ASIAN PATENT ATTORNEYS ASSOCIATION. 62 nd Council Meeting. Hanoi, Vietnam. Patent Committee Report: INDIA. Hari Subramaniam, Neeti Dewan, Sanjay Kumar

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1 ASIAN PATENT ATTORNEYS ASSOCIATION 62 nd Council Meeting Hanoi, Vietnam Patent Committee Report: INDIA Hari Subramaniam, Neeti Dewan, Sanjay Kumar 1

2 India: Patents 2013 There have been no changes in statutory law or in regulations since we last presented our report in Chiang Mai in However, the past one year has again seen several judicial pronouncements, by various High Courts and by the Intellectual Property Appellate Board (IPAB) that have resulted in significant changes in practice due to interpretation and clarification of existing statutory provisions. The IPAB and the High Courts of New Delhi and Chennai have been active in patent law interpretation on both procedural and substantive issues. These decisions have resulted in certainty in some areas of practice. Some of these decisions are discussed below: I. Deficit fee at the time of filing the application: Under the law, when a document has to be accompanied by fee, the date of filing the document is deemed to be the date on which the full fee is tendered. There is no provision for deferring the fee or paying fee in parts. However, the Intellectual Property Appellate Board has held that a patent application cannot be rejected only because full fee was not paid at the time of filing the application. It ruled that not paying full fee was only an irregularity in procedure which could be corrected. II. Divisional applications: Under Section 16 of our Patents Act, 1970, any time before the grant of a patent, an applicant may if he so desires or to remedy an objection raised by the Controller on the ground that. The application relates to more than one invention, file a further (divisional) application.. As in most jurisdictions, it was until a few years ago, possible to file a file wrapper divisional in case it appeared that the original application may be rejected. The Intellectual Property Appellate Board (IPAB), has through a series of decisions, held such file wrapper divisionals are void ab initio. The Patent Office and the IPAB have also rejected several divisional out of divisionals on the ground that at the time such divisional out of divisional was filed the grant parent application had already proceeded to grant. While, we do not subscribe to the views of the Patent Office or IPAB, this position will continue to be the law until reversed by the High Court. 2

3 III. SECTION 8 REQUIREMENTS. We had reported in our last Report that our Patents Act has a ubiquitous provision in Section 8 which has become a thorn in the flesh for the applicants. There are two mandatory requirements under Section 8. Firstly, an applicant has a duty at the time of filing of the Indian application or within six months thereafter, to convey details of all corresponding foreign applications to the Patent Office. Thereafter, details in respect of subsequent filing should be conveyed within six months of the date of such filings. The time periods are extendible by the Controller for a period of just one month. Any further delay may be condoned on a petition made before the Controller. Failure to comply with this requirement is statutory ground for rejection on an application in the event of an opposition. This provision encompasses an ongoing duty to keep the Patent Office informed of any developments on such applications including publication, publication number, refusals, abandonment, grants and patent numbers, until the Indian application proceeds to grant or refusal. The problem with this provision is that the actual date of grant following allowance is indefinite. There have been matters where patents have been granted within few days. In the case of many applications, the grant is known to take place only several months and at time years after allowance. Secondly, Section 8 also places a duty on an Applicant to provide copies of search and examination reports on the Applicant s foreign applications when required to do so by the Controller. The deadline is six months after the request is made by the Controller. In a judgement in August 2009 the Delhi High Court again said that this duty under Section 8 cannot be ignored since it flows from a statutory provision. Effectively today, it is recommended that all Applicants contemplating filing in India maintain a docket by which their Indian Attorneys are periodically informed of the status of foreign applications. Once an application is examined the frequency by which the information is provided to the Indian Attorneys can be increased in order to ensure that good faith is shown in terms of compliance with this requirement. In Chemtura vs. Union of India, the High Court in fact refused grant of interim 3

4 injunction since failure to comply with requirements of Section 8 was considered, inter alia, a serious enough issue affecting the validity of the patent. The IPAB has now in a series of judgments reaffirmed the importance of this provision and has revoked several patents on the ground that Section 8 requirements had not been complied with. It has also inssued directions to the Controller of Patents to enforce Section (8) requirements more seriously. IV. LATEST POSITION ON SECTION 3(d) The inclusion of the amended version of Section 3(d) in 2005 provided the Patent Office a convenient basis for refusing applications. This trend has started changing over the past few months. In December 2009, the Patent Office interpreted Section 3(d) broadly and held that a challenge based on Section 3(d) would not succeed merely because the cited compound and the claimed compound shared a similar activity and a certain degree of similarity in structure. In Novartis vs. Cipla, (for nilotenib), Cipla argued that nilotenib was unpatentable under Section 3(d) based on imatinib, since both compounds shared a similarity in structure and similar activity. The Patent Office took a more liberal stand and held that this in itself would not lend strength to a Section 3(d) rejection. It also held that such compounds must be considered New Chemical Entitites, unless an opponent is able to demonstrate otherwise. The Patent Office also held that an Applicant is entitled to rely on subsequently obtained/submitted data to show enhancement in efficacy. This view was also upheld in Hoffman La-Roche vs, Cipla on a patent relating to dosage forms of inter alia, ibandronate. The Patent Office held that enabling delivery of an active at a specific target side overcoming problems of stability, bioavailability and intracellular transfer were sufficient to reach a conclusion of patentability and inventive step as well as efficacy. However, in the Novartis vs. Union of India & Others, the Supreme Court of India upheld the lower Court s i.e., IPAB s decision that beta 4

5 crystalline form of imatinib mesylate which showed 30% increase in bioavailability was not patentable in view of Section 3(d) since there was no evidence that the bioavailability, which is only a property, resulted in increase in therapeutic efficacy. CONCLUSION While, the statutory provisions have remained the same, interpretation by both the Patent Office and the Courts has been relatively progressive in some case liberal but in others, a little restrictive. The decisions of the Delhi High Court in 2012 have ensured a greater degree of certainty for an applicant for patent, particularly for pharmaceutical inventions, that was unfortunately lacking prior to January At least in four cases, involving Indian Patentees and Indian defendants, the courts have passed interim orders of injunctions. We are hopeful that judicial intervention will result in greater clarity of law in the coming years. 5