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Athens Court confirms validity of Janssen’s Patent and grants high amount of compensations
  • Dr Helen G Papaconstantinou and Partners Law Firm
  • Greece
  • December 6 2017

In Janssen Pharmaceutica N.V. against Greek pharmaceutical companies (Decision no. 21112017, June 22, 2017) the Athens Court of First Instance

Marketing prior to Directive 6565 authorisation precludes SPC, rules the ECJ
  • Herbert Smith Freehills LLP
  • United Kingdom, European Union
  • August 1 2011

On 28 July the ECJ handed down two rulings primarily concerning the interpretation of Article 2 of Regulation 176892 (the Supplementary Protection Certificate Regulation, now replaced by 4692009EC).

Janssen v Mylan, unsuccessful PMNOC proceedings, galantamine, November 11, 2010
  • Gowling WLG
  • Canada
  • November 24 2010

Janssen sought an order of prohibition until expiry of its '950 patent which claimed the use of an optimum dosing regimen of galantamine to treat Alzheimer's Disease.

Court finds allegations of invalidity justified on basis that patent claims method of medical treatment
  • Borden Ladner Gervais LLP
  • Canada
  • November 23 2010

In a proceeding under the NOC Regulations, the Court dismissed the proceeding on the basis that it had concluded that the relevant claims constitute unpatentable subject matter.

NICE provisionally recommends Alzheimer’s drugs for early and moderate stage treatment
  • Bird & Bird
  • United Kingdom
  • October 21 2010

On 7 October 2010, NICE issued draft guidance, subject to appeal, recommending that Aricept (donepezil, manufactured by Eisai), Reminyl (galantamine, manufactured by Shire) and Exelon (rivastigmine, manufactured by Novartis) be made available to patients with early to moderate stage Alzheimer's disease.

Enablement in the "unpredictable arts"
  • Fish & Richardson PC
  • USA
  • January 26 2010

In a recent Federal Circuit case, In re '318 Patent Infringement Litigation, 583 F.3d 1317 (Fed. Cir. 2009), a split panel decision underscored the importance of working examples in a patent application claiming a method of clinical treatment.

Court of Appeal refers further questions on the interpretation of the SPC Regulation to the ECJ
  • Bird & Bird
  • United Kingdom, European Union
  • December 15 2009

On 10 May 2009, the High Court handed down its judgment in Generics (UK) Limited v Synaptech Inc holding that the "first authorisation to place the product on the market in the Community" in Article 13 of the EC Council Regulation 176892 (the "SPC Regulation") referred only to marketing authorisations granted in accordance with Directive 6565EEC.

Patent claiming a method of treatment was not enabled where it failed to establish utility
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • October 31 2009

In In re ’318 Patent Infringement Litigation, Nos. 08-1594, 09-1070, -1088 (Fed. Cir. Sept. 25, 2009), the Federal Circuit affirmed the district court’s judgment against Janssen Pharmaceutica N.V., Janssen L.P., and Synaptech, Inc. (collectively “Janssen”), holding that the claims of U.S. Patent No. 4,663,318 (“the ’318 patent”) were invalid for lack of enablement.

Specification comprising summaries of papers and no experimental data does not enable treatment claims
  • McDermott Will & Emery
  • USA
  • October 31 2009

The U.S. Court of Appeals for the Federal Circuit invalidated claims for a method of treating Alzheimer’s disease because the specification comprised a summary of six scientific papers and reported no data on the use of the compound at issue in humans.

ECJ on generics and pre-EU accession marketing authorisations
  • Fasken
  • United Kingdom, European Union
  • October 26 2009

The European Court of Justice has ruled on whether an applicant for a marketing authorisation can rely on the marketing authorisation of a reference drug if that earlier marketing authorisation does not meet EU standards.