This article has been written by Mr. Atul Chaudhary, a 3rd Year Student of M.S. Law College, Mumbai.
Introduction
A patent is an exclusive right granted for an invention, which is a product or a process that provides, in general, a new way of doing something, or offers a new technical solution to a problem. To get a patent, technical information about the invention must be disclosed to the public in a patent application.
The history of Patent law in India starts from 1911 when the Indian Patents and Designs Act, 1911 was enacted.
The Patents Act, 1970 is the legislation that till date governs patents in India. It first came into force in 1972.
The Office of the Controller General of Patents, Designs and Trade Marks or CGPDTM is the body responsible for the Indian Patent Act.
Like many developing countries, India currently maintains weak patent laws in order to provide inexpensive products to its citizens.1 Such laws also benefit the development of India’s national infrastructure by allowing Indian companies to compete on a more favorable basis with the local facilities of multinational corporations. This Note examines the impact of TRIPs on current Indian patent law as it relates to the pharmaceutical industry. Part II provides an overview of the current state of patent protection in India, the rationales behind Indian patent policy, and the effect of current law on the Indian pharmaceutical market. Part III discusses changes to Indian patent law required to comply with TRIPs. Part IV examines opposition to Indian patent reform. Part V analyzes legislation in India implementing TRIPs and raises issues likely to arise as reform efforts proceed. Part VI draws a comparison to the development of modern Japanese patent law and suggests that opposition to patent reform in India is unfounded. This Note concludes in Part VII that although there is some basis for the fears of its opponents, Indian patent reform will provide a net benefit by encouraging investment in Indian industries, especially the pharmaceutical industry, and by providing more pharmaceuticals to the Indian public
Abstract
The Patent Law Treaty is an international agreement used to simplify the process and formalities for registration of Patenting of idea. This treaty is introduced to avoid rigid and multiple registration for registering in multiple countries. Applicant can designate contracting parties or other treaty countries in which they would like to have a design patent. Earlier it was difficult to get the filing date and process was too rigid with this treaty coming into existence making it easier for the applicant to receive a filing date for patent application. The one part of this treaty also includes Hague Design Treaty. This part of the PLT Act allows a person to file one design application in the United States and request patent registration in any treaty countries. This makes it easier to receive international design patents as this also aligns with the other U.S. patent laws. This paper analyses some of the provisions of a draft substantive patent law treaty (SPLT) that were considered in the Tenth Session of the Standing Committee on the Law of Patents, WIPO in 2004. A key question in this regard is whether or not the harmonisation of patent laws, through the adoption of the SPLT, marks a step towards introducing a TRIPS-plus regime in terms of the obligations of signatory countries. It finds that flexibilities currently available under TRIPS could be considerably eroded if patent harmonisation initiated under the WIPO Patent Agenda moves towards higher and stricter standards. Clear linkages between the TRIPS and SPLT negotiating processes have not been established at the multilateral or domestic level in developing countries and there is an urgent need for these nations to make their presence felt at the SPLT negotiations.
Indian Implementation on patent law treaty
India is also a signatory to several IPR related conventions, including the Berne Convention, which governs copyright, the Budapest Treaty, the Paris Convention for the Protection of Industrial Property, and the Patent Cooperation Treaty (PCT), all of which govern various patent-related matters.
India has its own separate act known as Patents Act, 1970 Later it was amended in 2005 and introduces patent protection for Food, Chemicals and Pharmaceuticals Though it has very limited scope of protection but under this law, patent rights are granted for inventions securing a new and inventive process, product or an article that are able to satisfy the patent eligibility requirements of having novelty, inventive steps, and are capable of industrial application.
The Patent Office has its headquarters in Calcutta and has branches in New Delhi, Chennai and Mumbai. The office of the CGPDTM is based in Mumbai. Nagpur hosts the office of the Patent Information System and also the National Institute for Intellectual Property Management.
The Patents Act has been repeatedly amended in 1999, 2002, 2005, 2006 respectively. These amendments were required to make the Patents Act TRIPS compliant. TRIPS stands for Trade-Related Aspects of Intellectual Property Rights. In this amendment patents were extended to all fields like drugs, food, Chemical etc.
Term of Patent
The term of the patent is 20 years from the date of application. 20 years from the date of application of patent. However in case applications filed under Patent Cooperative treaty (PCT), The term of 20 years begins from the international filing date.
Case Laws
Bayer Corporation vs Union Of India :-
India’s First Compulsory License
On March 9, 2012, the Indian Patent Office granted its first Compulsory License to Natco Pharma Ltd. for producing generic version of Bayer Corporations’s patented medicine Nexavar (Sorafenib Tosylate), which is used in the treatment of Liver and Kidney cancer. While the multinational giant was selling the drug at INR 2.80 lakh for a month’s course, Natco promised to make available the same at a price of about 3 % (INR 8800) of what was charged by Bayer. Natco was directed to pay 6 percent of the net sales of the drug as royalty to Bayer. Among other important terms and condition of the non assignable, non exclusive license were directions to Natco to manufacture the patented drug only at their own manufacturing facility, selling the drug only within the Indian Territory and supplying the patented drug to at least 600 needy and deserving patients per year free of cost.
