTECH) acquired the status of an IDA on 4 October 2002 marking the
amendment of existing systems in India. The position was made more clear after the 2002
amendment of the Indian Patents Act, 1970 whereby microorganisms can be patented
provided they satisfy the other requirements. 35

THE PATENT AMENDMENT ACTS

The Patent Amendment Act 2002 came into force in May 2003, bringing microorganisms
within the realm of patentability. Section 3(j) was couched in terms of Article 27(3) (b). It
states that: plants and animals in whole or any part thereof other than microorganisms but
including seeds, varieties and species and essentially biological processes for production or
propagation of plants and animals are not inventions within the meaning of this Act. It
excluded microorganisms from the exceptions to patent protection and allowed patenting
of processespertaining to microorganisms as well as non-biological and microbiological
processes.

Subsequently, The Patents Act, 1970 was once again amended in the year 2005, so as to
establish congruence with TRIPS. The amendment deleted Section 5 of the Act, which
provided for only process patents. The provision included inventions where only methods or
processes of manufacture were patentable. Therefore, the deletion of this section paves way
for product patents, which is in stark opposition to US approach that argues patenting of life
forms has tremendous advantages. 36

Despite concerns against the patenting of microorganisms, this position may augur well for
the biotechnology industry as it is growing at an inexorable pace.

DIMMINACO A G v. CONTROLLER OF PATENTS AND DESIGNS

Patentability of biotechnological process with living end product was ascertained by Calcutta
High Court decision in the case of Dimminaco A G v. Controller of Patents (2002). 37 The
facts of this case are that – Dimminaco A.G., a Swiss Company applied for patenting the
process for preparation of a live vaccine for Bursitis. Bursitis is an infectious poultry disease
and the invention involved a live (attenuated) vaccine to combat the disease.

The Controller of Patents refused to allow application on the ground that as the vaccine
involved processing of certain micro-organic substances, this was only a natural process
devoid of any manufacturing activities and hence not patentable under S.2(1)(j). This was in
consonance with the prevailing practice that granted patents only to non-living and tangible
inventions that fulfilled the patentability criteria, even though the Patent Act imposed no such
limitation.

However, on appeal, the Calcutta High Court diverted from the above position. It rejected the
contention of the controller that a patent is given only for a process that results either in an
article, substance or manufacture and that a vaccine with a living organism is not an article,
substance or manufacture. 38 The Controller had claimed that the dictionary meaning of
article is a ‘material thing, item, a thing of a particular class or kind as distinguished from a
thing of any class of kind’. The Controller said the definition does not cover living
things. Law does not bar processes where the end-product is living – No statutory bar in the
Act to accept a manner of manufacture as patentable even if the end product contains a living
organism.

Through creative judicial exposition, the Calcutta High Court held that: ‘The Indian statute
on patents does not put any fetters on patentability of microorganisms developed in a
controlled environment in the laboratories’.

Taking recourse to the normal dictionary meaning of manufacture, the court observed that
manufacture is where ‘the material in question after going through the process of
manufacture has undergone any change by the inventive process and it becomes a material
which is different from the starting material’. 39 The court held that this meaning of
manufacture does not exclude the process of preparing a product that contains a living
substance from patentability.

Court also held that the process for creating a vaccine leads to a vendible product even if the
end product contains living material. 40 The court said that if the invention results in the
production of some vendible items or improves or restores formal conditions of vendible item
or its effect in preservations and prevention from deterioration of some vendible product, then
such an invention would pass the vendibility test. Therefore, as the claim process for patent
leads to a vendible product, it is certainly a substance after going through the process of
manufacture. The court concluded that a new and useful art or process is an invention and
where the end product is a new article, the process leading to its manufacture is an invention.

This decision on the Calcutta High Court was synchronous with the position in the United
States, most of the European countries as well as Japan, as most processes in the
biotechnology field will be patentable: irrespective of whether resultant product is living or
non-living. After the Dimminaco decision, the Indian law kept pace with the needs of thriving
biotechnology industry.

CONCLUSION

Patenting of life forms may have many dimensions that relate to the use of intellectual
property rights concept in the industrialized world and its appropriateness in the aspect of
rights on knowledge, their ownership, use, transfer and dissemination. In the global scenario,
the TRIPS agreement makes it mandatory to provide patent protection to microorganisms and
non-biological and microbiological production of plants and animals. This makes it difficult
for the developing countries to exclude inventions within this category altogether. Hence, the
strategy should be how to limit the scope of these provisions. As far as the patent protection
of microorganism is concerned, TRIPS does not provide a definition of microorganism. The
national rule-makers must define microorganism in such a way as to include the following:
bacteria, virus, and fungus and algae.

