Roche denied India patent for powder formulation for anti-HIV drug Valcyte

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Chennai | Published: February 6, 2019 5:10:21 AM

The pharma major’s original Valganciclovir patent, granted in 2007, was revoked in 2015 after generic companies such as Ranbaxy, Cipla, Bakul Pharma and Matrix Labs along with some patient organisations filed a pre-grant opposition against the patent.

Roche, anti-HIV drug Valcyte, Valganciclovir patent, Matrix Labs, Cipla, Ranbaxy, Bakul PharmaPatent evergreening generally refers to the strategy of obtaining multiple patents that cover different aspects of the same product, typically by obtaining patents on improved versions of existing products.

In a setback to Swiss pharma major F Hoffmann-La Roche (Roche), the Indian patent office has rejected the company’s application for a powder formulation for Valganciclovir, its anti-viral drug for HIV patients sold under brand name Valcyte. The Chennai patent office refused the patent for the formulation on the ground of lack of novelty.

The pharma major’s original Valganciclovir patent, granted in 2007, was revoked in 2015 after generic companies such as Ranbaxy, Cipla, Bakul Pharma and Matrix Labs along with some patient organisations filed a pre-grant opposition against the patent.

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The legal tussle generated much heat and dust in the pharma industry as the grant of the patent in India was viewed as restrictions or a threat to cheaper generic versions of the drug. Though the patient organisations secured a victory in their fight for access to medicines as Roche’s patent on Valganciclovir was revoked by the Chennai patent office, the victory was not overwhelming, since the patent’s term expired almost simultaneously.

The patent application for Valganciclovir was filed in 1995 and the life-span of a patent is 20 years from the date of filing of the application. The revocation of it in 2015, after being in legal tangle in many forums like Supreme Court, high courts and IPAB, thus, coincided with the deadline of the patent expiry.

Roche subsequently, in 2009, filed an application relating to a powder formulation for Valganciclovir, in a bid to weave exclusivity protection around the drug, if granted a patent. It is common practice among the pharma companies to file different patent applications, with variations in formulations, for the same drug, with a view to evergreening of the patent.

Patent evergreening generally refers to the strategy of obtaining multiple patents that cover different aspects of the same product, typically by obtaining patents on improved versions of existing products. Although the patent system allows improvement patents to be obtained in any industry, evergreening is said to be most common in the pharmaceutical industry.

S P Subramaniyan, deputy controller of patents and designs, Chennai patent office, in his January 30, 2019, order while rejecting a patent for the powder formulation for Valganciclovir observed there was no technical advancement achieved from the present ‘invention’. Using fumeric acid in place of citric acid which exhibits similar stability profile in terms of recovery of Valganciclovir and amount of total impurities, was a choice of alternate organic acid available within the reported pH range.

When contacted, Roche, in an e-mailed response to FE, said: “Roche stands behind the work and innovation that brought Valcyte to the Indian market, benefiting many patients in India. We are committed towards delivering innovation in healthcare by developing medicines that significantly improve people’s lives in the country.”
The tussle over Valganciclovir drug patent dates back to 1995, when Roche filed a patent application covering Valganciclovir. Valganciclovir is an oral prodrug of Ganciclovir that is used in the treatment of cytomegalovirus infections, primarily in immunocompromised patients such as HIV/AIDS patients or patients who have undergone organ transplants. The drug cost around rS 2.7 lakh for one course of treatment of a patient during that time.

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