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Generic Drugs Italy

Hogan Lovells

Italy: Formulation patents may prevent reimbursement of generics… but, are you innovative enough?

Hogan Lovells on

The possibility for the patent owner to prevent the reimbursement of medicinal products before expiry of patent protection is still an open issue. While the law covers prohibition of reimbursement for medicinal generic...more

Hogan Lovells

Pharma advertising in Italy – Online publication of OTC medicinal products list, prices and reimbursability

Hogan Lovells on

The Court of Milan held in a Judgment recently handed down in the proceedings brought by Bayer S.p.a. against the generic manufacturer DOC Generici S.r.l. that online publication of over-the-counter (OTC) medicinal products...more

Hogan Lovells

Italian time-machine : Limitation of the duration of an SPC may be decided by the Italian Patent Office

Hogan Lovells on

The Board of Appeal of the Italian Patent Office (Commissione dei Ricorsi), by decision published on June 26, 2017, acknowledged the right of the patent holder to ask the Italian Patent Office for the limitation of the...more

Hogan Lovells

Court of Milan rules on interim measure ordering the halt of the pricing and reimbursement procedure of a generic product

Hogan Lovells on

By order issued on June 18, 2017, in summary proceedings brought by Teva against Mylan and Synthon for the alleged infringement of EP 2 361 924 (covering a manufacturing process for the active ingredient glatiramer acetate),...more

Jones Day

European Commission Sets its Sights on Allegedly Excessive Drug Prices

Jones Day on

In the European Union, Big Pharma has been operating with a target on its back for the best part of the last decade. Following its 2008 sector inquiry into the pharmaceutical sector, the Commission vowed to clamp down on...more

Hogan Lovells

NEWSFLASH: What happens if you purchase a marketing authorisation then revoked for serious noncompliances with the Good Clinical...

Hogan Lovells on

Transfer of a MA, its subsequent revocation and compensation for damages - What happens if you purchase a marketing authorisation and that is then revoked for serious non-compliances with the Good Clinical Practice...more

Bryan Cave Leighton Paisner

EU & Competition Law Update - March 2016

Welcome to March's edition of our EU & Competition Law Bulletin covering recent legal developments impacting upon you and your business: - ..United Kindgdom: Large pay for delay fine imposed by CMA. ..Germany and...more

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