Archive for October, 2009

Who Owns First? Stanford University v. Roche Molecular Systems

Wednesday, October 28th, 2009

Attached is an article written by Ron Schutz of Robins, Kaplan, Miller and Ciresi and is posted with his permission.

APaTS Who Owns First.pdf


Friday, October 23rd, 2009

I have heard rumors for some months that the dreaded “Second Pair of Eyes” review of Examiners’ intent-to-allow patent applications had been eliminated. For those of you who are not on the front lines of patent prosecution, the “SPOE” review began in 2000 in response to the high rate of allowance of business method patents in Group 705. A “senior examiner and a review panel” (as one writer described it) was inserted between the Examiner and the Office of Patent Quality Assurance (which reviews about 4-5% of all proposed allowances) to block allowed applications in this Group from even reaching OPQA. This apparently worked quite well, and by 2001-02, the PTO had extended SPOE to other examining groups, including biotechnology. Like the sorcerer’s apprentice who could not control the forces he unleashed, SPOE cut the overall allowance rate of patent applications from about 72% in 2000 to about 44% in 2008. One Examiner told me that if he received two “reversals” from an SPOE review, he could be fired. Examiners get points if an application is allowed or abandoned. With this sort of threat hanging over every allowance, which path would you choose, especially if you were an Examiner working in a controversial area like most of biotechnology? But did this program lead to a perception that the quality of issued patents was improving?

Director Kappos apparently does not think so. In his address to the members of AIPLA at their recent annual meeting in Washington, DC, he explicitly called for reform of the present “count system” (which I hear is undergoing reform right now) and implicitly criticized SPOE review, by stating that a system that attempts to measure quality after allowance (that is, after an initial determination of “quality”) was not tenable. As noted above, the very existence of such a system caused Examiners to err on the side of rejection, and the SPOE reviewers necessarily felt pressured to reverse a certain number of Examiners in any case (or why should they be quality reviewers in the first place?). Since then, I have asked many practitioners if SPOE has been terminated. The answers were all ambiguous but seem to add up to a qualified “yes.” Apparently the program will continue to operate at a reduced level to try to control rogue Examiners who issue too few or two many applications (Yes, Virginia, there are Examiners in the latter group). So as Halloween looms, perhaps one of the scariest PTO innovations in a long time will not be stalking our claims much longer.

(I want to thank posts by E. B. Chen, NC Jolt Online Ed. and Gene Quinn in for some background material I used in this note.)


Friday, October 16th, 2009

Judge Randall Rader of the Federal Circuit was the luncheon speaker at the AIPLA Annual Meeting Friday in DC and, as usual, he spoke well. So many of his fellow- (and one female) judges where there that he quipped: “Now that we’re here and we have a quorum, shall we vote on inequitable conduct?” (Nervous laughter from large audience.) He set up his comments by recalling a meeting he had with the judiciary in Brazil, where he encountered a “Patent Skeptisauros” judge who argued that the patent system itself was outdated, nonfunctional and was doing damage to Brazil and other less-developed countries.

Judge Rader said he replied that it was the accuser’s understanding that was non-functional and destructive. He argued that we live in a world where technology is decentralized and that no single entity can “keep pace with the patent system.” Rather, the patent system functions to bring innovators together to cooperate and to coordinate their work. A “patent thicket” should not be thought of as a legal minefield, but rather as an invitation to begin such cooperation and coordination. He recalled a conversation with a Japanese colleague who said, in effect, that the comparative global advantage of the U.S. going forward is innovation and invention and asked, “Why are you trying to limit it?”

While the title of the talk was “Trolls and Other Creatures of the Night,” Judge Rader spent relatively little time on that topic. He dismissed the definition of patent troll as one who holds patents but does not practice them (commercially) as unfairly including universities and other research institutions. He said that the proper definition is “anyone who asserts a patent far beyond its value” and that the power of trolls can be limited if district court judges can develop procedures to properly value IP early in the litigation process, where they must be the “gatekeepers of damages.”

In addition, Judge Rader acknowledged the role of patent litigation in setting the fence lines of IP, and urged us to consider that “Good fences make good neighbors.”

