|Good morning, Toronto!|
Following a manic dash to the Eaton Centre to find suitable convention attire following lost baggage, this AIPPI Congress newcomer settled down to hear the deliberations of Working Committee Q238 on "Second medical use and other second indication claims".
At the outset, the Committee expressed an ambition to pass a resolution that went further than merely endorsing the status quo. The Working Committee rose to the challenge, and the wording of the resolution was duly agreed which called for changes to both the legal and regulatory framework.
Highlights included discussion on how infringement of second medical use claims should be assessed when the product has a skinny label with a carve-out for the patented indication. There was agreement that the offering or promotion of a skinny label product, where such offer or promotion (e.g. by sales reps) specifically referred to the patented second medical use should constitute infringement. The Working Committee then went further, and approved a non-exhaustive list of 9 factors that should be taken into account when determining whether acts relating to skinny label products might amount to an infringement, even where there is no explicit reference to the patented indication. This list included: (1) subjective factors, such as the alleged infringer's intent; (2) the alleged infringer's actions, including any steps taken by the alleged infringer to discourage or encourage infringing use for patented indication; and (3) wholly external factors such as the economics of the relevant market, and the prescription practices of relevant professionals. This list of factors, to be considered on a case by case basis, recognises that second medical use claims may require special treatment when considering the issue of patent infringement.
The Working Committee also resolved that the pharmaceutical regulatory framework "governing the marketing of pharmaceuticals, their labelling, prescription, distribution, dispensing and reimbursement should be transparent as to whether drugs are being dispensed for patented medical uses, and, while not preventing the legitimate commercialisation of products for second medical uses that are not patent protected, facilitate the proper enforcement of patent protection for second medical uses.” Many jurisdictions had raised concerns about the regulatory framework in their national responses to Q238. In view of the fact that the pharmaceutical market was so heavily regulated, to do otherwise would mean that regulatory law would be allowed to distort patent law.
The Working Committee concluded by passing a further resolution proposed shortly before lunch, urging the relevant authorities to approve necessary measures so that effective protection of second medical use patents is not jeopardised by the regulatory framework.Q238 is being discussed right now in today's plenary session. Eibhlin will be back to report on the outcome in due course.