Ranbaxy gets relief in Roche drug case

In a ruling that gives Gurgaon-based Ranbaxy Laboratories some relief in its patent litigation, a US court has ruled that the company’s generic version of anti-viral drug valganciclovir does not infringe the patent held by Swiss major Roche, whose product is marketed by the brand name Valcyte.

In the same vein, however, the US District Court for New Jersey, which gave the ruling, has upheld Roche’s patent for Valcyte as valid.

The verdict comes on a complaint filed by Roche in April 2006, accusing Ranbaxy of patent infringement, soon after the latter submitted an abbreviated new drug application to the US Food and Drug Administration seeking approval to market and manufacture a generic version of Valcyte.

Ranbaxy had then stated that its generic version would not infringe Roche’s patent as its form of the active ingredient, valganciclovir, was amorphous, rather than crystalline in nature.

However, Roche had countered Ranbaxy’s argument saying generic would infringe its patent as the active ingredient would turn crystalline almost spontaneously.

The court has disagreed with Roche’s argument as the company could not prove the spontaneous change of form in the generic as also that Ranbaxy’s version contained a crystalline form of valganciclovir.

A Ranbaxy spokesperson said the company is happy with the verdict and sees it as a positive development.

However, the verdict is only from a district court, so there is scope for an appeal in the Federal Circuit by either party.

According to patent lawyers, Ranbaxy can appeal to the Federal Circuit challenging Roche’s patent as it is for the crystalline form of valganciclovir. “Ranbaxy can strongly appeal on the ground that if the amorphous form spontaneously turns to crystalline, then the patent for the crystalline form of valganciclovir is invalidated,” said a patent expert based in Mumbai.

The Ranbaxy spokesperson, however, refused to comment on future appeals.

The verdict will give Ranbaxy space to seek final approval from the USFDA (it got tentative approval in June 2008).

However, if it were to get the approval and introduce the product now, it would be at a risk since Roche can still appeal that the generic infringes the patent on the ground that the amorphous form turns to crystalline, said a Delhi-based intellectual property and patent law expert.

Roche officials were not available for comment.

Valganciclovir is used to preserve eyesight in AIDS patients infected with cytomegalovirus, which destroys the retinal cells and leads to blindness. The product has global sales of around $300 million.

Valganciclovir has been in the eye of a storm in India since it was granted a patent in June 2007 by the Chennai Patent Office. Generic drugmakers such as Cipla, Matrix Labs, and Ranbaxy, as well as patients groups such as the Network for People Living with HIV-AIDS, have filed post-grant opposition questioning the validity of the patent in India on technical grounds, arguing that valganciclovir is a new form of a known drug ganciclovir and hence, as per the provisions of the Indian Patent Act, is not eligible for a patent.

The verdict of the US district court will not have any impact on the patent battle in India.