Posts Tagged ‘WDR’

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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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BSC v. J & J – Written Description Requirement Spreads its Wings

Monday, July 11th, 2011

On June 7th, in a Fed. Cir. panel decision written by Judge Moore, the panel affirmed the invalidation of four J&J patents (a copy of these patents is available at the end of this post) for failure to meet the written description requirement of s.112(1). The patents claimed drug eluting stents, used to keep angioplastied arteries from re-closing, or undergoing restenosis. Boston Scientific Corp. v. Johnson & Johnson, App. No. 2010- 1230-1234 (Fed. Cir. June 7, 2011). The stents disclosed in the specifications all released rapamycin, a macrocyclic lactone, but the claims were broader, and used terms like “rapamycin or a macrocyclic lactone analog of rapamycin” or a” macrocyclic triene analog of rapamycin.” However, no such rapamycin analogs were disclosed in the specification.

The “problem” with the summary judgment below, at least as J&J saw it, was that a number of workable rapamycin analogs were known to the art as of the effective filing date of the applications. In fact, BSC was using one of them in its stents. J&J felt it could rely on the court’s holding in Capon v Eshhar, 418 F.3d 1349 (Fed. Cir. 2005) which affirmed that claims to chimeric DNA molecules were adequately supported by the specification in combination with evidence that many examples of useful subunits were known.

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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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Centocor v. Abbott Labs. – “Antibody Exception” To Written Description Requirement Under Fire

Monday, March 29th, 2010

Abbott Laboratories markets a recombinant human antibody, HUMIRA, as a treatment for rheumatoid arthritis. This antibody binds to a receptor on TNF. NYU and Centocor own US Pat No 7070775 which claims an isolated recombinant anti-TNF-a antibody (Ab) comprising a human constant region, where said Ab competitively inhibit binding of the mouse A2 antibody to human TNF-a and binds to a neutralizing epitope of human TNF-a in vivo with the recited affinity. The A2 mouse antibody is the only species disclosed in the specification, and is not the subject of claim 1.

The string of 13 patent applications that yielded this patent began with an application filed in 1991. The ‘775 patent issued in 2006 and Centocor sued Abbott for infringement. The district court denied Abbott’s motion for JMOL that the specification of the ‘775 patent failed to meet the written description requirement of s.112, and Abbott has appealed to the Federal Circuit. Centocor v. Abbott Labs., No. 2:07CV139-TJW, 2009 U.S. Dist. Lexis 102427 (E.D. Tex. Nov. 4, 2009).

A little bit of history. As pointed out by Lilly in its Amicus Brief supporting Abbott (a PDF is provided at the end of this posting), after years of R&D, antibody-based therapies have come of age: “Rapid growth in the field of antibody research has led to the introduction of nineteen monoclonal antibody [MCA] drugs into the U.S. market since 1994, while only one such MCA drug was approved by the FDA prior to 1994.” When I started prosecuting biotech applications in the early 80’s, MCAs were seen primarily as “research tools,” that might have value in diagnostic assays. If a researcher discovered a new polypeptide that might be useful as a disease marker, broad claims were routinely allowed by the PTO, e.g.: “A purified antibody which specifically reacts with protein x [a possible marker for, e.g., prostate cancer], wherein said antibody does not significantly react with prostate specific antigen.” Put simply, if you knew the structure of the antigen, you could get a claim to any antibody that bound to that antigen. In fact, if you could get a claim to the antigen, the antibody claims pretty much got tossed in gratis. Maybe we have the legal death of In re Durden in 1995 to “blame” for this, but that is a story for another day.

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