Patent

Pfizer’s Pregabalin – An IP Tale of Pain and Second Medical Use patents, Part II


(Image Source: https://commons.wikimedia.org/wiki/File:Lyrica.jpg)

(Image Source: https://commons.wikimedia.org/wiki/File:Lyrica.jpg)

This is the second post in a two-part post dealing with the England-Wales Patent Court’s recent judgment on Pfizer Group’s Warner-Lambert Company’s dispute regarding its Lyrica medicines and second use patents. The first post dealt with the background of the issue, the validity of the patent in question and the threat claims; the second post deals with the infringement claim, and concludes the post.

Infringement

Justice Arnold considered the question of infringement of patents, proceeding under the assumption that the patents he had declared to be invalid were found valid. This is, arguably, the most fascinating part of the judgment, as it deals directly with the issue of Second Medical Use patents, and provides much-needed jurisprudence for the nascent field here. The claim for infringement was tested as against S. 60 (1) and (2) of the UK Patents Act 1977. The majority of the judgment focuses on S. 60 (1), with S. 60 (2) being dealt with shortly. Justice Arnold found no infringement to have occurred under the terms of S. 60 (2), as there was no act of manufacture by any party downstream from Actavis.

Keeping in mind the fact that the claims in question were registered with Swiss forms, Justice Arnold considered the question of infringement on the part of Actavis at three time periods: 8 December 2014, 17 February 2015, and 15 July 2015; i.e., the dates where Actavis placed orders for its generic pregabalin. At 8 December 2015, Actavis manufactured its first quantity of generic pregabalin. It was during this period that it conducted its market studies et alia, and made the decision to market its pregabalin under a ‘skinny label’. While Justice Arnold agreed that it was foreseeable at this stage that Actavis’ drug would end up being prescribed as pain medication, he did not find that sufficient to indicate that it was foreseeable that this would happen intentionally except in de minimis proportion of cases. In coming to this conclusion, he took into account the fact that Actavis had notified superintendent pharmacists specifically that Lecaent was not licensed for the treatment of neuropathic pain. Similarly, Justice Arnold found that due to changing circumstances even if it had become foreseeable to Actavis in June-October 2014 that a more than de minimis proportion of its generic pregabalin would be intentionally administered for the treatment of pain, the same did not remain foreseeable as at 17 February 2015.

Finally, as of July 2015, multiple circumstances had changed. NHS England had till then issued its guidance that Lyrica should be prescribed for pain, with NHS Wales and North Ireland following suit, the software providers had modified their software, Lyrica prescriptions had risen, Actavis had become aware of the steps Pfizer had taken to ensure that generic pregabalin was not prescribed for pain, and that it had retained 80% of the market. Perhaps most importantly, Actavis was aware that there was no evidence that its generic pregabalin was being prescribed for pain on a substantial scale, regardless of intent. Thus, even at this point of time where Acatavis’ third batch of generic pregabalin was presumably ordered, Actavis was found to not have infringed Pfizer’s patent.

Justice Arnold also separately analysed the liability of a doctor, a pharmacist and a patient for infringement in such a case. He concluded that the patient and the doctor are in no case liable (¶ 686, 688). But in the case of pharmacists, he found that S. 60 (1) of the UK Patents Acts being a strict liability tort, one may very well be liable for infringement if the intent to prescribe the medicine in question for a use that another manufacturer holds the patent for is established.

Conclusion

Moving forward, the Court stated that there was clearly a need for a more organised system than the ad-hoc method used in the current case for handling Second Medical Use patents, though based on the same principle. As Justice Arnold stated, “…I remain more convinced than ever that the best solution to the problem of protecting the monopoly conferred by a second medical use patent while allowing lawful generic competition for non-patented indications of the substance in question is to separate the patented market for the substance from the non-patented market by ensuring that prescribers write prescriptions for the patented indication by reference to the patentee’s brand name and write prescriptions for non-patented indications by reference to the generic name of the substance”.

In the United States too there is a similar situation; however, courts have remained silent about liability. In AstraZeneca vs Apotex, the Federal circuit for the first time held that generic applicants can “carve out” patented indications from their ANDA’s and submit a skinny label(sec viii statement) in order to protect themselves from a contributory infringement suit. Patentees have pointed out that this would result in generics carving out the patented indications on “paper”, but doctors and pharmacists would end up prescribing the generic drug for the patented use anyway, since more often than not doctors and other healthcare providers are unaware of the specifics of patented indications. In response to patent holder’s objections the court said that Section 271(e)(2) does not cover ‘artificial’ inducement of infringement based on “assumptions” that some doctors may prescribe the generic drug for patented indications. Consequently, the patent holders face higher evidentiary burdens to assert a claim of inducing infringement against doctors/pharmacists/healthcare providers.

Thus, while Pfizer has lost on the counts of the threats made by it and the validity of substantial portions of its patents (which it plans to appeal), on the issue of Second Medical Use patents, its original demand of having a clearer system and medicines being prescribed by brand rather than their generic names were actually endorsed by the Court. And through the same, this case brings about very welcome guidance on a complex and developing area of law. This is a very well-written and detailed judgment, and quite possibly one that will be crucial for the development of the law in this field. The full judgment is available here.

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