Posts Tagged ‘biotechnology’
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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Tags: AIA, America Invents Act, AMP, ANDA, Bayh-Dole Act, biotechnology, biotechnology law, biotechnology news, caraco, court of appeals, Dr. Stefan Danner, European patent, Federal Circuit, intellectual property, ip, microsoft v i4i, Myriad, Patent Law, patents, Paul Cole, Pharmaceutical law, Prometheus v. Mayo, saint-gobain, Schutz, sherley, Stanford v Roche, Supreme Court, Therasense, USPTO, Warren Woessner, WDR
Posted in Miscellaneous | Comments Off
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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Tags: ACLU, AMP, Association of Molecular Pathology, biotechnology, biotechnology law, biotechnology news, BRCA DNA, Chakrabarty, diagnostic methods, Federal Circuit, Myriad, Myriad lawsuit, patent attorney, Patent Law, patents, SLW, Supreme Court, Warren Woessner
Posted in Patentable Subject Matter | Comments Off
Sunday, October 16th, 2011
As a much younger attorney, I gave a presentation at the 1990 AIPLA Annual Meeting: “A Review of Recent Federal Circuit Decisions Relating to Infringement” (AIPLA Selected Legal Papers, 9, 3 (July 1991)), in which I wrestled with the question of whether or not a novel and unobvious chemical composition would infringe under the doctrine of equivalents. Since this is the central issue that the Supreme Court will be asked to resolve in Saint-Gobain Ceramics v. Siemens Med. Sol’ns, Supreme Ct. No. 11-301, I thought these excerpts might be of interest:
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“Although no recent case (or any case) was found where the unobviousness of a substituted ingredient led to a holding of non-infringement of an accused composition that otherwise met the tripartite test, such a holding would be appropriate. At the very least, Atlas Powder Co. v. DuPont DeNemours & Co., 750 F.2d 1569 (Fed. Cir. 1985), suggests that an unexpected result achieved by the accused composition would support a finding of non-interchangeability [and thus, noninfringement].
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Tags: AIPLA, biotechnology, biotechnology law, doctrine of equivalents, Federal Circuit, intellectual property, ip, IP law tools, Patent Law, patents, saint-gobain, Supreme Court, Warren Woessner
Posted in Doctrine of Equivalents, Infringement | Comments Off
Friday, October 14th, 2011
Saint-Gobain Ceramics (“S-G”) has asked the Supreme Court to review the Fed. Cir. panel below, 647 F.3d 1373 (Fed. Cir. 2011) in which the panel decision refused to reverse a district court decision that instructed the jury that it could find infringement by S-G under the doctrine of equivalents (DOE) of a Siemens Medical Solutions USA patent on “LSO crystals” using a preponderance of the evidence standard, rather than the higher “clear and convincing” evidence standard, even though S-G held its own patent on a variation of the infringing crystals – “10% Y LYSO crystals.”
The jury found S-G guilty of infringement under the DOE and assessed damages. The Fed. Cir. affirmed that the jury had been instructed to apply the appropriate legal standard and a divided court denied the petition for rehearing en banc. 647 F.3d 1373 (2011). The denial crystallizes the central point that will be appealed, and it is all you need to read to get at the heart of the case. The majority opinions affirming the district court and the order denying rehearing were both authored by Judge Lourie, but there were three concurring opinions denying rehearing and a dissenting opinion by Judge Dyk, joined by Gajarsa and Prost- and all in twenty pages. This one is teed up for Supreme Court review.
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Tags: biotechnology, biotechnology law, biotechnology news, doctrine of equivalents, DOE, Federal Circuit, intellectual property, ip, LSO crystals, Patent Law, patents, saint-gobain, siemens, Supreme Court, Warren Woessner
Posted in Doctrine of Equivalents | 1 Comment »