India: Patent Oppositions - An International Perspective

A patent is an exclusive right granted to the inventor for a novel product or a novel process that provides, a unique way of doing something, or which discloses a new technical solution to a problem.2 Patents are provided as economic incentives for research and development and to facilitate and encourage disclosure of innovations so as to make it available in public domain. Laws providing for opposition of patent are essential to prevent wrongful grant of patent. However, this has led to undue delay in grant of patent, which has hit the main rationale behind incentive based patent system.

Opposition proceedings are structured to restrain wrongful obtaining of patents and claiming of the frivolous inventions. On 1st January 2005, India ratified the Trade Related Aspects of Intellectual Property Rights (TRIPS) Agreement, due to which Section 25 of the Patents Act, 1970 ("The Act") was amended in light of the TRIPS agreement to introduce an integrated system of both pre-grant and post-grant opposition in India. Under Indian Patent act, there are two provisions when opposition may be filed either via pre-grant opposition or post-grant opposition provision depending upon the stage of the patent.

PRE-GRANT OPPOSITION

Section 25(1) of the Patent (Amendment) Act 2005 provides provisions for Pre-Grant opposition of Patent. Under this provision any person or any third party or Government may challenge the application of grant of patent and inform to the controller of Patents for opposition, before the grant of a patent, under Form 7(A) read with Rule 55 of the Patent Rules 2003..

Pre-grant opposition can be made on the grounds listed under section 25(1)(a) to (k) of the Patent (Amendment) Act, 2005. Pre-grant opposition acts as a defensive shield to confirm the validity of the patent applications before patents are granted to applicants. The efficacy of this provision has been widely debated because some argue that the pre-grant system can remedy the lack of information during the initial examination by the Patent Office and this contention has been opposed on the grounds that it delays the prosecution and consequent grant of patent.

This system of opposition has hit the pharmaceutical industry badly. Interestingly, in the Gleevec Case,3 the Constitutional validity of Section 3(d) was challenged in the Madras High Court at a time when there was no such similar section in any member country4. The refusal to grant patent by the Intellectual Property Appellate Board and the hon'ble Supreme Court of India, was seen as not a very good outcome in the International community and it was felt that it will be difficult for the foreign companies to work in India in such patent regime.

POST GRANT OPPOSITION

It acts like a second window under the Patent (Amendment) Act, 2005 which may be filed at any time after the grant of patent but before the expiry of a period of one year from the date of publication of grant of the patent. In accordance with Rule 55A of the Patent Rules, 2003 any person interested5 may give notice of opposition to the Controller, under Form 7 on any of the grounds mentioned in Section 25(2) of the Patent (Amendment) Act 2005. It is notable that many of the grounds are similar to the grounds required for filing pre-grant opposition and there is nothing to preclude a pre-grant opponent from subsequently filing a postgrant opposition.

The main drawback of the post-grant opposition process is that this remedy is available only through the courts, making redressal a lengthy process, and in the case of frivolous patents, allowing a patent holder to enjoy a wrongful monopoly.

In the case of Novartis AG v. UOI & Anr.,6 it is submitted that Novartis used the same base called imatinib and added it with a new acid known as mesylate which resulted into a new compound called imatinib mesylate. However, it was contended by Novartis that imatinib is in its new betacrystalline form instead of its earlier known alpha form. The opposition which came was that imatinib was earlier disclosed and mere change from its alpha form to betacrystalline form does not amount to a therapeutic change under Section 3(d) of The Act. Hence, the patent was not granted to Novartis inspite of the fact it was given a patent in other jurisdictions till 2005.

CONCLUSION (INDIA)

Pre-grant proceedings may be initiated by 'any person', while only a 'person interested' can introduce a post grant opposition. In addition to this, there can be no infringement proceedings during a pre-grant opposition as the patent does not cross the application stage. Patent opposition process has principally affected the pharmaceuticals industry because the patent applicants are now exposed to multiple pre-grant oppositions which have fuelled fears among innovator companies.

EPO OPPOSITIONS

Opposition to any European patent granted by the EPO under the European Patent Convention, may be filed by any member of the public except for the proprietor himself. Opposition must be filed within nine months of the publication of the mention that the patent has been granted. The procedure may involve multiple opponents. In accordance with Article 100 EPC, any opposition may be filed. Notice of opposition may be filed online or in writing with the EPO (Munich, Hague or Berlin), and an opposition fee is payable as prescribed.

UNITED STATES

It relies predominantly upon the process of reexamination for arguing against the validity of a patent. Reexamination is conducted by the USPTO, with a course of appeal lying with the Court of Appeals for the Federal Circuit. Reexamination is only applicable to issued patents and it is ex parte in nature. A request for reexamination can be made under Section 3027 on the basis on any prior art cited under Section 3018. Moreover, it allows request for inter partes reexamination under Section 3119, under which any third party requester may file an application on the basis of the prior art cited. If a substantial new question of patentability is identified, then reexamination will be granted.

The US does not recognize any pre-grant opposition but allows for a protest under Chapter 190110 which is designed to bring information to the attention of the USPTO that is relevant to avoiding the issue of invalid patents. It occurs during patent prosecution and must be submitted prior to either the publication of the patent application, or the mailing of a notice of allowance, whichever occurs first.

