Signs of divergence in Europe for skinny labels

The Swiss-type claims involve the terminology "use of drug X in the manufacture of a medicament in the treatment of disease Y" found acceptable by the Enlarged Board of Appeal (G5/83 and related cases) to permit patent protection for the second and subsequent uses of known pharmaceutically active compounds. The fiction lay in the "manufacture of the medicament" and the purpose of that manufacture in avoiding the prevailing prohibition of patents on methods of treating the human body. The claim related to such manufacture for that purpose.

All practitioners in the field were aware that come the day a question of infringement arose, there might be difficulties. This case, the first of its kind to reach the High Court, was a perfect example of what everyone was waiting for.

Pregabalin is the active ingredient of the Warner Lambert (now Pfizer) product Lyrica® approved for three medical indications: treatment of epilepsy, generalised anxiety disorder (GAD) and neuropathic pain. The first two indications were disclosed and encompassed by the claims of the "basic patent" which had expired (patent and supplementary protection certificate (SPC)). Neuropathic pain was an indication covered by the Swiss-type use claims of a later patent extending beyond the expiration of the basic patent, its SPC and any period of data exclusivity.

Actavis prepared to launch a generic version of pregabalin (Lecaent®) using the "skinny label" technique whereby the indication still subject of patent protection was deleted. This step was specifically permitted by Articles 10 and 11 of EU Directive 2001/83/EC. In advance of full trial concerning the validity of the later patent, Warner Lambert applied to the court for an interim injunction requiring Actavis to take a series of steps to ensure Lecaent would not be dispensed for neuropathic pain.

There is much detail in the judgment as to the steps both parties had already taken or were prepared to undertake to try and preserve their respective positions. Pfizer itself demonstrated that it had a strategy in place to educate doctors to only prescribe Lyrica for this indication. Ultimately, the judge acknowledged that as meritorious as the efforts from all parties was, in reality, doctors tend to, and are encouraged to prescribe generically and pharmacists were unlikely to know which of the approved indications a patient was being prescribed pregabalin for. The judge even considered the possibility of pharmacists consulting with their customers but the statistics supported a high proportion of prescriptions being dispensed to persons other than that named on the prescription.

Section 60(1)(c) of the UK Patents Act

From a legal perspective however, the fascinating point of the judgment is that Justice Arnold decided that there was no serious issue to be tried under section 60(1)(c) regarding infringement of the claim 1. This section of the Patents Act was applicable as Swiss claims relate to a process of manufacture and not a product, and importantly the manufacturer was Actavis and not anyone else further downstream. This is the area of the decision that may be different when EPC2000 use claims are considered in the future.

Actavis successfully argued that infringement of a Swiss claim required demonstration of a "subjective intention" that Warner Lambert failed to demonstrate. Warner Lambert have reserved the right to amend their pleadings in advance of the full trial to make such an allegation.

Warner Lambert had additionally pleaded infringement under sections 60(1)(a) and 60(2) which the judge acknowledged as wisely not pressed as section 60(1)(a) relates to products and section 60(2) would require Actavis to be supplying an essential means to prepare the composition, something which clearly would not occur.

For the sake of completion, the judge analysed the balance of convenience if he was wrong on the primary point. Here as in many cases of its kind, the balance was fine. The usual consideration of relative harm to each party and the ease of assessing damage was considered. Interestingly, when considering the harm to Actavis the judge was swayed "strongly" by the fact that even if marketing with a label explaining the patent situation and non-use for the pain indication, Actavis may have been prevented from performing acts that were perfectly permissible, ie the sale of pregabalin for epilepsy and GAD.

Again, as is often the case in such generic launch cases, both parties were criticised for not having commenced their respective strategies earlier (preserving the pain market or clearing the way for activities) but ultimately, the judge again ruled that the balance of the risk of injustice would be in Actavis' favour.

Although this judgment provides for the first time some guidance on the infringement of Swiss-type medical use claims, there are aspects of the judgment that are limited to this particular scenario and others that remain to be resolved at full trial when both infringement and validity will be at issue. Swiss-type claims will be with us for a few more years yet, so the ultimate conclusion of this case will set the tone for the coming years in the UK.

The view from The Hague

Hot on the heels of this UK decision, the Court of Appeal in The Hague has reached the opposite conclusion regarding Sun Pharmaceutical's skinny label for zolendronic acid.

The patent relates to a Swiss claim for treatment of osteoporosis using a particular dosing schedule. Sun obtained a marketing authorisation for both osteoporosis and Paget's disease and then requested the patented indication to be "carved out". Sun entered the general market including an unconditional tender to supply one of the healthcare insurers. The patent may be remembered for the UK litigation where it was held not to be entitled to priority and therefore lacked novelty. The Dutch court reached a similar conclusion at first instance but this was overturned on appeal leading to consideration of infringement.

On the facts, there was little doubt that the vast majority of zolendronic acid was used to treat osteoporosis and that treatment of Paget's disease only required a single dose. In Novartis' estimation, osteoporosis accounted for 97.3% of the market. Sun had made some efforts to inform pharmacists and the healthcare insurer that supply was only for Paget's disease, but ultimately the court did not consider that they had taken sufficient steps and an injunction with regard indirect infringement was granted.

UK and Dutch court judgments

This will immediately be seen to be in contrast to the UK pregabalin judgment discussed above. However, there are differences. Firstly, the Dutch judgment was reached under Article 73 of the Dutch Patent Act relating to indirect infringement whereas the UK judgment was reached under section 60(1)(c) of the UK Patents Act which governs infringement of process claims. As discussed above, the UK judge did not consider indirect infringement (section 60(2)) to be relevant. Furthermore, the different systems for general prescribing and dispensing in the Netherlands, as well as the exclusive unconditional supply to the insurer, are worthy points of distinction.

The further issues of infringement that may be pursued at full trial in the UK are likely to result in further development of the law in this area.

Notes

Under section 60(1)(c) of the Patents Act 1977 it is an infringement to keep, dispose of or offer to dispose of "any product obtained directly by means of [the claimed] process"

Useful link

Full decision of Warner Lambert v Activis & others, neutral citation number: [2015] EWHC 72 (Pat): http://dycip.com/warnerlambertvactivis