IPAB revokes GSK patent in latest blow to Big Pharma

However, it dismissed another revocation petition on basic patent of the same drug

The Intellectual Property Appellate Board (IPAB) has issued an order to revoke a patent of Glaxo Group, on its breast cancer drug Tykerb, while dismissing another revocation petition on the basic patent of the same drug. The orders came on applications filed by Fresinius Kabi Oncology Ltd.

 

The corum of IPAB, consisting of Chairman Justice Prabha Sridevan and Technical Member (Patent) D P S Parmar, ordered that the claimed invention of a salt variation of the drug, under Patent No IN221171, Lapotinib ditosylate, "is obvious and is hit by Section 3(d) and Patent No 221171 is revoked."

 

Fresinius Kabi argued that by a combination of the existing knowledge, related to the salt form, ditosylate salt, one would arrive at this Invention. They said the ditosylate salt was one of the 19 salts disclosed with an earlier patent, Patent No 221017. This was the other patent which Fresinius Kabi Oncology disputed in another application and upheld by the IPAB, on the same day, July 27, 2013.

 

The order elaborated, "We are of the opinion that to the Person Skilled in The Art taught by the exhibits, the invention was obvious.  According to our Act, the patent is revoked if the invention is obvious.  So the secondary considerations cannot change that.  It is true that the applicant has not filed any evidence by way of affidavit, but the prior arts have been filed and on the facts of this case this material is sufficient."

 

Meanwhile, the Bord has dismissed an application for revocation of the basic patent of Tykerb, Patent No 221017, which is the pharmaceutical compound, Lapatinib. The Board said that it did not find the invention as obvious and the claim that the said compound was a derivative of a known compound has not been proved.

 

The revocation petiton was based on the grounds of obviousness, insufficiency of description,non-patentability and non-disclosure under Section 8 of Patents Act, 1970.

 

Commenting on the IPAB order, a GSK spokesperson said, "We are pleased that the IPAB in India has upheld our basic patent for the lapatinib compound, the active ingredient in Tykerb. This patent has an expiry date in January 2019." As part of its access strategy, it is already offer discounted prices for Tykerb in India. 

 

"We are, however, disappointed that the IPAB has revoked our later expiring patent for the lapatinib ditosylate salt...We are studying the IPAB’s decision but maintain our belief in the inventiveness of the lapatinib ditosylate salt and will consider the possibility of taking further steps before the appropriate authorities to validate this," added the company.

 

The two orders, one upholding the original patent of the breast cancer drug and another revoking a patent for the innovation stating that it is obvious, comes at a time when the multinational pharmaceutical companies are raising their protest against the patent protection systems and laws in India.

 

It may also be noted that the Supreme Court of India has dismissed Swiss pharma major Novartis AG's appeal to give patent protection to its cancer drug Glivec, in the beginning of April, this year, in which the patentability of a different form of the drug was a matter of dispute.