Aggrieved by the Controller’s decision, Bayer immediately moved to the Intellectual Property Appellate Board (IPAB) for stay on the orderalleging that the grant of compulsory license was illegal and unsustainable. The Board rejected Bayer’s appeal holding that if stay was granted, it would definitely jeopardize the interest of the public who need the drug at the later stage of the disease. It further held that the right of access to affordable medicine was as much a matter of right to dignity of the patients and to grant stay at this juncture would really affect them.
Bayer then filed an appeal challenging the compulsory licence granted to Natco by the Controller-General. The Board stated that the invention must be available to the public at a reasonably affordable price and if not, compulsory licence can be issued and observed that the Sub-sections (a), (b) and (c) of Section 84(1) are separated by the disjunctive ‘or’ and therefore, even if one condition is satisfied, the Controller will be well within his rights to order compulsory license.
The Board further noted that The R&D costs and the prices of other drugs do not assist in deciding what the public can afford reasonably. It stated that the reasonably affordable price necessarily has to be fixed from the view point of the public and the word ‘afford’ itself indicates whether the public can afford to buy the drug. It also stated that even if it takes the appellant’s own number (i.e. the number of affected patients) it finds that the supply made by it cannot be said to be adequate and the price definitely is the factor that will determine whether the public will reach out for a particular invention.
The Board held that the Controller was right in holding that the sales of the drug by the appellant at the price of about 280,000/- wasalone relevant for the determination of public requirement and he was also right in considering the purchasing capacity of the public and the evidence available to conclude that the invention was not reasonably affordable to the public.
On the percentage of royalty that was to be paid by the Respondent to the Appellant (6% that was fixed by the Controller), IPAB increased it by 1 percent but did not change any other terms and conditions of the licence.
The IPAB dismissed the appeal and confirmed the grant of Compulsory license stating that it has dealt with each of the issue indetail in view of the significance of the order of compulsory licence made in India for the first time.
Novartis v. Union of India (2013) 6 SCC 1 :-
Rejection of a patent for a Drug which was not ‘inventive’ or had an superior ‘efficacy’-
Novartis filled an application to patent one of its drugs called ‘Gleevec’ by covering it under the word invention mentioned in Section 3 of the Patents Act,1970. The Supreme Court rejected their application after a 7 year long battle by giving the following reasons: Firstly there was no invention of a new drug, as a mere discovery of an existing drug would not amount to invention. Secondly Supreme Court upheld the view that under Indian Patent Act for grant of pharmaceutical patents apart from proving the traditional tests of novelty, inventive step and application, there is a new test of enhanced therapeutic efficacy for claims that cover incremental changes to existing drugs which also Novartis’s drug did not qualify. This became a landmark judgment because the court looked beyond the technicalities and into the fact that the attempt of such companies to ‘evergreen’ their patents and making them inaccessible at nominal rates.
Some of the case laws of design patent
SAMSUNG ELECTRONICS CO., LTD. V. APPLE INC. (S.CT. 2016)
The U.S. Supreme Court addresses the issue of damages in design patents under 35 U.S.C. 289. In this decision, the Supreme Court ruled that the relevant “article of manufacture” for arriving at a § 289 damages award need not be the end product sold to the consumer but may be only a component of that product.
This decision overrules the Federal Circuit’s 2015 Apple v. Samsung decision, at least as it applies to damage calculations under Section 289.
APPLE INC. V. SAMSUNG ELECTRONICS CO., LTD. (FED. CIR. 2015)
The is the primary appeal from the nearly $1 billion dollar trial verdict in the Apple v. Samsung litigation. In this decision Federal Circuit overturned the verdict with respect to Apple’s trade dress rights, finding that the evidence showed that the trade dress was functional and unprotected. However, the Federal Circuit held that the functional aspects in Apple’s design patents did not prevent a finding of infringement of those elements. The Federal Circuit found that it was not necessary to ignore functional elements in a design patent when considering infringement. The Federal Circuit also found that Apple should be awarded Samsung’s profits on the entirety of the infringing cell phones, a decision that was overturned by the Supreme Court.
ETHICON ENDO-SURGERY, INC. V. COVIDIEN, INC. (FED. CIR. 2015)
The Federal Circuit considered how to consider alternative designs when analyzing whether a design patent is invalid for being directed to a functional design. The Federal Circuit clarified that there is no mandatory test for determining whether a claimed design is dictated by its function. Nonetheless, an inquiry into whether a design is functional should being with “an inquiry into the existence of alternative designs.” As for infringement, the Ethicon decision clarified that the Egyptian Goddess case requires a consideration of the prior art only if the patented design and the accused device are not plainly dissimilar. Because the accused devise was not similar to the patented design, there is no reason to consider the prior art.
Conclusion
India patent act has many drawbacks and patent law treaty somewhere helps specially the developing countries to implement the act in a more better and precise way. Under this treaty the application of patent has become more efficient and effective.
References
This article was originally written by Suresh Koshy publishd on Boston University. The link for the same is herein.
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