Another important limitation in the scope of patent protection to biological materials is the
lack of defining the concept of invention and discovery. Microorganisms as such occur in
nature and their discovery cannot be called invention. Microorganism when genetically
modified falls in the category of invention because of human input. Genetically modified
microorganism may perform any number of activities, hence patenting of this genetically
modified microorganism will result in blocking of further research on that microorganism.

The numerous concerns raised against patentability of microorganisms can be addressed by

defining the term microorganism in a precise and scientific manner; substantiating the
differences between discovery and invention; by granting patents to only those inventions,
which involve substantial human intervention (for example, genetic engineering).
From Diamond v. Chakrabarty to TRIPS and beyond, manifests huge interest of biotech
industry for constant innovation and endeavor, paving way for increased inventions that aim
at human welfare. The criterion of utility is deeply embedded behind the rationale of
patenting microorganisms, whether it is the usefulness of those microorganisms in treating oil
spills, preventing an infectious disease or the creation of new drugs to combat life-threatening
diseases. Without an efficacious patent protection, the vast reservoir of such information may
remain a trade secret, without being brought into public domain. This proves the need for a
sheltered and substantial patent system for the protection of the research concerning
microorganisms.

Indian report on patenting microorganisms

GRAIN | 15 November 2000 | BIO-IPR (1997-2009)

TITLE: Patenting of Microorganisms AUTHOR: Patent Facilitating Centre, New Delhi

DATE: circa June 2000 URL:
http://www.indianpatents.org/ach/micro.htm

PATENTING OF MICROORGANISMS

For the first time in India perhaps in any developing country, a comprehensive report on
Patenting of Microorganisms has been prepared by the Patent Facilitating Centre. Ever since
the US Supreme Court allowed the patenting of microorganisms in 1980, this subject has
been drawing a great deal of attention all over the world. As microorganisms are important
constituents of biodiversity, issues like the origin of a microorganism and its patentability and
ownership have gained importance.

Main Features of the Report

The report has certain features which make it unique. It has analysed patent laws of
developed and developing countries in relation to microorganisms, patent granted for
microbiological processes and microorganisms per se, and also the policy implications, and
put forward an action plan. The most interesting part of the report is the responses received
from many developing and developed countries in regard to interpretation of the term
microorganism. Case studies of patents issued by the USPTO and European Patent Office
(EPO) have been presented in the report with specific information about what really have
been the subjects of these patents. The report provides an insight into the depositary
mechanism followed at one of the International Depository Authorities and the examinations
standards followed while determining the patentability of microorganism related inventions.

The report is of use to industries, R&D institutes, scientists, technologists, consultants,

research scholars dealing with drugs and pharmaceuticals, chemicals, life sciences, food
processing and genetic engineering. It is also of benefit to lawyers, patent attorneys and
policy makers. The report is now available for Rs.500/- .

Major Findings

The study mainly focuses on the patentability criteria of microorganisms per se based on laws
and practices of 30 countries, both developed and developing. In order to have a feel about
the claims awarded by different patent offices, about 10,000 patent titles were scanned . The
report traces the history of patenting in this area, discusses the deposition mechanism and
examination standards followed by some countries covering different aspects of patenting of
microorganism (per se) are also included.

1. It would appear that India is not obliged to introduce laws for patenting microorganisms
per se before 31.12.2004. This is derived from the fact that per se patent is equivalent to a
product patent. Therefore, the transition period available to us should be fully utilised for
understanding the intricacies of patenting in this area and also making allied preparations for
launching a product patent regime by 31.12. 2004. However, process patents for
microbiological inventions will be required to be given for a period of 20 years from the date
of filing after 31.12.1999. Presently this period is either 5 years from the date of grant or 7
years from the date of filing. Some preparations are also essential for awarding process
patents e.g., the patent examiners have to be trained in examining such applications which
entail modern and complex scientific concepts and methodologies.

