EPLAW Patent Blog

NL - Chief IPO Philips: The quality of patents should improve: only focus on inventions which matter

Ruud Peters, Chief Intellectual Property Officer Philips, The quality of patents should improve: only focus on inventions which matter (published previously in the Financiële Dagblad on Saturday 28 July 2012)

“Therefore I propose to have patent applications only examined on a limited basis, the search. This search consists of a novelty research conducted by the patent office, including a written opinion as well as the applicant’s written response to the written opinion. However, this preliminary, relatively cheap, public research does not lead to a grant of the patent. The application stays in a ‘twilight zone’. For an in-depth research, the examination, which can lead to a grant of the patent, a special request should be submitted at the patent office. Every party having an interest in acquiring quick clarity with respect to the validity of the patent is entitled to submit such special request. This could be the applicant himself or a third party. One should pay an additional fee for such an in-depth investigation. If after, for example, five years no one has filed for examination the application will automatically lapse. This makes it possible for the market and the community to prioritize the work load of the  patent offices.”   
  
Read the article (in Dutch) here.

EU - Commission starts citalopram 'pay for delay' case against Lundbeck, Merck, Ranbaxy and others

Antitrust: Commission sends Statement of Objections to Lundbeck and others for preventing market entry of generic antidepressant medicine

The European Commission has informed the Danish pharmaceutical company Lundbeck of its objections regarding agreements concluded with four generic competitors concerning citalopram, a blockbuster antidepressant. The Commission is of the preliminary view that the agreements aimed at preventing the market entry of cheaper generic medicines, in violation of EU antitrust rules. The Statement of Objections is also addressed to Merck KGaA, Generics UK, Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma, A.L. Industrier and Ranbaxy, which belonged to the generic groups that concluded the agreements. The sending of a Statement of Objections does not prejudge the final outcome of the investigation.

In its Statement of Objections, the Commission takes the preliminary view that Lundbeck concluded agreements with generic companies to prevent the market entry of competing generic versions of its best-selling medicine citalopram. Generic entry became in principle possible when certain of Lundbeck's citalopram patents had expired. But the companies entered into agreements that foresaw substantial value transfers from Lundbeck to its four generic competitors, who subsequently abstained from entering the market with generic citalopram. The value transfers included direct payments from Lundbeck to the generic competitors and also occurred in other forms, such as the purchase of generic citalopram stock for destruction or guaranteed profits in a distribution agreement.

UK - Mylan v. Yeda

Generics [UK] Limited (trading as Mylan) v Yeda Research and Development Co. Ltd & Anor [2012] EWHC 1848 (Pat), 11 July 2012, Patents Court, Arnold J.

In this action the Claimant (“Mylan”) sought revocation of European Patent (UK) No. 0 762 888 (“the Patent”) and a declaration of non-infringement.  The First Defendant (“Yeda”) and the Second Defendant (“Teva”) were respectively the proprietor of, and the exclusive licensee under, the Patent. The Patent relates to a material known as copolymer-1, a polymer composed of amino acids alanine, glutamic acid, lysine and tyrosine in a particular ratio. The claims protect Copolymer 1 in a specified molecular weight range, and use of this for the treatment of multiple sclerosis (“MS”). Teva sells a product which it claims is protected by the Patent under the trade mark Copaxone (non-proprietary name glatiramer acetate) for the treatment of relapsing-remitting MS.

The action raised a large number of issues: whether the claims are entitled to the first claimed priority date; whether the Patent is invalid for obviousness over the prior art; whether the Patent is invalid for obviousness as making no technical contribution, but rather being an arbitrary selection from known copolymer-1 material; whether the Patent is invalid for insufficiency because the claims are ambiguous; whether the Patent is invalid for insufficiency on classical grounds; whether the Patent is invalid for insufficiency because it makes no technical contribution; whether the Patent is invalid for added matter; and whether the sale of Mylan’s glatiramer acetate product would infringe any of the claims of the Patent.

In respect of these issues it was held: none of claims 2-3 and 5-12 is entitled to priority from the Priority Document; none of the claimed inventions is obvious in the light of the prior art, Teitelbaum 1971, Bornstein 1987 or Johnson 1994; the product claims are not obvious as being an arbitrary selection; the Patent is not insufficient in any of the ways alleged; none of the claims is invalid for added matter; and; the proposed glatiramer acetate product would infringe the Patent.

UK - Schenck Rotec v. Universal Balancing

Schenck Rotec GmbH v. Universal Balancing Limited, Patents Court, High Court of Justice, HH Judge Birss QC (sitting as a judge of the High Court) London, UK, 12 July 2012, Case No. [2012] EWHC 1920 (Pat)

This case concerned Schenck’s patent EP 1 520 161, relating to a device and method for fastening weights to the outside of a rotor as a counterbalance, and its alleged infringement by Universal Balancing. Universal Balancing counterclaimed for revocation of EP ’161, as well as contending that it had the benefit of a prior use defence under section 64 of the Patents Act 1977 (i.e. the right to do or continue to do an act that it had done or made effective and serious preparations to do, in good faith, before the priority date of the invention) or, if found to infringe, a defence of innocent infringement to any damages claim under section 62(1) of the 1977 Act.

