Archive for September, 2009

Guessing Right Is Not Sufficient — The Ghost Of Rasmusson Walks Among Us!

Tuesday, September 29th, 2009

Rasmussen v. SmithKline Beecham Corp., 413 F.3d 1318 (Fed. Cir. 2005) (link below) was a truly scary decision that many of us practitioners hoped would be ignored by future Fed. Cir. panels as an aberration brought on by over-extensive prosecution, a litigation setting, and good lawyering. In that decision a Merck application filed early in a chain of nine applications was held to be non-enabled, and Merck’s priority claim was denied. The application, as I recall, claimed the use of a known compound to treat prostate cancer. Clearly, it worked or at least showed promise, or the interference would not have advanced so far. However, the court held that Merck’s early applications were non-enabled, affirming the Board’s finding that Merck provided no experimental data confirming the alleged anti-cancer activity and “no reasonable scientific basis for [the art worker] to conclude that method would [work].” Citing In re Novak (CCPA 1962). The court reasoned:

“If mere plausibility were the test for enablement…applicants could obtain patents rights to ‘inventions’ consisting of little more than respectable guesses as to the likelihood of success. When one of the guesses later proved true, the ‘inventor’ would be rewarded…instead of the party who demonstrated that the invention actually works.”

In 2005, while I noted that the early applications had no experimental data at all, even in vitro tests, I also noted that the court recognized that the applications did have a discussion of the scientific basis of the method of treatment. I closed a slideshow on this decision by noting that “Merck ‘guessed right’–the method of treatment worked and for the reason Merck said it did…. Merck met most of the Wands factors (except working examples, which are not required to meet s. 112)…We want early disclosures of drugs and medical treatments.”

Apparently not so much. In Janssen Pharmaceutica v Teva, appeal no. 2008-1594, 2009-1070 (Fed. Cir. Sept. 25, 2009) a split panel affirmed the invalidation of U.S. Pat. No. 4663318, claiming the use of a known compound, galanthamine, to treat the symptoms of Alzheimer’s disease, on the basis that the specification “does not satisfy the enablement requirement because [the specification] did not establish utility.” Yes, the specification was short, there was no experimental test data (even in vitro) and the inventor offered little in the way of explanation for the mechanism of action (e.g., did not say “While not intending to be bound by any theory of action, it is believed that…”), but honorable jurists, HE GUESSED RIGHT! Subsequent animal model tests were positive and, as the majority noted without comment: “In February 2001 [the inventor] received approval from the [FDA] for using galantamine to treat mild to moderate Alzheimer’s disease.”

The majority cites In re Fisher, which held that ESTs lacked practical utility, but that is a far cry from denying a patent on a new use for an old compound, when that new use is far from incredible on its face and of great social importance. While stopping just short of requiring in vitro testing that can be correlated to efficacy (something the PTO longed for in the 90’s), the majority left little hope for those inventors who cannot come up with test results during prosecution (even if the Examiner does not require it): “Thus at the end of the day, the specification, even read in the light of the knowledge of those skilled in the art, does no more than state a hypothesis and propose testing to determine the accuracy of that hypothesis. That is not sufficient. See Rasmusson…. ” Janssen had argued that “analytic reasoning” should be sufficient to establish utility. While finding no case law contradicting this position, the majority simply found that “[t]hese insights are nowhere described in the specification.”

Read Judge Gajarsa’s dissent first; it will amplify your stress/distress level at Judge Dyk’s and Judge Mayer’s stern opinion, that comes perilously close to moralizing. Judge Gajarsa reminds the majority that it is the defendants’ burden to invalidate the patent by showing that “its model for Alzheimer’s therapy, is not sufficient for a skilled artisan to believe the invention’s utility.” He closes by stating that “[the panel] cannot defer to the district court’s legal conclusion or [deficient] fact-findings, and thus, it is particularly problematic for the majority to require Janssen to demonstrate on appeal that its patent is valid.” Unfortunately, this is a dissent and, as the patentee learned with a vengeance: No flash of genius goes unpunished.

Janssen Pharmaceutica.pdf

WARF and Life Sciences in Wisconsin – A Memoir

Monday, September 28th, 2009

Yesterday and today, the Minneapolis StarTribune has run lengthy stories contrasting the development of the biotechnology industry in Wisconsin with that in Minnesota. Today’s story focuses on the Wisconsin Alumni Research Foundation (WARF) and its successful efforts to found and promote life science start-ups based on technology developed at the University of Wisconsin.

While today’s article notes that WARF was founded in 1925, in my opinion, it could have given a better sense of just how long WARF has been contributing to the “state of the art” of bioscience in Wisconsin, and points beyond. For example, when I got to the office today, I opened my 1973 edition of “Choate on Patents,” the hornbook I used in law school in 1980. Two cases from the early 1940’s were abstracted involving the Steenbock process for enriching milk in vitamin D by irradiating it with UV light. This process was developed at the University of Wisconsin at about the time my father was a graduate student there, and WARF was already there to obtain the patents and to enforce them. Among other “home runs” in the late 1940’s and 50’s, WARF was involved in commercializing Warfarin (Coumadin), a “blood thinner” still widely in use, and in backing Professor Hector DeLuca’s successful effort to develop vitamin D metabolites and analogs in the sixties. Today WARF occupies one of the biggest buildings on campus and has revenue from investments in many aspects of Wisconsin’s economy.

