In my recent post on the Centocor v. Abbott decision, I noted that the Fed. Cir. had at least preserved the “antibody exception,” which I define as permitting broad claims to structurally uncharacterized antibodies (monoclonal and polyclonal) if the structure of the antigen is known (and preferably is novel) and methods of preparing the antibodies are routine. This dicta has been recently “followed” by the Canadian Patent Appeal Board in an appeal involving Immunex.
Learn more here.
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].’”
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.
Bad Behavior has blocked 558 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