Raltegravir / Dolutegravir - UK

On Nov 25, 2016, The English High Court has ruled in favour of Merck Sharp & Dohme in a patent battle against Shionogi, over Merck’s product Isentress (raltegravir).

Japan-based Shionogi had claimed that Merck had infringed European patent number 1,422,218, titled “antiviral agent”. The patent covers Shionogi’s product Tivicay (dolutegravir), marketed by Viiv Healthcare since 2013.

Merck denied infringement and claimed that the patent should be revoked on the grounds of lack of inventive step, insufficiency and added matter. The ‘218 patent was opposed by Merck, and the European Patent Office opposition division maintained it in amended form in 2015. However, as the decision was under appeal, the amendment was suspended.

In the meantime, Shionogi made an unconditional application to amend the patent in accordance with claims maintained by the opposition division, as well as two conditional applications to amend.

On Friday, November 25, the court held that Shionogi’s patent was invalid, on the ground that it lacked inventive step and there was insufficient disclosure.

There are currently parallel proceedings going on before the courts of Germany and the Netherlands.

Sofosbuvir - UK

On Nov 08, 2016, The Court of Appeal (UK) has upheld Arnold J’s judgment on the Gilead v Idenix case, which concerned the validity of Idenix’s patent EP(UK)1 523 489 covering a family of nucleoside analogues for the treatment of hepatitis C and other Flaviviridae infections and whether it was infringed by Gilead’s hepatitis C drug sofosbuvir (brand name SOVALDI).

At first instance, Arnold J found that sofosbuvir infringed EP’489 but that the patent was invalid for lack of novelty and inventive step, insufficiency and added matter. In second instance The Court of Appeal dismissed the appeal by Idenix and affirmed the decision of first instance and held patent invalid.

Copaxone - Netherlands

On Oct 25, 2016, Court of appeal, The Hague rejected the appeal and confirmed the nullification of EP2361924 patent for lack of inventive step.

Teva is the proprietor of EP'924 patent for a “process for preparation of mixtures of trifluoroacetyl glatiramer acetate using purified hydrobromic acid”. This patent had been nullified by the District Court of The Hague in proceedings in first instance initiated by Synthon, for lack of inventive step.

Teva lodged an appeal against this decision based on auxiliary requests. In essence, the appeal judgment focussed on the assessment of novelty and inventive step of the claimed process for obtaining glatiramer acetate (GA), which process involved the use of a solution of hydrobromic acid (HBr) in acetic acid which is essentially devoid of free bromine and which comprises less than 100 ppm of metal ion impurities.

With respect to novelty the court found that EP ‘924 novel over public prior use and declaration of Chemada (Teva’s supplier of the HBr/acetic acid solution). But with respect to Inventive step, court found that the insight that the presence of free bromine in the HBr/acetic acid solution should be reduced as much as possible to avoid bromination of tyrosine during the synthesis of GA, was obvious. 

Thus Court of Appeal rejected the appeal and confirmed the nullification of EP ‘924 for lack of inventive step.

Pregabalin - UK

On Oct 13, 2016, The Court of Appeal (UK) has delivered its much-anticipated decision in the dispute concerning Warner-Lambert's second medical use patent for pain indication of pregabalin and skinny labelled generic products. The Court of Appeal has upheld the decision of lower court which held European Patent (UK) No. 0 934 061 invalid in Nov 2015. Court subsequently decided that it would be an abuse of process for Warner-Lambert to amend a claim of the Patent to limit its scope and thereby exclude part of the claim vulnerable to the insufficiency attack.