INDIAN PATENT LAW: SOME REFLECTIONS

The aim of this article is analyse some of the salient features of the Indian Patent law, i.e. the Patents Act, 1970. An effort has been made to analyse it in the light of TRIPS Agreement. India is a signatory to the TRIPS Agreement hence it modified its patents law in conformity with TRIPS Agreement. I. Introduction The existence of IPRs is very old. The basic aim of conferring an IPR upon the person owning the same is to give a social recognition to its holder. This social recognition can further bring economic benefits to its holders. It is just and reasonable to award a person an IPR in the form of “limited monopolistic rights” for his/her labour and efforts. At the same time, exceptions in the form of various licences are also made so that public interest cannot be compromised. The public interest and personal interests are thus reconciled in the form of limited period duration of these rights and their abuses can be tackled stringently, especially when public interest demands so. The problem of IPRs violations was not as much in ancient times as it is in the contemporary society. This has happened due to the advent of information technology (IT) and “Conflicts of laws” in various countries. The need of harmonisation of law concerning IPRs was felt at the international level. Thus, the TRIPS Agreement was formulated to bring basic level harmonisation in IPRs laws all over the world. The provisions of TRIPS Agreement are the most extensive and rigorous in nature. They protect all the forms of IPRs collectively. The protective umbrella of TRIPS covers the following IPRs: (1) Copyright and Related Rights, (2) Trademarks, (3) Geographical Indications, (4) Industrial Designs, (5) Patents, (6) Layout designs of Integrated Circuits, and (7) Protection of Undisclosed Information. It must be noted that by virtue of Article 1(2) of the TRIPS Agreements, the Control of Anti-Competitive Practices in Contractual Licences has been excluded from the definition of “intellectual property”. Thus, the TRIPS Agreement covers virtually the entire gamut of IPRs. II. Patents Act, 1970 and TRIPS Agreement The Indian Patents Act, 1970 provides patent protection in India. The same is in accordance with the provisions of the TRIPS Agreement. The recent conferment of “product patent” along with the “process patent” is an example of such compatibility. The protection to plant varieties has been excluded from the realm of patent law and a separate Act has been made for that purpose. Further, the provisions of “international patent application” and “compulsory licenses” are also in conformity with TRIPS Agreement and Doha Declaration respectively. Thus, the interest of the public at large has also been taken care of by the Indian Patents Act, 1970 and there is no need of being panicked from product patent of medicines. However, there is no need of a “further protection” to pharmaceuticals in the form of “Data Exclusivity” as the protection under the Patents Act, 1970 is not only sufficient but also in conformity with the TRIPS Agreement. The protection in the form of “Data Exclusivity” is a “TRIPS plus” provision to which Indian does not owe any obligation. III. Salient features of Indian Patent law The Patent law of India has the following salient features that decide whether a patent will be granted or not: (a) The object: The object of patent law is to encourage scientific research, new technology and industrial progress. The price of the grant of the monopoly is the disclosure of the invention at the Patent Office, which, after the expiry of the fixed period of the monopoly, passes into the public domain. (b) Inventive step: The fundamental principle of Patent law is that a patent is granted only for an invention which must have novelty and utility. It is essential for the validity of a patent that it must be the inventor's own discovery as opposed to mere verification of what was, already known before the date of the patent. (c) Useful: The previous Act, i.e. Act of 1911, does not specify the requirement of being, useful, in the definition of ‘invention”, but courts have always taken the view that a patentable invention, apart from being a new manufacture, must also be useful. (d) Improvement: In order to be patentable, an improvement on something known before or a combination of different matters already known, should be something more than a mere workshop improvement, and must independently satisfy the test of invention or an inventive step. It must produce a new result, or a new article or a better or cheaper article than before. The new subject matter must involve "invention" over what is old. Mere collocation of more than one, integers or things, not involving the exercise of any inventive faculty does not qualify for the grant of a patent.

