Notification dates, (co)exclusivity, similar drugs, orphans and the FDA: a comment

Further to Marc Nevant's observations, posted on The SPC Blog yesterday (here), Mike Snodin -- whose article Marc cited -- has added some further comments of his own. Says Mike:

The EMA’s reliance upon the Notification Date for calculating periods (data exclusivity and orphan market exclusivity) running from the date of a MA is confirmed in the answer to question 12 in “EMA Procedural advice for users of the centralised procedure for generic/hybrid applications” (see this link).

The EMA’s practice on this point was the basis of one of the arguments in my article from October 2011. The legal basis for that practice is Article 297(2) of the Treaty on the Functioning of the EU, which is a point noted in my article from October 2014.

The decision in T-140/12 is fascinating, as it appears to mean that the (co-)exclusivity awarded to one product can effectively extend the period of (co-)exclusivity on the market for another, “similar” product. In this respect, that decision is similar to that in Depomed Inc. v U.S. Department of Health and Human Services et al., Case No. 1:12-cv-01592, where orphan exclusivity was awarded to a non-identical drug in circumstances where “clinical superiority” of that drug had not been demonstrated over an already approved, “similar” drug.

The FDA does not appear to be inclined to follow the ruling in Depomed (see this link), and so it will be very interesting to see what Teva does in respect of the ruling in T140/12 – and whether the CJEU will eventually get to rule on this aspect of orphan marketing exclusivities.

Thanks, Mike!

Determination of periods of regulatory exclusivity: grant date v notification again!

From our friend and reader Marc Nevant (French and European Patent Attorney, Cabinet Beau de Loménie, Paris) comes the following note, for which The SPC Blog offers its sincere thanks. Writes Marc:

I have recently come across Case T-140/12, a General Court of the European Union ruling in Teva v European Medicines Agency (EMA). In short, Teva sought an order to annul the EMA’s refusal to grant its application for marketing authorisation (MA) for imatinib Ratiopharm, a generic version of (Novartis's) orphan drug product imatinib (trade name Glivec), in so far as it concerned therapeutic indications for the treatment of chronic myeloid leukaemia (CML).

The matter is essentially about orphan drug exclusivity and the interpretation of Regulation 141/2000 on orphan medicinal products. There is, however, a parapraph in the decision that should be of interest for the readers of this blog. Paragraph 12 mentions that 

“Pursuant to Article 8 of Regulation No 141/2000, the period of market exclusivity enjoyed by the medicinal product imatinib, marketed under the commercial name Glivec, in so far as concerns the CML therapeutic indications — the original marketing authorisation for which took effect on 12 November 2001 — expired on 12 November 2011”.

It turns out that 12 November 2001 is the date of notification of the MA (the grant date being 7 November 2001). This suggests that the determination of periods of Regulatory Exclusivity for centrally approved products could be affected by the “grant date v notification date” debate, and further suggests (if the decision is transposed to SPC cases) that, for centrally approved products, the date of notification of the MA is de facto the date referred to in §1 of Article 13 of SPC Regulation 469/2009, as already argued at length by Mike Snodin (see e.g. the post on this blog of 30 October 2014).

Let’s hope that the judges in Seattle Genetics (on which see earlier posts here and here) will share this view!