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].’”
Even though the panel reaffirmed that actual possession (e.g., working examples) are not required to meet the WDR, Centocor’s arguments that they had described the properties of their all-human antibodies adequately were dismissed by the panel as no more than a “mere wish or plan for how one might search for a fully-human antibody that satisfies the claims,” e.g. has the recited binding affinity and neutralizing activity.
Some years ago I gave a talk on the WDR entitled “make it or fake it,” and the case law that has developed in this area has made it manifest that these are the only choices available to inventors of early-stage biotechnology. Centocor set forth quite clearly the properties that its antibody should possess (that Judge Lourie suggested in UC v. Lilly might be sufficient) but, without structure, and even with testimony that the specification was enabling, Centorcor still lost. Centocor hadn’t been able to “make it” as of the filing date of the priority document (have actual “possession”), and it was not possible to “fake” such a complex polypeptidyl structure. This can be contrasted with small-molecule pharma patent practice where, given even one structure, it is relatively easy to expand it into a Markush group of reasonable breadth. Not so in much of biotech. In Noelle v. Lederman, 35 F.3d 1343 (Fed. Cir. 2004), possession of the rat antigen and the rat antibody thereto was held insufficient to describe the human antibody.
On the brighter side, I spoke too soon when I stated that the “antibody exception” to the WDR was destroyed in the Alonso decision. The Centocor court affirmed the propriety of the PTO’s longstanding practice of allowing claims to antibodies specific for a novel, well-characterized antigen. See USPTO, Written Description Training Materials Rev. 1 (Mar. 25, 2008) at 45-46. Judge Prost wrote, “While our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly characterized antigens where creation of the claimed antibodies is routine.” The court found the creation of fully humanized anti-TNF-alpha antibodes with the recited properties to be far from routine but, these days, let’s be thankful for small favors.