Pharma

Pharma, an abbreviation commonly used for the pharmaceutical industry, discovers, develops, produces and markets drugs or pharmaceutical drugs for use as medication. Pharma depends heavily on patents to protect its inventions worldwide, as well as on Supplementary Protection Certificates (SPCs). Pharmaceutical companies are subject to laws and regulations that govern the patenting, testing, safety, efficacy and marketing of drugs. Pharma includes production of generic medicines. Pharma may also refer to (patent) litigation related to pharmaceutical products.

Austria, Belgium, Bulgaria, Czech Republic, Denmark, Estonia, European Union, Extent of Protection, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Netherlands, Norway, Pharma, Poland, Portugal, Romania, Scope of protection, Slovakia, Slovenia, Spain, SPC, Sweden, United Kingdom, Validity

(Bristows)/ /2 Comments

Yesterday, 25 April 2018, AG Wathelet has handed down his opinion in the Teva v Gilead reference (Case C-121/17) suggesting that the question should be answered as follows: “The fact that a substance or combination of substances falls within the scope of protection of the basic patent is a necessary, but not sufficient, requirement for…

EPC, Inventive step, Pharma, Pharmaceutical patent, Prior art, Public prior use

(Hoffmann Eitle)/ /9 Comments

Suppose you are a (patent) attorney in a pharmaceutical company and want to advise your company how to best protect the results of a clinical trial designed to find out the best possible treatment regimen of a certain known and approved drug X. The researchers of your company have devised and been allowed to conduct…

Biologics, Conference, Pharma, Pharmaceutical patent, SPC

(Bristows)/

The afternoon of the first day of C5’s Pharma & Biotech conference in Amsterdam (27 February 2018) concluded with a lively panel session on biosimilars. Chaired by Bristows partner Dom Adair, the panel comprised Dr Corinna Sundermann (Senior Vice President, IP, Fresenius Kabi), Dr Lorenz Kallenbach (Corporate Patent Counsel, Merck) and Brian Coggio (Of Counsel, Fish…

Litigation, Pharma, Pharmaceutical patent, United States of America

, (Kramer Levin)/ /21 Comments

Over the last few decades, the United States has been incrementally harmonizing its patent law with the rest of the world.  Those efforts continued with the signing of the America Invents Act (“AIA”) in 2011.  For example, the AIA created a first inventor-to-file patent system, while all but eliminating the best mode requirement. One area…

Litigation, Pharma, Pharmaceutical patent, United States of America

(Kramer Levin Naftalis & Frankel LLP)/

Three pending cases have the potential to reshape – or even eliminate – inter partes review, a procedure for challenging patent validity introduced by the 2011 America Invents Act (“AIA”).  On November 27, the Supreme Court will hear oral argument in two of those cases.  In Oil States Energy Services, LLC v. Greene’s Energy Group,…

European Union, Netherlands, Pharma, Pharmaceutical patent, SPC, TRIPs Agreement

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When a company is not prepared to charge a socially acceptable price in the Netherlands for a medicine, the government should use other instruments such as compulsory licences, encouraging pharmacy preparation and allowing patients to order medicinal products abroad in order to ensure that the medicine is available for patients. The Dutch Council for Public…

Australia, Pharma, Pharmaceutical patent

, , (Clayton Utz)/

On 23 October 2017, IP Australia released the draft Intellectual Property Laws Amendment (Productivity Commission Response Part 1 and Other Measures) Bill 2017 for public comment.  The purpose of the Bill is to implement the Government’s response to the Productivity Commission’s recommendations on Australia’s IP Arrangements (our coverage of the Government’s response can be found…

Litigation, Pharma, Pharmaceutical patent, United States of America

(Kramer Levin Naftalis & Frankel LLP)/ /1 Comment

Allergan’s assignment of the patents on one of its blockbuster drugs to an American Indian tribe in an attempt to dismiss a USPTO inter partes review (IPR) proceeding on “tribal sovereign immunity” grounds has shaken up the patent bar – with some dismissing this as, at most, a temporary loophole and others saying “why didn’t…

EPC, EPO, Equivalents, Inventive step, Litigation, Novelty, Pharma, Pharmaceutical patent, Prior art, Revocation, Second Medical Use, United Kingdom, Validity

(Bristows)/

Patent lawyers in the UK have spent the last three months pondering, debating and at times indulging in an element of despair (to put it mildly) about what might be the impact of the judgment of the Supreme Court in Actavis v Eli Lilly [2017] UKSC 48 on issues of validity (see here). Today they…