As lunch speeches go, this was no rubber chicken, and I applaud Judge Rader for getting AIPLA’s new business year (and new President, Alan Kasper) off to a good start.


Monday, October 12th, 2009

On October 5, 2009, Ariad filed a 60 page brief (not counting attached appendices) with the Federal Circuit in support of its appeal in Ariad v. Lilly. (Attached below.) As you will recall from my post of August 24th, the Fed. Cir. granted en banc rehearing of a panel decision invalidating the claims-in-suit for failure to meet the WDR. See also, my posts of April 13, 2009 and May 5, 2009, on the panel’s decision in Ariad v Lilly and Judge Linn’s concurrence, urging a return of the WDR to post-Lilly status:

“The question is, ‘Does the written description describe the invention recited in the claims – themselves part of the specification – in terms that are sufficient to enable one of skill in the art to make and use the invention and practice the best mode contemplated by the inventor?’ That is the mandate of the statute and is all our precedent required, prior to Lilly.”

The questions to be resolved en banc, however, are 1) Does s. 112(1) contain a WDR separate from the enablement requirement, and 2) If it does, what is its scope and purpose? The Ariad brief answers “no” to question 1 but seems to retract its “no” in answering question 2. As part of its short answer to question 2 on page 1 of the brief, Ariad asserts: “Properly interpreted, the statute itself requires the specification to describe (i) what the invention is, and (ii) how to make and use it.” At pages 43-46 of the Brief (the only parts you need to read if you are conversant with the debate), Ariad argues:

“[I]t necessarily follows that the statute provides no scope or purpose for a separate written description requirement. Properly interpreted, the written description requirement of s. 112(1) requires, first, that the specification describe (identify) what the invention is and second, that the specification teach how to make and use the invention…Identifying the invention is necessary for enablement, since a specification that does not teach one of ordinary skill what to make and use does not enable the skilled artisan to make and use the unidentified subject matter.”

What a minute! This seems like ascribing an “identifying function” to the WDR that is separate from the enablement requirement. A sentence later, Ariad tries to ascribe this function to the claims, stating: “However, original claims necessarily identify the subject matter that they define; since they are part of the disclosure at the time of filing and ‘constitute their own description’”.

This argument is akin to taking the position that claims that meet s. 112(2) also satisfy the “description function” of s. 112(1), but Ariad must have felt that statutory redundancy was not much of an argument, even though paragraph 2 of 112 requires “The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.”

If Judge Lourie has been the Big Bad Wolf leading the pack who supports a heightened WDR to police biotechnology, he should be licking his legal chops over arguments like this. As soon as Ariad concedes that the WDR of s. 112(1) requires the specification to describe “what the invention is,” the Pandora’s box filled with descriptors has been flung wide open; the courts are left to grapple with “How much description of the invention should the specification contain?” Well, how about “a precise definition, such as by structure, formula, chemical name, or physical properties.” Lilly, 119 F.3d at 1566. Again, it bears repeating that adequate claims do not need to contain this level of description, e.g., they can describe the invention functionally or with mixed structural/functional terminology in some cases. For example, “An antibody that binds specifically to cytokine hBAD.” Such a claim will still be weighed against the enablement requirement of s. 112(1), but a specification that adequately teaches how to “make and use” such an antibody should meet s. 112(1) without more.

As I wrote in early 2003, “the legal battle lines are sharply drawn. One camp of judges, led by Judge Rader, believes that the WDR is no more than a semantic test for the ‘right to use’ the claim language in question. If the claim language is supported by the specification, the WDR is satisfied. Enablement is a separate issue that is to be resolved by the very specific Wands factors. … The camp led by Judge Lourie expects a lot more from the WDR; along with the enablement requirement, it now imparts or denies the ‘right to claim’ the invention at issue. That is nearly as equitable a doctrine as that assigned to the doctrine of equivalents.”

At pages 46-50, the Ariad brief contains a rather confusing discussion of two cases decided in the 1850’s that is supposed to convince the Fed. Cir. that Supreme Court precedent illustrates “[t]he proper approach to the enabling-description requirement of s. 112(1)”. In my next post on Ariad, I review a hypothetical fact situation based on two biotech inventions that is a bit more modern. Eventually, we may even reach the merits of the case.
Ariad v Lilly Brief.pdf