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Hospira clears the way for generic Herceptin

The development of Herceptin (trastuzumab) in the late 1980s and 1990s is one of the most remarkable advances in the treatment of breast cancer. The story of the drug and its pioneer, the “velvet jackhammer”, Dennis Slamon, is neatly summarised in Siddhartha Mukherjee’s award winning novel: “The Emperor of All Maladies – a Biography of Cancer” – a fascinating if not necessarily uplifting read.

In short, unlike traditional chemotherapy, trastuzumab is a monoclonal antibody which specifically targets a receptor known as HER-2 which is involved in the development of breast cancer. No-one disputes that the development of Herceptin was a landmark advance in the field of oncology [...]

Implications Of The Proposed USPTO Attributable Owner Rules

Pursuant to a U.S. White House initiative aimed at addressing the “challenges from Patent Assertion Entities (PAEs)” and stemming the economic drain of meritless patent litigation, the USPTO has issued propose rules to require patent applicants and patent owners to disclose patent ownership information during and after patent prosecution and during any Patent Trial and Appeal Board proceedings. Written comments on the proposed rules are due by April 24, 2014 (extended from the original March 25 deadline). While many patent offices require disclosure of the entity entitled to pursue a patent, the proposed USPTO Attributable Owner rules could go much farther, and could be difficult and costl [...]

German Court is Soothsaying What the Future will Bring for FRAND and Compulsory License Defenses

by Dr. Simon Klopschinski

In one of its latest orders the Karlsruhe Higher Regional Court has used the opportunity to take a glimpse into the crystal ball, in order to see what decision the Court of Justice of the European Union (CJEU) is going to render in response to the pending referral for preliminary ruling regarding the FRAND and compulsory license defense in case of standard essential patents (SEPs).

In recent years the information and telecommunication (ITC) sector has seen a wave of patent lawsuits in various jurisdictions, including Germany. Since most of the patents asserted in these proceedings form part of a standard, a core questions is whether enforcing SEPs complies with anti [...]

Can the clarity of amended claims be challenged in an unrestricted manner in opposition proceedings? – T 373/12 refers four questions to the Enlarged Board of Appeal

In decision T 373/12 of 2 April 2014 the Enlarged Board has been asked to decide on the extent to which the clarity of claims amended during opposition proceedings and opposition appeal proceedings can be challenged when the amendments are based on dependent claims as granted.

Dipeptidyl-Peptidase-Inhibitoren, Federal Court of Justice Germany, 11 September 2013

a) The applicant is not obliged to limit the protective scope to explicitly described embodiments, but may make certain generalisations to cover the entire invention.

b) Whether a claim containing generalisations is enabled depends on whether the protective scope extends beyond the most generalized teaching solving the underlying problem.

c) Functionally describing a group of compounds is not precluded by the fact that such wording encompasses not only compounds already known in the art or disclosed in the specification, but also compounds that may be provided in the future; even if their provision requires inventive activity.

The full summary of this case has been published on Kluwer IP Law [...]

Ratification by Belgium of the UPC agreement

piter black and white2On 2 April 2014 the parliamentary committee Foreign Affairs of the Belgian House of Representatives voted in favor of the ratification of the UPC agreement. The vote in plenary session is planned for the week of 22 April 2014, but should be no more than a formality. This means that after Austria and France, Belgium will be the third member state to actually ratify the UPC Agreement.

The ratification law comes just in time as the Belgian parliament shall be dissolved at the end of April in preparation of the upcoming national elections of 24 May 2014. Although the government already decided in May last year in principle to ratify the UPC agreement, it took some time to politically agree on th [...]

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