ELI LILLY FILES PATENT INFRINGEMENT SUIT AGAINST SUN PHARMACEUTICAL INDUSTRIES

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US drug giant Eli Lilly & Co has filed a patent infringement suit against Sun Pharmaceutical Industries to prevent the latter from selling a generic version of its hyperactivity-disorder drug Strattera in the US. Sun Pharma is seeking approval to sell a generic version of the drug, insisting that Eli Lilly’s running patent on Strattera is not valid.

In a complaint filed last week in a Detroit court, Eli Lilly asked that the US Food and Drug Administration’s (FDA’s) approval be blocked until its patent expires on May 26, 2017. The disputed patent (patent number 590) covers the method of treatment and was issued by the US patent office on August 19, 1997.

“Lilly will be irreparably harmed” if the generic drug is not blocked, a news agency report quoted the US company as saying in the complaint. Strattera, known under its chemical name as atomoxetine hydrochloride, is a medication used in the treatment of Attention-Deficit/ Hyperactivity Disorder (ADHD), and recorded sales of $580 million in 2006 in the US alone.

When contacted, Sun Pharma spokesperson said: “As a policy, we do not comment on patent challenges.”

Mumbai-based Sun Pharma is not the first company to challenge Eli Lilly’s patent. Last August, Iceland’s Actavis was sued over its application to sell atomoxetine hydrochloride tablets while Sandoz, Novartis AG’s generic arm, filed a suit against Eli Lilly seeking declaratory judgement of invalidity of the patent. Teva Pharmaceutical Industries, Mylan Laboratories, Synthon, The Apotex Group and India’s Glenmark Pharmaceuticals, Cadila Healthcare and Aurobindo Pharma have also challenged Eli Lilly’s patent.

As a result, even if the court were to rule in favour of Sun Pharma, it may not benefit from a 180-day exclusivity period in the generic, which goes only to the first company to challenge Eli Lilly’s patent. “However, generic pharma companies can also challenge a patent only to ensure that they will be able to launch the drug on the very first day of non-exclusivity,” said a senior industry analyst.

Sun Pharma has been struggling over the last few months to gain control over Israel’s Taro Pharmaceutical Industries. Sun had agreed last May to buy Taro Pharma for about $454 million, or $7.75 per ordinary share. However, the deal had hit a roadblock as a section of Taro’s shareholders announced that they would vote against the deal on grounds the price offered by Sun was too low. Templeton Asset Management, a minority shareholder, filed petitions with the Tel Aviv District Court.

The battle between Sun and Taro’s minority shareholders gained momentum last week as the judge hearing the case opposing Templeton Asset Management to Taro remarked: “I cannot understand how it is possible to undertake a merger without financial reports. That is a scandal in itself, and contravenes the Companies Law.”

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