BAYER CORPORATION v. UNION OF INDIA [162(2009) DLT 371]
The case of Bayer Corporation v. Union of India [162(2009) DLT 371] set a precedent in Indian patent law by offering a more flexible interpretation of patent linkage, aligning it with the compulsory license framework and the application of the Bolar provision. The dispute involved Bayer Corporation, a US-based company holding a patent for the drug Sorafenib Tosylate used in kidney and liver cancer treatment, marketed as Nexavar in India. Natco Pharma Ltd., an Indian pharmaceutical company, sought a compulsory license after Bayer rejected their request for a voluntary license. The court analyzed Section 84(1) of the Indian Patents Act and ruled in favor of Natco, meeting the requirements for granting a compulsory license. The judgment emphasized public health concerns and the importance of balancing patent rights with public access to medications, raising concerns about the impact of patent linkage on generic drug availability and market monopolies.
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Introduction
Bayer Corporation v. Union of India and Others was the first case to give a liberal and more flexible interpretation of Indian patent linkage in line with its compulsory licence regime and application of the bolar provision.
The company involved in this case, the petitioner Bayer Corporation, is based in the United States. They researched and made a drug to help people with diseases related to kidney cancer and liver cancer. In India in 2008, the petitioner bought the patent for a drug called Sorafenib Tosylate. This drug is sold under the brand name Nexavar.
Natco Pharma Ltd. is the company at respondent in this case. It is an Indian pharmaceutical company that makes drugs.
Facts of the Case
Bayer Corporation, which is based in the United States, did research and made a drug to help people with diseases related to kidney cancer and liver cancer. The petitioner got the patent for the drug in 2008 in India. The drug is called Sorafenib Tosylate. Bayer turned down the request and didn't give Natco a grant of voluntary licence. After the 3-year period was up, Natco put in a request for a compulsory licence. Natco has been given a forced licence to make and sell the drug that Bayer invented and patented. Bayer also asked the company to pay a royalty of 6% of the total amount of drugs sold. Natco can't give the patent rights they were given to any of their heirs because they can't be given away or sold.
Issues
1. Whether the wants under Section 84(1) were glad for granting a required license?
2. Whether or not counterfeiters of a patented drug should be taken into account to see if an affordable demand test has been met.
3. Does the Medicines Act consider a drug or formulation that breaks a patent to be a "spurious drug"?
What the Indian Patent Law has to say
- Section 84(1) of Indian Patent Act, 1970
Section 84 of the Indian Patent Act is about giving out mandatory licences. Compulsory licences are given out so that: Patents don't get used as monopolies too often; Make it possible for someone who wants to do business with the patented invention to do so;
- Section 48 of Indian Patent Act, 1970
The Indian Patents Act of 1970 doesn't say exactly what kinds of actions violate patents. However, Section 48 of the Indian Patents Act of 1970 gives the patentee the right to stop others from making, importing, using, selling, or offering for sale the patented invention.
- Section 156 of Indian Patent Act, 1970
Patents can be used to bind the government. - Relating to the other parts of this Act, a patent has the same effect on the government as it does on any other person.
Analysis of the judgement
The Court ruled that all three of the requirements in clauses (a), (b), and (c) of Section 84(1) for giving an obligatory licence had been met. The court said that the question of whether or not the general public has been met should be answered by looking at the evidence that each party has brought forward. This kind of linkage probably hurts the "Bolar/Early Working" exception, which helps generic medicines get to markets after their patents expire quickly. This is a serious idea for public policy in Bharat, which has a lot of public health problems.
Conclusion
The court ruled in favour of the Respondents and said that the instrument petition could be put off. Patent Linkage forces regulatory authorities to do something that is totally in two different areas. This means that legal rights are constantly changing from being personal to being public. If patent linkage has to be used, it should be checked to make sure it doesn't get in the way of mandatory licencing. It could also stop foreign pharmaceutical companies from having a monopoly on the Indian market.
