Showing posts sorted by relevance for query danisco. Sort by date Show all posts
Showing posts sorted by relevance for query danisco. Sort by date Show all posts

Thursday, 20 March 2014

Pre-issuance conduct and declaratory judgment actions in the US

cornIn the recent case of Danisco v Novozymes, the Court of Appeals for the Federal Circuit held that the patentee’s conduct prior to issuance of a patent may be sufficient to satisfy the ‘actual controversy’ requirement to establish declaratory judgment jurisdiction (see 28 USC s. 2201(a)). The court reversed the judgment rendered by the District Court for the Northern District of California, relying on the teaching of the Supreme Court in MedImmune v Genentech and adopting a standard based on the ‘totality of the circumstances’. The panel also rejected the district court’s categorical distinction between pre and post issuance conduct.

Danisco and Novozymes are competitors in the market for industrial enzymes used to convert corn and other plant-based material into ethanol. In the past decade, Novozymes repeatedly sued Danisco for patent infringement. Danisco filed a patent application, later issued as US Patent 8,084,240, claiming a BSG alpha-amilase variant polypeptide with an E188P substitution, the active ingredient of the company’s rapid starch liquefaction products. Shortly after issuance of a Notice of Allowance of Danisco’s application, Novozymes amended one of its pending patent applications to claim the same polypeptide, requesting an interference contesting entitlement to priority of invention. The examiner rejected both the interference request and a subsequent request for continued examination. Novozymes noted that it refused to ‘acquiesce’ to or otherwise be ‘estopped’ by the examiner’s erroneous decision. On the day of issuance of Novozymes’ amended application as US Patent 8,252,573, Danisco filed the declaratory judgment action that gave rise to the present dispute.

At first instance, the district court recognized that many of the circumstances adduced by Danisco, including the parties’ status in the industry, past litigation, and the prosecution history and timing, suggested that Novozymes had pursued the E118P substitution claim in the ’573 patent with the objective of asserting it against Danisco’s products. It noted, however, that the declaratory judgment plaintiff had not provided proof of any affirmative act by Novozymes to enforce its patent rights, and that the temporal coincidence between the issuance of the patent and the filing of the declaratory judgment action suggested that Novozymes had not even had the time to take any enforcement action. The court, dismissing the action for lack of subject matter jurisdiction, concluded that ‘[w]hile matters such as a prior litigation history and statements made during prosecutions sometimes support a conclusion that an actual controversy exists, there is no precedent for finding jurisdiction based on such pre-patent issuance events alone, without any affirmative act of attempted enforcement’.

The Federal Circuit disagreed. Right from the outset, the panel clarified that the lack of specific accusations of infringement against the declaratory judgment plaintiff is not a decisive element to establish whether an actual controversy exists (citing Arkema Inc. v Honeywell International Inc.). Instead, the court recited the teaching of MedImmune, where the Supreme Court held that ‘[b]asically, the question in each case is whether the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment’. The Federal Circuit found that the prior litigation history between the companies (see 3M Co. v Avery Dennison Corp.), and the adverse positions taken during prosecution of the ‘240 and the ‘573 patents, satisfied the ‘actual controversy’ requirement as outlined by the Supreme Court. Further, the judges added that Novozymes’ response to the rejection of its interference action suggested that the company believed that Danisco’s alpha-amylase variant infringed its patent.

The court observed that ‘[t]he district court’s categorical distinction between pre- and post-issuance conduct is … irreconcilable with the Supreme Court’s insistence on applying a flexible totality of the circumstances test, its rejection of technical bright line rules in the context of justiciability, and our own precedent’. Novozymes’ conduct, in this perspective, ‘shows a preparedness and a willingness to enforce its patent rights’, which put Danisco in the position of either abandoning the production of its rapid starch liquefaction products, or running the risk of an infringement suit. This situations resembles the same dilemma that, according to MedImmune, the Declaratory Judgment Act aimed to ameliorate.

The evolution of the Federal Circuit’s approach to the ‘actual controversy’ requirement is particularly interesting. After MedImmune, the Federal Circuit definitively abandoned the formalism embedded in its ‘reasonable apprehension of suit’ standard, although it struggled to part with the idea that ‘some affirmative act by the patentee’ is indeed required (SanDisk Co. v STMicroelectronics Inc.). The present case highlights how a multiplicity of factors, including prior litigation history and pre-issuance conduct, can effectively signal the presence of a justiciable controversy between the parties. A couple of articles, here and here, provide a good overview of the matter for all interested readers.

