Mapi Pharma filed Israel Patent Application No. 220476 titled “Long Acting Depot System Comprising a Pharmaceutically Acceptable Salt of Glatiramer” which is used in the treatment of multiple sclerosis. The application is the national phase of a PCT submitted on 9 August 2010, claiming priority from a US application submitted on 4 January 2010.
The patent application was examined, allowed, and published for opposition purposes in the March 2016 patent office journal. On 28 June 2016, Teva Pharmaceutical Industries (TEVA) submitted an opposition. After the parties had submitted their statement of case, TEVA announced that they were withdrawing the opposition for commercial reasons.
In a detailed ruling dated 22 March 2018, Deputy Commissioner Jacqueline Bracha announced that she would exercise her discretion to refuse the patent under Section 34 of the Israel Patent Law 1967 based on the publication of WO 2005/041933 to TEVA dated 12 May 2005, which she considered anticipated the claimed invention. Furthermore, she considered the claims were insufficiently supported by the specification which is contrary to Section 13.
The applicant responded in a detailed explanation, stating why the claimed invention was patentable and the differences between the invention as claimed and that disclosed in WO 2005/041933.
The applicant then held a hearing wherein these arguments were presented orally.
The Deputy Commissioner accepts that the claimed invention is significantly different from that described in WO 2005/041933; whereas WO 2005/041933 teaches providing Glatiramer in fixed dosages, the Application teaches dispensing by slow release over time.
WO 2005/041933 relates to attaching the active ingredient to nano-particles by its outer part by electrical means to slow down the degradation of the peptide. In WO 2005/041933 it was explained that this approach is superior to the known approach of creating a depot, which is planted within the patient’s body and releases the drug, since creating such a depot is not appropriate for peptides and large proteins that are insoluble, such as Glatiramer.
In light of the above, WO 2005/041933 teaches away from the invention.
The applicant further clarified that, as is shown in the specification and particularly in Fig. 1, the Application describes formulations that release only 20% of the active ingredient over a month, so these formulations are suitable for use over 5 months, and the claims are fairly supported by the specification.
The patent is allowed.
Glatiramer is the active ingredient of Copaxone, TEVA’s blockbuster drug that has recently come off-patent. TEVA have tried to get effective extended protection by fiddling with the dosages and frequencies thereof. However, Mapi Pharma is just one of several generic competitors.
Following a slump in their share price and turnover, TEVA has recently laid off a large number of their patent staff in cutbacks and so it is quite feasible that their decision not to continue with the Opposition was indeed a financial one and is not indicative of whether the claimed invention is truly novel or inventive. Ms Bracha is to be commended for both being prepared to handle the opposition in an inquisitorial manner based on first impressions from the statement of case, and to being open to persuasion. Nevertheless, as the opposition continued as an ex-partes proceeding, one wonders if the claimed invention was truly novel, inventive and supported and, were TEVA to have continued, whether they would have won or lost the opposition.