A WARF fellowship to a young professor in the Department of Medicinal Chemistry made it possible for him to hire me as his first postdoctoral fellow in 1971. When a colleague, Professor Charles Sih, developed a practical synthesis of prostaglandins, he patented it through WARF, who licensed the patents to Miles Laboratories. Miles in turn opened a Natural Products Laboratory in Madison (renting space from a WARF subsidiary) and Prof. Sih hired me as the first Research Chemist for the lab in 1972. Miles employed about 15 people in the lab by the late 70’s and, believe me, in a town where Ph.D.’s drive cabs, these were “good-paying jobs.”

In contrast, the University of Minnesota did not have a “modern” tech transfer office until the mid-1980’s when it hired three patent attorneys, and began to do the missionary work necessary to attract disclosures of promising inventions from the faculty. To give you an idea of how little patenting the University of Minnesota had been doing prior to that time, Merchant & Gould, where I was then an associate, had only opened about thirty matters for the University of Minnesota in the entire history of the firm. The first patent application I filed for the University of Minnesota was in June of 1984 (U.S. Pat. No. 4,713,340), “Biodegradation of Pentachlorophenol.” (The Chakrabarty patent had only issued three years earlier, but life sciences patenting at the University was underway.) I was also fortunate enough to obtain the first of a series of patents for Professor Robert Vince that covers the anti-HIV drug Abacavir, which is marketed by Glaxo, and has yielded more licensing revenue over the years than almost any other invention patented at any university. Still, given what is essentially a sixty year head start, it is unrealistic to expect the University of Minnesota to somehow “catch up” to WARF. Our Office of Technology Transfer needs to be user-friendly, opportunistic and ready to set the hook and start reeling when the next big one strikes.

Does a Slideshow Show Too Much? In re Klopfenstein Revisited

Friday, September 25th, 2009

In re Lister, the Federal Circuit repeatedly cited In re Klopfenstein, 380 F.3d 1345 (Fed. Cir. 2004) (link below), a decision that held that a poster presentation that was available for viewing at a meeting for 2-3 days was a “printed publication” under 102(b). This decision has lots of interesting dicta that indicates, for example, that a slideshow with an oral presentation would not necessarily be considered a “printed publication” if no printed copies were available since the slides were only transiently visible. A thesis defense per se would also not be considered a printed publication. Even the brief display of a poster may not qualify as a printed publication, and presentation of the poster at a meeting with a non-copying notice may have disqualified the poster as a printed publication.

So if “your professor” tells you that he or she disclosed the invention in a slideshow or a poster at a scientific meeting, don’t assume that all rights are gone, or even that absolute novelty has been lost abroad. I spoke to a UK associate some years ago who told me that the burden of proof imposed by the court on a defendant who tries to rely on an oral presentation or slideshow as novelty-destroying is extremely high. (I won’t go into detail here, since associates may well differ on this point, and you should contact your own, of course.) ‘Nuff said!

In Re Klopfenstein.pdf

Fed. Cir. Tees Off On Board's Evidence of Timing of Publication

Thursday, September 24th, 2009

ln re Lister, appeal no. 2009-1060 (Fed. Cir, Sept. 22, 2009) (link at bottom) the panel found that a manuscript by the inventor, “Advanced Handicap Alternatives for Golf” which he had sent into the Copyright Office some time prior to filing a patent application on his “method for playing an organized game of golf,” was sufficiently publicly accessible to qualify as a printed publication. The panel found that, while the Copyright Office’s catalog was not adequately searchable, the automated data had been entered into the Westlaw and Dialog databases. Unlike the Copyright Office “automated catalog,” these databases are keyword searchable, and that fact was sufficient for the court to hold that the manuscript was a printed publication under 102(b).

However, the court ultimately reversed and remanded, holding that the Examiner and the Board had not presented sufficient evidence as to when the manuscript was available to the interested public, i.e. when it was “listed” in either the Westlaw or Dialog databases. The court found the failure of proof analogous to the (improper) use by an Examiner of an “undated reference” that discloses a claimed inventor as prior art against the claims.

Probably of lower importance, but still interesting, is whether or not the claim to this “method” of playing a game would be patent-eligible under the Bilski “machine or transformation” test. The only step in the independent claim given in the opinion that is not a data gathering step that could be performed in the mind of the player (recording strokes and comparing numbers of strokes) is the step of giving the players permission “to raise or tee the ball up above turf level at any time during play” (not just at the first stroke of each hole, but not on the green or in “designated hazard areas”). I don’t see any matter being transformed into another state by letting players tee up the ball throughout the game (in fact, smooth turf is more likely to stay smooth). I also don’t see that the game is tied to any particular machine. A golf tee is a machine (a platform), I guess, but there are probably many different styles of golf tee that could (and probably have) been devised over the years. The claim does not positively recite that the ball is stroked and, in any case, does not say what it is hit with. Patentable subject matter? I think not!

However, the claim in question here does point out one application of the “M or T” test; it would eliminate patents on simple games. Under the courts’ interpretation of section 101, games are patentable, and that includes games as simple as tag or “rock, paper, scissors.” In contrast, the EPC cuts right to the chase and bars patents on “schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers.” Art. 22. See, Paul Cole, “Fundamentals of Patent Drafting”, CIPA (2006) at Ch. 4.