On January 30th, the White House released a press release expanding upon President Obama’s mention of “precision medicine” in his State of the Union Address. Not surprisingly, the details are pretty much what we who are involved in various aspects of “personalized medicine” would expect – an emphasis on the use of genomic diagnostics to improve treatment selection – especially for cancer patients. The largest of the “Key Investments” listed would be to the NIH to develop what looks like the creation of a reference data base “through engaged participants and open, responsible data sharing.” The NCI would get $70 million to “identify genomic drivers in cancer” and develop more effective approaches to treatment.
Posts Tagged ‘biotechnology law’
Although the primary focus of this four day meeting was licensing, there were two simultaneous tracks that contained at least a section of the effect/uncertainty of the recent judicial decisions and PTO Guidelines on licensor/licensee relationships. (I spoke at one of them, and my short slideshow is posted on the AIPLA website, along with a longer “law review”-type article that is, by now, a bit out of date.)
What got me out of bed this morning was the “President’s Forum –What’s Next for Patent Eligibility: Federal Circuit and the USPTO Gloss.” It was chaired by Sharon Israelson, current AIPLA president and included Jerry Selinger – who is heading up an AIPLA working group on the issue, Myra McCormack of J&J, Nate Kelly, Solicitor, USPTO and Jim Crowne of AIPLA. Of course, this was too many speakers for an hour-long forum.
Yesterday, Myriad announced it has settled the BRCA assay litigations that had been ongoing—and not going well– with Pathway Genomics, Invitae and Gene by Gene (and I assume….Ambry and Labcorp). Although I was just about at the brink of shouting “Stop The Madness” – the settlements mean that the IP community will not learn if Myriad had any patent-eligible claims in any of their assay patents. Would claims directed to mutations at specific positions of the BRCA1 or 2 genes have passed muster as that elusive “inventive concept” that both the Fed. Cir. and the S. Ct. extracted from Mayo as the standard by which to judge assays reciting abstract ideas or natural phenomena (which one is it?)?
You can read an article about the settlement on the GenomeWeb page by clicking here.
Although much more attention has been focused on the portion of this recent Fed. Cir. decision that held a defendant could “induce itself” into infringement under s. 271(1)(f), by sending one part of a kit to be assembled abroad, the s. 112, para. 1 portion of the decision deserves some attention. This is particularly true in the written description requirement (WDR) era the biotech industry has been living in since the Ariad decision enshrined the WDR as an effective claim killer. Promega Corp. v. Life Technologies, App. No 2013, -1029, -1376 (Fed. Cir., December 15, 2014) (a copy is available at the end of this post).
Trying to make a long decision short, Promega asserted patents claiming kits having primers that would co-amplify a set of at least three STR loci wherein the set of loci are selected from the sets of loci consisting of D3S1539, D19S253…etc. As you might imagine, Life Technologies, these claims were treated as closed, and Life Technologies easily avoided infringing them.