JUDGE RADER DEFENDS THE FUTURE OF IP

Posted on October 16, 2009 by Warren Woessner

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judiciary in Brazil, where he encountered a “Patent Skeptisauros” judge who argued that the patent system itself was outdated, nonfunctional and was doing damage to Brazil and other less-developed countries.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.

Posted in Post-Grant Issues | Tagged , , | Leave a comment

TALKING WRITTEN DESCRIPTION REQUIREMENT BLUES – ARIAD WOBBLES

Posted on October 12, 2009 by Warren Woessner

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

Posted in Written Description Requirements (WDR) | Tagged , , , , , , , , | Leave a comment

Director Kappos Kills Prosecution Regulations Package

Posted on October 8, 2009 by Warren Woessner

Two years of fear and loathing have ended, as the USPTO has announced that it is rescinding the “Continuations” and “Claims” rules that have been hanging over the heads of practitioners, and will move to dismiss/vacate the pending lawsuit over the rules. Like a legal sword of Damocles, there was always the chance that the rules would drop into place and cut-off our ability to prosecute patent families to completion. Remember, earlier this year the Federal Circuit gave the PTO permission to implement all but the rule limiting continuations. As an attorney who felt forced to begin to compress claim sets in pending applications near the eve of the rules going into force in 2007, the potential financial hardships to small pharma/biotech companies attempting to protect nascent technologies in a step-wise fashion was manifest. And did it ever make sense, at a time when PTO filings were dropping off, to implement rules that would further reduce filings? (One senior Examiner/union rep told me that opposition among the Examiners was almost universal.) Luckily, Glaxo and Dr. Tafas had the nerve to challenge the right of the PTO to promulgate such rules. They didn’t win it all in court, but bought us all time for a new Administration and blessed restraint.

USPTO Press Release.pdf

Posted in USPTO Practice and Policy | Tagged , , , , , , , | 1 Comment

Hal Wegner Wakes Up ACI Biotech Patents Forum in Boston

Posted on October 4, 2009 by Warren Woessner

On Sept. 30th, Harold C. (Hal) Wegner gave a talk on current developments that emphasized the importance of inter partes reexamination, particularly as a weapon of patent destruction. His opinion, summarized by me, is that KSR is increasingly being applied to biotech claims by Examiners. Applicants then are forced to put in declarations arguing secondary factors and to argue criticality in order to get claims allowed. Requestors are aware that, during inter partes reexamination at the PTO level, 60% of patents have all their claims cancelled and 80% have independent claims cancelled. Attacker-requestors will put in declarations to show that “everything was expected.” If the Examiner and the Board support the attacker, patentee is dead since, if the attacker put in substantial evidence, the Federal Circuit will give deference to the PTO finding. Also, if the attacker argues that a claim should be interpreted so as to read on the prior art, claim interpretation will be an open question before the Federal Circuit, who reviews claim construction de novo as a question of law.

On the other hand, Hal noted that, in the past, almost no merits appeals ever reached the Board from reexamination proceedings. This is in part because it is easy for either party to slow the proceedings nearly to a standstill by submitting boxes of prior art (I have seen a patentee in litigation do this) or by introducing hundreds of claims. Hal also noted that, as of 2002, no reexaminations had been concluded by appeal to the Federal Circuit. If Director Kappos manages to shorten the appeal process at the Board, as by moving Examiners from the corps to the Board, in the fairly near future all of these patent-killing mechanisms could rise in prominence.

Posted in Post-Grant Issues | Tagged , , , , , , | Leave a comment