In a decision handed down on 12 July 2012, the High Court has held that EP ’161 is novel and inventive over the pleaded prior art, and infringed by Universal Balancing’s KISS-234 balancing machine. In particular, in construing the claims, the Court found that a patent claim requiring a gripper-like device to be "constructed to receive" a plurality of balancing weights did not mean that the device had to be designed, in the sense of intended, to receive a plurality of weights, but that it had to be constructed in such a way that it was capable of receiving a plurality of weights.

The Court held that Universal Balancing’s section 64 defence failed, but that its defence to damages under section 62 applied until the date on which the patent was raised at a meeting between the parties.

BE - Escitalopram / PI based on EP annulled at first instance

Brussels court of appeal, 27 June 2012, Lundbeck / Eurogenerics, case number 2012/KR/129 and 2012/KR/137 (PI proceedings)

In an earlier decision from the Belgian supreme court (reported here on the EPLAW Patent Blog), the Belgian tier of a European patent was declared prima facie valid despite having been revoked by the EPO Opposition Division.  It was held that, in view of the suspensive effect of the appeal that was lodged before the EPO Board of Appeal against that decision (Article 106(1) EPC), the revocation could not prevent a PI being granted on the basis of that patent.

The Brussels court of appeal has now declared this reasoning applicable to invalidity decisions issued by Belgian first instance courts. Lundbeck’s SPC for escitalopram was declared invalid by the Brussels commercial court in October 2011 in proceedings against the generic manufacturers Teva and Tiefenbacher.  Lundbeck has in the meantime appealed this decision and has already obtained a partial reversal of the first instance decision.  It now sought to enforce the same SPC against another generic manufacturer of escitalopram, Eurogenerics.  Eurogenerics argued that the patent was not prima facie valid because it had been annulled at first instance. The Brussels court of appeal did not accept this defence and stated that, by analogy to the supreme court decision on Article 106(1) EPC, the SPC should be considered prima facie valid for the purpose of PI proceedings, given the pending appeal against the first instance nullity decision.

Read the decision (in French) here.

Head note: Philippe de Jong

 

NL - Actavis v. AstraZeneca

Actavis Group PTC EHF v. AstraZeneca AB, District Court The Hague, The Netherlands, 25 July 2012, Case no. 405170 / HA ZA 11-2545, with thanks to Willem Hoyng, Hoyng Monegier, for sending in the judgment

Actavis had claimed invalidation of two European Patents, EP 1 124 539 and EP 0 984 773, both relating to a formulation of omeprazole or either of its enantiomers (including esomeprazole). However, Actavis had not sent a notification letter before initiating proceedings, setting out the reasons why it considered the patents to be invalid and requesting AstraZeneca to voluntarily abandon the patents.

After Actavis had commenced proceedings, AstraZeneca abandoned the (Dutch parts of) these European Patents. Actavis had nevertheless continued the proceedings, maintaining its claim for invalidation of the patents. It argued that it still had interest in this claim, as the abandonment of patent rights did not have retrospective effect. Furthermore, it maintained its claim for a full cost award, arguing that it was necessary to make these costs, because AstraZeneca had only abandoned the patents after Actavis had served its writ of summons.

The District Court ruled that Actavis no longer had any interest in its invalidation claim, because, contrary to what Actavis had argued, the abandonment did have retrospective effect. This is explicitly set out in Article 63 Dutch Patent Act, which article was amended in 2008. In the version of Article 63 that was in force until 2008, an abandonment did not have retrospective effect. Furthermore, the Court did not agree that Actavis was be entitled to a full cost award, even though AstraZeneca has only abandoned the Dutch parts of the two patents after commencement of proceedings. The Court ruled that Actavis should have sent AstraZeneca a letter before initiating proceedings, requesting AstraZeneca to voluntarily abandon the patents, to avoid unnecessary proceedings.

In light of this, the Court denied Actavis’ claims and ruled in favour of AstraZeneca.

Read the judgment (in Dutch) here.

Head note: Jaap Bremer

NL - BASF v. Leolac

BASF Polyurethanes Benelux B.V. v. Leolac B.V., preliminary injunction proceedings, District Court The Hague, The Netherlands, 17 July 2012, Case No. / Docket No. 417538 / KG ZA 12-410

The parent company of defendant Leolac is the owner of a European patent for a method of manufacturing a laminated foam article, and a foam article obtained by the method and the use of such article. BASF, amongst others, opposed the grant of the patent. The Opposition Division ruled the patent valid in an amended form.

Leolac has sent a warning letter to BASF and its customer PPI. BASF replied to his letter by sending a summons letter to Leolac ordering Leolac to refrain from stating or suggesting that BASF or its customers are infringing Leolac’s patent. Leolac did not comply with the demands of BASF since it is of the opinion that the warning letter was not really intended as a summons letter. The letter was only aimed at notifying BASF and its customers of the outcome of the opposition against the patent and an invitation to enter into cooperation with Leolac.

