INDIAN PATENT REGIME-RECENT CASE LAWS
Earlier there were only four forms of Intellectual Property Rights prevalent in India, namely, patents, copyrights, trademarks and designs. Indian patent laws were comparable to those of many countries except that product patents in the areas of drugs, chemicals and food items, which were excluded from the list of patentable items. However, it has been ten years since India amended the Patents Act, 1970 to bring it in line with the agreement on the Trade related Aspects of Intellectual Property Rights (TRIPS). The most important of these amendments related to the introduction of product patents for 20 years, safeguards to prevent ever greening of patents, expansion the scope of compulsory licensing, introduction of concept of post grant opposition, expansion of list of what is and what is not patentable in India, etc.
EVER GREENING OF PATENTS AND SECTION 3(d) OF THE PATENTS ACT, 1970
Ever greening is a method by which technology producers keep their products updated, with the intent of maintaining patent protection for longer periods of time than would normally be permissible under the law. It refers to increasing the life of the patent or the patent term beyond 20 years to reap the benefits for a much longer period of time. The ultimate consequence could be that the generic equivalent would be prohibited from entering the market so the prices of the drug of the Innovator Company will be higher after the patent expiry in absence of competition from generic drug maker.
This concept is highly discouraged by Indian law, especially S. 3(d) of the Act which provides that mere a discovery of new form or process of a product without any technical advancement or a mere use of a known process, product or apparatus without any new product resultant is not patentable.
In Novartis v. Union of India,(2013) 6 SCC 1, the Hon’ble Supreme Court observed that it is the duty of the Applicant for patent to furnish a comparative data of enhancement of efficacy, which is not a physical attribute of the product rather a therapeutic efficacy vis-à-vis an old product. The Hon’ble Supreme Court of India stated that, ‘a patent law that treats incremental innovation and significant innovation in the same way, encourages companies to prioritize less important research over the more important ones.’
Keeping in tune with the judgment, the application (106/DELNP/2008) of M/s Alfa Wasserman, SPA Italy for “POLYMORPHIC FORMS OF RIFAMIXIN, PROCESS FOR THEIR PRODUCTION AND USE THEREOF IN MEDICINAL PREPARATIONS” was granted by the IPO observing that the objection under Section 3(d) of the Act was successfully dealt with by the Applicant as the enhancement in efficacy lay in the fact that the polymorph had an in vivo absorption level of about 100 times lower than the original form, resulting in reduction of the toxicity 100 times due to absorption.
Likewise, S. 3(e) of the Act makes a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance, non patentable. It has been observed by the Indian courts that an admixture exhibiting synergistic properties of all the components is not considered as mere admixture under this Section, e.g., soap, detergent, lubricants and polymer composition etc.
In DuPont v. Solvay, the patentee amended the application at the post-grant opposition stage clarifying that the invention is a synergistic composition, comprising a fire extinguishing agent and a propellant, which are two separate elements and distinct. Additionally, the patentee also submitted evidence that the combination had an unexpected advantage resulting from synergy between its components. The IPAB analyzed and focused on the word ‘synergy’ and thus allowed the proposed amendments.
Further, in Newage Laminaters v. SPL’s Siddhartha Limited, the Intellectual Property Appellate Board (IPAB) held that when a substance is obtained by adding various components in a proper and a definite proportion, amounts at particular temperature and in a particular sequence then the resultant substance is not a mere admixture
Compulsory licensing is a system whereby the Government allows third parties (other than the patent holder) to produce and market a patented product or process without the consent of the patent owner. Under the patents act, compulsory licensing is provided under S. 84, on the grounds that the reasonable requirements of the public have not been met, patentable invention is not available to the public at reasonably affordable price, patented invention is not worked in India, there is a national emergence or a state of extreme urgency and there is a public non-commercial use.
India granted its first compulsory license to NATCO for Bayer’s patented drug Nexavar, an anti cancer drug. While upholding the order of grant of compulsory license, the Hon’ble Supreme Court held that reasonable efforts must be undertaken by the applicant to obtain a compulsory license from the patentee. Further, the initial burden is on the applicant to establish that reasonable requirement of the public is not satisfied with regard to the patented drug. The Hon’ble Court also observed that in respect of medicines the adequate extent test has to be 100% i.e. to the fullest extent. Since, medicines must be made available to every patient.
Although, the policy of Compulsory licensing, as followed by India, is in compliance with the directives of the provisions of the Indian Constitution, it has been severely criticized world over. Indian government is essentially a ‘Welfare State’ and public welfare is the top of its agenda, yet the Courts have not lost track of the fact that an application for Compulsory Licensing must be made only as a last resort after the Applicant has made reasonable efforts to acquire the voluntary license from the patentee (BDR Pharmaceuticals v. M/s. Bristol Myers Squibb)and even in such cases, while granting such license several considerations weigh with the court and it is not granted as a matter of routine.
