The Global Significance of India’s Pharmaceutical Patent Laws

Dr. Rajeshkumar Acharya

Patents are one of the major forms of Intellectual Property Rights (IPRs) used in the pharmaceutical industry. Significant changes to India’s patent system occurred after India signed the Trade Related Aspects of Intellectual Property Rights (TRIPS) agreement in 1995. India being a signatory of the TRIPS agreement was under a contractual obligation to amend its Patents law to make it compliant with the provisions of the agreement. The first amendment in this series was in the form of the Patents (Amendment) Act, 1999 to give a pipeline protection[1] till the country starts giving product patents for pharmaceutically based inventions. It laid down the provisions for filing of applications for product patents in the field of drugs and agrochemicals with effect from 1st January 1995 as mailbox applications and introduced the grant of Exclusive Marketing Rights (EMRs) on those patents. To comply with the second set of TRIPS obligations, India further amended the Patents Act, 1970 by the Patents (Amendment) Act, 2002. Through this amendment provision of 20 years uniform term[2] of patent for all categories of invention was introduced, i.e. patents have a limited term of 20 years counted from the date of filing the patent application.

The third set of amendments in the patent law was introduced as the Patents (Amendment) Act, 2005. In 2005 the Indian Patents Act, 1970, which provides patent protection for pharmaceutical products and drugs, was amended. This amendment, however, only provided patentability of pharmaceutical substances to the extent that patents would apply to new chemical entities. Section 3(d) of the Patents Act, 1970, explains that a new form of a known substance, new property / new use for a known substance and the mere use of a known process are not patentable and is not considered distinct from the known substance. Based on this principle, inventions using known substances are not patentable unless, for example, the alleged invention displays a significant increase in efficacy. Though there were several outcries from both the generic pharmaceutical and other innovator companies, the fact of the day is that section 3(d) still controls patent eligibility[3]. There are still several patents that are being granted for salts, ethers, esters, polymorphs and other “derivatives of known substance” as mentioned in the clause. This is because the Indian law provides a provision for patenting such derivatives if there is an enhancement of efficacy.

India had agreed to oppositions as a founding member of World Trade Organisation (WTO) more than ten years ago. The oppositions are mainly pre-grant, wherein an opposition can be filed till the date of grant of application; post-grant, wherein the opposition can be filed till one year from the date of grant; and revocation that is filed after one year of grant.

Nevertheless, effective use of these opposition provisions is not being made by many companies and only a small percentage of granted patents are being opposed. It must be admitted that the oppositions can become tiresome because in India. A pre-grant opposition does not prevent the same or a different party from applying for post-grant opposition and, later, a revocation. This leads to delay in the execution of the Patents and such delays are of course, a big cause of worry for multinational corporations (MNCs,) as a patent’s term starts from the date of filing of the application. On the other hand, the Indian Patent Office, in most cases, decides oppositions much faster than many other countries.

Suggestion to link generic approvals with patents

In India, a generic manufacturing company can apply for marketing approval of a generic product even if the patent status of the originator reference product is valid. However, the approved generic drug cannot be brought to the market if the patent of the originator drug is in force. There are different authorities responsible for the grant of a patent and marketing approval in India. Currently, the Indian Patent Office grants the patent and Drug Controller General of India (DCGI) provides marketing approvals without cross-checking with the other division. There is “patent linkage” between or among India’s national regulatory authorities. Moreover, the DCGI does not maintain any register of patented pharmaceuticals like the “orange book” in the United States.[4] Hence, a generic manufacturer who launches a new drug product in Indian market does so at their own risk and without necessarily being aware of any conflicting patents.

Patent linkage is not available, but a direct attempt to push Patent linkage was attempted in India by Bristol-Myers Squibb Company prohibiting the Drug Comptroller General of India (DCGI) from granting marketing approval for a generic version of Sprycel (dasatinib, used to treat chronic myeloid leukemia) and secured an exparte injunction.[5] There are proposals to link marketing approvals with patents. However, there are still some major roadblocks for this proposal. Currently, as a temporary solution, DCGI has asked the industry to provide details of granted patent for new medicine, with an intention to pass patent details to the Indian Patent Office and obtain an opinion before approving generic drugs.

Biological Products

In terms of novelty, the complication for a biotechnologist is demonstrating that their creation is a ‘new’ process rather than merely a natural one. Obtaining a patent also requires that an inventor demonstrate that their invention is the first in the world to do its specified action (i.e., the mechanism of action of its therapeutic process). When an inventor applies for a patent, he or she must demonstrate that the creation meets specific eligibility requirements: an invention must fall under subject-matter eligibility, have utility, novelty, be non-obvious, and not have been previously disclosed. Biotechnology inventors may have difficulty demonstrating the novelty of their proposed invention because many biotech creations are iterations or improvements of naturally occurring methods or processes. One specific issue that faces confusion in this field is gene-editing technology. Controversies surrounding this area of biotechnology patents were particularly felt after the U.S. Supreme Court’s 2012 decision[6] in Myriad v. Association for Molecular Pathology v. Myriad Genetics.[7]

Many biotechnological firms believe that the law is not clear on patentability of biomolecules, i.e. nucleic acids and polypeptides, and determinations of patent eligibility remains too subjective.

