Mumbai: Swiss drug maker F Hoffman La Roche Ltd last week filed a third lawsuit in a US court to block an application by Indian firm Orchid Chemicals and Pharmaceutical Ltd. seeking marketing approval for a generic version of Boniva, Roche’s best-selling prescription drug for osteoporosis.
Boniva had 2007 sales of about $700 million, or Rs3,451 crore now, in the US, making it the fourth largest revenue earner for the company.
The new lawsuit, filed in the district court of New Jersey, claims that Orchid is trying to make and market the generic version before Roche’s new patent for “Boniva-once-monthly”, numbered 7,410,957 and granted in August 2008, expires in 2023. Two earlier patents for Boniva expire in March 2012.
Orchid is one of six generic players which have sought approval for marketing generic versions of this drug, known as ibandronate sodium, in the US under the so-called abbreviated new drug application, or ANDA.
These companies—India’s Dr Reddy’s Laboratories Ltd, Teva Pharmaceuticals USA Inc., Canada’s Apotex Inc., and two subsidiaries of Iceland’s Actavis Group—had filed the ANDA with the US food and drug administration (FDA) in 2007.
An Orchid spokesperson in Chennai confirmed the development, but declined to give details as the matter is before the court.
“The company will defend its stand in all the three cases in the US courts,” he said. An email to F Hoffman La Roche remained unanswered over the weekend.
Roche, which holds exclusive marketing rights for this drug in the US under two different patents, numbered 7,192,938 and 6,294,196, secured a third patent in the US claiming innovation in its latest version called “Boniva-once-monthly” and sold as a post-menopausal osteoporosis oral medication.
Roche has also filed two similar cases against the generic companies in other US courts complaining that their applications violate existing patents. The latest lawsuit was triggered when Orchid informed the company last week through a mandatory note that the company has modified its marketing approval application with FDA to cover all forms of the drug and that Roche’s new patent is invalid.
IP Law360, a US newswire for intellectual property rights’ professionals, reported last week that Roche has sought a judgement and decree that the new patent is valid and enforceable, and that the effective date of any FDA approval of Orchid’s ANDAs can’t be earlier than the 2023 expiration of this patent. Orchid’s application to FDA for launching its generic version in the US challenges these patents.
Orchid moved the FDA application for this drug in 2007 under paragraph 4 of the Hatch Waxman Act provision of US patent law that allows generics to get market approval challenging an existing patent or through a non-infringing route.
The Hatch Waxman Act of 1984 is meant to promote cheaper generic drugs while giving companies a financial incentive to develop new drugs. Under the Act, generics can win marketing approval by submitting bioequivalence studies for a patented drug.
A separate provision grants a 30-month stay when a drug maker files a suit against a generic version that challenges its patent(s). However, this has become a point of debate in recent years, as pharmaceutical companies have kept generics off the market by protecting their drugs with extra patents of poor quality and then filing cases to get the extra market exclusivity.
The strategy is widely criticized by Indian industry experts as being a cover for an extension on a product’s market exclusivity for another 20 years.