RedHill waves a red Flag

redhill
Sometimes, companies publish the oddest press releases. Here is one that is doing the rounds on the Internet, and, with a dearth of decisions due to court recesses (and yes, I have been scratching around for things to write about this past month) this press release has been noticed:
RedHill Biopharma (NASDAQ: RDHL) announced that it has received a Notice of Allowance from the Israeli Patent Office (ILPO) for a new Israeli patent No. 207420 covering the formulation of RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties.
The Israeli patent application No. 207420 is entitled “Methods and Compositions for Treating Inflammatory Bowel Disease”. Once granted, the patent is expected to be valid through at least 2029.
The new patent allowance in Israel further extends the geographic reach of RedHill’s intellectual property for RHB-104 and is an addition to already granted U.S. patents and pending filings in other countries.
RHB-104 is currently undergoing a first Phase III study for Crohn’s disease in the U.S. and additional countries, including Israel (the MAP US study), and a second Phase III study (the MAP EU study) is planned to be conducted in selected European countries in parallel with the ongoing MAP US Phase III study. Interim analysis of the ongoing randomized, double-blind, placebo-controlled MAP US Phase III study is expected in the second half of 2016, after half of the 270 patients planned to be enrolled in the study will have completed 26 weeks of treatment.
RHB-104 is also being evaluated as a treatment for relapsing-remitting multiple sclerosis (RRMS). The last patient has been enrolled in an open label Phase IIa, proof-of-concept clinical study evaluating RHB-104 as an add-on therapy to interferon beta-1a in patients treated for RRMS (the CEASE-MS study). Top-line interim results are expected either in the fourth quarter of 2015 or the first quarter of 2016.

COMMENTS

Several things struck me about the press release:

  • Regardless of the title, methods of treatment of inflammatory bowel disease’ are not patentable in Israel or most other countries. Without looking at the allowed claims, one assumes that the claims directed to a method of treatment were cancelled.
  • Following the cancellation of the claims directed to the method of treatment, the title is misleading and should be amended. If the Israel Examiner did not require this, one suspects he/she was less than conscientious in examining this application.
  • One suspects that the case was allowed under section 17c based on a granted US patent directed to the Compositions. In other words, the Israel Examiner probably rubber stamped the application.
  • Unlike opposition procedures in the US and Europe which challenge the validity of an issued patent and may result in its cancellation, in Israel publication for a three month opposition period is part of the pre-issuance examination process. There is no assumption of validity. The Israel Patent Office essentially invites the public to comment on the validity of the patent application once the examiner has been satisfied.
  • In many fields of human innovation oppositions to Israel applications issuing are rare. However, in the field of pharmaceuticals, oppositions are extremely common. Both Teva and Unipharm are very active opposing patent applications for pharmaceuticals, and, they have a very good success rate.
  • Opposition processes in Israel are open book inter-partes affairs. Many large and established pharmaceutical companies abandon allowed patent applications in Israel on a Notice of Opposition being filed, being prepared to lose a small market of 7-8 million rather than having the prior art and arguments of record as these may result in drug patents being canceled overseas. This has happened with patents to Glaxosmithkline, to Lundbeck, to Novartis and others.
  • In the circumstances, one wonders why RedHill published this press release. It is premature and only serves to warn Teva and Unipharm that there is a new kid on the block.
  • In this instance, according to the press-release, RHB-104 is being evaluated for relapse remitting multiple schlerosis. One would assume that Teva, whose drug Copaxone (glatiramer acetate) is also used to treat relapsing-remitting multiple sclerosis, will certainly note this patenting having passed the examiner stage in Israel, now that has been flagged in a press-release, and will be considering opposing this patent.

So am I right?

I had a quick look at the file wrapper. It transpired that the Applicant amended claims to those of Issued United States Patent Number US 8,343,511 and requested allowance under Section 17c.

The title was amended to “PHARMACEUTICAL COMPOSITION COMPRISING RIFABUTIN, CLARITHROMYCIN AND CLOFAZIMINE AND A METHOD OF FORMULATING THE COMPOSITION”. Thus the patent office did its job. The press release gives the wrong title. One therefore wonders how much else is accurate.

We now wait to see if, on publication, the application is opposed.

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