In an unusual (if not unprecedented) move, the Solicitor General of the United States wrote a letter to the Federal Circuit asking that oral argument in Association for Molecular Pathology v. Myriad Genetics be scheduled for April 4, 2011. The Solicitor General (Neal Katyal) noted that “the United States will file an unopposed motion to participate in the oral argument” and that he intends to ”personally be presenting the oral argument on behalf of the United States.”

The Department of Justice’s Position In Myriad

As I wrote previously, the United States Department of Justice filed an amicus brief in the Federal Circuit appeal that took a position between that of the ACLU and Myriad. One the one hand, the DOJ argued that engineered DNA molecules, including cDNAs, are human-made inventions that are eligible for patent protection. On the other hand, the DOJ argued that isolated but otherwise unmodified genomic DNA is not a human-made invention and so is not eligible for patent protection.

The DOJ brief was remarkable for admittedly taking a position contrary to longstanding USPTO and NIH positions:

We acknowledge that this conclusion is contrary to the longstanding practice of the Patent and Trademark Office, as well as the practice of the National Institutes of Health and other government agencies that have in the past sought and obtained patents for isolated genomic DNA. The district court’s judgment in this case, however, prompted the United States to reevaluate the relationship between such patents and the settled principle under Supreme Court precedent that the patent laws do not extend to products of nature. For the reasons below, the United States has concluded that isolated but otherwise unaltered genomic DNA is not patent-eligible subject matter under 35 U.S.C. § 101.

The Solicitor General’s announcement that he will “personally” argue this position at the Federal Circuit shines an even brighter spotlight on this case. While many biotech patent practitioners disagree with the DOJ’s position on the non-patent-eligibiity of “isolated” DNA, it will be up to the Federal Circuit in the first instance, and then the Supreme Court, to say what the law is.


**New Feature: Life Sciences Agreements**

I am excited to announce a new feature on PharmaPatentsBlog. Starting tomorrow, my colleague David Charapp will be periodically writing about interesting collaboration and licensing deals in the life sciences space. David is chair of Foley & Lardner’s Life Sciences Collaborations & Licensing Practice and a member of the firm’s Private Equity & Venture Capital and Transactional & Securities Practices. He represents life sciences and technology companies in structuring, drafting and negotiating many different types of collaborations and agreements, and looks forward to sharing his insights with our readers.