Patent EP 2 203 462 B1 relates to sofosbuvir for treatment of a hepatitis C infection in mammals.
Brief outline of the case
The OD decided that the patent as granted added subject-matter because the application as filed did not disclose the individual diastereomers depicted in claims 2 and 3, but AR1 consisting of claims 1 and 4 as granted was allowable.
The proprietor and the 10 opponents appealed the decision of the OD.
At the end of a first OP, the board decided that
- priority applications D1 and D2 disclosed the invention claimed in AR 1 in an enabling manner, and
- the subject-matter of auxiliary request 1 was inventive if only the cited documents published before the earliest priority date were considered.
The board stayed the proceedings awaiting the decision G 1/22 and G 2/22.
The present decision ends the procedure after the stay.
The priorities were considered valid and the objection of lack of sufficiency raised by opponent 2 did not apply to claim 1 of AR1.
The board decided thus maintenance according to AR1 and finally dismissed all the appeals.
Validity of priority
In accordance with G 1/22 and G 2/22 the opponents did not rebut the presumption that the applicant, Pharmasset, Inc., was entitled to claim the priority from applications D1 and D2.
Therefore, the Board concludes that Pharmasset, Inc. was entitled to claim the priority of applications D1 and D2, with the consequence that AR 1 enjoys the priority dates of 30.03.2007 and 24.10.2007.
Documents D6, D8 and D9 were thus not prior art under Art 54(2).
Sufficiency
As claims 2 and 3 as granted were deleted in AR1, the objection of lack of sufficiency against those claims was moot.
Opponent 2 argued that the sufficiency objection still applied to AR1.
As the sufficiency objection of Opponent 2 relied on allegations not supported by evidence raising serious doubts as to the skilled person’s ability to separate diastereomers and assign their corresponding configurations without undue burden, the objection was rejected.
Comments
Pharmasset was bought in 2011 by Gilead Sciences for about $11 billion.
Sofosbuvir is listed as an essential medicine by the World Health Organization.
When sofosbuvir was marketed in 2014 in Europe, there was a big outcry about the exorbitant price asked by Gilead for a treatment of hepatitis C with sofosbuvir. For instance, in 2014 in Germany, the original price was 700 € per tablet. It was later reduced to 488 € per tablet. Based on a cost-benefit analysis, the price of sofosbuvir was considered not commensurate with the benefit for three quarters of the German patient population.
One could think that Gilead needed to recover part of its expenses for acquiring Pharmaset.
On the other hand, a treatment by monoclonal antibodies is not cheaper. For example, a treatment for asthma with dupilumab amounts presently to 700€/injection, twice a month.
That developing a medicine is not for free and may involve heavy investments is certain, but the apparent greed of the pharmaceutical industry raises some societal questions.
Will society be able to afford the costs of new medicines? Could it be that in the end, some medicines will stay on the shelf as hardly anybody will be able to afford them, in spite of the wishes of the population to be treated against any possible ailment?
https://www.epo.org/en/boards-of-appeal/decisions/t162643eu2
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