These are two decisions of English courts relating to the sale of generic pregabalin. The patent protection for the product expired in 2013, however Warner-Lambert has a second medical use patent with a Swiss-type claim (“i.e. use of X in the manufacture of a medicament for treating Y”) covering the use of pregabalin in the preparation of a medicament for treating pain.
This patent would clearly be infringed by a competitor marketing pregabalin for this indication, however, Actavis marketed its generic version (under the brand name Lecaent) with a marketing authorisation only for the treatment of epilepsy and generalised anxiety disorders (GAD), i.e. non-patented indications.
Warner-Lambert applied for an interim injunction. The English Court refused the application. This decision was appealed and the hearing is listed (floating) to be heard on 28 – 29 April 2015. The initial decision is one of the first decisions in the EU on the infringement of a second medical use patent. Accordingly, it is an important decision and it gives some practical guidance on how to avoid infringement.
Warner-Lambert was seeking an interim injunction to force Actavis to take particular steps to ensure that Lecaent was not prescribed for the patented indication. These included notices on the packaging and agreeing contractual terms with the pharmacies.
The judge at first instance on the injunction application held that the word “for” in Swiss-type claims (in this case, for the treatment of pain) imports a requirement of subjective intention on the part of the manufacturer that the medicament or pharmaceutical composition will be used for treating the patented indications. On this basis, the interim injunction was refused on the ground that no such intent had been pleaded and because the balance of the risk of injustice favoured Actavis. Proof of subjective intent is a high hurdle but the decision considers various objective factors from which a subjective intent could be inferred. These include if a manufacturer put the patented indication on its Summary of Product Characteristics or Patient Information Leaflet or promoted the prescribing or dispensing of the product for the patented indication in another way.
Warner-Lambert’s main claim was in relation to direct infringement, however indirect infringement was also considered and rejected by the judge at first instance. This was on the basis that there can only be indirect infringement if there can be infringement by the person supplied or a user further down the chain of supply. The judge held that a Swiss-type claim is a process claim, not a product claim. Accordingly, in order to infringe Warner-Lambert’s patent the wholesaler and/or pharmacist would have to use Laceant to prepare a pharmaceutical composition, which in the normal course of supplying and/or dispensing Laceant, they would not do.
The trial of the infringement action is due to take place in June 2015 and Warner-Lambert has been allowed to amend its pleadings to include the element of subjective intent. There is going to be further argument as to whether a claim to indirect infringement should be allowed to proceed to trial.
Warner-Lambert has also issued infringement proceedings against Teva and Dr. Reddy’s laboratories. The latter obtained a marketing authorisation for its generic pregabalin product for the treatment of epilepsy and GAD in February 2015.
Since the decision, the English Patents Court has ordered the NHS Commissioning Board to issue guidance that pregabalin should be prescribed by reference to the brand name Lyrica (Warner-Lambert’s product) when prescribed for the patented indication (i.e. neuropathic pain) and should be prescribed by reference to the generic name, when prescribed for non-patented indications ( EWHC 485 (Pat)). NHS England is to issue the guidance to the Clinical Commissioning Groups and the NHS Business Service Authority.
The decision is important because it sets a requirement for the manufacturer to have an intention to directly infringe a patent where there are Swiss-type claims. Whether this is correct is an open point. Indeed, we understand a court in Hamburg, Germany has since granted a preliminary injunction in favour of Warner-Lambert in relation to the same patent. No reasons for the decision are yet available, but the outcome indicates a certain level of disagreement across the courts in the EU. A further point is whether a Swiss-type claim is properly construed as a process claim. The argument is that this construction is too literal and gives insufficient weight to purposive construction and the fair balance required by Art 69 of the European Patent Convention (EPC) and/or the Protocol on Interpretation of Art 69 of the EPC. It has been argued that the correct construction is either a:
- purpose-limited product claim (i.e. the same as an Article 54(5) EPC 2000 second medical use claim); or
- process claim, where the process involves not just the manufacture but also packaging, labelling, distribution and prescription.
A further problem is that effective enforcement of a Swiss-type claim may require a national Court to craft remedies that reflect the national system for prescribing and reimbursement and these can vary significantly between EPC contracting states. Looking forward a few years, this may cause problems for the Unified Patent Court (UPC), which is likely to have difficulty formulating unitary remedies that are effective across all UPC contracting states.