Medical Device Daily Washington Editor

Moving a big bill through Congress is never easy, and patent reform — on the docket on Capitol Hill off and on for several years — has behaved much like a big bill. Signs earlier this year indicated that provisions for apportionment of damages might sink the current effort at patent reform in the Senate (Medical Device Daily, Feb. 8), and a couple of recent postings on Senate websites suggest that this has happened.

One of these postings is at the website for Sen. Patrick Leahy (D-Vermont), chairman of the Senate Judiciary Committee, who states that he is "disappointed that just a handful of words have stalled the Senate's debate on this important patent legislation." Leahy laments the "thousands of hours ... spent in negotiations to address the concerns of 100 Senators, hundreds of Representatives, and dozens of stakeholders."

Leahy's statement seems to take a swipe at opponents of the apportionment provision, saying that "the time for patent reform is now" but that "unfortunately, some have yet to fully grasp this fact, and have stalled meaningful reform."

Sen. Arlen Specter (R-Pennsylvania), ranking Republican on the Senate Judiciary Committee, posted a statement on his website saying that he and Leahy "differ on a number of aspects of the proposed patent reform legislation," specifically "how to assess damages in patent infringement lawsuits. We thought we had reached an agreement on this matter, but the language continued to shift." He expresses hope "that we can reach an agreement, but more work has to be done to get it right."

Industry and big labor have both weighed in on the bill, the net effect of their aggregate influence seeming to be a zero.

The Biotechnology Industry Association (BIO; Washington) has expressed disappointment with the apportionment provisions in the Senate bill, BIO CEO Jim Greenwood saying early this month that the "negative impact of a poorly crafted bill on the U.S. economy and our global competitiveness is too great to proceed with a vote before ensuring that the legislation will truly enhance our nation's patent reform system."

In a July 24 letter to the House Judiciary Committee, William Samuel, legislative director of the AFL-CIO (Washington), wrote that the courts "already follow a multi-point system for considering damages [which] should remain intact, rather than be constricted to limit damage settlements."

Information technology firms, however, see a different world, one in which the Research in Motion suit sticks out conspicuously. An October 24 letter to Senate majority and minority leaders Harry Reid (D-Nevada) and Mitch McConnell (R-Kentucky) by the Coalition for Patent Fairness (Washington) urged Senate passage of S. 1145 with the provisions for apportionment as they stood. Among its members are Intel (Santa Clara, California) and Microsoft (Redmond, Washington).

All this suggests that the light for patent reform has flickered out, especially given a heavy legislative calendar in the Senate, leading to August recess and Congressional elections after summer. While neither Leahy nor Specter is up for re-election until 2010, activity on Capitol Hill does not set speed records in such circumstances. And with a new Congress next year, the entire effort may start from scratch in January.

Mark Leahy, executive director of the Medical Device Manufacturers Association (MDMA; Washington) e-mailed a statement to Medical Device Daily saying that the association has "concerns with many of the current provisions, including damages, post grant review and inequitable conduct." Lacking changes, "MDMA will oppose the bill because it will weaken the patent system and harm innovators."

Glaxo scores win in PTO case

The U.S. Patent and Trademark Office has not waited for Congress to act on sources of drag on the application process, but a lawsuit by a biotech firm has scuttled one of the agency's efforts to streamline the patent prosecution process.

GlaxoSmithKline (London) won a recent ruling in the U.S. District Court in Virginia that prevented USPTO from implementing rules that would limit to two the number of times a patent application can be resubmitted, unless the applicant can show reason why the sought-after update could not have been prosecuted earlier.

USPTO also sought to use its regulatory charter to limit the number of claims per application to 25, one of its many recent efforts to simplify the application process (Medical Device Daily, March 14).

The Oct. 10 complaint by Glaxo says USPTO rolled out the rules "without proper legal authority," and that the relevant portions of the U.S. code "do not grant the PTO the authority to restrict the number of continuing applications, requests for continuing examination, or claims that may be filed."

Glaxo also stated in the complaint that it has about "100 or more pending applications in which two or more continuations or continuations-in-part" on file at USPTO in addition to another 30 for which the firm has filed a request for continuation.

The final decision by Judge James Cacheris, said the USPTO rule would "constitute a drastic departure from the terms of the Patent Act as ... presently understood" and exceed the scope of the USPTO's rulemaking authority under" law.