Stories about: Patent Law

Will the Supreme Court’s decision on “gene patents” stifle medical innovation?

(bobosh_t/Flickr)
The Supreme Court's ruling did not hand a clear victory to either party.(bobosh_t/Flickr)
Nicole D. Kling, PhD, is a patent specialist at Nixon Peabody LLP who focuses on patent prosecution in biotechnology, the life sciences and biomedical advances. David Resnick, JD, of Nixon Peabody contributed to this post. Opinions expressed in this article represent only those of the authors, not Nixon Peabody or its clients.

The recent ruling by the U.S. Supreme Court brought Association for Molecular Pathology v. Myriad Genetics back to the headlines, with interest being stoked by Angelina Jolie’s recent disclosure of her double mastectomy.

The lawsuit revolved around patents owned by Myriad related to its BRACAnalysis test, which assesses the likelihood that a person will develop certain cancers, including breast cancer, by searching the DNA for disease-causing sequences. The patents under focus in this lawsuit claim genetic sequences isolated from, or derived from, human DNA—molecules created by manipulating, changing or adding to the DNA.

Myriad argued that the molecules they claimed do not exist as such in human cells and are instead the result of human manipulation and innovation.

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The battle over “gene patents” continues: the Department of Justice brief

Human GeneticsIn an earlier Vector post, I explained that Judge Sweet’s decision in The Association of Molecular Pathology v. The United States Patent and Trademark Office (also known as the ACLU v. Myriad case), invalidating Myriad Genetics patents on BRCA1 and BRCA2 DNA and testing, was only the first step in a long process to a final decision.  The next step was Myriad’s appeal to the Court of Appeals for the Federal Circuit, the federal court that hears all appeals in patent.  Myriad did file an appeal and as part of that process, interested parties were invited to file amicus curiae or friend of the court briefs.

Last week, many in the life sciences community were shocked when the Department of Justice (DOJ), representing the U.S.  government, filed a brief advocating for a change in policy on  the patent-eligibility of isolated genomic DNA. 

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