2. Patenting of microorganisms and their related processes and products involves some
unresolved questions and seems to be in a state of flux. Considering that the patenting of
microorganism per se started in 1981, it is natural that the laws and practices in this regard
will need some time to stabilise. This situation is further complicated by the rapid scientific
and technological developments in biotechnology. The technical complexity involved in the
patenting of microorganisms needs to be understood by Indian professionals. They need to sit
down and study different patent documents and claims to determine whether such claims /
some new claims should be allowed or not keeping the status of Indian R&D and trade in
mind. This report may be used as a first step in that direction.

3. The question whether the term microorganism should be defined in a generic manner or
not will need to be decided carefully. Considering our near zero experience in this area, it
would be better to keep away from finding a generic definition. Instead, it would be advisable
to spell out the scope of this term. This will be in line with the practices followed by many
countries. It would, however, be prudent to review the situation after 5 to 10 years to re-
establish the usefulness of this approach.

4. There is one clear and important distinction between the legal practices of the developing
and developed countries. The former, unlike the latter, do not allow patenting of
microorganisms already existing in nature; some do not even consider such a `discovery' an
invention. However, as WTO members many countries have now allowed patenting of
genetically modified organisms. It may be noted , at this point, that the R&D and industrial
base in this area in the developing countries would be very small and in some cases non-
existent. Therefore, their legal practices are based more on the experience of other countries
and these may be considered for developing broad principles.

5. The other important thing to be noted from the laws of many countries is the detailing of
requirements for the deposition and the rules for accessing microorganisms from depositories.
In this respect laws of Finland may be read which are quite explicit and easy to understand.
As strict biosafety norms have to be followed while handling microorganisms, the laws for
accessing strains from a depository have to be carefully worked out to ensure that these do
not land into wrong and/ or technically incompetent hands. Our patent laws for protecting
microorganisms will have to spell out requirements for deposition and rules for accessing
strains from a depository. It would be essential to build an internationally recognised
depository in the country before introducing patenting of microorganisms per se if not before
that. Obviously, to have an internationally recognised depository for facilitating patenting of
microorganisms and microbiological inventions, India will have to become a member of the
Budapest Treaty. As some time will be required to set up a depository of that class and
substantial funds may also be required, it would be desirable to become a member of the
Budapest Treaty at an early date and utilise the transition time up to 31.12.2004 for building a
world class depository in India and having it accredited by under the said Treaty. A thought
may also be given to the building of more than one depository.
6. The moment process patents are started in India for microbiological inventions, the Indian
Patent Office will have to find a way out to accept the accession numbers of microorganisms
allotted by foreign depositories. This may not be possible until we become a member of the
Budapest Treaty. Otherwise, we may have to insist that samples are also deposited in one of
our recognised laboratories such as IMTEC in Chandigarh. This may require some
understanding with some foreign depositories.

7. It is known that deposition of samples in a foreign depository will be very expensive, Any
sample going from India, for example, to the ATCC, USA would be subject to some
additional screening and in vivo/ in vitro tests for biosafety which may be time consuming
and costly. Each sample may cost about Rs 2 lakhs. The depository may decide not to store
the sample even after such testing. Once we have our own depository, we save such costs and
time. The most important outcome will be that our researchers would start depositing samples
of microorganisms isolated or developed in the local depository.

8. It may be made mandatory that microorganisms isolated in India and their modified forms
under any type of R&D programme, including collaborative programmes being carried out in
India partially or fully, with outside agencies, should be deposited in the Indian depository.
This step needs to be further supplemented by a tracking exercise on a continuous basis to
find out if microorganisms from India have been deposited in foreign depositories.

9. It has been shown in the report that samples of microorganisms isolated from India are
being deposited in the ATCC. One could easily guess that such depositions are also being
made in depositories situated in other countries. The information so collected may be linked
with R&D or other activities under which such microorganisms would have been isolated.
This would be best done by making references to different government agencies involved in
funding, coordinating and clearing such programmes.

10. Patenting of GMOs per se will also entail some additional questions. Would the gene
responsible for designing the GMO be patentable? If an already known and isolated gene is
used, who then, will be the owner of the GMO? Should a GMO satisfy biosafety conditions
before it is granted a patent? It is felt that, once a GMO is patented, there will be a tendency
to establish biosafety with short term trials which may not be really adequate. Therefore, in
such cases where there is no evidence of meeting of the biosafety requirements in a patent
document, a statement may appear in the document stating that the GMO has not undergone
detailed biosafety trials. Further, it may be remembered that inventions , which are likely to
be injurious to public health do not qualify for patents. As the behaviour of GMOs, when put
into real use, may not be completely known before hand, thought needs to be given as to
whether patents should be granted at all with out the GMO meeting the safety requirements.
The other question is whether all systems for determining biosafety of a GMO should be in
place in India before allowing patenting of GMO. These questions will also be applicable
while allowing process patent in respect of microbiological inventions involving GMOs.