Thursday, 21 June 2012

Inspection of redacted documents in patent trials

Don't ask for a copy of this extempore judgment, since it's not on BAILII and you'd need to be a Lawtel subscriber to read the Marten Walsh Cherer computer-aided transcript, but Danisco A/S v Novozymes A/S [2012] EWHC 1641 (Pat) is an interesting little Patents Court, England and Wales, judgment from Mr Justice Arnold (yes, he can produce short judgments too: this one covers just four sides). The topic is a delicate one: disclosure of documents and the inspection of redacted [i.e. censored] parts of them.

In short, Daniusco applied for specific disclosure and/or inspection of certain documents in the possession of Novozymes, this being in the course of Danisco's application to revoke a Novozymes patent, there being parallel proceedings in respect of the same patent before the European Patent Office (EPO). One of the documents, a May 2009 report, had been redacted for disclosure but Novozymes' solicitors let Danisco's solicitors inspect it.  Inspection of further redacted monthly reports was also sought. In Danisco's view was that disclosure of the document  was necessary in order to help it understand documents already disclosed; that the redacted parts of the May 2009 report should not have been redacted in the first place and that they were in any event relevant to the dispute; and that the redacted parts of the further monthly reports were relevant to Novozymes' evidence of its production capacity in 2004/5.

Arnold J allowed the application in part. In his opinion:

  • The document in question set out the statistical method which was referred to by a number of disclosed documents.  Danisco was not just speculatively fishing when seeking it, but it still had to be asked whether it was actually relevant to the dispute which was the subject of the litigation.
  • The document was actually necessary in order to understand the figures in another document that had already been disclosed -- though ultimately it might not possess any evidential weight.
  • Disclosure of that document would not place any substantial burden on Novozymes, nor was it unfair to ask Novozymes to disclose it with the EPO hearing being just two weeks away. In any event, Novozymes could have disclosed the document earlier and, regarding the EPO hearing, the EPO would not allow Novozymes to be prejudiced by this disclosure.
  •  As to the redacted parts of the May 2009 report, inspection would be ordered.  The report was sufficiently relevant to be able to support Danisco's case or undermine Novozymes'.  If this wasn't a patent trial, disclosure would have been ordered, the problem here only being that Danisco's application for inspection was made outside the four-year window for disclosure in patent cases. Again, no burden would be placed on Novozymes in complying with the inspection request.
  • Disclosure of the redacted parts of the further monthly reports would not be ordered: they post-dated the issues to which Danisco claimed they were relevant by one-and-a-half to two years.

Wednesday, 25 July 2012

Strategic use of UK disclosure aids Danisco in EPO rulng

Via Jason Costa comes news of victory for Danisco before the European Patent Office (EPO) in its long-running dispute with Novozymes.  Both are Danish biotech businesses that are engaged in enzyme manufacture. In these proceedings Danisco revoked one of Novozymes’ European patents for coated animal feed enzymes, which had been asserted by Novozymes in Denmark, Germany, the Netherlands and the United Kingdom (with proceedings under related utility models in Finland). PatLit reported here on proceedings between the same companies in England and Wales in June of this year.


According to the information received:
"The EPO revocation was based in part on Novozymes’ own documents (obtained by disclosure in the United Kingdom and released for use in the EPO by the Patents Court for England and Wales), which undermined Novozymes’ submissions in the EPO. This revocation restores the ability of Danisco -- acquired by DuPont in May 2011 -- to engage in commercial activities in Europe and provide customers with innovative solutions in the animal feed business.

Disclosure!
This decision sheds light on the discussions concerning the impending unitary patent in Europe, because it emphasises the importance of UK-style disclosure in determining the validity of commercially important patents. Novozymes initially refused to allow the documents to be used in the EPO.  However, the decision of the Patents Court at [2012] EWHC 696 (Pat) [this is not yet available online on BAILII] made the crucial documents available. The Patents Court and Court of Appeal initially refused to make the documents available to the EPO, but this position changed after Novozymes was held to be at fault in requesting a late adjournment of the UK trial. The decision also indicates the speed with which the EPO can decide accelerated proceedings: the patent was granted on 11 November 2009, opposed on 30 March 2010, revoked by the Opposition Division on 7 July 2011 and finally revoked by the Technical Board of Appeal on 29 June 2012 (31.5 months from grant to final revocation)".
This does not mean that the matter is at an end:
"Danisco will also seek compensation for the damage caused by a preliminary injunction originally obtained by Novozymes in Denmark. On May 25, 2012, before the Technical Board of Appeal revoked the EP'592 patent, the Eastern High Court in Copenhagen had revoked that preliminary injunction and ordered Novozymes to pay Danisco 1.5 million DKK (Danish kroner) in legal costs".