Cheap viagra softt=”" width=”150″ height=”150″ />On Tuesday, the Supreme Court denied Centocor’s (now “Janssen”) petition for cert. and so let stand a ruling that Centocor’s patents on humanized monoclonal antibodies (covering Abbott’s Humira) are invalid for failure to meet the written description requirement (WDR) of s. 112(1). Since cert. was not requested following the en banc decision in Ariad v. Lilly, which essentially reached the same conclusion on drugs — not yet discovered — that might alter the NF-kB pathway, this was the first good chance the Supreme Court had to weigh in on the heightened WDR that has been applied with regularity by panels of the Fed. Cir. to invalidate biotech patents claiming early stage inventions since it was articulated by Judge Lourie in the 1997 U. of Cal. v. Lilly decision. As I have written in a number of posts on subsequent decisions, this new and improved WDR has led biotech patentees down a trail of legal tears as, with few exceptions, their patents have failed the WDR – even if the claims were arguably enabled by the specification—a question that the Fed. Cir. has increasingly refused even to consider once the increasingly easy button of the WDR has been used to invalidate the patent.
Archive for the ‘Written Description Requirements (WDR)’ Category
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.
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].’”
On December 8, 2010, the Fed. Cir. (Rader writing) reversed the district court’s holding that claims to a process for rendering a half-tone image of a digital image were patent ineligible as an attempt to claim an abstract idea. Research Corp. Technologies, Inc. v. Microsoft Corp., 2010-1037 (Fed. Cir. Dec. 8, 2010). (A copy is at the end of this post.) The claims given in the opinion involved the use of an “improved blue noise mask.” The panel spent 10 pages of its 25 page opinion explaining the technology and reproducing claims, and I still don’t have a clue how this technology works (it involves use of an algorithm as well!). The main process claims quite clearly would fail the M or T test, but the courts have more to work with now, and the panel got right to work.
Not surprisingly, the panel had a lot to say about the Supreme Court’s Bilski decision, particularly what it left unsaid:
“Indeed, the Supreme Court in Bilski re-focused this court’s inquiry into processes on the question of whether the subject matter of the invention is abstract. The Supreme Court did not presume to provide a rigid formula or definition for abstractness [citation omitted]. Instead, the Supreme Court invited this court to develop ‘other limiting criteria that further the purposes of the Patent Act and are not inconsistent with its text.”