The team is joined by GuestKats Mirko Brüß, Rosie Burbidge, Nedim Malovic, Frantzeska Papadopolou, Mathilde Pavis, and Eibhlin Vardy
InternKats: Rose Hughes, Ieva Giedrimaite, and Cecilia Sbrolli
SpecialKats: Verónica Rodríguez Arguijo (TechieKat), Hayleigh Bosher (Book Review Editor), and Tian Lu (Asia Correspondent).

Monday, 15 September 2014

AIPPI Congress Report 2: Second medical use heats up a Sunday morning

Good morning, Toronto!
Sunday mornings. Normally, the AmeriKat can be found burrowing under her comforter (not her "duvet" while she is on this side of the Atlantic) clinging to her final hours of pyjama-wearing, work-avoiding bliss. However, yesterday morning was different. At the crack of dawn she sprinted to the hotel gym before a dizzying whirlwind of client meetings and navigating her way through the streets of Toronto to show her whiskers at a plethora of law firm hosted sessions. The AmeriKat's colleague, Eibhlin Vardy, had a similarly eventful morning at the AIPPI Congress. Eibhlin reports:
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.


Anonymous said...

Nice to see a "balanced" approach has been cobbled together by the brand industry's lawyers. Perhaps this nine point checklist could be presented for approval at the next European Patent Judges conference? Now there's an idea, perhaps as part of a moot on a new UPC action.....?

Anonymous said...

Surely any guidelines which make it easier to classify a party as an infringer of a second medical use claim need to also have adequate safeguards to protect innocent parties? The onus must remain on the patentee to show infringement, and where that is contributory infringement (which presumably is the case here) then intention/knowledge etc of infringement also needs to be shown. There has to be recognition that the patentee was not able to gain product claims or 'first' medical use claims, and therefore a different standard for infringement applies.

Anonymous said...

If I can just clarify the position of the first two anons:

"We either work in or support the generic industry, such that we believe its needs should override those of R&D companies. As such, we believe the generic industry has the right to market products having patented second medical use indications for said patented indication. There are many underhand ways in which we can do this and we don't want legislation to get in our way and block our planned devious practices. So what if we take a few key buyers to Monaco for the weekend and explain how our generic does everything the brand can do, but cheaper. Remind them to keep this to themselves and they will be on to a nice little earner themselves."

Anonymous said...

The working committee refers to pyrazolopyrimidinone compounds as being well known for treating heart disease, prior to the Viagra invention. Does anyone know what these medicines are?

Anonymous said...

Re Anon 17 Sept at 08.56.

You refer to: "...underhand ways" and "...planned devious practices" when referring to the activities generic industry.

Please can you clarify what you mean?

Anonymous said...

I gave an example in my post. I can think of numerous ways of getting across the message that a generic is also equally suitable for a patented second medical use, without leaving a blatant trail of evidence for the patentee to make use of. Can't you?

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