The English and Dutch Courts have recently explored whether the sale of a generic medicine for a non-patented use (a so-called "skinny label" product) could nevertheless infringe a second medical use patent. The judgments emanating from London and The Hague followed different lines of argument and resulted in opposing outcomes.
The January 2015 decision of Warner-Lambert Company, LLC v Actavis Group PTC EHF & Others1 concerned an interim application for relief by Warner-Lambert in respect of its prescription drug pregabalin (LYRICA), which is used to treat epilepsy, generalised anxiety disorder and neuropathic pain. All patents and Supplementary Protection Certificates protecting pregabalin as such have fallen away, except for a Swiss form second medical use patent protecting the use of pregabalin in the preparation of a medicament for the treatment of pain. Actavis seeks to enter the market with a skinny label limiting its generic pregabalin (LECAENT) to the two non-patented indications.
Warner-Lambert argued that such a launch would infringe its patent in the UK, where prescriptions are usually written generically and without any indication and the lower price of generic drugs provides a commercial incentive for generic versions to be dispensed against all generic prescriptions. Warner-Lambert sought relief which included imposing obligations on Actavis to incorporate certain contractual conditions in agreements with suppliers, to insert notifications on LECAENT supplies and to directly inform various health organisations of the restrictions on the authorised use of LECAENT.
The English Court held that Swiss form claims are process claims for the method of preparation of a pharmaceutical product. It observed that intermediaries/dispensers will not be using LECAENT to manufacture drugs and addressed Actavis' alleged infringement under section 60(1)(c) Patents Act 1977 (dealing with a product obtained directly by means of the claimed process). Ultimately, the Court held that there was no serious issue to be tried, because the word "for" in the Swiss form claim required Actavis (as manufacturer) to subjectively intend LECAENT be used for the treatment of pain in order for infringement to occur. No such intention was pleaded, nor was it found on the evidence when the parties returned to Court with amended pleadings on 3 February 20152. Thus, the English Court refused to grant the relief sought by Warner-Lambert.
In the period between the two Warner-Lambert decisions, the Court of Appeal in the Hague handed down its judgment in Novartis AG v Sun Pharmaceutical Industries (Europe) BV3. This case concerns Novartis' zoledronic acid drug (ACLASTA), used for the treatment of osteoporosis (protected by a Swiss form second medical use patent) and the rarer and unprotected treatment of Paget's disease, and Sun's launch of generic zoledronic acid for the treatment of Paget's disease only.
The Dutch Court treated the Swiss form claim as a product claim and assessed infringement on an indirect, rather than direct, basis (equivalent to Section 60(2) Patents Act 1977, supply of an essential element for putting the invention into effect). It was common ground between the parties that Sun's generic product was an essential element of the invention. The meaning of "for" in the Swiss form claim was not addressed at all. Knowledge of infringing use, rather than intention, was the test applied.
In addition to the different legal approach, factual matters distinguished this case from Warner-Lambert. Most significantly, the amount of generic product supplied by Sun outstripped that required to treat Paget's disease in the Dutch market and Sun had an agreement to supply all zoledronic acid to out-patients covered by the insurer VGZ, irrespective of the indication. Consequently, Sun's generic product would inevitably be dispensed for the treatment of osteoporosis.
The Court held that Sun had the requisite knowledge for infringement and that it should take additional steps to prevent infringement by others. Such steps include clearly notifying intermediaries/dispensers of the restricted use of the generic product and ensuring that effective measures are taken to distinguish between patented and non-patent uses, both in relation to tenders and physical supply.
The divergence between these two cases appears to be due to counsel advancing different arguments (direct vs indirect infringement) in combination with differing factual matrices. Even if the legal arguments were to converge more closely, the different healthcare system practices across European states will inform the knowledge/intention of the generic manufacturer in each instance.
Revealingly, in Warner-Lambert the English Court urged the English and Welsh health authorities to issue guidance on prescribing practices to address the problem. The current advice issued by the British National Formulary to prescribers is that generic names should be used in prescribing to enable any suitable product to be dispensed, thereby saving delay to the patient and sometimes expense to the health service. The only exception is where there is a demonstrable difference in clinical effect between each manufacturer's version of the formulation, making it important that the patient should always receive the same brand. This advice is widely endorsed by local commissioners. It is difficult to conceive, particularly in the current economic climate, that there will be any inclination on the part of health authorities and prescribers to deviate from that approach and prescribe using a brand name which may be more expensive than a generic alternative where the clinical benefits are identical. For now, drug companies facing passive/indirect infringement in England of their Swiss form second medical use patents may have to settle for whatever protective measures and undertakings they can get vis-à-vis the generic competitor to minimise the risk of infringement. They may also seek to "educate" prescribers and health authorities that theirs is the only drug licensed for the particular indication in question but, as the facts of the Warner-Lambert case showed, persuading doctors and pharmacists not to prescribe and dispense generically will be difficult.