InternationalUSRemember you can easily switch between MIP US and MIP International at any time

The Netherlands: Swiss-type medical use claims and direct infringement




In the Dutch saga of the cross-border legal dispute between Novartis and Sun regarding commercialisation of zoledronic acid for treating osteoporosis, the Hague District Court in proceedings on the merits ruled in a verdict of April 5 2017 (ECLI:NL:RBDHA:2017:3430) that Sun directly infringes a Swiss-type medical use claim in European patent 1 296 689 B3, owned by Novartis.

It is the general opinion that Swiss-type medical use claims are in the category of claims directed to methods for manufacturing medicaments. In its decision, the District Court argued that the phrasing "for (the treatment of)" in the Swiss-type medical use claim at issue encompasses a mental element, namely knowledge of the fact, or foreseeability, that the manufactured zoledronic acid is to be marketed for the patented indication, namely treatment of osteoporosis.

Although the generic zoledronic acid was produced in India by a company in the Sun concern, the District Court expressly noted that this might not prevent Sun from literally infringing the Swiss-type medical use claim as a process claim in the Netherlands. The reason is that Sun provided the Indian manufacturer with specific instructions on packaging and patient leaflet information, held a manufacturing/import authorisation and executed product quality control in the Netherlands. Under these circumstances, Sun could potentially be considered a co-manufacturer according to the Court. Nevertheless, the ruling of direct infringement was based on the fact that Sun knew, or could foresee, that the medicament directly obtained by the Swiss-type medical use claim would be commercialised for the patented indication. Interestingly, with this decision, the District Court accepts that a Swiss-type medical use claim also, to some extent, confers purpose-limited product protection.

The mental element was considered to be present, for the reason that (1) Sun's marketing authorisation was inter alia obtained for the patented use, (2) the online SmPC and patient information leaflet did not contain the carve-out for the patented use, (3) the tender of health care insurance company VGZ, which Sun won, did not distinguish between patented and non-patented indications and (4) the size of the market for zoledronic acid, and the sales numbers, were such that it was foreseeable for Sun that the product was also sold for the patented indication.

Abe_Takanori
Jetze Beeksma

V.O.
Carnegieplein 5, 2517 KJ
The Hague
The Netherlands
Tel: +31 70 416 67 11
Fax: +31 70 416 67 99
info@vo.eu
www.vo.eu


Comments






profile

Managing IP

ManagingIP

ManagingIP profile

Come visit the Managing IP team at booth 131 at #INTA2018. We have the IP STARS trademark handbook, the latest MIP… https://t.co/9RV9VpiUWd

May 20 2018 06:57 ·  reply ·  retweet ·  favourite
ManagingIP profile

UK publishes Trade Secrets Regulations 2018 https://t.co/aujzXPhn3H Main change from draft is introduction of a new… https://t.co/d0FSbTiVMF

May 18 2018 04:29 ·  reply ·  retweet ·  favourite
ManagingIP profile

In a two-part series on patent marking, Binal Patel and Kirk Sigmon of @BannerWitcoff discuss "Steering clear of fi… https://t.co/ypN5OhxbzG

May 18 2018 04:10 ·  reply ·  retweet ·  favourite
More from the Managing IP blog


null null null

null null null

May 2018

Technology alters the anti-counterfeiting landscape

Ellie Mertens reveals evolving technologies are changing the counterfeiting game on both sides, as a tool for both prevention and evasion



Most read articles

Supplements