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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 – [...]

Hospira v. Novartis, Court of Appeal of England and Wales, 19 December 2013 ”

The Court of Appeal upheld the judgment of the High Court (Arnold J) that claims concerning treatment of osteoporosis with zoledronic acid were not entitled to an earlier priority date and were therefore invalid over an intervening publication. The Court held that the disclosure in the priority document was either too general or too specific, and therefore did not support a claim to the use of zoledronic acid administered intravenously about once a year to treat osteoporosis with a dose of 2-10mg.

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

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Intermediate Generalisations – How far can you go where?

Article 123 (2) EPC and corresponding national provisions prohibit an applicant or patentee from amending a patent application or patent such that its subject-matter extends beyond the content of the application as originally filed. The statute is the same throughout Europe, but the practice is not always so. An issue where the Case Law of the EPO and the national courts seems to increasingly diverge is the admissibility of intermediate generalisations.

What are intermediate generalisations? Imagine the following exemplary situation: An EP application has a broad claim 1 consisting of features A, B and C. The application further contains several working examples which are directed to various [...]

Moving the SPC Goal Posts or a Necessary Amendment?

It is hard to think of a recent SPC case before the UK courts where the judge has not had to refer questions to the CJEU in order to either clarify the terms of the SPC Regulation or the CJEU’s earlier interpretations.  This necessity has arisen at an early stage in an action between Actavis and Boehringer Ingelheim before the High Court of England & Wales ([2013] EWHC 2927 (Pat)) concerning the validity of an SPC for a combination product.

Boehringer Ingelheim were the proprietors of EP (UK) 0,502,314 which expired on 30 January 2012. Claim 5 of this patent was said to protect the active ingredient Telmisartan (used for the treatment of hypertension). This is the active ingredient in Bo [...]

Smart Card Patents that were not so Smart

and Carissa Kendall-Palmer

In HTC Corporation v Gemalto SA and HTC Corporation v Gemalto NV [2013] EWHC 1876 (Pat), Mr Justice Birss ruled upon the validity and infringement of two telecommunications patents concerning smart/chip card technology. The Claimant came to the High Court of England and Wales seeking revocation of the patents; the Defendant counterclaimed for infringement.

The 865 patent

The 865 patent, entitled ‘Using a High Level Programming Language with a Microcontroller’, was said to relate to using a high level programming language with a smart card or microcontroller. Gemalto contended that claims 1, 3, 8, 9, 15 and 18 were independently valid, and save for claim 9, they [...]

Generics [UK] Ltd (trading as Mylan) v Yeda Research and Development Co. Ltd and Teva Pharmaceutical Industries Ltd [2013] EWCA Civ 925

Introduction
In my previous post of 2 August 2013 I made passing reference to the recent decision of the English Court of Appeal in the Copaxone litigation. This case was an appeal of the decision of Arnold J (previously reported here) where he found Yeda’s patent valid and infringed. With permission of the court, Mylan appealed that decision.

Background facts
Yeda is the registered proprietor (and Teva is the exclusive licensee) of EP (UK) 0 762 888 (the “Patent”) relating to a synthetic copolymer known as copolymer-1. Teva markets a product containing copolymer-1 under the brand name Copaxone, which is used for the treatment of relapsing-remitting multiple sclerosis (the most common [...]

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