The judge does not follow Leolac in its defence. According to the judge the letter can hardly be perceived as anything different from a threat that Leolac shall invoke its patent if no cooperation is reached between Leolac and the receivers of the letter.   

Sending a ‘warning letter’ to alleged infringers and their customers is in principle not unlawful even if it turns out afterwards that the invoked patent claim will not hold. However, when the holder of a patent could reasonably have known that the party who received the warning letter did not infringe the patent, sending a warning letter is considered unlawful. The judge ruled that this is the case here and holds Leolac liable for sending the warning letter.   

Read the entire decision (in Dutch) here.
 
Head note: Wim Maas

NL - Georgetown / Queensland - Referral CJEU

District Court of the Hague, 11 July 2012, cases AWB 10/4769 (Georgetown University/NL Octrooicentrum) and AWB 10/7362 (The University of Queensland/NL Octrooicentrum)

These rulings of the District Court of the Hague concern sub c of Article 3 of the SPC-regulation (469/2009). They follow on the recent rulings of the ECJ in the Queensland (C-630/10), Georgetown University (C-422/10) and Medeva (C-322/10) cases of 24 and 25 November 2011 (concerning sub a and b of Article 3 of the SPC-Regulation). From those cases it followed that an applicant may base its request for an SPC for a single active substance on a marketing authorization in which this substance is included in a combination with other active substances.

In the present cases, the question is whether sub c of Article 3 precludes the grant of an SPC for more than one product covered by the same base patent. Georgetown University and the University of Queensland both hold patents for vaccines. They had obtained an authorisation for a ‘multi-component’ variant of the vaccine and requested an SPC for this vaccine (the “original application”). This SPC was initially refused with reference to sub b of Article 3 of the Regulation, but parties agree that in light of the decisions cited above the refusal was incorrect. However, the Patent Office now refuses to grant the SPC’s under reference to sub c of Article 3 of the Regulation.

 

EU - Solvay v. Honeywell

Solvay SA v Honeywell Fluorine Products Europe BV,Honeywell Belgium NV, Honeywell Europe NV,Court of Justice, 12 July 2012, Case No C-616/10

1.      Article 6(1) of Council Regulation (EC) No 44/2001 of 22 December 2000 on jurisdiction and the recognition and enforcement of judgments in civil and commercial matters, must be interpreted as meaning that a situation where two or more companies established in different Member States, in proceedings pending before a court of one of those Member States, are each separately accused of committing an infringement of the same national part of a European patent which is in force in yet another Member State by virtue of their performance of reserved actions with regard to the same product, is capable of leading to ‘irreconcilable judgments’ resulting from separate proceedings as referred to in that provision. It is for the referring court to assess whether such a risk exists, taking into account all the relevant information in the file.

2.      Article 22(4) of Regulation No 44/2001 must be interpreted as not precluding, in circumstances such as those at issue in the main proceedings, the application of Article 31 of that regulation.

Read the judgment (in English) here.

UK - Dr Reddy’s v. Pfizer

(1) Dr Reddy’s Laboratories (UK) Limited (2) Dr Reddy’s Laboratories Limited v. Warner-Lambert Company LLC, Patents Court, Chancery Division, High Court of Justice, London, UK, 28 June 2012, [2012] EWHC 1791 (Pat)

The Patents Court rejected Dr Reddy’s application for the Court to make a reference to the European Court of Justice (CJEU) in advance of the trial for a preliminary ruling under Article 267 TFEU regarding Regulation (EC) 1901/2206 (“the Paediatric Regulation”).

Pfizer (of which Warner-Lambert is a part ) was the proprietor of a patent, EP (UK) 0 247 633 B1, for atorvastatin, a statin marketed under the trade name LIPITOR. Pfizer also had the benefit of a supplementary protection certification, SPC/GB97/011, and a six month paediatric extension under the Paediatric Regulation. Dr Reddy’s applied to revoke the paediatric extension and applied for the Court to make a reference to the CJEU in advance of the trial for a preliminary ruling under Article 267 TFEU regarding the Paediatric Regulation.

Dr Reddy’s argued that the paediatric investigate plan (PIP) that was approved for Pfizer’s paediatric extension was not a lawful PIP because one of studies included had not been completed and so the approval was invalid. Pfizer argued that it was not necessary for all studies to be completed for a PIP to be valid under the Paediatric Regulation. Pfizer also raised a number of further arguments as to why it was not appropriate to make a reference to the CJEU in advance of the trial.

Mr Justice Roth held that it would be inappropriate to make a reference before the trial as it was possible the case could be resolved without a reference being necesssary. Furthermore, given the trial could take place in about six months' time, it was not a case where either significant delay or very substantial costs would be avoided by making a reference at this stage of the proceedings.

Read the judgment (in English) here.

Head note: Robert Fitt