AUSTRALIA

A patent opposition process allows a person to challenge the validity of an innovation patent, or an application for a standard patent before it is granted. Patent oppositions can be made against an accepted standard patent application or a certified innovation patent. 11There have been changes in the opposition and following are the period for opposition:

For oppositions commenced on or after 15 April 2013: 12

Type of opposition

Time for filing a notice of opposition

Opposition to the grant of a patent (sec 59)

3 months from the publication of the acceptance of the application

Opposition to an innovation patent (sec 101M)

Any time after Certification

Opposition to an extension of term (sec 75)

3 months from the publication of the acceptance of the extension

Opposition to an amendment (sec 104)

2 months from the publication of the Grant of Leave to Amend *

Opposition to an extension of time (sec 223)

2 months from the publication of the extension

Opposition to the grant of a licence (reg 22.21)

2 months from being given a copy of the request for a licence

In the case of an opposition under section 104, the opposition period will remain 3 months if the amendment was advertised before 15 April 2013, and the notice of opposition is filed on or after 15 April 2013.

JAPAN

The Japanese patent system resembles the European patent system. Recent changes to Japanese patent law in 1996 included the move from a pre-Grant patent opposition system (three months to file opposition) to a post-Grant opposition system (six months to file opposition, but the patent is valid until declared otherwise). Under the old system, examined patents were published pre-grant ('kokoku'). The Patent Opposition System allows any party desiring to do so the opportunity to file an opposition to a granted patent after the patent right is granted. The goal of the Patent Opposition System is to increase public confidence in the patent system. When an opposition is filed, the Patent Office reexamines the appropriateness of its initial decision to grant the patent and remedies any flaws that are discovered. 13

In Japan, once a patent has been granted, it is published for opposition in the Patent Gazette. Any third party may file an opposition to the grant of a patent within six months of publication for opposition. The grounds for an opposition are similar to the grounds for rejection of an application by an examiner. In an opposition, however, grounds based on joint ownership, unity of the invention, claims not conforming to patent rules, and lack of right to obtain a patent are not applicable. As with an appeal, an opposition is most commonly heard by a group of three examiners. The patent owner will be given an opportunity to amend the specification or claims to the extent permitted after a final Office Action. 14

An unusual feature of the Japanese patent system is that applications are not automatically examined. The applicant has seven years from the filing date to file a request for examination. The patent is then usually examined in 24 to 30 months. However, as many applicants use this system to evaluate market developments, typical pendency between filing and examination is five to seven years. Some patent applications can be processed much faster, being examined and published within 15 to 18 months of filing.

Japan's Patent Law was amended in 2003 under which the post-grant opposition system was abolished, while the invalidation trial system was revised, w.e.f. 1st January 2004, to allow any entity to demand an invalidation trial without interest. 15 Under the new invalidation trial, the trial may be demanded at anytime, both parties are involved in adversary system during the trial procedure and the demanding party may appeal against the trial decision affirming the patent at issue to the Tokyo High Court.

SWITZERLAND

When a patent has been granted in Switzerland, the title is entered into the Swiss Patent Register and published. Any person can file opposition against a patent with the Institute within nine months of the granting. The CHF 800 fee must be paid and the ground for the opposition must be in writing. The only acceptable ground for opposition is that the patent contains inventions which are excluded from patenting (Art. 1a, 1b and 2 Patent Act). Such inventions are, for example, the human body at all phases of formation and development, or naturally occurring sequences or partial sequences of genes.

Opposition can also be filed against inventions which are contrary to human dignity or disregard the dignity of a creature, or in any other way contrary to public convention or morality. If the novelty, inventive step or disclosure of the invention is missing, a petition for nullity must be filed, not opposition proceedings. The Institute decides whether the opposition should be rejected or the patent revoked, or whether the patent can be upheld with a modified scope. 16

Footnotes

1 Legal Intern

2 Section 2(1)(m) of The Patents Act, 1970

3 Novartis A.G. v. UOI & Anr. (2007)

4 MLJ 1153, Civil Appeal Nos. 2706-2716 of 2013. 4 TRIMS Agreement: Agreement on Trade-Related Investment Measures, Apr. 15, 1994, Marrakesh Agreement Establishing the World Trade Organization, Annex 1A, THE LEGAL TEXTS: THE RESULTS OF THE URUGUAY ROUND OF MULTILATERAL TRADE NEGOTIATIONS 143 (1999), 1868 U.N.T.S. 186

5 Section 2(1)(t) of The Patents Act, 1970: includes a person engaged in, or in promoting, research in the same filed as that to which the invention relates. In addition, interested person may also include any organization that has a manufacturing or trading/ financial interest in the goods related to the patented product.

6 Civil Appeal Nos. 2706-2716 of 2013.

7 35 U.S.C. 302

8 35 U.S.C. 301

9 35 U.S.C. 311

10 37 CFR 1.291

11 http://www.ipaustralia.gov.au/get-the-right-ip/patents/manage-your-patent/dealing-with-oppositions/

12 http://www.ipaustralia.gov.au/about-us/news-and-media/feature-articles-listing/patent-oppositions

13 http://www.jpo.go.jp/cgi/linke.cgi?url=/tetuzuki_e/t_tokkyo_e/opposition_guide.htm?url=/tetuzuki_e/t_tokkyo_e/opposition_guide.htm

14 http://www.ryuka.com/cn/services/jpatentprocess.shtml

15 http://www.jpaa.or.jp/english/law/2003amendment.html

16 https://www.ige.ch/en/patents/after-issuance.html  

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