Who Owns that Gene? Angelina Jolie, BRCA1, and Intellectual Property

DNA

While Angelina Jolie is well known as an A-list actress and partner of Brad Pitt, she also became a lightning rod in the very personal fight against breast cancer this week by announcing that she underwent a preventative double mastectomy after learning that she carries a mutation of the BRCA1 gene, which sharply increases her risk of developing breast cancer and ovarian cancer.

BRCA stands for breast cancer susceptibility genes, a class of genes known as tumor suppressors, according to the  National Cancer Institute.

What Does This Have to do With Intellectual Property?

Quite a bit actually. The U.S. Supreme Court recently heard arguments in Association for Molecular Pathology v Myriad Genetics. The case concerns the patentability of human genetic material (including the BRCA1 gene) and could have serious implications for the biotechnology industry, as well as impact a company’s risk analysis and IP insurance needs.

Back in May 2009 the Public Patent Foundation and the American Civil Liberties Union filed suit against Myriad Genetics, the University of Utah Research Foundation and the U.S. Patent and Trademark Office. The lawsuit alleged that Myriad’s patents on human genes associated with increased risk of developing breast and ovarian cancer were invalid. The case deals with the question of whether Myriad Genetics’ claims to isolated genes that have been derived from humans are eligible for patent protection.

Should compositions of matter – actual human genes – be eligible for patent protection?  The position taken by the plaintiffs is that these claimed DNA molecules are essentially the same as what already exists in nature, and that whatever changes have been made to them are not sufficient to merit patent protection.  In order for a patent to be issued, it generally must adhere to the four prongs of patentability:

The plaintiffs further contend that Myriad’s patent rights grant it an effective monopoly over diagnostic testing for mutations and abnormalities in the relevant genes, therefore preventing others from developing alternative diagnostic methods.

Ramifications for IP Risk Management and Biotech

Supreme Court is expected to hand down its decision within the next couple of months. While it is difficult to predict what effects the Supreme Court’s eventual ruling could have on the biotech industry, it may affect companies that are researching and developing other types of products derived from natural sources. If that is the case, then the consequences of the Supreme Court’s ruling could be very far-reaching indeed.

With an exploding market in intellectual property (IP) comes an inevitable rise in increasingly complex and expensive litigation, with far-reaching ramifications. The Myriad case is an example of the multibillion-dollar legal  battles fought over IP rights and the high levels of risk associated with IP-driven industries.

Although the significant value and risk of IP may be well-understood by executives and board members,  companies typically react to IP risk only when threats are imminent and adopt reactive approaches to deal with them. In dealing with cutting edge technologies, such as the Myriad patents, companies would be well served to be proactive in analyzing their potential risk in using or developing new technology.

An oversight of IP risks all too often leads to severe consequences for companies.  There’s no instant resolution, proactive, but disciplined, integrated use of sound risk management practices will help minimize intellectual property risk.

 

About Karl Pedersen

Karl is Willis' Senior Vice President for intellectual property and E&O insurance coverage, including media, te…
Categories: Intellectual Property, Life Sciences | Tags: , ,

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