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].’”