Archive for December, 2011

Top 2011 IP Stories on Patents4Life

Saturday, December 31st, 2011

I spent a day or two looking back over the breaking IP news that resulted in posts on Patents4Life. I wrote most of them, but want to take a pause to thank regular contributors Paul Cole, Ron Schutz and Stefan Danner for their help. Patents4Life was originally intended to be a “blawg” focused on IP developments affecting the Life Sciences and, as 2011 comes to a close, I have put together a “top ten” list of stories to which attention had to be paid – by all of us in most cases – litigators, prosecutors and tech transfer professionals in the U.S. and abroad. The single most-apparent trend in IP last year was the increasing globalization of IP law – consider inter-office work-sharing and the prosecution highway. But I don’t want this column to go on into 2012, so here, in reverse order, are the “legal events” that dominated the netwaves in 2011. (I apologize for what I hope will be minor errors of fact and spelling – I am writing this from notes I made while back-tracking through the year.)

10. The Stem Cell Suits. In Sherley v. Sebelius, the district court finally dismissed the suit which had resulted in a ban on Federal funding for stem cell research, after the Court of appeals reversed its initial decision. (See Post, July 28th). However, in October, the Court of Justice of the EU ruled that claims to embryonic stem cells or even to cells that could become sources for embryonic stem cells were not patentable. (See post, Oct. 18th). Some types of gene therapy were indicated to be allowable. The future of embryonic stem cells is cloudy with a chance of further retreats like Geron’s.

9. On October 18th, Saint-Gobain petitioned for cert., urging the Supreme Court to answer a burden of proof question that comes down to: “Does holding a patent on an improvement on a patented invention that does not literally infringe insulate the accused infringer from infringement under the doctrine of equivalents?” This question has been simmering under the surface of infringement law for decades, the Fed. Cir. is clearly divided and the Supreme Court might bite. See Post of March 8, 2011 as well as October 14th post.

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AMP Petitions for Cert. and A Look Back

Friday, December 16th, 2011

The Association for Molecular Pathology (AMP) has petitioned the Supreme Court to review the Fed. Cir.’s opinion of July 29th, that isolated BRCA DNA sequences are patentable subject matter. Its brief (a copy available at the end of this post) contains little that is new in the way of argumentation, and relies heavily on the “rule” it found in Chakrabarty that a composition of matter must possess markedly new characteristics upon isolation, as compared to its naturally-occurring state, in order to be patent eligible.

But as the year closes, let’s take a minute to mourn what was lost in July. As I noted in my July 31st post on the decision, “The one hundred plus pages of opinion spent only about five pages on the ‘diagnostic’ method claims….Judge Lourie took care to distinguish the transformative elements of the claims at issue in the Prometheus decision from the minimalist Myriad method claims.” In fact, Judge Lourie found that the method claims which only involve “comparing” and “analyzing” DNA sequences fail the M&T test and are no more than abstract ideas. However, in re-reading the opinion, I was surprised to note that at least one “diagnostic method” claim was also found patent-ineligible. Claim 2 of the ‘857 patent reads:

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Oral Argument in Mayo v. Prometheus – Why Mayo Will Lose

Friday, December 9th, 2011

On December 7th at 10:05 a.m., the Supreme Court heard oral arguments (transcript at end of this post) in the “Prometheus case,” presented by Stephen M. Shapiro of Meyer Brown (Mayo) and Richard P. Bess of Latham & Watkins. Solicitor General Verrilli also argued.  In earlier posts on this appeal, e.g., on November 7th, I noted that Mayo’s brief de facto asks the Court to follow the “LabCorp dissent” (548 U.S. 132, 136). In this dissent from a dismissal of cert. as improvidently granted, Justice Breyer, joined by Souter and Stevens, urged the Court to consider that all simple diagnostic tests that correlate a level of a chemical marker (like homocysteine) to a pathology (like a vitamin deficiency) are no more than impermissible attempts to patent natural phenomena: “[T]he process is no more than an instruction to read some numbers in light of medical knowledge.”

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BIO’s Modest Proposal – Eliminate Rule 56

Wednesday, December 7th, 2011

BIO recently sent Director Kappos 13 pages of comments on the PTO’s proposed revisions to 37 C.F.R. §1.56(b). (A copy of the comments is available at the end of this post.) BIO clearly is struggling to reconcile the differing views  of its members, and mostly succeeds. The comments give a good background on the development of the PTO’s duty of disclosure and the role of the judiciary in developing the inequitable conduct defense:

“Paradoxically, the development of the [IC] doctrine was driven, at least initially, by the well-intentioned belief that the judicial enforcement of applicant disclosure obligations in private actions to which the USPTO is not a party would nevertheless help the USPTO in getting its job done.”

This has obviously not occurred, and the comments note that in Therasense, the Fed. Cir. “declined to adopt the USPTO’s  definition of materiality as the judicial standard, recognizing that its prior efforts to enforce the USPTO’s materiality standards had actually contributed to the problems that led the court to take up this case in the first place.”

Despite this inherent tension, the comments go on to conclude:

“The USPTO proposes a literal importation of the judicial materiality standard into its Rule 56…There is good reason to believe, however, that the Therasense standard, in the course of judicial interpretation, will be subject to drift in the courts over time….thereby inviting creep and uncertainty in the operation of Rule 56….In short, most BIO members do not agree that administration of a judicial standard that is sure to evolve – and likely to erode – over time is the approach that will most benefit the USPTO and the applicant community.”

Responding to member input that there are few types of prior art that are not readily available to Examiners, and that the AIA pre- and post-issuance procedures will provide even more relevant information to Examiners, the comments get to the heart of the question and put a stake through it:

“The USPTO has not provided a clear explanation of why it continues to need Rule 56. If the  PTO wants only the Therasense standard ["hard" but-for materiality and specific intent to deceive], then there would seem to be no need for the rule – it is already the law. If the intention is to prevent fraud, lying, falsification, perjury and the like, federal statutes such as Section 1001  of Title 18 of the U.S. Code provide the applicable standard and the appropriate reach. The USPTO should affirm that it seeks nothing more.” 

Not just pretty words!

BIO Comments