Israel generic pharmaceutical manufacturer and patent buster Unipharm has succeeded in preventing Israel Patent Number IL 117035 from issuing.
The patent, titled “Paroxetine hydrochloride anhydrate substantially free of bound propan-2-ol processes for its preparation and pharmaceutical compositions containing it” claimed novelty for a metastable anhydrate and for the method of manufacture. The composition is claimed to be useful in treating a number of medical disorders including alcoholism, anxiety, depression, anorexia, obesity and pre-menstrual syndrome.
the problem is that an earlier British Patent issued to the same applicant, Smithkline Beecham, GB 26407 claims the same anhydrous salt, together with a method of fabrication. Apparently, the previous method was tried and tested, did work back then, but no longer does so, yielding instead, the stabler hemi-hydrate. As anyone trying out these tricky syntheses will testify, its rather like trying to bake a mother’s cake, in that following the recipe is insufficient. Without the right tempo of stirring, the right impurities in the water, or whatever, the results bear some similarity but are, nevertheless, different.
The applicant claimed that in this new synthesis the anhydrate was obtained by the stage of washing with an aqueous solution, which would appear to be sufficiently counter-intuitive that it provides an inventive step.
Since in the opposition proceedings the applicant failed to pursue the method of manufacture, even as a fall-back position, but went full steam ahead for the product, the Arbitrator of Intellectual Property, Noach Shalev Shmulovich, ruled that the method claims are void as well. He justified this position by claiming that applicant had failed to point out the existence of the UK application in contravention to duty of disclosure under Section 18, citing 14/92 Nazareth District Court (Pelason Maagan Michael Factories LTD. vs. Freddy Freenet), that failure to disclose Prior Art known to applicant can invalidate patent (not just citations).
The decision leaves some open issues however: claims 15-17 are independent method claims and why should the existence of the product by a different processing route cancel these?
Applicant asserted that mentioning a European application that claims priority from the British patent essentially incorporated it by reference and thus it was disclosed. Shmulovich is correct that this argument is weak, but one notes that the Commissioner of Patents has requested to only submit prior art cited in corresponding applications and not to submit all art known to applicants. Personally I advocate supplying details of all art known to applicant, and do so (I note that this was the general recommendation of Agents of Applicant Luzzatto et Luzzatto – at least at the time I worked there at the beginning of my career).
Of note, Shmulovich took the opportunity to admit his mistake and to cancel his ruling concerning IL 142049 Giraffa vs. Melnicke where he’d mistakenly decided that should an independent claim be disqualified, the dependent claims fall with it. No-one took the ruling seriously; nevertheless it takes guts to state that one was wrong and we salute him for so doing.
Unipharm was represented by Adi Levit and Smithkline Beecham by Richard Luthi and Co.
In a second case, published at the same time, the Arbitrator of Patents rejected Unipharm’s opposition and upheld Smithkline Beecham’s Patent Number 133,137 for the combination of Rosiglitzone RSG and sulhponylurea useful for the treatment of diabetes, despite the combination being disclosed in an earlier patent (EP749751) to Takeda. In this case the Arbitrator of Intellectual Property ruled that specific dosages provided a surprising synergy that enabled maintaining a constant blood sugar level over time and thus constituted novelty and inventive step.