14 November 2017Big Pharma

Reasonable foresight required for second medical use infringement: Dutch Supreme Court

Swiss-type second medical use patents can be infringed if a generic producer could have reasonably foreseen that its product would be used intentionally for the claimed use, according to the Supreme Court of the Netherlands.

On November 3, the court handed down its decision in a clash between Merck Sharpe & Dohme (MSD) and Teva over generics.

MSD is the holder of European patent number 0,956,861, a combination therapy comprising ribavirin and interferon alpha, and is in the form of a Swiss-type claim.

The therapy is used to treat a specific group of patients with chronic Hepatitis C infection, and is marketed under the trade names Rebetol and Copegus.

“There is still a lot of ambiguity about the scope and infringement of second medical indication patents,” noted the court (translated) in its opening statement.

In 2009, Teva received two authorisations for the marketing of generic ribavirin, with Rebetol and Copegus as reference medicines. Teva introduced its generic to the Dutch market in 2011.

Before the generic launch, MSD accused Teva of infringing the ‘861 patent, but Teva claimed that it did not infringe as the patent was not original or inventive.

The Court of The Hague rejected MSD’s claims in 2010, finding non-infringement by Teva. Five years later, the Court of Appeal of The Hague affirmed the lower court’s decision.

MSD appealed against the higher court’s decision to the Supreme Court.

The Supreme Court held that second medical use claims can be both directly and indirectly infringed.

Hogan Lovells, in a blog post on the subject, said: “The Supreme Court held that the patented use protected by Swiss-type claims constitutes a ‘means relating to an essential element of the invention’, which is a requirement for finding indirect infringement pursuant to article 73, Dutch Patent Act.”

This means that a generic supplier indirectly infringes if it knows or it’s reasonably foreseeable that the generic is suitable and intended for the second medical use.

On direct infringement, the court found that a generic manufacturer/seller infringes a second medical use claim if it’s “reasonably foreseeable that the generic product will be used intentionally for the patented use”, said Hogan Lovells.

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