EX-PARTE INTERIM INJUNCTION ORDERS
The Indian law is pretty strict, when it comes to infringement cases. In the preliminary proceedings, even ex-parte injunction is commonly granted to protect the interest of patent holder.
In Ericsson v. Xiaomi, the Delhi High Court granted an ex-parte injunction on the sale, manufacture, advertisement, and import of Xiaomi’s devices. In another patent litigation case, Delhi High court barred Indian generic drugmaker Cipla from making or selling generic copy of Novartis’s “Onbrez” by giving temporary injunction to Novartis. Citing famous Roche vs Cipla case, the court observed that Novartis has a strong prima facia case and as the validity of the patent is not seriously questioned, there is a clear way out to grant injunction (Novartis v. Cipla).
In February 2014, the Delhi High court granted an ad-interim ex-parte injunction restraining ZTE from importing, selling, advertising, installing or operating devices that comprise the infringing components (Vringo v. ZTE).
In SYMED Labs vs. Glenmark Pharmaceuticals, Symed Labs Ltd. sued Glenmark Pharmaceuticals Laboratories before the Delhi High Court for allegedly infringing two of its patents; IN213062 & 213063. First patent was granted for “Novel intermediates for Linezolid and related compounds” while the ‘063 patent was granted for “A novel process for the preparation of linezolid and related compounds. While declaring the judgment on 9th Jan 2015, the judge convinced that the Plaintiff has got good prima facie case in favour of SYMED.
However, in Merck v. Glenmarck, the Hon’ble Supreme Court of India on Special Leave Petition filed by Glenmark stayed the Delhi High Court order which passed injunction against Glenmark for the generic drug Sitagliptin till 28th April 2015.
QUICK DISPOSAL OF IPR RELATED CASES
Indian Courts have consistently emphasized the importance of speedy disposal of a case. The Hon’ble Supreme Court has recognized that speedy justice forms a part of Article 21 of the Constitution of India as one of the Fundamental Rights. Courts often emphasize on the fact that “justice delayed is justice denied”.
Keeping in tune with this philosophy, the Hon’ble Supreme Court in Bajaj Auto Limited v. TVS Motor Company Limited, JT 2009 (12) SC 103, has directed all the Courts in India for speedy trial and disposal of intellectual property related cases in the courts in India. In a nearly two-year-old dispute involving two companies, which have been locked in a patent dispute over the use of a twin-spark plug engine technology, the Supreme Court observed that suits relating to the matters of patents, trademarks and copyrights are pending for years and years and litigation is mainly fought between the parties about the temporary injunction.
The Supreme Court directed that hearing in the intellectual property matter, there should be a strict compliance of Proviso (a) to Order XVII Rule 1(2). Once hearing of the suit commences, it shall be continued on day-to-day basis, unless exceptional reasons necessitate adjournment of the hearing beyond the following day.
Drug counterfeiting has become a worldwide problem. There is no country, which can deter the existence of counterfeit drugs in its pharmaceutical market. Counterfeiting or falsified medicines requires collaboration at national, regional and international levels between the law providers, enforcement agencies, manufacturers and suppliers. However, under the Indian Patent Act, the right of the patentee has been protected. If the monopoly rights of the patentee are violated, his rights are secured by the Act through judicial intervention. The patentee has to institute a suit for infringement. The relief’s which may be awarded in such a suit are Interlocutory/ interim injunction, Damages or account of profits, Permanent injunction.
Various government agencies in cases of counterfeiting have taken action both on their own accord as well as upon receipt of a complaint, either from the private sector, the right owners or the consumers themselves. The owners of rights being more aware of their rights have now become more prudent and are swift in taking action. The Legislative policies have also seen a considerable change and more importantly the Courts in India too have woken up to the need of protecting IPRs in the need of not only protecting the statutory rights of right holders but more in the interest of protecting the unwary and unsuspecting consumer who would be eventual victim.
India has come a long way and has leaps to move in its IPR Regimes. Undoubtedly, the Indian Patent Law policies which are still in quite naïve stage, however, it is not to be lost track of that the Indian IPR law is also of recent origin. Though, India is often criticized for its strict patent laws and the same being anti-TRIPS compliant, looked deeper, all these prejudices would fade away if the balancing approach of the Courts between the laws (Indian as well as International) and need of the poor citizens of this country is understood.