EPLAW Patent Blog

UK - Actavis v Eli Lilly

Actavis Group HF v Eli Lilly and Company; Medis EHF v Eli Lilly and Company,Patents Court, London, UK, 27 November 2012, Case Nos. HC12E02962 and HC12A03340

The UK Patents Court has held that the UK court can decide whether a declaration of non-infringement should be granted in respect of French, German, Italian and Spanish designations of a European Patent, where the UK designation is also in issue and the validity of the patents will not be called into question by the potential infringer.

Points of particular interest in this decision include:

- Lilly consented in correspondence to service of proceedings and this consent was held to apply to the proceedings concerning the non-UK patents as well as the UK one.

- Actavis (the potential infringer) had undertaken not to challenge validity, or to contend that the patent is invalid, at any stage of the proceedings if the UK court accepted jurisdiction.  (One of the Actavis group companies was in fact a party to an EPO opposition of the Patent and Arnold J noted that the Actavis group had therefore voluntarily bifurcated the infringement and validity aspects of the case.)

UK - Eli Lily v. Human Genome Science

Eli Lilly and Company v. Human Genome Sciences, Court of Appeal, London, UK, 5 September 2012, with thanks to Penny Gilbert, Powell Gilbert, for sending in the case

"This follows on from the Supreme Court's finding that the HGS patent had industrial application, leaving the Court of Appeal to review issues on the law of sufficiency in relation to antibody claims and an issue of extension of protection.  The HGS appeal succeeded, and Lilly's Appeal was dismissed, so that all claims of the HGS patent were held valid."

Read the decision (in English) here.  

[Further head note follows]

UK - Eli Lilly v. Human Genome Sciences

Eli Lilly and Company v Human Genome Sciences Inc, Patents Court, 3 August 2012, [2012] EWHC 2290 (Pat)

This decision concerned supplementary protection certificates (SPCs) and specifically the questions of (i) whether a person is permitted to obtain an SPC based upon a marketing authorisation (MA) obtained by another, and (ii) whether the relevant patent claim sufficiently identified or specified a particular antibody in order for an SPC to be obtained in the light of the CJEU ruling in Medeva, Queensland and related cases. 

Eli Lilly’s concern was that if it obtained an MA for its antibody before the Patent expired, HGS might then seek an SPC based on Eli Lilly’s MA.  Eli Lilly therefore commenced proceedings seeking a declaration from the court that HGS was not entitled to obtain a valid SPC.  Eli Lilly then brought an application requesting the court to make an immediate reference to the CJEU in order to enable the above questions to be determined.  HGS applied for Eli Lilly’s claim for a declaration to be struck out, on the basis that it had been made prematurely and could not be resolved whilst the factual position was unclear.

The relevant patent was HGS’s EP (UK) No. 0 939 804.  The Patent has already been heavily litigated in proceedings between Eli Lilly and HGS, including a leading decision of the UK Supreme Court reversing the earlier findings of the Patent Court and Court of Appeal that the Patent was invalid for insufficiency.  The Supreme Court remitted certain outstanding validity issues back to the Court of Appeal.  Validity of the Patent was therefore the subject of other proceedings and still to be determined.

The judge (Warren J) held as follows:

FR - Sandoz v. Eli Lilly

SAS Sandoz v. Eli Lilly and Company, Court of Appeal of Paris, France, 13 January 2012, Case No. 10/17727, with thanks to Dominique Menard and Stanislas Roux-Vaillard, Hogan Lovells, for providing the judgment and an extended summary in English

On 13 January 2012, the Court of appeal of Paris confirmed the judgment which found that the French part of Eli Lilly's patent No. EP 0 577 303 regarding a process for stereoselective glycosylation shows inventive activity, is sufficiently disclosed and consequently valid. The failing generics company is ordered to pay half a million Euros in attorney's fees.

Read the entire summary (in English) here.

Read the judgment (in French) here.

NL - Ratiopharm v. Eli Lilly / Olanzapine patent invalid

Ratiopharm GmbH, Ratiopharm Nederland B.V., Ratiopharm B.V. v. Eli Lilly and Co Ltd., District Court The Hague, The Netherlands, 24 March 2010, Case No. 2008/2126, including the English translation, with thanks to Chantal Morel & Moïra Truijens, Klos Morel Vos & Schaap

Now including the English translation and a summary/comments in English

The Dutch part of Eli Lilly's patent and SPC re olanzapine was found to be invalid since the  substance olanzapine was  already directly and unambiguously disclosed in the earlier Schauzu publication. The error in Schauzu will, according to the court in The Hague, immediately be recognized by the man skilled in the art. The way this error can be corrected can also directly be derived from Schauzu. There is no trigger for the man skilled in the art to consult an other document.

