Ajinomoto v. Global Bio-Chem Technology, Helm et all. District Court The Hague, The Netherlands, 20 March 2013, Case No. C/09.268116 / HA ZA 06-2131
Ajinomoto is the proprietor of EP 0 796 912 relating to a “novel lysine decarboxylase gene and process for producing L-lysine”. Both Ajinomoto and defendants Global et al. produce and sell L-lysine. Global et al. claim that the L-lysine produced by them is produces using fermentation methods with micro-organisms. On 20 March 2013, the District Court of The Hague ruled that EP ‘912 was valid, in spite of Gobal et al.’s arguments based on lack of novelty, obviousness, insufficient disclosure and added matter, and it ruled that Global et al. had infringed the patent.
Hospira UK Limited and Generics (U.K.) Limited trading as Mylan v Novartis AG, UK Patents Court, 15 March 2013, [2013] EWHC 516 (Pat)
Hospira and Mylan commenced proceedings for revocation of European Patents (UK) Nos. 1296689 and 1591122. Both concerned the administration of bisphosphonates, in particular, zoledronic acid or a salt – zoledronate – at intervals of at least six months for the treatment of osteoporosis.
It was accepted by Novartis that, if the patents were not entitled to one of their priority claims, then both patents would be invalid due to an intervening publication (Reid et al, “A single annual injection of the bisphosphonate …, Bone 28(5), S89 (2001)). The judge (Arnold J) conducted a thorough analysis of the relevant priority document and concluded that none of the patent claims was entitled to the claimed priority. For example, although the priority document disclosed a unit dose form of 1-10 mg, this was not linked to the other features of the claims.
Furthermore, several of the patent claims were also held to be invalid for insufficiency. The claims in issue required the skilled team to carry out a substantial program of clinical trials to find out what doses and dosing intervals were efficacious – they were not enabled across their breadth and were therefore insufficient.
Regeneron Pharmaceuticals Inc. and Bayer Pharma AG v. Genentech Inc., Court of Appeal, London, UK, 21 February 2013, [2013] EWCA Civ 93
The Court of Appeal upheld the decision of the Patents Court that Genentech’s patent was valid and infringed.
Regeneron and Bayer applied to revoke Genentech’s patent, EP (UK) 1 238 986, regarding the use of human vascular endothelial growth factor (hVEGF) antagonists for the treatment of non-cancerous (non-neoplastic) diseases which are characterised by excessive blood vessel growth (neovascularisation or angiogenesis). Regeneron and Bayer attacked the patent on the grounds of lack of novelty, obviousness and insufficiency.
Regeneron and Bayer also sought a declaration of non-infringement in respect of a product called VEGF-Trap which had been developed by Regeneron and licensed to Bayer. Bayer intended to sell VEGF-Trap in the UK for the treatment of neovascular age-related macular degeneration (ARMD), a leading cause of premature blindness. Genentech counterclaimed for infringement.
In the Patents Court, Mr Justice Floyd held the patent to be valid and infringed. Regeneron and Bayer appealed this decision.
On appeal, Regeneron and Bayer argued that the Judge had misconstrued the claims of the patent as not requiring any therapeutic effect on the disease or disorder in question and that he was inconsistent in applying his construction when considering validity. They also argued that the Judge had wrongly held that the claims encompassed any variant of a naturally receptor which retained the ability to bind VEGF and inhibit its activity. The Court of Appeal rejected the appellants’ arguments on construction. The specification clearly showed that Genentech intended variants to be included within the scope of the monopoly and VEGF-Trap fell within the scope of the patent.
Omnipharm Limited v Merial, Court of Appeal (Civil Division), London, UK, 23 January 2013, Case No [2013] EWCA Civ 2
This was an appeal against the judgment of Floyd J, dated 21 December 2011, following a trial of an action brought by Omnipharm to revoke two of Merial’s patents, EP (UK) 0 881 881 (the ‘881 patent) and EP (UK) 2 317 564 (the ‘564 patent) on the grounds of obviousness and insufficiency. The patents in suit both relate to ‘spot on’ formulations of parasiticide for protecting small animals against ticks and fleas; the ‘881 patent relating to formulations of fipronil and the ‘564 patent relating to fipronil in combination with an insect growth regulator (“IGR”). The patents protect Merial’s “Frontline” products which provide Merial with global sales of approximately $1 billion per year.
