Archive for February, 2011

Centocor v. Abbott: Fed. Cir. Takes New Written Description Requirement Out For A Spin.

Friday, February 25th, 2011

In an important post-Ariad decision, the Federal Circuit reversed a district court decision that Abbott’s Humira infringed claims of a Centocor patent that could have cost Abbott $1.67 billion in damages. (A copy of the decision is at the end of this post.) Humira is a fully-humanized antibody against TNF-alpha. While Centocor obtained U.S. Pat. No. 7,070,775 (a copy is available below), that contained claims to such antibodies, it needed to be able to assert the priority of an earlier application in a long chain of CIP filings, in order to pre-date the filing date of Abbott’s patent covering the product. Applying the Ariad v. Lilly written description requirement standards, the Fed. Cir. panel denied Centocor priority, essentially finding no adequate description of a completely humanized antibody in the priority document and thus no description adequate to support the later-issued claims.

Although a number of commentators have already written on this decision, two aspects stand out as deserving attention. The first is how the “new” written description requirement is being used as an “easy button” by the Fed. Cir. to dispose of what, in some cases, are pioneering biotech patents that issue with broad claims. (Apart from Ariad, think back to U. of Rochester v. Searle or even to UC v. Lilly itself). No need to resolve messy and complex factual issues involving enablement issues when, as Judge Prost put it, “A patent also can be held invalid for failure to meet the written description requirement based solely on the face of the patent specification [citing, U of Rochester v. G.D. Searle]…Ultimately, ‘the specification must describe an invention understandable to [a POSA] and show that the inventor actually invented the invention claimed [citing UC v. Lilly].’”

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Mumbo Jumbo: The Patentability of Biological Materials In Australia

Friday, February 25th, 2011

From Vaughn Barlow of Pizzeys Patent and Trade Mark Attorneys.

1. Introduction

The Patent Amendment (Human Genes and Biological Materials) Bill (2010) is currently being debated before the Australian parliament. The Bill seeks to ban the patenting of all biological material that is “identical or substantially identical to such materials as they exist in nature”. If passed, this legislation would represent a major shift in Australian patent law. It may also significantly jeopardize the biotechnology, pharmaceutical, medical and agricultural industries in Australia.  This article therefore examines the current patentability of biological materials in Australia, charts the evolution of public debate surrounding this issue, sets out the proposed ban on patentable subject matter, and briefly discusses the ramifications of such a ban.

You can download the entire article here.

Patentability of biological materials in AU FINAL VPB

AUTM Panel To Address A “Myriad” Of Challenges

Thursday, February 24th, 2011

Robert S. MacWright, J.D., Ph.D., the new head of tech transfer at the Salk Institute, will moderate a panel at the 2011 Annual Meeting of the Association of University Technology Managers (AUTM) on March 1st in Las Vegas.  The panel, entitled, “The Ever Changing Kaleidoscope of U.S. Patent Law,” will examine what MacWright terms “a decade of meddling by the legislature and the courts.” The “panel of experts” – that will include, Sandra Kuzmich of Frommer Lawrence, Gonzalo Merino, J.D., Ph.D., of Columbia and me – will review the current state of affairs and “with considerable risk of error, [we] will also make predictions about other changes that may lie ahead.”

Apart from encouraging you to attend this session (Tuesday, D1 on the program), the trend of judicial decisions at all levels to weaken patent protection for pharma/biotech inventions is alarming. The big losses like KSR (which eliminated the rigorous TSM test for obviousness), Merck v. Integra (expanded safe harbor for drug research), Ariad (“Yes, Virginia, Section 112 does contain a written description requirement”), and Myriad (No patent protection for DNA or for diagnostics used in personalized medicine) have tended to overshadow smaller but still significant anti-patent decisions like In re Kubin (Deuel reversed), In re Fisher (ESTs and SNPs lack utility) and In re Alonso (good-bye to the “monoclonal antibody exception”).

The Federal Circuit’s holding in Prometheus v. Mayo was one of the few bright spots (methods of screening for drug efficacy and medical treatment are patentable – yea!) but even this decision may be reviewed by the  Supreme Court – again (it granted cert. once). And while it is difficult to see the Supreme Court’s Bilski decision as a good thing, at least an entire category of patentable subject matter was not eliminated. If the “M or T” test had been affirmed, the Federal Circuit would have been required to invalidate most of the Myraid diagnosis claims. Now Judge Rader has to figure out how to support a holding that the Myriad “comparing DNA sequence” claims are less abstract than Bilski’s claims to hedging commodity risk. And he is the judge that the ACLU is trying to recuse as prejudiced in favor of biotech! It’s going to be an interesting year.

AIPLA Webinar on KSR Features Woessner and Lewis

Monday, February 21st, 2011

On March 2nd, I will be presenting with Jeffrey Lewis of Patterson, Belknap, Webb & Tyler in an AIPLA live online seminar entitled, “KSR and the Ripple Effect: Examining the Broad and Increasing Impact of KSR on Patent Litigation and Practice.”

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Click here for further information.