The Hindu Business Line : Innovator co delists patents — Merck move to deprive Ranbaxy, Ivax of exclusivity

PHARMACEUTICAL companies in the US are trying various strategies to ensure that no single competitor offering cheaper versions of drugs grabs a major share of their business.

In the case of blockbuster medicines going off patent, instead of letting one rival charge ahead in the race, these companies seem to favour opening the gates to all.

Take Merck, for instance. To ensure that companies such as Ranbaxy and Ivax do not make a killing by exclusively selling generic versions of its $5.9-billion cholesterol-lowering drug Zocor (simvastatin) for 180 days after the patent expires, the company decided to delist two patents — US RE36481 and US RE36520 — expiring in 2008 and 2009 respectively.

According to analysts, had the patents continued to be listed, Ranbaxy could have gained $60-70 million during the six-month exclusivity on the 80-mg version of the drug.

Merck has also received a shot in the arm with the Federal Trade Commission of the view that innovators should be allowed to de-list wrongfully listed patents.

Ranbaxy has filed a Citizen's Petition (CP) on the issue, reclaiming the 180-day exclusivity. Its spokesman said: "Ranbaxy believes the delisting of the two simvastatin patents was improper and has filed a Citizen's Petition with regard to this. Ivax has also filed a CP with regard to the same. Ranbaxy's latest filing is in response to the Federal Trade Commission's filing in Ivax's CP. Ranbaxy believes its six-month exclusivity on the 80-mg strength for simvastatin should be restored, and the CP process is the first step in getting the exclusivity back."

Ranbaxy, in its most recent filing, provides a declaration from its scientists and legal counsel that Merck's product actually contains the compounds claimed in those two patents. Analysts say this could perhaps be the first time that a company is providing some evidence that the patents were rightfully listed.

Ranbaxy was the first to file for the 80-mg version of the drug and had challenged the two listed patents. However, the US-based pharma major had decided to de-list the patent to take advantage of the existing practice whereby generic companies are not eligible for exclusivity if there are no listed patents.

Ivax was the other company to file first for the other strengths of the same drug.

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