(e) The guiding tests: To decide whether an alleged invention involves novelty and an inventive step, certain broad criteria can be indicated. Firstly if the "manner of manufacture" patented, was publicly known, used or practised in the country before or at the date of the patent, it will negative novelty or `subject matter'. Prior public knowledge of the alleged invention can be by word of mouth or by publication through books or other media. Secondly, the alleged discovery must not be the obvious or natural suggestion of what was previously known. In short the “invention” must involve an inventive step and the same must be capable of “industrial application”. It must be supplemented by the concept of “non-obviousness”. III. Conclusion The Indian patents Act, 1970 is not only a complete Act but also in conformity with the TRIPS Agreement. It, however, needs enunciations in the form of judicial precedents as the same are lacking in case of patent law. It further must be analysed in the light of international developments in this field. The Indian Patent law must also be analysed in the light of both “Public International law” and the “Private International Law” as the same may create some problems in future. In the subsequent series, I will try to pick one by one each areas associated with Indian patent Law.

This article is submitted by Praveen Dalal, Arbitrator, Consultant and Adovate, Supreme Court of India, Managing Partner - Perry4law (Law Firm, New Delhi) (pd37@rediffmail.com/ perry4law@yahoo.com)

26th April: World IP Day

April 26 is the World IP Day as decided by WIPO member states in 2000 to designate a World Intellectual Property Day to raise awarness of the role of intellectual property in our daily lives, and to celebrate the contribution made by innovators and artists to the development of societies across the globe. April 26 was chosen as this was the date on which the Convention establishing WIPO entered into force in 1970. WIPO and its member states have celebrated World Intellectual Property Day on April 26 each year since its inception in 2001. Message by Dr. Kamil Idris, Director General of the World Intellectual Property Organization (WIPO) on the occasion of sixth World IP Day - World Intellectual Property Day is an opportunity to encourage people to think about the role played by intellectual property in everyday life, and about its importance in stimulating and safeguarding innovation and creativity. This year we celebrate the starting point of all intellectual property, the seeds from which all innovations and creative works grow – ideas. Mankind's inexhaustible capacity for producing ideas makes us unique. Yet this extraordinary ability is often taken for granted. We hardly notice the countless ideas we generate every day, or how much of what we value is the fruit of others' ideas: labor-saving inventions, pleasing designs, life-saving technologies. Ideas shape our world. They are the raw materials on which our future prosperity and heritage depend. This is why it is important to provide environments in which innovative ideas are encouraged and rewarded. This is why intellectual property exists. From the words, music and images which move us, to the brands which attract us; from the bicycle to bio-fuel; from the microchip to mobile phone – it all starts with an idea. For further information on World IP Day visit: http://www.wipo.int/about-ip/en/world_ip/2006/

Mining & Refining IP Sources: PIUG

The Patent Information Users Group, Inc. (PIUG), the International Society for Patent Information is a not-for-profit organization for worldwide professionals having technical, scientific or professional interest in patents. Their Official website contains complied information regarding worldwide patent attorneys and law firm directories, very exhaustive information regarding patent search databases and various paid tools/softwares for analyzing patents. PC Rating: ** (* No comments ** Informative *** Good **** Very Good ***** Excellent, keep on visiting for regular updates)

Intellectual Property Law Firms in India

List of Intellectual Property Law firms in India can be search out at IP menu and Legal 500.com. Top recommended Indian IP firms engaged in Patent & Trademarks practice are available at Legal 500.com.

Indian Patent Search Database

Visit http://www.indianpatents.org.in for list of patent applications filed in India from January 1995 to December 2003 and list of patent applications open for pre-grant opposition from January 1995 to December 2004. The database is maintained and developed by Patent Facilitating Centre, TIFAC which is further bifurcated into two sub-databases, namely, Ekaswa A Database (list of patent applications filed in India) and Ekaswa B Database (list of patent applications open for pre-grant opposition). However, this database has limited features and is not so efficient as compared to international patent search databases.

List of candidates appearing for Patent Agent Qualifying Examination

Indian Patent Office has advertised list of candidates appearing for Patent Agent Qualifying Examination scheduled on 24th and 25th April 2006. Total 292 candidates will be appearing for April 2006 exams.

