Is a Patent Applicant obliged to make clinical trials available to prove the efficiacy and non-obviousness of an invention?

Unipharm, Israel’s generic drug importer and distributor is opposing Novartis’ Israel Patent Application No. 141762, for New Controlled Release Formulations of Rivastigmine.

In a counter statement of case, Novartis related to clinical trials that showed the efficacy of the controlled release formulation and provided a laconic report.

Unipharm countered by requesting that Novartis make fuller records of the clinical trials available. Novartis responded to this demand by claiming that the clinical trials  were trade-secrets and requested that they be allowed to keep the details confidential and that they could correct their counter statement of case to remove reference to the clinical trials, and to retract the report relating to these.

Unipharm then alleged that the full clinical trials were essential to prove the alleged utility and inventive step of the claimed invention and that Novartis’ failure to make these available undermined the validity of the patent due to lack of utility and inventive step, and was indicative of inequitable behavior and failure of the duty of disclosure.

The adjudicator at the Israel Patent Office – identity unknown since for some reason, the interim decision is not signed – was unswayed and felt that the applicant is only responsible to make publications available to examiners during prosecution, not clinical trials, if the application is sufficiently enabled and convincing to show inventive step and utility, and if not, then during the opposition proceedings the onus is on the opposer to show lack of inventive step (obviousness) or lack of utility. The adjudicator went on to rule that there are no discovery rights under Israel Patent Law that force the applicant to provide documentation of clinical trials.

Novartis was therefore allowed to amend their counter-claim to delete reference to the clinical trials and were not obliged to disclose the results. Costs of NIS 3000 were awarded against Unipharm.

Interim Decision re Opposition to IL 141762, unsigned and undated!

 COMMENT

Rivastigmine, marketed as Exelon, is used for  the treatment of mild to moderately severe dementia related to Alzheimer’s disease. corresponding patents have issued in the US and Europe. It is tempting to make a flippant remark regarding the IPO forgetting to sign and date the decision and Novartis forgetting to submit a report of the clinical trials. However, there is, of course, nothing amusing about Alzheimer’s disease.

The active ingredient has been available in slow release patches. I can see why a convenient oral pill that produces a slow release effect, thereby increasing the efficacy may be considered useful. I note, however, that in other pharmaceutical applications the previous commissioner has ruled that the standard of obviousness required to invalidate a patent based on lack of inventive step is ‘obvious to try’. It seems to me therefore, that despite the adjudicator’s contention that inventive step is objective and not subjective, the circumstances surrounding the clinical trials could indicate if this development is obvious or non-obvious.  No doubt the final ruling in the opposition will be more enlightening, and will probably go to appeal as these things tend to.

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