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U.S. Appeals Court Renders First Interpretations Of Biosimilars Law

In Amgen v. Sandoz, Fed. Cir., No. 15-1499 (July 21, 2015), a divided panel of the U.S. Court of Appeals for the Federal Circuit issued its first decision interpreting the Biologics Price Competition and Innovation Act (BPCIA), and did so in a manner that favors biosimilar applicants in one respect while favoring reference product sponsors (e.g., owners of original biologic products) in another. The result for Amgen and Sandoz is that Sandoz can start selling Zarxio™, its biosimilar version of Amgen’s Neupogen® (filgrastim) product, on September 2, 2015. The result for other biosimilar applicants is less clear, since the court’s decision leaves open more questions than it answers.

The [...]

Sweden: Post-injunction liability for third party actions clarified

This time I want to introduce a fellow author from Sweden, Kristian Fredrikson, who promised to write about this interesting recent decision from the Supreme Court (Högsta domstolen 18 June 2015, case no B6341-13). It does not concern patents per se but an infringer’s liability for a third party’s infringement after an injunction has been decided, and it’s principle content should be directly applicable in similar situations where a patent have been infringed.

A Swedish furniture company (“the infringer”) sold chairs (“Stilo”) that were found by the courts to infringe the copyright pertaining to a well-known Swedish design chair held by another Swedish furniture company (“th [...]

Finally, More Clarity from the Boards of Appeal of the EPO

No, not what you might perhaps have hoped for. A lot is currently ongoing at the European Patent Office about the status, the independence, the future location and the (self-)administration of the EPO’s Boards of Appeal, but this blogger is neither sufficiently well-informed nor competent to comment on the big picture. So let’s stick to our guns and praise Board of Appeal 3.3.07 for a little ex-parte appeal decision (T 1882/12) that combines clarity with common sense in an admirable fashion.

The decision relates to a problem that many patent practitioners have been encountering for a number of years. Rule 162 EPC along with the EPO’s Rules relating to Fees definitely discourage applicants fr [...]

Salt limitation leads to sweet and sour Court of Appeal judgment

by Gregory Bacon and Brian Cordery

The Actavis v Eli Lilly UK litigation concerning pemetrexed (sold by Eli Lilly under the brand Alimta(®) has already been widely reported in light of Actavis’ innovative application to the English court for declarations of non-infringement (DNIs) of national designations of a European Patent in addition to the UK designation. The latest instalment concerns the Court of Appeal’s judgment in the appeal on the merits. In summary, the Court of Appeal refused to grant the declarations sought by Actavis. This overturned the decision of Mr Justice Arnold in the Patents Court, who had held that each of the UK, French, Italian and Spanish national designatio [...]

The best things in life are unexpected because there were no expectations (Eli Khamarov)

Apart from the enthralling Lyrica saga which began in earnest back in January, and the main trial of which recently began before Arnold J, 2015 has not witnessed many significant pharmaceutical patent decisions from the UK patents courts. Thus, three cases in this field which, rather like London buses, arrived almost simultaneously, have provided welcome food for thought to life sciences patent enthusiasts.

The three cases were Smith & Nephew v Convatec (24 June 2015) and Eli Lilly v Actavis (25 June 2015) from the Court of Appeal and a decision from Arnold J in Hospira v Genentech (24 June 2015), part of the on-going campaign to clear the way in respect of certain Genentech patents relatin [...]

Offer for development no obvious pre-use

by Miriam Büttner

In a recent decision the German Bundesgerichtshof (Federal Court of Justice, FCJ) dealt with the requirements of an obvious pre-use (judgment of 9 December 2014, docket no. X ZR 6/13 – Presszange).

In 2011 plaintiff attacked the German part of the European Patent 1 223 008 (DE 502 06 178.2), which concerns the construction of a crimping plier. Such crimping pliers are mainly used for sanitary installations to connect two pipes via a connecting piece called “fitting”. Plaintiff based its nullity suit inter alia on an obvious pre-use of the protected invention. In this regard plaintiff submitted correspondence with a manufacturer of crimping pliers to develop a crimpin [...]

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