Janssen sues Hetero over generic HIV treatment

Janssen Products, a subsidiary of Johnson & Johnson, has sued Indian pharmaceutical company Hetero Drugs for applying to market a generic version of its HIV treatment Prezista.

The lawsuit is the latest in a series of attempts by Janssen and Johnson & Johnson subsidiary, Tibotec, (which is now a part of Janssen’s research and development arm) to block the release of generic Prezista tablets in the US.

In its latest complaint filed on Friday, March 8, Janssen has accused Hetero of infringing its US patents 7,126,015 and 7,595,408, which expire in 2023 and 2025. The complaint also alleges that, Hetero has written to Janssen challenging the patents’ validity.

Janssen is seeking a declaration of infringement and an injunction blocking imports and sales of Hetero’s generic in the US until its patents expire. It is also seeking a declaration that the case “is exceptional”.

Johnson & Johnson licenses its patents covering the active compound in Prezista and methods of manufacturing the drug from Pfizer and the National Institute of Health.

But Mylan, Lupin, Teva and Hetero have all filed abbreviated new drug applications (ANDAs) seeking approval for generic versions of Prezista from the US Food and Drug Administration (FDA) before the patents’ US expiry dates.

In November 2010, Tibotec filed patent infringement lawsuits against Mylan and Lupin Pharmaceuticals and, in March 2011, against Teva Pharmaceuticals. Its dispute with Hetero began in March 2011.

In July 2011, the district court for New Jersey announced it would consolidate these disputes and deliver one binding decision. The outcome of these cases has not yet been reached.

While Tibotec has been fighting off generic competition for HIV treatments in the US, it has signed voluntary licensing agreements with Hetero, Mylan's Matrix Laboratories and Asphen Pharmacare of South Africa, but has reportedly refused to join UNITAID’s Medicines Patent Pool.

The licensing agreements were signed in 2011 and allow Hetero, Mylan and Aspen to sell generic versions of Tibotec’s anti-viral HIV treatment Rilpivirine (also known as TMC278) in sub-Saharan Africa, India and the world’s least developed countries (LDCs).

Hetero Drugs did not respond to requests for comment. Johnson & Johnson declined to comment on pending litigation.