The court further states that it realizes that its decision deviates from earlier decisions in the United States, China, The Czech Republic, Slovakia, Romania, Ukraine, Russia, Germany, United Kingdom, Austria and Spain. The patent was also invalidated in Canada, but based on a different argument (not a valid selection patent).

Read the decision (in Dutch) here.
Read the decsion (in English) here.

Read a summary in English and comments (provided by András Kupecz and Peter Meyer) here.

UK - Eli Lilly v Human Genome Sciences Inc / Appeal

Eli Lilly and Company v. Human Genome Sciences inc, High court of Justice, Court of Appeal (Civil Division), London, UK, 9 February 2010, Case No. [2010] EWCA Civ 33

The English Court of Appeal dismissed HGS's appeal against the decision that HGS's patent, which related to a protein it called Neutrokine-α, was invalid.  It held that the invention was not "susceptible of industrial application" so as to satisfy the requirements of Article 57 EPC.  Specifically, the fact that numerous different - in some cases contradictory - possible applications of Neutrokine-α were claimed in the patent pointed to the conclusion that the claims were purely speculative.  Moreover, while Neutrokine-α belonged to a superfamily of proteins which shared certain properties, members of this superfamily had differing, sometimes unique, characteristics and only one member has been found to have any therapeutic application. 

This decision was contrary to that given earlier in parallel EPO proceedings.  Jacob LJ noted that the different decisions resulted from two different readings of the facts, rather than any issue of law.  In such circumstances the Court was not bound to follow the EPO's conclusions.

Read the judgment (in English) here.

EPO - T0018/09 - Cooperation between Board of Appeal and National Court / acceleration of appeal proceedings

Human Genome Sciences (patentee) v. Eli Lilly (opponent), Cooperation between Board of Appeal and National Court / Acceleration of appeal proceedings, EPO Board of Appeal, 21 October 2009, Case No. T0018/09

In this case, the UK Court of Appeals requested the Board of Appeal to accelerate the parallel EPO appeal proceedings in order to have that appeal decided prior to the UK appeal hearing (which was then scheduled for December 2009, see Eli Lilly and Company v. Human Genome Sciences, Inc. [2008] EWCA Civ 168).

The Board acknowledged the practical and economic benefit of the national court's request and stated that it agrees entirely with the national appeal court that parties to such parallel proceedings should inform both tribunals of the position as early as possible and ask the appropriate tribunal for acceleration in order to avoid duplication of proceedings. Whether acceleration is requested by one party, or both or all parties in agreement, or by a national court, all parties must accept a strict procedural framework including short time limits. It must also be understood that acceleration can have no effect on the equal treatment of all parties and cannot confer any advantage on any one party.

UK - Dr Reddy’s Laboratories v. Eli Lilly and Company Limited / Olanzapine

Dr Reddy’s Laboratories (UK) Limited v. Eli Lilly and Company Limited, Court of Appeal (Civil Division), UK, 18 December 2009, Docket No: Case No.A3/2008/2966, with thanks to Robert Fitt, Bristows

The Court of Appeal upheld the decision of Mr Justice Floyd and confirmed that Lilly’s (selection) patent concerning the drug olanzapine is valid.

Olanzapine is one of the 10¹⁹ compounds and one of the 86,000 preferred compounds mentioned in the '235 patent. It is not mentioned specifically. Dr Reddy's Research Laboratories (DRL) contention that the specific compound lacks novelty, was rejected (i) as a matter of a priori reasoning (a generalised prior description does not disclose a specific matter within it) and (ii) because it is inconsistent with EPO Board of Appeal Case Law (Hoechst Enantiomers T 0296/87).

The pre-EPC rules, as formulated in I.G. Farbenindustrie's Patents should be regarded as part of legal history, not as part of the living law. The better approach is to see what the EPO Boards do (AgrEvo (T 0939/92) and Wyeth (T133/01). "The EPO jurisprudence is founded firmly around a fundamental question: has the patentee made a novel, non-obvious technical advance and provided sufficient justification for it to be credible?" An 'arbitrary selection' provides no technical contribution.

UK - Dr Reddy's Laboratories (UK) Ltd v. Eli Lilly

Dr Reddy's Laboratories (UK) Ltd v. Eli Lilly and Company Limited, High Court of Justice, Chancery Division, Patents Court, 13 October 2008, Case No. [2008] EWHC 2345 (Pat), 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.