11. With the introduction of sui generis system for the protection of new plant variety, new
seeds including seeds produced through the transgenic route will be protected. In spite of the
fact that microorganisms and genes do not have any protection through patents in India, these
will get a indirect protection through the protection of new seeds and plant variety in India. In
the proposed plant variety Act, a stipulation may be considered so that the genes used in such
protected variety may not get any protection.

12. How the criteria of novelty and inventive step will be applied in respect of
microbiological inventions, especially for patenting of microorganism per se, is an important
issue. There is one fundamental question to be resolved and that is, whether discovery of a
microorganism from the nature for the first time can be considered to embody novelty and
inventive step. To avoid this basic issue, some countries have put a condition that the
microorganism should not have been described in the literature. Some countries have
associated the element of human intervention with the discovery for it to be patentable. As a
microorganism exists in nature as a part of the nature, its discovery cannot be considered an
invention. The moment it is treated as an invention, the logic of treating scientific theories
and principles as non- patentable inventions gets defeated. This may lead to a shift in the
basic thinking that scientific principles are meant for the larger good of the humanity and
therefore these are kept outside the patent regime.

13. If microorganisms isolated from the nature for the first time are considered patentable,
then minerals and ores discovered from the interior of earth and deep sea bed would qualify
for patenting. The isolation of ores and minerals from deep sea bed and greater depths of
earth , than the presently achieved, will call for a much higher class of technology and large
financial resources. Obviously, the countries having such resources will have a very distinct
advantage and smaller countries may have the risk of losing their own resources if the ores
and minerals are allowed to be patented. Thus, the issue needs to be discussed in detail.
14. Following microorganisms and biological materials are considered patentable in many
countries: bacteria, virus, filamental fungi, protozoa, unicellular algae, plant and animal virus,
plant and animal cells ( cell lines, tissue culture ), fused cells, mushrooms, DNA ( eukaryotic
and prokaryotic origin ), transformants and pure culture. Types of patents and claims being
awarded in these countries have been detailed in the report. The information may be used by
the practitioners of this technology and its patenting including scientists, technologists, legal
professionals, science managers and policy makers to decide how many of these
microorganisms and biological materials may be considered for patenting in India.

15. A discussion in international fora on shifting from the term ' microorganisms' to
'biological materials' may come up soon. It would be desirable to stick to the term
'microorganism' as TRIPS uses this term and we still do not have enough experience in this
area to figure out relative advantages of shifting from one term to the other.

16. Patents granted abroad on microorganisms (per se patents) do not have an influence on
the domestic scenario in India, because product patents are not granted in India at present.
Many product patents will be granted in India and other countries after the introduction of
product patent regime in India and this would lead to a highly competitive situation in India.
However, process patents may have significant effects from the commercial angle as these
can be patented in India at present. It may be borne in mind that patent documents are a
source of tremendous knowledge and these should be used for deciding our R&D goals and
corporate objectives.

17. Patent examiners, patent attorneys, scientists and technologists working in the area of
biotechnology are not really familiar with the patenting of microorganisms and
microbiological inventions. On one hand there is a need to create awareness among scientists,
on the other hand there is an urgent need for training patent examiners and attorneys to
handle applications in the area.

Patentability of Microorganisms

Category: WTO Sub-category: Intellectual Property

Document type: article

- Shradha Diwan, Research Analyst

5 Feb, 2008

Are life forms patentable? Can microorganisms, for instance, be patented? Prior to 1980 the
answer to this question was: NO. Microorganisms were clearly "products of nature" and as
such were not considered patentable. However, the era of maneuvering DNA between
organisms changed that.

In 1980, the Supreme Court of USA, in the case of Anand Chakrabarty, one of the scientists
of General Electric Corporation, ruled that genetically altered microorganisms were indeed
patentable based on the following criteria:

 They were man-made

 They were products of human manipulation and therefore considered similar to any
other invention
 They had a specified industrial application (one criterion for patenting is that the
invention has utility).

Chakrabarty had filed a patent application for bacteria, a strain of Pseudomonas containing
two plasmids after genetic manipulation, which had an enhanced propensity to digest oil
hydrocarbons. Although getting bugs to eat oil seems like a neat trick, the Patent Office had
initially rejected the application.

