Medical Device Daily Washington Editor
The Senate Judiciary Committee has taken the lid off the latest iteration of patent reform legislation, making this the fifth year running that the committee has taken up such a bill. While the current version addresses some points of contention that held up S. 515 last year, the biggest question of all remains, that of whether the House will of Representatives will pass a bill of its own in time to get legislation onto the Oval Office desk this year.
As was the case last year, S. 515 would switch the U.S. to a first-to-file system, a large break from the current first-to-invent approach, which allows entities to claim a patent if they can document work on a patentable item. This feature seems to generate little controversy in the Senate, but small inventors and university researchers alike are less than fond of the change.
The bill also addresses the patent obviousness question in a manner in keeping with the Supreme Court decision in KSR v. Teleflex, which many observers anticipated would precipitate a rash of lawsuits over existing patents (Medical Device Daily, September 26, 2008). However, that deluge of litigation has apparently not occurred.
The first window for post-grant review would be trimmed under this bill by a quarter, from 12 months to nine, and the inter-partes re-examination of a patent would be available only when the challenger could demonstrate a “reasonable likelihood“ that the contended patent would be overturned. Just how malleable the meaning of the phrase “reasonable likelihood“ would be in practice is difficult to predict.
On the subject of inequitable conduct, it appears that Sen. Orrin Hatch (R-Utah) has lost the struggle to add language that would statutorily set standards for proof. This issue served as a flashpoint last year during the Senate Judiciary mark-up, when Hatch left the hearing room visibly riled over the omission.
The damages provision that appeared in last year's mark-up of S. 515 reappears essentially whole, which means that the gatekeeper approach to determination of damages in the Senate bill is almost certainly headed for a showdown with the House Judiciary Committee's patent reform bill. House Judiciary chairman John Conyers (D-Michigan) indicated last year that he would stick to his guns on the apportionment rubric for calculations of damages, but the common view of the overall dynamic suggests that Conyers will wait until the Senate passes a finished bill before he would devote any committee time to a House bill. The House passed a patent reform bill in 2007, only to watch the Senate Judiciary Committee leave the issue hanging.
Willful infringement also appears in S. 515, which would disallow the defendant's knowledge of the existence of the allegedly infringed item to suffice to indicate willfulness, but a litigant who charges willful infringement would also have to make that case in its initial filing and would have to make a more specific case for willfulness than is currently required.
In a March 4 statement, Senate Judiciary chairman Pat Leahy (D-Vermont), said the new bill puts the Senate “closer than ever to advancing patent reform legislation.“ He said that he and Hatch “have worked through many Congresses to make meaningful reforms to the nation's patent system, and I appreciate his commitment to this effort.“ Leahy acknowledged that the compromise “may not be everything that everyone wants, but [that] it makes important reforms to the outdated patent system.“
In an unattributed March 5 statement, the Innovation Alliance (IA; Washington) said that recent case law had addressed “virtually all of the substantive issues that originally prompted calls“ for patent reform, including the venue issue and patentability standards. All the same, IA states that the post-grant review provisions “move the legislation toward a more balanced administrative review system that can work for“ large and small innovators. The letter closes by stating that the organization does “not oppose the passage“ of the bill as written.
Thoratec asks for destination coverage
The ventricular assist device as a bridge to transplant is covered by the Centers for Medicare and Medicaid Services, but now that Thoratec (Pleasanton, California) has won FDA approval of the HeartMate II as a destination therapy, the firm is appealing to CMS for coverage. However, it appears that the best the company will do is to obtain coverage under some sort of clinical trial provision for evidence development.
In a Jan. 5 letter to CMS, Robin Bostic, Thoratec's VP for health policy, noted that the HeartMate II is small enough to use in “smaller sized non-cardiac transplant patients,“ a group that includes many women. However, those with anatomical features that would preclude the use of a larger VAD device would also benefit. Bostic notes also that a study review appearing in the Nov. 17, 2009, edition of the New England Journal of Medicine indicates that the device compared favorably to a pulsatile VAD and both devices “significantly improved the quality of life and functional capacity,“ according to the NEJM article.
Fairly typical of some of the comments CMS received on the idea was the comment posted by Richard Pierson, MD, of the University of Maryland Medical Center (Baltimore), who wrote in a March 1 letter that the evaluation of the HeartMate II for this application “should be performed in the context of a prospective study design, preferably one designed to include an appropriate reference group.“ Pierson added that the National Institutes of Health has proposed such a study and that NIH has received some responses to a request for applications, a fact which he said demonstrates “that centers are eager and willing to perform a pivotal study with NIH support.“
Judy Rosenbloom, president of the reimbursement consultancy JRAssociates (Los Angeles) told Medical Device Daily that the comments submitted to CMS seemed to come up short of a recommendation for coverage. “The result of this reconsideration could be coverage with study participation,“ she said, adding that the clinical community seemed disinclined to recommend anything more.
FDA adds 14 days for 510(k) comments
FDA said yesterday that it will extend the open public comment period for the Feb. 18 meeting on the 510(k) program, which was covered in the Feb. 19 and 20 editions of Medical Device Daily. The agency has extended the open public comment period to March 19 after initially proposing to close off comments by March 5.
Mark McCarty, 703-268-5690