Medical Device Daily Washington Editor

WASHINGTON – Observers of the legal turf that device makers call home have had a lot to look at over the past year, including the case of Riegel v. Medtronic and the subsequent legislative proposal to end federal pre-emption of liability for pre-market approval (PMA) devices, but another set of developments have reshaped the way that patents are obtained and held.

The proliferation of devices for cardiovascular use, including stents and catheters, have been an especially ripe source of patent conflicts, with Abbott Laboratories (Abbott Park, Illinois), Medtronic (Minneapolis) and Boston Scientific (Natick, Massachusetts) all in court with one another and with other manufacturers pursuing remedies for allegedly infringed patents.

At this week's AdvaMed 2008 conference, sponsored by the Advanced Medical Technology Association (AdvaMed; Washington), several attorneys in both academe and in practice took to the microphones to give a roundup of those recent developments.

The session's moderator, Brian Hopkins, a partner working out of the New York office of Mintz Levin (Boston) pointed out that one recent issue was settled in a lawsuit filed by GlaxoSmithKline (London) against Jon Dudas, director of the U.S. Patent and Trademark Office (PTO), over rules changes that the firm alleged were of sufficient importance that they went beyond the agency's authority.

PTO made the decision last year to limit the number of continuations a patent holder could apply for in connection with a patent. Hopkins noted that the agency lost that suit because "they were substantive changes, not procedural," but noted that PTO's appeal is pending. One of the factors behind the court's ruling was that PTO wanted to apply the rules change retroactively.

John Thomas, a professor of law at Georgetown University (Washington), said he is "one of four or five people who actually liked the rules," except for retroactivity. Nonetheless, he said the federal appeals court will probably uphold the district court's ruling.

William Murray, divisional counsel at Abbott, said some of the rules in question "are procedural in many aspects and have merit." However, he said retroactivity is "what the court went off on." He said that for biotech and pharma, it is nearly impossible to predict which compounds that are in development will go into trials, which makes it difficult to know how much effort to put into any given patent application.

Joe Havrilla, senior VP for innovation at Medrad (Warrendale, Pennsylvania), described retroactivity as "a problem and a misstep," but said "to limit patentees ability to file continuations later not only limits ability to invent, but also put a higher burden and higher cost ... on inventions that otherwise might not warrant that kind of investment." A patentee will have to predict how to structure claims, which "will ultimately hurt innovation and the patentee." He said the limitation on continued claims is helpful from an administrative standpoint, but not a good idea for device makers.

Hopkins asked if the administrative headaches associated with continuances could be dealt with by boosting the related fee. Thomas replied, "Congress has already thought about this," but took no action. He also said PTO proposed six or seven years ago to boost the fees but the idea "got shot down by the independent inventor community."

The European Patent Office has not been sitting idly by, either, Hopkins noted, and among the provisions of recent regulatory changes is one that allows applicants to file their patents in English only, rather than file in the languages of each of the 27 member nations. While this seems to promise much greater convenience, the panel stated that this can be a hazardous route to take.

Thomas said language is "a very emotive subject" and that "on the one hand, most of these translations are never read," but "on the other hand, English is not that commonly spoken" in many EU nations, at least outside their national capitals.

Murray said, "you really have to think through the invention ... and if you think there's a chance you're going to have to litigate it, you should bite the bullet" and get the original application translated. He said this allows more control over the accuracy of translations, and the problem is not limited to Europe. "The translation problems in China are just huge."

Panelist David Schramm, a senior IP litigation attorney at Medrad, also recommended getting translations checked by a third party. "Multiple firms have told us they lost [patent cases] because of the translation."

The Supreme Court decision in KSR v. Teleflex, which the court ruled on in April 2007, also is seen as having a wide-ranging effect on patent law. The case arose when KSR connected an adjustable vehicle control pedal to an electronic throttle control. KSR's position was essentially that this combination of elements was obvious and hence deserved no patent protection.

The justices decided the case on the language of the related law, which states that "a person of ordinary skill in the art" is protected when to making a thing that is covered by a patent when that item is, in a word, obvious. Justice Anthony Kennedy wrote in his opinion that the phrase "a person of ordinary skill" entails the notion that such an individual is "also a person of ordinary creativity, not an automaton."

Thomas said, "When you read the opinion, it's earth-shaking. It turns obviousness on its head" and "dispenses 25 years of opinions." He warned that "now marketplace forces are supposed to dictate" the question of obviousness.

The court's unanimous opinion also states that a test of obviousness is whether "there existed at the time of invention a known problem for which there was an obvious solution encompassed by the patent's claims." The court also said that the proper question "was whether a pedal designer of ordinary skill, facing the wide range of needs created by developments in the field of endeavor, would have seen a benefit to upgrading [a prior art patent] with a sensor."

Murray said, "The biggest impact of KSR is prophetic inventions" that have been granted, but which have not been put into play. Schramm said the decision means "now you're going to have to argue around" a previous explanation of a patent, should the holder of a patent attempt to file an infringement suit.