Israel Patent Office Voids Smithkline Beecham Patent for Metastable Polymorph

Israel generic pharmaceutical manufacturer and patent buster Unipharm has succeeded in preventing Israel Patent Number IL 117035 from issuing.

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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.



Categories: Intellectual Property, Israel IP, Israel Patent Office, Israel Patent Office Rulings, News, Opinion, Patents, pharmaceuticals, pharmaceuticals and Biotechnology

2 replies

  1. Section 18(2) refers to any relevant prior art known to the applicant. The Notice before Examination sent by the Patent Office indeed relates only to citations, though; perhaps a reformulation is in order.

    • I am reproducing the law below – using the English text available from WIPO.

      18.-(a) The examiner shall use at least one of the following additional means of examination:

      (1) the list of documents used by patent authorities in any foreign state in the examination of a patent application on the same patent application, submitted in a foreign country by the applicant or by his predecessor in title to the invention;

      (2) a list of documents published before the application date, known to the applicant and directly connected with the invention;

      (3) copies of publications and documents, a list of which the applicant must submit under this Article, if the examiner so demands;

      (4) copies of publications and documents mentioned in publications and documents, a list of which the applicant must submit under this Article, if the examiner so demands;

      (5) transmission of the specifications of the application-in order to search for material that will enable the Office make the examination-to an institution is Israel or abroad, with which the Office contracted under any Law by an agreement drawn up by the Registrar, including a section on keeping any patent application confidential and on nondisclosure under section 165;

      and to that end he may do one or more of the following:

      (1) require the applicant to submit to him all the documents specified in paragraphs (1) to (4);

      (2) transmit the specification in the application for the search said in paragraph (5).

      [Applicant must keep Office informed]

      18A. Until the application is accepted the applicant must keep the Office informed of any change in the list of publications and documents said in section 18, if he or his representative was made aware of the said changes.

      Several leading practitioners including Adv. Arnan Gavrieli – senior partner at Seligsohn Gabrieli & Co. and a leading litigator and lecturer at Tel Aviv law school, believe that since the Patent Office only asks for citations, that is all one needs to provide. Others, including myself and Kfir Luzzatto believe that one shoul provide anything known.

      The trouble with this case and the Nazareth ruling is that they relate to extreme examples. The Patent Office certainly does not want to be flooded with long lists of prior art.

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