EPLAW Patent Blog

UK - Novartis AG v Generics (UK) Limited (trading as Mylan)

Novartis AG v Generics (UK) Limited, Court of Appeal (Civil Division), London, UK, 12 December 2012Case No. A3/2011/2970

In this decision, the UK Court of Appeal confirmed that obviousness must be assessed by reference to the invention as described and claimed by a patentee.  In order to undertake that assessment, all the circumstances including, where appropriate, whether it was obvious to try a particular route with a reasonable or fair expectation of success, must be taken into account.  What is a reasonable or fair expectation of success will again depend upon all the circumstances, and is fact dependent.

Sometimes, it may be appropriate to consider whether it is more or less self-evident that what is being tested ought to work. However, simply including something in a research project in the hope that something might turn up is unlikely to be enough.  The Court rejected that a finding of obviousness can only be made where it is manifest that a test ought to work.  Such a straightjacket upon the assessment of obviousness is not warranted by the statutory test and would, for example, preclude a finding of obviousness in a case where the results of an entirely routine test are unpredictable.

EUCJ - Opinion A-G Mengozzi / SPC Galantamine

Generics (UK) Ltd v Synaptech Inc, Opinion of Advocate General Mengozzi, 31 March 2011, Case C-427/09

"In the light of all of the foregoing considerations and, without prejudice to the observations at points 33 to 35 above, I propose that the following reply be given to the questions referred by the Court of Appeal for a preliminary ruling:

(1)      A marketing authorisation for a medicinal product granted by the competent authorities of a Member State pursuant to the transitional arrangements introduced by Article 24 of Council Directive 65/65/EEC of 26 January 1965 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products – in conjunction with Article 39 of Council Directive 75/319/EEC of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products, and as amended by Article 37 of that directive – on the basis of a marketing authorisation granted prior to the transposition of Directive 65/65 into the legal order of that Member State, may constitute the first marketing authorisation for the purposes of Article 13 of Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products.

For the purposes of the application of Article 13 of Regulation No 1768/92, an authorisation granted for use of a product, as a medicinal product, other than that or those protected by the patent which is the basic patent within the meaning of Article 1(c) of the regulation, may also constitute the first authorisation to place the product on the market in the Community.

(2)      A marketing authorisation for a medicinal product granted by the competent Austrian authorities in accordance with the national legislation, and maintained in force following the accession of Austria to the European Economic Area, initially, and to the Community, subsequently, must be treated as an authorisation granted in accordance with Directive 65/65 for the purposes of applying Article 13 of Regulation No 1768/92."

Read the Opinion (in English) here.  

DK - Sandoz v. AstraZeneca / Appeal

Sandoz A/S v. AstraZeneca AB, High court of Eastern Denmark, Kopenhagen, Denmark, 28 February 2011, with thanks to Peter-Ulrik Plesner and Kasper Frahm, Plesner, for sending in the cases and the translations

The Danish High Court has for the first time upheld a preliminary injunction based on fingerprint analyses and differences in process yield.

AstraZeneca is the owner of patent concerning the process for manufacturing the active pharmaceutical ingredient ("API") esomeprazol.In September 2009 AstraZeneca A/S and AstraZeneca AB submitted a preliminary injunction request against Sandoz A/S for the marketing and sale of a generic pharmaceutical named 'Esomeprazol "Sandoz"'.

The esomeprazol in Sandoz' product was being manufactured by the Indian producer Hetero. AstraZeneca claimed that the API was being produced according to AstraZeneca's protected process ("the AstraZeneca process"). Sandoz claimed that the API was being produced according to a different process ("the Hetero process").

AstraZeneca claimed during the case that the use of the AstraZeneca process would leave small amounts of four different impurities in the final product and that the finding of these impurities in Sandoz' product should be considered "fingerprints", i.e. indications of the use of the AstraZeneca process.

UK - Generics v Daiichi / Appeal

Generics (UK) v Daiichi, Court of Appeal, London, UK, 2 July 2009, Case No. [2009] EWCA Civ 646, with thanks to Marc Döring, Simmons & Simmons

In this case, the Court of Appeal has upheld the decision of Kitchin J that, although a course of action was obvious, the skilled person's motivation to pursue it to the point of making the invention was weak; and that accordingly the invention (an enantiomer of an antibiotic) was not obvious.

Read the extended summary (provided by Rowan Freeland and Scott Parker) here.

Read the appeal decision here.

Read the first instance decision here.

UK - Generics (UK) Limited and others v H Lundbeck A/S - House of Lords

Generics (UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents), House of Lords, UK, 25 February 2009, Case No. [2009] UKHL 12, with thanks to Marc Döring and Kevin Mooney, Simmons & Simmons

The Court of Appeal decision in Generics (UK) Limited v Lundbeck A/S followed Mr Justice Kitchin's High Court judgment in May 2007. The case was subsequently appealed to the House of Lords who gave their decision on 25 February 2009. The key issue for the Court of Appeal was the extent of the monopoly given by a product claim in a patent. Kitchin J had extended the application of the Biogen test for patent insufficiency such that the scope of the monopoly for a product claim could be severely reduced. Lundbeck's successful appeal, therefore, has significant commercial implications for the pharmaceutical industry as a whole.

Read the extended summary (prepared by Kevin Mooney) here.

Read the decision in first instance (in English) here.

Read the appeal decision (in English) here.
Read the decision of the House of Lords (in English) here.

UK - Generics (UK) Ltd v. Daiichi Pharmaceutical

Generics (UK) Ltd v. Daiichi Pharmaceutical Co. Ltd and Daiichi Sankyo Co. Ltd, High Court of Justice, Chancery Division, Patents Court, 15 October 2008, with thanks to Marc Döring, Simmons & Simmons

The English Patents Court's decisions in Dr Reddy's v Eli Lilly (Floyd J - 13 October 2008) and Generics (UK) v Daiichi (Kitchin J - 15 October 2008) are further welcome news for patentees. In both instances the patent (for a compound within the scope of a "Markush formula" of an earlier patent application in the first case and for an enantiomer in the second case) was upheld.

Read the extended summary here.

Read the judgment (in English) here.

UK - Generics (UK) Ltd. v. H Lundbeck

Generics (UK) Ltd. v. H Lundbeck A/S, Court of Appeal, London, UK, 2 August 2006, Case No. [2006] EWCA Civ 1261, with thanks to Marc Döring and Rowan Freeland, Simmons & Simmons

The UK Court of Appeal has ruled that suppliers of active pharmaceutical ingredients (API) are not to be considered joint infringers of a patent solely on the basis that they have provided information to the pharmaceutical regulators. The court also held that the burden of proof of non-infringement, which shifts to the alleged infringer if the invention is a process for a new product, can be discharged at an interlocutory stage.

Read the extended summary (prepared by Rowan Freeland) here.

Read the appeal decision (in English) here.