In Opposition proceedings brought by Teva regarding IL 130424 to Pfizer, the IP Arbitrator at the Israel Patent Office decided, that Inventiveness is not something dependent on how an invention was discovered, but depends on objective criteria. Thus, if optimization was achieved by some breakthrough, but could be achieved by routine engineering practice, then there is no inventive step. Based on this logic, Shmulovich, the IP Arbitrator, decided that there was no case for opponent of a patent issuing to request that applicant provides evidence of how they made the invention.
So far so good. The problem appears to be that with sufficient experimentation, with an infinite number of monkeys mixing chemicals, or with computerized simulations, it is possible to optimize anything. Does this mean that all chemistry optimization patents are out as lacking inventive step? Teva will probably have mixed feelings about that as they have synthesis and dosing patents themselves…
I have mixed feelings regarding testing hunches on human beings and believe that Edward Jenner, the discover of vaccinations, should be retroactively tried for crimes against humanity for infecting a boy with small pox to test his theory that cow pox provides immunity, since, as far as research with humans is concerned, I do not accept that the ends justify the means. I have no problem with animal experiments and vivisection for the human good, at least as far as drug development goes, but have an ethical dilemma as far as the free choice available to prisoners in gaols, but I digress.
My point is that unlike Novelty which is objective, Inventiveness is subjective and is not defined anywhere. Certainly, when prosecuting applications before the examiners in Israel, as a patent attorney representing the applicant, I argue that there is an inventive step and the examiner argues that there isn’t. Each of us has a job to do, one of us wins, but there is nothing ‘objective’ in our relative positions or in the eventual scope of the patent that is allowed, and it is a little extreme for Shmulovich to claim otherwise.
A minor victory for Pfizer, with a 2000 NIS fine ($500) imposed on Teva for trying an imaginative and creative, but ill-considered defense.
An excellent article (Amy Nelson/”Obviousness or Inventive Step as Applied to Nucleic Acid
Molecules: A Global Perspective”,NORTH CAROLINA JOURNAL OF LAW & TECHNOLOGY
VOLUME 6, ISSUE 1: FALL 2004) provides a review of the approaches to inventiveness related to nucleic acids and peptides, in various countries.
for example, in US:
“One of the earliest court decisions regarding obviousness as
it applies to nucleic acid molecules in the United States related to
isolation of a human genomic DNA encoding erythropoietin
(“EPO”) (Amgen Inc. v. Chugai Pharm. Co. Ltd., 927 F.2d 1200 (Fed. Cir. 1991)) …the court
focused on the likelihood that the method of DNA isolation would
succeed.”
“In stark contrast to the Amgen decision, more recent
decisions by the Federal Circuit have focused on the structural
obviousness of the nucleic acid molecules themselves, rather than
on the obviousness of the methods for their isolation.”