Patent office told to reconsider Boehringer's application

The order is in an appeal filed by the company against the decision of the Controller of Patent

The Intellectual Property Appellate Board (IPAB) has asked the Controller General of Patents, Designs and Trademarks (CGPDT) to reconsider the patent application of German pharmaceutical major Boehringer Ingelheim International GmbH for Pradaxa, a crystalline form of blood thinning medicine used to prevent strokes and blood clots in cardiac patients.

Short notice
CGPDT has been told to decide on the matter afresh within two months from the receipt of the order. When asked for a comment, Boehringer Ingelheim officials in India said the company “wouldn’t be able to participate because of the short notice”.

The IPAB order pertains to an appeal filed by the company against CGPDT’s decision to reject a patent for the product. CGPDT had said there was no inventive step in the matter, as an international patent application disclosed all the features in the claim.

Prior art refers to all relevant information of the claimed invention already available in the public domain.

IPAB’s order said, “In the result, we are left with no option but to send this case back for reconsideration by the respondent…The respondent (CGPDT) shall not consider D1 (a document of international patent application) as prior art, but decide the matter afresh, according to the law, within two months from the receipt of this order. The appellant shall be given the opportunity to present his case again.”

“Had the controller checked the date of publication while considering the published prior art, this could have been avoided,” the order added.

CGPDT had, in an order dated January 12, 2011, refused patent for the form, saying the documents disclosed all the features defined in the four claims and, therefore, the claimed invention wasn’t new and lacked an inventive step under Section 2(1)(j) of the Patent Act. It added the applicant’s four claims fell within the scope of Section 3(d) and the claimed process was a mere use of a known process to prepare polymorphic forms of a substance.

According to Boehringer Ingelheim’s website, the company is poised for exponential growth, with planned launches of important molecules such as Pradaxa and Trajenta. The website adds the company planned to launch Pradaxa as its first patented product in India. This would mark the company’s foray into India.

“Pradaxa, offering big opportunities, is also accompanied by the challenge of changing ingrained behaviour, with existing therapy options that are about 50 years old. To ensure a landmark launch in the Indian market and make Pradaxa the drug of choice, preparatory measures will be taken a year before the launch,” it said in a webpost, probably put up last year.