Archive for the ‘Utility/How-To-Use’ Category

Neutrokine-α litigation – On a different record from that before the EPO Appeal Board, the UK Court of Appeal finds different facts with a different result

Thursday, February 11th, 2010

From Paul Cole of Lucas & Cole

On February 9th the Court of Appeal ([2010] EWCA Civ 33; Jacob L.J.) held that Human Genome Sciences Patent EP-B-093

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9804 for Neutrokine-α did not meet the industrial applicability requirement of a.52(1) EPC and should be revoked for the United Kingdom. In reaching its decision the Court affirmed a first instance finding of Kitchen J. ([2008] EWHC 1903) but differed from a 2009 finding of the EPO Appeal Board (Neutrokine/HUMAN GENOME SCIENCES Case T 0018/09) that the patent was valid. Since the proceedings relate to the national phase of the granted European patent, protection in other EPC contracting states is unaffected by the decision.

The patent in issue reported the discovery of the new protein and stated that it might be relevant to the treatment of a wide range of diseases ranging from solid tumours to schistosomiasis and other parasitic diseases. No experimental evidence was included in the specification to support these claims which were described at first instance by Kitchen J as “extravagant and sometimes contradictory”. Kitchen J. commented:

“I accept Professor Saklatvala’s evidence that the idea that Neutrokine-α and antagonists to Neutrokine-α could be used to treat the extraordinary range of diseases identified was fanciful. He found it hard to believe that anyone could seriously suggest on the basis of no experimental data at all that that Neutrokine-α was the answer to so many conditions, from treating cancer to treating worms. In my judgment the skilled person would come to the conclusion that the inventors had no idea as to the activity of Neutrokine-α when drafting the Patent.”

In affirming the first instance decision, the court held that there was no difference as regards legal principles between the decision of Kitchin J. and the main decisions of the EPO Appeal Boards regarding DNA sequences and bioinformatics, including Max-Planck T 0870/04 (May 2005), Johns Hopkins T 1329/04 (June 2005), Genentech T 0604/04 (March 2006), ZymoGenetics T 0898/05 (July 2006), Bayer T 1452/06 (May 2007) and Schering T 1165/06 (July 2007). It was now settled that the research tool justification for patenting a new nucleotide sequence or polypeptide was not enough to satisfy the EPC. The following passage from the Max Plank decision showed the dangers if patenting too far upstream were allowed:

“[21] In the board’s judgment, although the present application describes a product (a polypeptide), means and methods for making it, and its prospective use thereof for basic science activities, it identifies no practical way of exploiting it in at least one field of industrial activity. In this respect, it is considered that a vague and speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool as described is not sufficient for fulfilment of the requirement of industrial applicability. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant.”

However, the Court of Appeal emphasized that what was binding was applicable legal principle, and that each case should be judged on its own facts. It was therefore not legitimate to invite the court to decide the case by reference to the facts of other cases.

Kitchin J.’s factual finding that the potential uses were merely speculative was supported inter alia by a statement of the time from real experts with no axe to grind who were not prepared to say that mere membership of the TNF-ligand superfamily was enough to indicate that any member of the family could be “a candidate for a novel treatment protocol” and his decision on the evidence before him could not be faulted. Although Kitchin J. and the Technical Board of Appeal asked the same key question and identified the same “kernel” the real difference was that Kitchin J. found on the facts before him that the “kernel” did not provide any basis for supposing that the invention was susceptible of industrial application whereas on the facts before it the Board thought there was. One difference in the relevant records was a last minute affidavit by a Dr. Kelsoe which was not before the UK court, and which had never been tested by cross-examination. On the evidence before Kitchen J. the Court of Appeal was not prepared to find that a skilled person would read the patent in the way adopted by the Board, and it was not proper to equate “a first step at the onset of research work” with “an immediate and concrete benefit”. The factual findings of Kitchin J. were to be preferred since they had been arrived at following an intensive examination of the evidence. In conclusion:

“The upshot of all this is that Board, working on different evidence and using a different procedure came to a different conclusion on the facts. We are not bound to follow, or even give deference to, the Board’s findings of fact.”

It is not yet known whether a further appeal to the Supreme Court (the successor to the House of Lords) will be attempted. As there is no dispute as to the underlying law, it seems unlikely that any further appeal will be permitted.

Human Genome Sciences will become one of the most important UK authorities on industrial applicability. It is also likely to be widely read for its observations concerning the differences between proceedings in national courts and in EPO oppositions and concerning the limitations on the extent to which EPO Appeal Board findings should be of persuasive authority for national courts of the EPC contracting states.

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