This intriguing compilation “Excerpts From 15 AMICI Briefs Supporting Respondent Prometheus: Mayo Collaborative Services v. Prometheus Laboratories, Inc.,” was sent to me by Mark Corallo of Corallo Media Strategies, Inc., Alexandria, VA.
UNH Law used to be Franklin Pierce Law Center. Interestingly, SAP filed an amicus brief. Not surprisingly, so did Myriad.
Key Excerpts – Amici Briefs – Combined Revised
Thank you to Dr. Stefan Danner, a German and European Patent Attorney at DHS Patentanwaltsgesellschaft mbH in Munich for letting us post the current issue of the biotech IP newsletter dealing with the recent EPO decision concerning the patentability of drug polymorphs. A PDF of the entire newsletter is attached at the end of this post.
———————————-
On May 24, 2011, the EPO Technical Board of Appeal (TBA) 3.3.01 handed down decision T777/08 concerning the inventiveness of (specific) polymorphic forms of a drug previously only known in solid amorphous form. This decision caused considerable attention in the pharmaceutical industry.
The relevant claimed subject matter of European Patent EP 1 148 049 relates to crystalline forms II and IV of the statin drug atorvastatin hydrate that are characterized by an X-ray powder diffraction pattern expressed in terms of 20 angles, d spacings, and relative intensities with a relative intensity of >15% determined using CuKα radiation.
The full document can be found here 10.11. Inventive Polymorphs.
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:
* * *
“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].
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.
Bad Behavior has blocked 674 access attempts in the last 7 days.
The commentary presented herein represents the opinions of the author and not of Schwegman Lundberg & Woessner, P.A. or any other employee thereof. This commentary is provided for general informational and discussion purposes and should not be considered to be, or used as, legal advice to address any particular situation.
Minnesota Web Development Company - First Scribe