Drug Patent Expiry

Recently, I have launched my new blog ‘Drug Patent Expiry’ related to patent expiry status of Drug molecules (APIs), more particularly for US and European jurisdictions. Soon I will also be adding a new section related to chemical compounds (APIs) patented in India.

Roche launched Tarceva in India

Roche Scientific Company has launched revolutionary its anti-cancer drug ‘Tarceva’ in India, which has earlier received US approval in November 2004 and European Union approval in September 2005. Erlotinib hydrochloride, the active ingredient of Tarceva is post-1995 molecule which inhibits the activity of the erbB family of oncogenic and protooncogenic protein tyrosine kinase, such as epidermal growth factor receptor (EGFR), and is useful in prolonging and improving survival in non-small cell lung cancer and pancreatic cancer. Erlotinib hydrochloride is disclosed and claimed in US Patent No. 5,747,498 and its corresponding Indian patent application 537/DEL/96 is still pending for grant in India since 1996. Indian patent application was filed under section 135 of the Patents Act 1970 by Pfizer, claiming priority date March 30, 1995 from US application. Erlotinib hydrochloride was discovered in joint collaborative effort by Pfizer & OSI Pharmaceuticals. Later, OSI Pharmaceutical entered into concurrent agreements with Genentech and Roche for global co-development and commercialization of Tarceva.

Federal Court reversed lower Court decision on Sanofi’s patent

U.S. Court of Appeals for the Federal Circuit has reversed a lower court decision invalidating Sanofi-Aventis’ U.S. Patent No. 5,389,618 for blood thinner Lovenox and threw the decision back to it for further proceedings. Earlier in June 2005, a U.S. District Court in California granted the generic makers summary judgment invalidating the patent. But U.S. Court of Appeals said it was convinced that Aventis intended to deceive the U.S. Patent and Trademark Office, as the generic drug makers had claimed. This patent lawsuit was result of Para IV certifications filed by two generic makers – Teva and Amphastar Pharmaceuticals – seeking permission to market generic version of Lovenox.

Pharmaceutical Patents: Exploring beyond the scope of section 3 (d)