In addition, limitations on the allowability of products under the section 3(d) and the requirements for disclosure of geographical origin and source of biological materials used for invention are still areas of concern for many biotechnological firms. Many firms are of the opinion that by revealing the source and origin, they are also providing information that would support opening a ground for opposition.

The Patents ahead

Many pharmaceutical giants have announced expansions of their Indian operations. However, even though pharmaceutical companies are increasing their footprint in India, they are still concerned about infringement. Thus, they are very cautious about product introduction until their patents are demonstrated to be effective at preventing infringement. There is, however, a longer-term issue that relates to evergreening[8] patents remain.  There are lingering concerns in many minds that if patent rights are extended using evergreening tactics, the de facto patent extensions will adversely affect access to medicines, particularly in developing countries. Extending patent protection by obtaining patents where only marginal improvements are disclosed may permit MNCs to impose or continue high drug costs (relative to generic formulations) that would affect drug accessibility. This is particularly problematic for poor, underserved, and third-world populations where high costs may preclude drug access. The pharmaceutical products in the developing countries where the patent laws are in transition face the risk of testing them for the first time, as there is high uncertainty regarding patent eligibility and enforceability in developing countries compare to IP/legal systems of developed countries.

One high-profile case that illustrates some of the challenges in patenting of medicines is the Tarceva case[9]. The Indian patent application on Tarceva was filed in 1996 by Roche and was granted in 2007.  Roche intermittently[10] obtained a market approval from the Drug Controller General of India to market Tarceva in 2006. Cipla, a competitor of Roche, launched a generic version of Tarceva in 2008. Roche filed a suit for infringement against Cipla immediately thereafter. A division bench of the Delhi High Court upheld an earlier ruling that allowed Cipla to manufacture and market a copy of patented drug Tarceva in the Indian market citing that there is a price difference between the drug sold by Roche and its generic version by Cipla. The court did not want patients to be deprived of a low-cost alternative by disallowing sales of the generic product as there was substantial price difference. For the first time in India, a court recognized the need to consider public interest in allowing or rejecting an order for injunction. While on the one hand MNCs are using evergreening tactics to extend their patent monopolies, section 3(d) is protecting poor people paying from higher money for their medications. Though, many innovator companies feel cheated as they are unable to recover the cost of “drug discovery”. Legal system in India will have many more such cases in coming years. There will be a need for having specialized court / legal experts’ pool to hear these legal cases. However, Indian government should continue to ensure that the best interests of its population are kept in mind without coming under the international pressures.

Before applying for a patent, researchers should carefully balance considerations relating to patentability and seek advice from a patent expert. The Indian patent law is an exemplary piece of patent legislation that is aimed to balance the interests of both the common man and the inventors but it is complex. After the introduction of product patent regime[11], a wide range of pharmaceutical products can be patented in India. Once acquired, patent rights can be transferred through assignment or licensing to other persons or companies. Organizations such as academic institutions and universities not having sufficient manufacturing or marketing capacities can use patents as an effective tool for technology transfer and product development. These organizations can outsource their patented products/ processes to third parties and in return they can earn revenues to recoup the investments made in the development of such products/ processes. Compulsory license[12] is also a tool to provide an opportunity to market the patented products under certain conditions.

References:

1. link.springer.com (Is ‘evergreening’ a cause for concern? A legal perspective- September 20, 2007 by Scott Parker & Kevin Mooney)
2. https://www.lawteacher.net/ (Product Patent Regime in the Indian Pharmaceuticals Industry- June 25, 2019)
3. https://indiankanoon.org/(Doc-64813, F. Hoffmann-La Roche Ltd. And Anr. vs Cipla Limited- March 19, 2008)
4. https://www.labiotech.eu (The complications around Patenting Biotechnology- Patentability requirements, August 01, 2019)
5. www.mondaq.com (India: Product Patent Regime & Pharmaceutical Industry In India - The Challenges Ahead- January 10, 2005)
6. https://www.biospace.com/ (The Biotechnology Patent Landscape by Carly Klein- complications obtaining biotech patents- April 26, 2019)
7. https://www.researchgate.net (The Impact of Patent Linkage on Marketing of Generic Drugs, Journal of Intellectual Property Rights 18, 2013 316-322)
8. Section 3(d) of the Patents (Amendment) Act, 2005, No. 15 of 2005 (April 4, 2005)