IPAB upholds Natco’s Compulsory License on Nexavar

Natco, Hyderabad-based generic manufacture, had filed for a Compulsory License on Bayer’s Cancer Drug Nexavar in July 2011 as the reasonable requirement of public was not met, drug was not available to public at reasonably affordable prices, and that the patentee failed to work the invention within the territory of India.

Based on the aforementioned reasons, India’s first compulsory license was granted to Natco. However, Bayer, German manufacturer of Cancer drug Naxevar, was highly disappointed with the ruling and thus appealed to The Intellectual Property Appellate Board. More details about the case can be found here

image taken from here

The Intellectual Property Appellate Board rejected the German drug maker’s appeal of the 2012 ruling on this Monday. It also ruled that under the license Natco must pay 7 percent in royalties on net sales to Bayer.

What would this ruling mean?

•  Price of the ant-cancer drug, Naxevar would come down remarkably. Natco’s version would cost Indian patients $175 a month, less than 1/30th as much as Bayer’s.

•  Encourage more generic companies to traverse the same path, and apply for Compulsory licenses to bring down healthcare costs and provide access to affordable drugs to treat diseases such as cancer, HIV and hepatitis.

• Pharmaceutical Research and Innovation may take a step –back.

• Affect the overall International Patent System.

 Bayer is disappointed with the ruling and has clearly expressed that it is not yet ready to throw in the towel. They are continuing the fight to overturn the decision in their favor by pursuing the case in Mumbai’s High Court.

Thriller Novel on Drug Patents to hit stands soon

Patent law has not been immune to fiction writing. Quite a few novels, ranging from science fiction to thriller stories,  have earlier been based on patents.

A Patent Lie by Goldstein, Professor at Stanford,  and Killer Smile, by  Scottoline, are two examples of patent thriller novels that have done well. Through realistic stories and relatable characters, these novels bring forth nuances of the patent system in a manner easily comprehensible by the common public. In the line  of said novels and inspired from real cases in India, Dr. Kalyan, one of our bloggers, has written a novel entitled, Road Humps and Sidewalks, relating to drug patents.

Road Humps and Sidewalks is the story of a young, blind lawyer's clash against a multi-national pharma company, in his quest to save lives. In Ms. Caroline Ncube's words, in her review of the novel  on IP Cat, "This 164 page IP law thriller has all the hallmarks of a winner; corporate espionage, attempted kidnapping, foiled hits, court room romance, a corrupt Chief Justice and a David v Goliath (Pharma v generic company and public hospitals) battle over patents for a life-saving drug. ... (read more)."  The novel is set to release shortly and is now available for pre-release order. You may visit www.kalyankankanala.com for more details about the novel. What storm awaits this novel by Kalyan? Only time will tell.

 By the way,for those of you, who are interested in getting your hands on this novel, Kalyan has started a free give away program on good reads. Three copies of the novel will be given away based on a random algorithm of good reads. You may visit, http://www.goodreads.com/giveaway/show/44748-road-humps-and-sidewalks, if you wish to opt for the free give away.

Australian Federal Court upholds BRCA1 gene as patent worthy!

In the landmark Australian case, Cancer Voices Australia (ABN 93 322 703 427) & Anor v Myriad Genetics Inc & Ors, the Federal Court of Australia has ruled in favor of Myriad Genetics saying that patent claims directed to the gene BRCA1, a human breast and ovarian cancer disposing gene to be worthy of a patent.



Amongst all the criteria for patentability, when it comes to patenting gene or genetic sequences, “subject matter” has been the most controversial. Also, subject matter with respect to gene patents is treated very differently from legislation to legislation.

The idea of patenting genes has always raised eyebrows. While anti-patent groups believe that genetic material (DNA and RNA) are naturally occurring and existing inside the cells of human body, thus cannot be subject of a patent. On the other hand, pro-patent groups argue that, material such as DNA which is isolated, extracted from cells differs from its intracellular counterpart in that it is no longer a part of a chromosome. Further, they claim only a protein-encoding part of a gene and not the intermediary sequences. Their argument is based on the fact that no isolated gene sequence occurs in nature, thus worthy of a patent.

The gene in question, in this case is BRCA1. The Federal Court of Australia affirmed the existing position in Australia and upheld that claims directed to the gene BRCA1 is patentable subject matter (i.e. a manner of manufacture)

Facts about BRCA gene

BRCA1 and BRCA2 are human genes that belong to a class of genes known as tumor suppressors. In normal cells, BRCA1 and BRCA2 ensure stability of the cell’s genetic material (DNA) and prevent uncontrolled cell growth.  A mutation of these genes has been correlated to the development of hereditary breast and ovarian cancer.

It would be interesting to see how various jurisdictions are influenced by the decision of Australian Federal Court to uphold patents on BRCA1 gene.

Image taken from here