Verdict is loud and clear after the Patents Amendment 2005. No patents for trivial pharmaceutical inventions. Mere discovery of polymorphic forms, resolution of racemic mixtures, new salts, esters and ethers of known substances, particle size, pure form, metabolites and combinations of known substance are considered to be quite obvious to overcome patentability bar. This legislative march is meant to prevent ever-greening of patents in the field of pharmaceuticals and to make sure only well merit inventions see the light of patent protections. This is what the patents are all about. Newly amended section 3 (d) of the Patents Act, 1970 has come into action after the post-2005 era, drawing the attention of both domestic and global pharmaceutical players towards the scope of section 3 (d). Patent applications filed during the transitional period (“mail-box applications”) are now undertaken for examination, paving way to product patents in the field of pharmaceuticals and drugs after a long gap of 35 years. Sooner or later, global pharma players will introduce their patented drugs in Indian market, putting end to the long era of launching re-engineered generic drugs in India. Attention is definitely mounting on the scope of section 3 (d) that is limited, not unlimited. Section 3 (d) “the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant. Explanation – For the purposes of this clause, salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be same substance, unless they differ significantly in properties with regard to efficacy;” Drawing a Silver Lining Section 3 (d) excludes majority of pharmaceutical inventions from patent protection, particularly new forms of known substance and new use for known substance. Unlike in US and Europe, new polymorphic forms and method of use (Swiss-type) claims will not be eligible for patent protection in India. This is not the end, there is silver lining too. It is a matter of reading between the lines and interpreting the hidden catch. What stands between in and out is the word ‘mere’. Section 3 (d) diminishes the fate of trivial inventions but at the same time keeps the thumb up for well merit inventions. Interpreting the hidden catch According to section 3 (d), the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance will not be considered as a patentable invention. This is a conditional statement, purporting that if a new form of a known substance is the mere discovery using conventionally known practices and devoid of any inventive feature then the new form will be not patentable unless the new form results in the enhancement of the known efficacy. This means that the mere discovery of a new form with improved efficacy will be enough to overcome patentability bar. For example, if a new polymorphic form is having substantially improved thermal stability as compared to earlier known efficacy then the stated improved thermal stability will be enough to stand the requirement of inventive-step under section 2 (1) (ja), and thereby overcome the barrier of section 3 (d). This, however, clearly connotes that the mere discovery of a new form of a known substance can be patentable subject to improved efficacy. Now let us consider the second “hidden” interpretation where the discovery of a new form involves substantive technical input, enough, to overcome the scope of word ‘mere’ and meet the requirement of inventive-step under the Patents Act, 1970 then in that case condition of enhancement of the known efficacy is not mandatory to meet patentability criteria. This situation falls beyond the scope of section 3 (d), clearly overcoming the barrier of section 3. This ‘hidden’ interpretation implies that a new form of a known substance which involves a technical merit sufficient to meet inventive-step under section 2 (1) (ja) of the Patents Act, 1970 can be patentable irrespective of any enhancement of the known efficacy. Show Technical Merit Usually Swiss-type or method of use claims is not eligible for patent protection in India. According to section 3 (d), the mere discovery of any new property or new use for a known substance will not be considered as a patentable invention. Here the use of conjunction ‘or’ between ‘new property’ and ‘new use’ is conjunctive. A close interpretation of section 3 (d) connotes that the mere discovery, such as scientific observation, of any new property or new use for a known substance will not be patentable. But if the discovery of any new property or new use is result of technical expertise coupled with technical solution/utility to stand the requirement of inventive-step under section 2 (1) (ja) of the Patents Act, 1970 then the discovery of any new property or new use for a known substance may overcome the scope of section 3 (d). The scope of section 3 (d) ends with the scope of word ‘mere’, suggesting that second and subsequent use for a known substance may also be patentable if their discovery involves technical merit to overcome the scope of ‘mere’ and stand the condition of inventive-step under section 2 (1) (ja) of the Patents Act, 1970. Game of Interpretation Statutory provisions are always open for interpretation, leading to numerous remarkable precedents by highest level of Courts and further paving way to jurisprudential interpretation. Patent law is not exception to that. A plain reading of section 3 (d) may look straight forward, ruling out the patentability of new form and new use of a known substance but a bird-eye view of it may invoke various interpretations. Weighing every single word of the provision and thereby interpreting it will be the key to patenting and future appeals against patent office both in Courts and Appellate Board. There is a bright silver lining hidden in section 3 (d) which needs to be discovered. To end with, it is all about knowing and doing, and doing and knowing.

Exemptions available under the Patents Act, 1970 - Part II

Regulatory Use According to section 107A (1), any act of making, constructing, using, selling or importing a patented invention solely for used 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 manufacturing, construction, use, sale or import of any product will not be considered as infringement of patents. According to this exemption, despite the patent in alive, performing research and tests for preparing regulatory approval, for instance by the Food and Drug Administration, does not constitute infringement. This exemption is particularly relevant to drugs manufacturing, allowing generic manufactures to prepare generic versions in advance of the patent expiration. However, this exemption originated from infamous case Roche Products v. Bolar Pharmaceutical and famously known as Bolar-provision. In US, this exemption is known as Safe-harbor exemption or technically called as § 271(e)(1) exemption or Hatch-Waxman exemption. The US Supreme Court recently revisited Merck v. Integra to determine the scope of Hatch-Waxman exemption. The Supreme Court held that the statue exempts from infringement all uses of compounds that are reasonably related to submission of information to the government under any law regulating the manufacture, use or distribution of drugs. However, issue of stockpiling is still not been dealt my Indian Patent Law.

