Posts Tagged ‘biotechnology news’

USPTO Report on State of Confirmatory Genetic Testing Comes off the Waffle Iron

Monday, October 12th, 2015

waffle-ironIn 2011—after the Fed. Cir. decision in Myriad upholding claims to BRACA1 and 2 genes—the PTO was tasked by a section of the AIA with providing Congress with a report on the effect of patenting on confirmatory genetic testing. The report has finally been released and, predictably, has little in the way of solid conclusions – especially since hard data in this area has always been wanting. (A copy of the report is available at the end of this post.) For example, addressing the question about the effect of access to confirmatory genetic testing on the quality of medical care, the report “concluded”: “Where evidence was available, it was often not of the magnitude, quality or rigor that scientists generally consider reliable in drawing conclusions.” The report estimated that only 1-5% of patients who were genetically tested, e.g., for mutations relating to a predisposition of a pathology, needed further testing.

Significant to the IP community, the report stated that the decisions in Myriad and Mayo invalidating many of the claims of the patents that were on appeal four years ago, has “dramatically changed” the “patent landscape” and cleared “some hurdles” that may have prevented patients from getting confirmatory  genetic diagnostic testing. Of course, post Myriad, the PTO and, more ambiguously, the Fed. Cir. have taken the position that most diagnostic claims are not patent eligible. That removes a lot of “hurdles” for any organization that wants to copy a diagnostic test that is, or could have been, patented not so long ago.


Physiology/Medicine Nobels Awarded for Discoveries of “Natural Products”

Thursday, October 8th, 2015

nobelIn re Roslin Institute, a Fed. Cir. panel consisting of Judges Dyk, Moore and Wallach ruled that clones including Dolly the sheep were not patent eligible. Judge Dyk, writing for the panel endorsed the “markedly different” structure requirement for patent eligibility that the PTO had proposed abandoning in December 2004:

“[According to Chakrabarty], discoveries that possess ‘markedly different characteristics from any found in nature,’ are eligible for patent protection. In contrast, any existing organism or new discovered plant found in the wild is not patentable.”

In Ariosa, Judges Renya, Linn and Wallach turned a method of isolation of cffDNA into a “natural product”:

“The method therefore begins and ends with a natural phenomenon. Thus the claims are directed to matter that is naturally occurring….Because the claims at issue are directed to naturally occurring  phenomena, …the practice of the method claims does not result in an inventive concept that transforms the natural phenomenon of cffDNA into a patentable invention.”


Shire v. Amneal Pharma – Adjusting the Rearview Mirror

Wednesday, September 30th, 2015

iStock_000023270394_SmallWhile the IP law world is being rocked by new developments in biosimilars, patent-eligible subject matter and IPR’s, it is almost refreshing to see a decision upholding the validity of claims to a “small molecule” drug based on application of the principles of obviousness–particularly the no-no of hindsight reconstruction. Shire LLC v. Amneal Pharmaceuticals, LLC, Appeal no. 2014-1736 et al. (Fed. Cir., September 24, 2015). (A copy of this decision can be found at the end of this post.)

This was a straightforward Hatch-Waxman infringement suit, during which Shire had to defend the validity of four patents covering a derivative of “speed,” L-lysine-d-amphetamine (“LDX”) dimesylate, marketed as Vyvanse® to treat autism. Defendants needed to convince the court that it would be obvious to both make the L-lysine derivative of d-amphetamine and then to make the dimesylate salt.


Sandoz Launches First Biosimilar Drug in U.S.

Friday, September 4th, 2015

AiStock_000013653107_Small new chapter in the generics/innovator wars began Thursday as Sandoz, Novartis’ generics division launched its Neupogen biosimilar, Zarxio, in the U.S. at about a 15-30% discount from the price of Neupogen. While biosimilars have been marketed in Europe since 2006, Congress established the regulatory framework for biosimilar drugs in the US in 2010, with the passage of “Obamacare.” Neupogen has been on the market for more than 20 years.