Mylan Loses Its Appeal to Invalidate UCB Pharma’s Method Of Treating Patent

A few days ago, the Board Of Appeal has rejected an appeal made by Generics [UK] Limited (Mylan) which was initiated from the decision of the Opposition Division of European Patent Office to the UCB Pharma’s EP patent 1 696 904 B1.

EP ‘904 relates to use of Rotigotine, its salts or prodrugs in the treatment of diseases which are associated with increased dopaminergic cellular decay.

Rotigotine is a non-ergoline dopamine agonist, which was developed by Aderis Pharmaceuticals and given worldwide license to Schwarz Pharma a subsidiary of UCB S.A. Wherein Rotigotine was first approved in Europe on Feb 15, 2006 for the treatment of Restless Legs Syndrome Parkinson Disease under the brand name Neupro.

The structure of Rotigotine is represented as:

512px-Rotigotine.svg

EP ‘904 was granted on Nov 16, 2011 containing 10 claims which comprises 1 independent claim and it is directed to Rotigotine, its salts or prodrugs thereof for use in the treatment of diseases which are associated with increased dopaminergic cellular decay, wherein the treatment is effected on individuals who are selected from the group
(a) of individuals without symptoms of Parkinson’s disease, but having an increased risk of Parkinson’s disease, wherein the individuals have a mutation in a PARK gene and/or
(b) of individuals in which at least three of the four cardinal symptoms of Parkinson’s disease (rigidity, passive tremor, bradykinesia, postural instability) are not yet present,
wherein the prodrug is selected from the group of esters, carbamates, acetals, petals, phosphates, phosphonates, sulphates, sulphonates and silyl ethers.

EP ‘904 was opposed by Generics [UK] Limited (trading as Mylan) on Aug 16, 2012 (9 months from the date of grant) on the grounds of lack of novelty and obviousness over the submitted documents. However, the requisition for revocation of EP ‘904 was rejected by the Opposition Division on Jan 20, 2014. Further, Generics [UK] Limited made an appeal (appeal no T 0760/14) against the decision of Opposition Division on Mar 31, 2014 (2 months from the date of decision) which was rejected by the Board Of Appeal as inadmissible (Rule 101 (1) EPC).

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Yet another IPR from Lupin.

Its raining IPR’s from Lupin. Lupin recently filed an Inter partes review to a US patent 8,518,987 B2, which is an OB listed patent for Darunavir Ethanolate.

Darunavir Ethanolate is a protease inhibitor and used to treat HIV infection which is developed by G.D. Searle LLC and given exclusive market license to JANSSEN PRODS, received its first FDA approval (N021976) on Feb 25, 2008 for marketing Darunavir Ethanolate in the form of Tablet;Oral under the brand name PREZISTA, further it also received FDA approvals for Suspension;Oral form of Darunavir Ethanolate on Dec 16, 2011 and for the combination of Cobicistat;Darunavir Ethanolate on Jan 29, 2015. The following structure represents Darunavir Ethanolate.

Darunavir

US ‘987 contains 4 independent claims which claims:
Claim 1: A hydrated form of Darunavir which is restricted by the molar ratio of Darunavir to water is about 1:0.5 to about 1:3.
Claim 2. Darunavir Hydrate (No restrictions).
Claim 3: Composition comprising a hydrate of Darunavir which the ratio of compound to water is about 1:0.5 to about 1:3, and an inert carrier.
Claim 6: Composition comprising a hydrate of Darunavir and an inert carrier.

Lupin challenged the claims of US ‘987 under the grounds of
i) Unpatentable Under 35 U.S.C. § 102;
ii) Unpatentable Under 35 U.S.C. § 103 over the disclosed prior art.

Updates will be posted sooonn……….

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