Friday, March 26, 2010

Blogs quiet on Ariad?

Many of the IP blogs have been quiet on the en banc Ariad decision, which represented a stunningly thorough repudiation of positions taken by a number of IP professors.

Patently-O noted:

My sense is that Ariad v. Eli Lilly has essentially no shot for Supreme Court review unless the Ariad can do a great job of convincing the court that the written description requirement as applied is (1) new and (2) is severely detrimental to the patenting of breakthrough inventions and discoveries.

[An article presented in SSRN by Dennis Crouch was cited in one of the opinions. Of citation to something in SSRN, one contemplates the "gray literature" debate in ClimateGate.]

Kevin Noonan had a detailed post, but did not mention all those law reviews written in favor of what turned out to be a losing (9-2) proposition. Noonan concluded:

Regardless of these disparate voices, the Court majority affirmed the existence of a separate written description requirement. This opinion puts to bed one of the many recurring examples of uncertainty that have crept into its jurisprudence in recent years (at least until sufficient members of the Court have accepted senior status and new judges bring their views to bear on the question).

See IPBiz post

En banc CAFC affirms written description; Ariad loses

**At least one professor did write about Ariad, Chris Holman:

Yesterday in Ariad v. Eli Lilly, a majority of the en banc Federal Circuit decided to retain both traditional and Lilly written description as distinct requirements of patentability. I filed an amicus brief in the case arguing against the Lilly written description requirement (LWD), the brief and some of my objections to LWD are available in earlier posts to this blog. Essentially, I have argued that any positive policy aspects of LWD can be better accomplished using the enablement requirement, and that the courts have failed to articulate any coherent standard for compliance with LWD beyond the requirements of enablement. Federal Circuit judges Linn and Rader recognize this problem in their dissents to Ariad.


In view of the widely held perception that LWD was bad for biotechnology, it might come as surprise to find that major biotechnology companies Amgen, Glaxo Smith Kline, and Abbott all filed amicus briefs in Araid supporting Lilly and retention of LWD. Note that the support comes from major biopharmaceutical companies selling blockbuster drugs, who like Eli Lilly see the pragmatic usefulness of LWD as a tool for invalidating unwarranted and irksome patents such as Ariad’s. Other biotechnology companies, presumably more concerned about the negative impact of LWD on their ability to obtain adequate patent protection for their biotechnology inventions than the threat of being sued for infringing and "unworthy" patent, joined me in arguing against LWD. Universities also filed an amicus brief arguing for elimination of LWD. The Biotechnology Industry Organization (BIO) did not weigh in with an amicus brief, I would guess because their membership, which includes universities, small biotechnology companies, as well as large biopharmaceutical companies like Eli Lilly, was too divided on the issue to take a unified stand.

As a practical matter, I don't think that retaining LWD will have a major impact on biotechnology or patent law in general. As shown in empirical studies conducted independently by me and Dennis Crouch of Patently-O fame, it appears to be very rare for a patent claim to be rejected or invalidated solely based on failure to comply with LWD (both studies are cited in Judge Rader's dissent). In most cases, enablement would be sufficient to handle the job. As shown in my Paper Tiger article, contrary to earlier predictions, LWD has for the most part not prevented biotechnology inventors from obtaining relatively broad scope of protection for their inventions. Its main function is to police claim scope, and in practice patent applicants are routinely granted broad scope of coverage for biomolecule inventions based on a relatively modest disclosure of some relationship between structure and function, or by describing a few representative molecular species falling within the claimed genus. LWD is being used to limit claim scope for some biomolecule inventions, but I would assert that the patent office could achieve the same policy objective using the enablement requirement if it did not have LWD, and in fact my experience looking at many Board of Patent Appeal and Interference decisions involving LWD usually enablement and LWD rejections are raised in tandem.

**Separately, of gray literature, from E. Shulenburger -->

For example, James Langer, the president of the American Physical Society, states that some of his colleagues, especially the string theorists, "for research purposes don't need print journals at all [7]. His colleagues rely on the Los Alamos server, a repository of unrefereed manuscripts. A common experience we all share is membership on list serves that present manuscripts reporting what colleagues in our own areas are doing. A search of any university website turns up manuscripts on many topics. This so-called "gray literature" provides access to scientists to much that is not owned or catalogued by our libraries.

But while the gray literature may provide access to material unavailable in one's university library it is not an acceptable substitute for library access to the scientific literature. The gray literature generally is not adequately indexed and archived such that one can systematically search or rely upon it as a repository of scientific information in the future. One can easily make the case that relying upon it as a source of transmitting and preserving the scientific literature will create great difficulties or impossibilities in accessing that literature in the future. (The author has cited some of the gray literature of the scholarly communications movement in footnotes. While web sites for this literature are accessible now, no assurance can be given that they will remain accessible 75 years into the future.) In addition, much of the gray literature is accessible only to those who are in certain social or professional networks.


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