Posts Tagged ‘Supreme Court’

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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HUMAN GENOME SCIENCES v. ELI LILLY – Increased European Harmony?

Friday, December 2nd, 2011

By Paul Cole, European Patent Attorney, Lucas & Co – Warlingham, UK

Judgement – Human Genome Sciences Inc (Appellant) v Eli Lilly
and Company (Respondent)

The above proceedings relate to European Patent (UK) 0,939,804 concerning a new  human  protein called Neutrokine-α. The specification explained (i) the existence and amino acid sequence of Neutrokine-α, (ii) the nucleotide sequence of the gene encoding for Neutrokine-α, (iii) the tissue distribution of Neutrokine-α, (iv) the expression of Neutrokine-α by its mRNA (the encoding gene) in T-cell and B-cell lymphomas, and (v) that Neutrokine-α is a member of the TNF ligand superfamily.  The specification described the invention as potentially useful for the diagnosis, prevention, or treatment of a large number of disorders of the immune system, either through Neutrokine-α itself or through its antagonists. However, nowhere in the Patent was there any data or any suggestion of in vitro or in vivo studies, so there was no experimental evidence to support any of those suggestions.

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