Also, the Supreme Court cited the fact that there was precedence for patenting living matter.
Since 1930 certain asexually reproduced plants have been protected by patenting. Further, in
1970 the Plant Variety Protection Act allowed for protection of some sexually reproduced
plants.

This ruling by the courts opened the door for biotechnology to become big business. Now
companies could protect products based on genetically altered organisms.

The next issue for the Patent Office regarding patenting of life forms became the patentability
of genetically manipulated animals. In 1988 a patent was allowed for the first genetically
altered animal, a mouse that was very susceptible to cancer. This mouse showed promise in
testing potential carcinogens.

Microorganisms, plants and animals have now all received U.S. patenting status. Europe
views patenting of "man-made" life in much the same manner as the U.S. patent office.
Canada, however, still does not allow patenting of life.

THE SCENARIO IN INDIA

The Indian Patents Act, 1970 has been amended with effect from January 2005 to comply
with the TRIPS agreement. The main provision of the Act is to allow the grant of product
patents in the field of chemical, pharmaceutical, food and biotechnology. Patentable
biotechnological inventions can be broadly categorized as:

'Products in the form of chemicals, microorganisms, plant extracts, fermented material;

processes/methods for using useful products and compositions/ formulations of product such
as vaccines, proteins, hormones'

India has allowed patenting of microorganisms but the Patent Act does not provide a
definition of the term "Microorganisms". This has led to many debates regarding patentability
of microbes. The Mashelkar committee report has clearly stated that microorganisms are
patentable subject matter in India. Further, the Patents Act does not allow patenting of plants
and animals per se, essentially biological processes for the production of plants and animals
and method of treatment of human and animals.

Inventions pertaining to Microorganisms and other Biological material were subjected to

product patent in India, unlike many developed countries. But with effect from 20.05.2003
India has started granting patents in respect of invention related to microorganisms, though
India was not obliged to introduce laws for patenting microorganisms per se before
31.12.2004. Microorganisms patenting per se being considered to be a product patent, the
period of protection was 5 years from the date of grant or, 7 years from the date of filing of
application for patent. Now grant of patents for microbiological inventions is for a period of
20 years from the date of filing.

According to Section 3(j) of the Indian Patent Act, 1970, the following are not patentable -
"Plants and animals in whole or in part thereof other than microorganisms, but including
seeds, varieties, and species and essentially biological process for production or propagation
of plants and animals." Section 3(c) of the Act excludes patents on "naturally occurring
microorganisms"; however, genetically modified microorganisms (GMOs) are patentable.
With regard to this, only those GMOs are patentable which do not fall under section 3(b);
section 3(b) excludes patents on those GMOs, "the exploitation of which could be contrary to
public order or morality or prejudicial to human, animal or plant life or health or to the
environment."

The most vital and important distinction between the legal practices of India and the
developed countries is that India, and the developing countries, do not allow patenting of
microorganisms that already exist in nature as the same is considered to be a discovery as per
the provisions of the section 3(d) and are therefore not patentable. But genetically modified
versions of the same microorganisms that result in enhancement of its known efficacies are
patentable. Section 3(d) of the Indian Patent Act, 1970 specifically states that - "The mere
discovery of a known substance which does not result in the enhancement of the known
efficacy of the substance" does not make it eligible for being patented.

The grants of Patent in respect of Microorganisms depend upon the regulations concerning
the requirements for the deposition of Microorganisms under the Budapest Treaty of which
India has become a member, and accessibility of that microorganism from the depositories.
As per proviso (ii) to section 10(d) the Microorganism if not being described fully and
particularly and is not available to public, the said Microorganism is to be deposited before
the International Depositary Authority under the Budapest Treaty with 3 months of making
application in India. All details, available characteristics of the Microorganisms, and details
of depositary institutions shall be mentioned in specification for correctly identifying the
same. Further access to the same is required to be made available only after date of
Application in India or date of priority. For the purpose of Microorganisms and other
Biological materials Microbial Type Culture Collection and Gene Bank (MTCC) is an
internationally recognized depository institution.

It is therefore advisable before proceeding to file a patent application in respect of

Microorganisms and other biological material to ensure that the same is not hit by the
provisions of the section 3(d) of the Indian Patent Act and the invention is not a mere
discovery of what already exist in nature and in case of genetically modified variant of the
Microorganism or other biological material the invention resu