Last week, we here at PAL joined 11 other consumer and public interest organizations in filing a amicus curiae (“friend of the Court”) brief in the case of Tafas / GSK v. Dudas et al. Details are below. PAL believes that manipulation of the patent process by pharmaceutical companies has a detrimental effect on consumers’ access to prescription drugs. The brief was written by the Public Patent Foundation, a member of the PAL coalition.

Press release issued by Public Patent Foundation:

Consumer and Public Interest Groups Back New U.S. Patent Rules That Would Curtail Abusive Behavior By Applicants

ALEXANDRIA, VA – December 20, 2007 – A coalition of consumer advocacy and public interest groups today filed legal papers supporting new U.S. Patent Office (USPTO) rules that would curtail abusive behavior by patent applicants and improve patent quality.

In a friend-of-the-court brief filed in U.S. District Court in Alexandria, VA., the groups urged that an injunction blocking the proposed rules be lifted and they be implemented immediately.

The proposed new regulations ask applicants to justify the need for more than two continuations per application and to assist the USPTO in performing initial technological research on applications that contain an excessive number of claims.

The groups joining in filing the Public Interest Amici brief are: The Public Patent Foundation (“PUBPAT”), Computer & Communications Industry Association (“CCIA”), AARP, Consumer Federation of America (“CFA”), Essential Action, Foundation for Taxpayer and Consumer Rights (“FTCR”), Initiative for Medicines, Access & Knowledge (“I-MAK”), Knowledge Ecology International (“KEI”), Prescription Access Litigation (“PAL”), Public Knowledge (“PK”), Research on Innovation (“ROI”), and Software Freedom Law Center (“SFLC”).

“The public interest overwhelmingly supports the USPTO’s Final Rules for at least two significant reasons,” the brief said. “First, they will enable the USPTO to curtail abuses of the patent application process made by those patent applicants who seek to pervert the system to gain an unfair advantage. Second, the Final Rules will help the USPTO improve patent quality, which is a critical issue for ensuring the patent system benefits the American public.”

The new rules were to have been implemented by the patent office on Nov. 1, but were blocked by suits brought by drug maker GlaxoSmithKline and inventor Triantafyllos Tafas.

Under current rules which allow unlimited continuations, USPTO examiners who have repeatedly rejected an application often face an endless stream of continuation applications that “may well succeed in ‘wearing down the examiner’, so that the applicant obtains a broad patent not because he deserves one, but because the examiner has neither the incentive nor will to hold out any longer,” according to professor Mark A. Lemley of Stanford Law School and Kimberly A. Moore, now a Circuit Judge on the U.S. Court of Appeals for the Federal Circuit.

Pharmaceutical companies are most likely to use continuations in order to help them keep monopolies over their drugs. According to the publication Nature Biotechnology, from 1995 to 1999, 41% of drug patents issued were based on continuations. In contrast only 22% of the patents issued in mechanical engineering were based on continuations.

The consumer and public interest groups’ brief said the new rules would:

– Curtail abuse of continuation applications and unlimited claiming, – Help the USPTO improve patent quality, and – Increase patent office efficiency.

The legal papers, available below, also noted that while briefs filed opposing the new rules claimed they were acting in the “public interest”, in fact they represented the narrow interests of patent holders and patent attorneys.

“Congress has intentionally implemented a patent system that balances the incentives provided to patentees with the benefit to the public of the disclosure and ultimate dedication of the resulting inventions to society,” the consumer groups said. “Thus, the public interest lies in an efficiently functioning patent system, not one that is subject to abuse and manipulation.”

The consumer and public interest groups said that despite having various missions and activities, they are united in their belief that patent law and policy should be crafted to ensure that it benefits the public interest. They “firmly believe that the Final Rules would significantly advance both the general public interest and the specific aspects of the public interest that they each separately exist to represent. Thus, the Public Interest Amici have united in this brief to express a single voice in support of the Final Rules.”

Papers Filed By Public Interest Amici Curiae, Public Patent Foundation et al., in Tafas / GSK v. Dudas et al.