Cases aimed at stopping approval of new generics

Galderma Laboratories, a joint venture dermatology company between Nestle and L'Oreal, and the New York University have sued Lupin Ltd for infringing the patent rights of one of its main drugs, Oracea.

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Sources said the lawsuit against Lupin and its US subsidiary, Lupin Pharmaceuticals, was jointly filed in the US District Court for Delaware on July 2 by the patent holders of the drug, New York University and Research Foundation of State University of New York, and patent licensee Galderma Laboratories, for infringing four US patents covering Oracea.

Oracea (doxycycline) is the only US Food and Drug Administration (FDA) approved oral drug to treat rosacea — a skin disorder in the face with inflammation, skin redness and spider veins. This disease affects 14 million Americans every year and its therapy is estimated to have a market worth $500 million.

The drug was developed by CollaGenex, a research company, and the universities. Switzerland-based Galderma acquired CollaGenex in February last year for $420 million to access this drug. The drug got FDA approval in May 2006 and had $52.5 million net sales in 2007, according to the last annual report CollaGenex filed with the US Securities and Exchange Commission (SEC), before its acquisition.

A Lupin spokesperson said the company would not comment on its patent litigations. The company has filed about 90 marketing applications in the US. Of this, 25 have got approval and at least 28 are believed to have first to file (FTF) status, he said.

Lupin filed an abbreviated new drug application (ANDA) with the US FDA to sell generic doxycycline delayed-release capsules in 40 mg dosage and intimated Galderma of the filing on May 29.

According to the US laws for selling generic drugs, a patent holder has to sue the generic ANDA filer within 45 days to prevent the FDA from approving the drug for the next 30 months. If approved, the first to file (FTF) applicant can sell the generic exclusively for 180 days upon patent expiry.

Patent experts said they were not sure if Lupin will get the FTF status for generic Oracea, as Galderma and New York University had sued US-based Mylan Laboratories in March, for infringing the patents on this.

Meanwhile, in another development, leading Japanese drug maker Takeda Pharmaceutical sued Ahmedabad-based Torrent Pharmaceuticals for infringing seven patents related to its blockbuster diabetes drug, Actos (pioglitazone). The drug has over $1 billion sales in the US.

Takeda filed its suit in the US District Court for the Southern District of New York last week, demanding no-approval for Torrent's ANDA till the patent expiry of Actos in 2016. Torrent sought FDA approval to make a generic version of Actos in 15 mg, 30 mg and 45 mg doses and this was notified to Takeda on May 30.

Ranbaxy Laboratories is believed to be the first one to have challenged the patent of Actos and the Daiichi Sankyo-owned company may get a six-month marketing exclusivity in the US after its patent expiry.

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