Patent Law

Assn for Medical Pathology v. USPTO & Myriad & the Directors of the University of Utah Research Foundation (S.D.N.Y. 2009)

A host of medical organizations, researchers, and cancer patients have filed a Section 1983 action against the USPTO, Myriad Genetics, and the University of Utah Research Foundation (via its directors) demanding that the BRCA gene patents be declared invalid as unpatentable under 35 USC Section 101.

"Because human genes are products of nature, laws of nature and/or natural phenomena, and abstract ideas or basic human knowledge or thought, the challenged claims are invalid under Article I, section 8 of the Constitution and 35 U.S.C. Section 101."

In addition, the suit alleges that the patents are unconstitutional under the First and Fourteenth Amendments to the US Constitution.

Myriad's patents allow the company to maintain a monopoly in the US over genetic testing for human BRCA1 and BRCA2 genes - markers for breast cancer. Claim 1 is directed to "an isolated DNA coding for BRCA1 polypeptide." (The patent defines the amino acid sequence of the polypeptide).

PubPat and the ACLU are serving as attorneys for the plaintiffs.

Notes:

• Read the Complaint: BRCA1 complaint.pdf
• NYTimes Article
• ACLU Blogs Here (with pictures of the plaintiffs).
• The gene patenting debate has been interesting - emphasis here on has been. The genome has been mapped and sequences published. Very few new patents claiming isolated human genes are being filed. The ones already patented will expire within the next decade -- most of them will expire before being put to any practical use.  
• Caplan of CNN Says "Lawyers who work on patents in the pharmaceutical and biotechnology industries are sweating bullets today." This is good, because the US is currently suffering under a bullet shortage.
• On May 6, PubPat filed two other lawsuits.
• PubPat v. Cumberland Packing (alleging false marking of its Sweet n Low sugar packets).
• PubPat v. Iovate (alleging false marking of Xenadrine).