Big pharma sues USPTO

Pharmaceutical giant GlaxoSmithKline PLC has filed suit against the US Patent and Trademark Office (USPTO), seeking to block implementation of new rules that would limit the number of claims contained in any one patent application and the number of times applications can be re-evaluated.

GSK's lawsuit, filed Oct. 10 in Federal District Court for the Eastern District of Virginia, represents the first major corporate challenge to rules scheduled to take effect Nov. 1. The USPTO says the new rules are needed to streamline the patenting process, but drug and biotech companies as well as university tech transfer officials claim the rules will make it more costly and time consuming for them to secure rights to their life sciences discoveries.

Calling them "vague, arbitrary, and capricious," GSK claims the new rules will damage the company's ability to obtain new patents, citing about 130 pending patent applications for which it has requested two or more continuations and/or continued examinations. In all, hundreds of thousands of patent applications may be similarly affected, experts say.

"[T]he legal questions presented threaten ... whether the life-saving drugs innovated by GSK and other similarly situated members of the pharmaceutical industry will be invented in the first place," the lawsuit states. The USPTO declined to comment. "Our policy is not to comment on pending litigation," USPTO spokesperson Brigid Quinn told The Scientist yesterday.

But the Federal court is unlikely to grant GSK's request for a preliminary injunction because it is not clear the company will suffer irreparable injury if the new rules are implemented, predicts Ronald Eisenstein, a partner in the biotech and intellectual property group at the law firm Nixon Peabody in Boston.

GSK claims the patent office lacks legal authority to impose the restrictions, noting that reform legislation (HR 1908) passed by the House of Representatives on Sept. 7 (but not yet in the Senate) retroactively grants the USPTO this power. "That's basically a concession the patent office doesn't have the authority to do what they are doing," Eisenstein told The Scientist yesterday.

Under the new rules, inventors will be limited to two new continuing applications through which they can add additional claims and one request for a continued examination, which can be filed after an application has been rejected. Currently, applicants can file an unlimited number of continuation requests accompanied by new arguments and evidence. The strategy is often used in the life sciences when the full scope of a discovery cannot be immediately established and when researchers seek to extend coverage from one or two new molecules to an entire class of compounds.

"It's not uncommon for big companies to have 5 to ten patents come off of one application, and sometimes many more," said Gene Quinn, a partner in the law firm White & Quinn in Waterford, VA. Any prolonged litigation involving the lawsuit is likely to throw patenting into a state of limbo for years to come, especially if the rules become effective only to be subsequently vacated, Quinn told The Scientist yesterday. (The two Quinns are not related.)

Ted Agres
mail@the-scientist.com


Links within this article:

GlaxoSmithKline
http://www.gsk.com

"Changes to Practice for Continued Examination Filings, Patent Applications Containing Patentably Indistinct Claims, and Examination of Claims in Patent Applications; Final Rule," Federal Register, Aug. 21, 2007
http://www.uspto.gov/web/offices/com/sol/notices/72fr46716.pdf

GSK lawsuit against USPTO
http://www.ipwatchdog.com/patents/SmithKline_Complaint-100907.pdf

T. Agres, "New patent rules hurt biotech?" The Scientist, August 21, 2007.
http://www.thescientist.com/news/display/53497/

T. Agres, "USPTO proposes controversial patent filing changes" The Scientist, March 1, 2006.
http://www.thescientist.com/article/display/23177

Ronald Eisenstein
http://www.nixonpeabody.com/attorneys_detail1.asp?ID=58

Patent Reform Act of 2007 (HR 1908)
http://thomas.loc.gov/

Gene Quinn
http://www.ipwatchdog.com/gene.html