After allowing Merial’s proposed amendments, the trial judge declared the ‘881 patent valid, but found the ‘564 patent invalid for insufficiency. He also ordered Merial pay 40% of Omnipharm’s costs. Merial appealed. By way of contingent cross-appeal, Omnipharm contended that if the ‘564 patent was found to be sufficient, the judge would or ought to have found it invalid for obviousness and by parity of reasoning, should also have found the ‘881 patent invalid for obviousness. The Court of Appeal upheld the trial judge’s decision on insufficiency. As a result the cross-appeal was not pursued.
Apple Inc. v. Samsung Electronics Co. Limited c.s., District Court The Hague, The Netherlands, 28 November 2012, Case/Docket No. 413294 / HA ZA 12-220
Proceedings on the merits with respect to Apple’s photo gallery “bounce-back” patent, EP 2 059 868. On 24 August 2011, the PI judge had provisionally held that Samsung’s Android 2.2.1 Galaxy products infringed upon that patent, but that this was not the case for the Galaxy products running Android 3.0 and higher. This in confirmed in the proceedings on the merits.
According to the Court, in the Android 3.0 products there is no “second movement” needed for skipping to the next photograph, but rather a movement which is longer than a certain threshold value. As a skilled man would interpret the features “first-” and “second” movement as alternating movements which thus follow one another in time, the Court held that the Galaxy 3.0 products did not meet this feature. This was held to be different for the Android 2.2.1 products, in which the skipping to a next photograph according to the Court would be co-dependent on the detection of a “second movement”, which, as allegedly confirmed by the description, would be covered by the claims. Not in dispute was that products that used the “blue flash” update which Samsung had introduced after the PI decision had been rendered, did not infringe.
Mölnlycke Health Care AB and Mölnlycke Health Care Limited v BSN Medical Limited and BSN Medical GMBH, 9 November 2012, Case No. HC09C03755, Neutral Citation Number: [2012] EWHC 3157
Mölnlycke Health Care alleged that BSN Medical’s “Cutimed Siltec” range of layered wound dressings infringed its European Patent (UK) No 0855921, which claimed a wound dressing comprising a layer of “holey” form coated with a layer of skin-adhering hydrophobic gel (e.g. silicone gel) wherein the walls of the holes in the foam were coated with gel at the ends which were proximal to the wearer’s skin. BSN claimed that the patent was invalid for want of novelty, inventive step and sufficiency.
Mr Justice Floyd held that the patent was valid, but not infringed by the BSN products.
In construing the patent, Mr Justice Floyd confirmed that in the context of a product claim, the court was concerned with the end result and not with the means by which that result was achieved. Thus the requirement in claim 1 that the foam be “coated” with hydrophobic gel would be understood by the skilled person to mean that the foam and gel must be in intimate contact with one another; investigation into how that contact was achieved was irrelevant for the purposes of the claim.
The assessment of infringement turned on: (i) whether the silicone layer of the BSN products constituted a “gel”; and (ii) whether the silicone in the BSN product coated the walls of the holes in the foam.
Lübbers Anlagen und Umwelttechnick GmbH v. Relco Wet & Dry B.V., accelerated patent proceedings before the District Court of The Hague, the Netherlands, 25 January 2012, Case No. 387236 / HA ZA 11-451
On 25 January 2012, the District Court of The Hague ruled in the case brought by Lübbers against Relco. Lübbers acted as the exclusive licensee for EP 1 105 202 (relating to an annular ring injector aimed at cleaning air purification chambers), which patent is owned by Dutch patent holder and licensor Korporam B.V. Lübbers sought an injunction against Relco for patent infringement, but saw the invoked patent partially invalidated instead. Relco attacked the patent on grounds of lack of clarity / insufficiency, lack of novelty and lack of inventive step.