Exemptions available under the Patents Act, 1970

The Patents Act, 1970 provides certain exemptions to the rights conferred by patents without harming the commercial interests of patentees. According to these exemptions, certain acts, even though infringing in nature, will not constitute infringement of patents when performed before the expiry of valid patent term. These exemptions however are borrowed from developed countries such as US and UK, and sometimes also referred as infringement defenses. In order to avoid any patent misuse or barrier to further scientific research, these exemptions are included as defenses against patent infringement. Article 30 of TRIPS agreements also provides its member nations to include exemptions to the exclusive rights conferred by patents, provided that such exemptions do not unreasonably conflict with normal exploitation of patents and do not unreasonably prejudice the legitimate interests of the patent owners, taking account of the legitimate interests of third parties. A patent issued under the Patents Act, 1970 confers upon the patentee the right to prevent unauthorized third parties from making, using, offering for sale, selling or importing patented product in territorial jurisdiction of India. Any individual, who makes, uses, offers to sale, sells or imports into India a patented invention without the consent of patentee/patent owner faces liability for patent infringement. However, the rights conferred upon the patentee are subject to certain exemptions provided under the Act. There are three exemptions available under the Act, these are, (1) Government Use (also known as Crown use in UK and Australia); (2) Experimental/Research Use; and (3) Regulatory Use (also known as Safe-harbor exemption in US or Bolar-exemption in Canada). Government Use According to section 47 (1) and 47 (2), Government or any person/organization on the behalf of Government may import or make or use any patented product or process for the purposes merely of Government own use. In case of a patent is respect of any medicine or drug, the medicine or drug may be imported by the Government for the purpose merely of its own or for distribution in any dispensary, hospital or other medical institution maintained by or on behalf of the Government or any other dispensary, hospital or other medicinal institution which the Central Government may, having regard to the public service that such dispensary, hospital or medicinal institution renders, specify in this behalf by notification in the Official Gazette (section 47 (4)). Experimental/Research Use According to section 47 (3), any person can use patent product or process for the purpose of experiment or research for non-commercial activities. This provision is merely for academic purpose and further research. However, this research exemption is an affirmative defense to infringement where the alleged infringer uses patented invention for research purpose. This doctrine originated in 1813 in Whittemore v. Cutter, 29 Fed. Cas. 1120 (C.C.D. Mass. 1813) where Justice Joseph Story famously wrote that the intent of the legislature could not have been to punish someone who infringes “merely for scientific experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its describe effects.” Subsequent judicial decisions later distinguished between commercial and non-commercial research. In 2002, the Court of Appeals for the Federal Circuit considerably limited the scope of the research exemption in Madey vs. Duke University, 307 F.3d 1351, 1362 (Fed. Cir. 2002). The court limited the scope of the research exemption only for amusement, to satisfy idle curiosity, or for strictly philosophical inquiry. However, in the absence of relevant case laws in India, the scope of experiment/research exemption is still unresolved. To be continued ….

Procter & Gamble settles patent dispute with Coca-Cola

Procter & Gamble (P&G) has settled two patent infringement lawsuits with Coca-Cola that involve adding calcium in juice and preserving non-frizzy drinks. However, companies haven’t disclosed terms of the settlement, but under the settlement, Coca-Cola may continue to sell its calcium juices and use Procter’s preservative technology. In 2002, P&G filed first suit against Coca-Cola in the U.S. District Court in Cincinnati for infringing its patented technology for making calcium enriched juice. P&G alleged that Coca-Cola infringes its Patent covering calcium-supplemented juice products. Second suit was filed in 2004 by P&G alleging that Coca-Cola infringes its patented preservative technology covered by three US Patents.

GSK Combivir Patent Application Opposed by NGO

GlaxoSmithKline’s Combivir patent application, claiming combination of two essential AIDS drugs – Zidovudine and Lamivudine – has been opposed under section 25 (1) by Delhi-based Non-Government Organization (NGO). Combivir patent application, filed under mail-box provision (section 5 (2)), has been opposed under the provision of pre-grant opposition questioning the validity of combivir patent application on the technical and health grounds. NGO’s objections states that the grant of patent will increase the cost anti-retroviral treatment for many living with HIV/AIDS and also endanger global availability of affordable medicines. Other objection questions the patentability of Combivir under the Patents Act, 1970 stating that it is mere combination of two known drugs.