Medical Device Daily Washington Editor

The House of Representatives has passed a bill that would temporarily give the Patent and Trademark Office the right to divert fees normally used for trademark activities into patent examinations. The move is widely seen as necessary to keep PTO from having to furlough patent examiners and may help take a bite out of a backlog of patent applications that is said to number well in excess of 700,000.

The July 8 passage of H.R. 3114 by voice vote means that the House and Senate, which passed the parallel bill S. 1358 by unanimous consent on June 25, can forge their respective versions and forward the bill to the White House for President Obama's signature.

Brian Pomper, executive director of the Innovation Alliance (Washington) said in a July 8 statement that the bill will help PTO "address its growing backlog of patent applications," which he said "is vital to the growth of a healthy innovation economy." Pomper also stated, "America's innovation community is grateful for the overwhelming support shown by Congress for the mission of the PTO and for the importance of our patent system."

In an unattributed statement, the Biotechnology Industry Organization (BIO; Washington) said "continued innovation in the U.S. biotechnology industry is dependent on a strong and well-functioning U.S. PTO" and that "furloughs or other measures that result in a reduction of patent examiners will have a negative impact on the ability of the PTO to examine critical biotech patent applications in a timely manner." The statement applauded "House Judiciary Committee Chairman John Conyers (D-Michigan) and ranking member Lamar Smith (R-Texas) for their quick action to address this matter."

CAFC to review Tafas and Glaxo cases

The Court of Appeals for the Federal Circuit (CAFC) has decided it will re-hear two cases against the U.S. Patent and Trademark Office, namely the cases filed by Triantafyllos Tafas, MD, and GlaxoSmithKline (London). Both cases deal with PTO's attempts to trim its patent load via regulatory mechanisms and both were decided previously by a three-judge CAFC panel, but the all the court's judges will participate in the new hearing.

The Tafas case, named for the founder of device maker Ikonisys (New Haven, Connecticut), revolves around an attempt by PTO to use its regulatory authority to limit the number of unique claims per application to five and to limit the number of patent continuations. The initial CAFC decision was a 2-1 split that concluded that the four elements of PTO's move were regulatory in nature and hence permissible within that context, but the decision also noted that one of the changes, the limitation on patent continuations, conflicted with established law. The fact that CAFC wants to review the case en banc suggests that at least some of the remaining nine members disagreed with the outcome.

CAFC's ruling in Tafas drew praise from a large set of information technology firms, including Microsoft (Redmond, Washington) and IBM (Armonk, New York), but some biotech firms see the issue differently because of the incremental nature of biotech development. The situation may put the Obama administration's nominee for PTO director David Kappos in a difficult position, inasmuch as he will leave his current job at IBM for the PTO post if confirmed (Medical Device Daily, June 22, 2009). Kappos' nomination encountered some criticism due to perceptions that his background would make him less than objective where PTO's regulatory discretion is concerned, and CAFC has indicated it will entertain a new brief from PTO in its review. Kappos, on the other hand, is said to have filed a friend-of-the-court document in support of the litigants in the first CAFC review.

The Glaxo case dealt with continuations of patent applications and, as was the case with Tafas, also dealt with the PTO rule limiting number of claims that could be attached to a patent. The two were consolidated in district court in April 2008, hence ending up together in the first run taken at the case by CAFC. According to, CAFC should have all the requested briefs in by the beginning of September, although it is not clear when the full 12-judge panel will examine the case.

House passes appropriations for FDA

FDA watchers who lament the funding problem at the agency's Center for Devices and Radiological Health had news to celebrate yesterday with the passage of the Agriculture Appropriations Act (H.R. 2997) for fiscal 2010, a bill that boosts spending at CDRH by more than $349 million over the current fiscal year.

Sponsored by Rep. Rosa DeLauro (D-Connecticut), the bill moved through the House fairly quickly, needing only about two weeks since its introduction to the House calendar on June 23.

In a June 9 statement, Steve Ubl, President/CEO of the Advanced Medical Technology Association (AdvaMed; Washington), said the association "commends the U.S. House of Representatives for providing a significant increase to FDA's medical device program budget for FY 2010," which he said "will help the agency continue to ensure the safety and effectiveness of medical devices and diagnostics."

The companion bill in the Senate, S. 1406, sponsored by Herb Kohl (D-Wisconsin), was placed on the Senate calendar on Tuesday, July 7.

Collins named for NIH post

The Obama administration has moved another notch closer to filling all agency posts at the Department of Health and Human Services with the nomination of Francis Collins, MD, for the directorship of the National Institutes of Health.

Collins, who led the Human Genome Project after 1993 when he replaced the inaugural director, James Watson, will vacate his position as the director of the National Human Genome Research Institute at NIH to take the director's job. In a July 8 statement released by the White House, President Obama described Collins as "one of the top scientists in the world" and said his "groundbreaking work has changed the very ways we consider our health and examine disease."

In a June 8 statement, Steve Ubl, President/CEO of AdvaMed, said the association "welcomes the nomination," adding that Collins' "ambitious leadership" on the genome project "helped to ensure that all scientists and researchers have new tools to correlate the risk of disease to a person's genetic makeup and helped usher in the new era of personalized medicine."