The Court ruled that although lack of clarity arguments under Article 84 EPC are not as such admissible in national proceedings, but that such arguments can indeed lead to invalidation on grounds of insufficiency (Article 83 EPC). Claim 4 is invalidated for that reason.
Johnson & Johnson Medical Limited, Johnson & Johnson Vision Care Inc and Ethicon v. Novartis AG, Cour d'Appel of Paris, France, 27 October 2010, Case no. 09/08135
Various decisions were handed down earlier in the worldwide litigation brought by Novartis against Johnson & Johnson about a patent for contact lenses. In a decision of Wednesday 27 October, the Cour d’Appel of Paris affirmed the 25 March 2009 judgment of the Tribunal de Grande Instance (which can be read here). In a nutshell, the Cour d’Appel rejects all Johnson & Johnson arguments of insufficiency and lack of novelty, thereby taking an opposite view to the English Court of Appeal and German Bundespatentgericht.
The patent was granted in 2001, revoked in opposition in 2003 and maintained in its original form by the Technical Board of Appeal 3.4.02 in its decision T 246/04 dated July 12, 2007. In the Netherlands, an injunction was granted against Drogisterij.net (which can be read here). In France, the Tribunal de Grande Instance in Paris gave a verdict on March 25, 2009, finding validity and infringement and ordering an injunction against J&J (read that decision here). The UK High Court held the patent to be new and inventive, the J&J lenses to be infringing, but the patent invalid on grounds of insufficiency. The Court of Jacksonville in Florida, USA, found the patent valid and J&J's lenses to be infringing. The German Bundespatentgericht judged the patent to be invalid in light of anticipation on December 14, 2009. An English Court of Appeal judgment from 29 September 2010 affirmed the High Court and revoked the patent for insufficiency (read that decision here).
Bayer Healthcare LLC v. Abbott B.V., District Court The Hague, The Netherlands, 20 October 2010, Case No. 356145 HA ZA 10-57, with thanks to Geert Theuws, Howrey, for sending in the judgment
The District Court of The Hague invalidates the Dutch part of Bayer's patent due to insufficiency. Bayer argues that Abbott's high affinity monoclonal TNF-alpha antibody Humira falls under the claims of its patent that relates to human monoclonal TNF-alpha antibodies. However, the method disclosed in Bayer's patent does not enable the skilled person to make such high affinity monoclonal antibodies. The court explains that it deviates from the decision of the TBA regading Bayer's patent because the TBA concluded that the claim did not see on high affinity antibodies. Now Bayer argues that high affinity antibodies do fall under the claim and the court finds that the claims do encompass high affinity antibodies but that the patent does not enable the skilled person to make these. Therefore the court finds that the patent is invalid for insufficiency, because the claims are too broad. The court finds further support for this in the decision T 1063/06, because in this situation the skilled person cannot carry out Bayer's invention within the entire scope claimed without undue burden.
Fosroc International Limited v. W.R. Grace & Co-Conn, Patents Court, Chancery Division, High Court of Justice, London, UK, 12 July 2010, [2010] EWHC 1702 (Pat)
The Patents Court has held Grace’s amended patent EP (UK) 0 415 799 to be valid.
Grace’s patent related to cement compositions used to form concrete and in particular the addition of higher trialkanolamine compounds.Fosroc sought to revoke the patent and as a result Grace made an unconditional application to amend the patent. Fosroc opposed the amendment on the basis of added matter and contended that the patent lacked inventive step even in its amended form. Forsoc also claimed that the patent was insufficient.
Mr Justice Floyd rejected the added matter objection and held that the amendments proposed by Grace were allowable in principle. The allegation of lack of inventive step based on four prior art documents failed as did the allegation of insufficiency. Mr Justice Floyd observed that a case of obviousness is seldom enhanced by the citation of multiple prior art references and the present case was no exception.
Recent Comments