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The EU Patent Package – Where does Europe stand End of June 2014?

1 Introduction

Reports that say there’s — that something hasn’t happened are always interesting to me, because as we know, there are known knowns; there are things that we know that we know. We also know there are known unknowns; that is to say we know there are some things we do not know. But there are also unknown unknowns, the ones we don’t know we don’t know.

Donald Rumsfeld, United States Secretary of Defense, 1975-1977 and 2001-2006

According to Article 89 of the Agreement on a Unified Patent Court (UPCA), the Agreement is set up to enter into force on one of three dates, whichever is the latest. The first date provided in the Agreement was 1 January 2014. As we all know, it did not h [...]

English Patents Court grants extra-territorial DNIs

Patent litigators around Europe will be taking note of the latest significant development from the English Patents Court in the case of Actavis v Eli Lilly [2014] EWHC 1511 (Pat) (judgment dated 15 May 2014), in which the English Court decided to grant declarations of non-infringement (DNIs) for three foreign designations of a European Patent in addition to that for the UK.  The decision of Mr Justice Arnold, the most senior UK patents judge at first instance, is wide-ranging and merits careful analysis by litigators throughout Europe in light of the potential impact on cross-jurisdictional litigation strategies.  Thus, the authors make no apology for this comparatively lengthy analysis or [...]

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 [...]

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