Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector
In this issue we report on the implementation of the controversial SPC waiver, as well as a new SPC referral from the Swedish Court of Appeal. We consider a change to the Patents Court Guide of note to any pharmaceutical company seeking an interim injunction, as well as a series of injunction cases from the Patents Court. There are updates to the French statute of limitations and consideration of prior use as a defence to infringement. In Hozelock the UK Patents Court considers what constitutes prior public disclosure and applies the doctrine of equivalents, in Allergan it applies the Supreme Court decision in Actavis v ICOS and in another recent case it refuses to grant Arrow relief. We also report on a purported waiver of an infringer's RAND rights and take a look at some key procedural updates from the Patents Court, including the recently implemented Disclosure Pilot Scheme. Finally, we report on some further guidance on BREXIT preparations in the pharmaceutical sector.
1. SPC updates
The much debated SPC waiver has been approved by the European Parliament and took effect from 1 July 2019. We consider some of the key provisions and the potential impact of the regulation on SPC holders. In other SPC news, the Swedish Court of Appeal has made another reference to the CJEU on Article 3(c) of the SPC regulation. The reference is the latest in a series which concern pharmaceutical companies seeking SPCs for new formulations or indications of previously known active ingredients.
2. Update on injunction decisions and guidance
A change to the Patents Court Guide should be noted by any pharmaceutical company seeking an injunction in the UK Courts. We also report on a string of recent injunction decisions: an attempt by Napp to fortify a cross-undertaking in damages given by Sandoz for an interim injunction, after expiry of that injunction; a failed application for an interim injunction against Edwards Lifesciences in relation to its PASCAL heart valve device; and the refusal of a stay of a final injunction against ZyXEL Communications where only three months remained until patent expiry.
3. Updates from France
The French statute of limitations has changed such that nullity actions are no longer time barred and the start date for the limitation period of infringement actions is now tied to the patentee's knowledge of the infringing acts. We also consider a French preliminary injunction decision in which the Court found that prior use of a product by another member of the defendant's corporate group could provide the grounds of a serious challenge to patent infringement.
4. Prior public disclosure in the UK, the doctrine of equivalents and garden hoses
In a recent decision of the UK Patents Court, Mr Justice Nugee considered whether prior use of an invention (in this case a garden hose) in the inventor's garden constituted a prior public disclosure that would render the patent invalid. The Judge separately applied the Actavis questions and found infringement by the defendant using the doctrine of equivalents.
5. The Patents Court applies Actavis v ICOS
Following the Supreme Court decision in Actavis v ICOS, the Patents Court has considered the issue of obviousness in relation to Allergan's patent for the formulation of eye drops.
6. Latest Patents Court case on Arrow declarations
The UK Patents Court refuses to grant Arrow relief requested by Pfizer.
7. Can a party waive its FRAND/RAND rights?
In a preliminary decision in the RAND dispute between TQ Delta and ZyXEL Communications, Mr Justice Birss was asked to vacate the non-technical RAND trial following a purported waiver of ZyXEL's rights. As part of his decision, the Judge considered the extent to which ZyXEL could in fact waive its RAND rights and the effect this would have, if any, on the RAND trial.
8. Procedural updates from the Patents Court
The Disclosure Pilot Scheme and changes to the IPEC Court Guide should be noted by any litigants in the UK courts. There have also been a string of noteworthy procedural decisions emanating from the Patents Court, including: consideration of scope of pre-action rules on the provision of samples to a patentee; the ability of parties to rely on expert evidence from previous proceedings; whether an assertion by a patentee as to which claims it considers to be independently valid amounts to an admission that requires the permission of the court to amend; and the court's approach to requests for expedition where a party has delayed in bringing proceedings.
9. Brexit and the Pharma Sector: further UK guidance
The MHRA has published further guidance as to what will happen on exit day, whether that be following a transition period or in a no-deal scenario. We consider some of the guidance on marketing authorisations, batch testing, vaccines and blood products, clinical trials, orphan medicines and medical devices.
10. Table of patents decisions
11. Table of other relevant decisions
The contents of this publication, current at the date of publication set out above, are for reference purposes only. They do not constitute legal advice and should not be relied upon as such. Specific legal advice about your specific circumstances should always be sought separately before taking any action based on this publication.
© Herbert Smith Freehills 2019