Patents – Trace Your Case

BAYER CORPORATION v. UNION OF INDIA

Bayer Leverkusen v. Union of India (2013) Indlaw IP AB 20

Whether a compulsory license can be granted in favour of Natco for the production of the patented drug?

Section 84(1) of the Patents Act allows any interested person to make an application to the Controller for the grant of Compulsory License after the expiry of three years from the date of grant of patent on any of the following grounds:
a) That the reasonable requirements of the public with respect to the patented invention have not been satisfied
b) That the patented invention is not available to the public at a reasonably affordable price
c) That the patented invention does not work in India.

Bayer, the Petitioner, is a corporation incorporated under the laws of the United States of America.
It invented and developed its patented drug to enable its administration to human beings named Nexavar. The patented drug is used in the treatment of patients suffering from Kidney Cancer and Liver Cancer.
Natco, a drug manufacturer in India, approached the Petitioner for a grant of a voluntary license for manufacturing and selling the patented drug in India.
The purpose behind it was to make the patented drug accessible to the public at an affordable price.
When applying for the voluntary license, Natco also stated the fact that the Petitioner had neither met the reasonable requirement of the public nor was it reasonably priced nor had it worked in the territory of India. Eventually, the petitioner rejected Natco’s application for a grant of a voluntary license.
Thereafter, Natco applied to the Controller General of Patents, Designs, and Trademarks for the grant of compulsory license which was granted by the Controller in 2011.
Aggrieved by this, Bayer filed a petition at the Intellectual Property Appellate Board, which also upheld the decision of the Controller. Finally, Bayer appealed to the Bombay High Court.

The Court saw no reason to interfere with the Tribunal granting a compulsory license under Section 84 of the Patent Act to Natco. Accordingly, the petition was dismissed.
The Court balanced patent rights and public health by noting the aim of increasing the availability of patented articles at reasonable prices.
The decision also highlighted the need for a balanced approach to patent law that considers both the interests of patent holders and the public interest in promoting access to essential medicines.

Association of Molecular Pathology v. Myriad Genetics, Inc., S. 576 (2013)

Whether isolated DNA sequences, which are human genes, patent eligible under Section 101 of the Patent Act?
Whether Myriad’s claimed invention BRCA 1 BRCA 2 and BRCA cDNA, the sequence of certain human genes in both isolated and purified forms, fall within the scope of inventions for which a patent may be granted?
Whether the product patents obtained by Myriad Laboratories on the discovery of genes, BRCA 1 and BRCA 2, and BRCA cDNA, on the human genome are valid under the provisions of 35 U. S. Code §101 and in consonance with the relevant jurisprudence on the matter?

35 U. S. Code §101: “Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”

The Association for Molecular Pathology, the Petitioner, sued Myriad Genetics Inc., the Respondent, challenging the validity of Myriad’s patents on the BRCA1 and BRCA2 genes.
These genes are associated with an increased risk of developing breast and ovarian cancer.
The Respondent had obtained patents on the genes themselves, as well as on methods of using the genes to diagnose and treat cancer.
The Petitioner argued that Myriad’s patents were invalid because they covered naturally occurring gene sequences that the genes are products of nature and that they cannot be patented.
The Respondent argued that its patents were valid because they covered the isolated and sequenced BRCA1 and BRCA2 genes, which are not naturally occurring.

However, the court agreed to grant a patent to the composition of cDNA because, it was clear that this was not a “product of nature”, in the sense that it did not exist in nature, its creation results in an exons-only molecule, which is not naturally occurring.
The Supreme Court held that naturally occurring gene sequences are not patent-eligible under Section 101 of the Patent Act.
It reasoned that genes are products of nature and that isolating or sequencing them does not create something new or different.
The Court also held that genes are not “manufactured” because they are not created by humans.