Current Patent Litigation Trends: UK and Germany

Keywords: Patent, Litigation, patentees, European Patent Office, Technical Board of Appeal.

1. Introduction

   Previously in this series we have emphasised the importance of patentees crafting a carefully thought out pan-European patent litigation strategy designed to achieve their commercial objectives, and the importance of the United Kingdom and Germany (amongst other countries) in any such strategy.

   Developing such a strategy inevitably involves a sophisticated understanding of the different legal systems in Europe, and how their advantages and disadvantages can be best incorporated into a bespoke strategy optimised for each patentee's particular objectives. Yet it must also involve an appreciation of the differences in the way the law is applied by the different legal systems in Europe. Opportunity may lie in these differences - whether it be to one's advantage or detriment.

   There is undoubtedly a general European trend of convergence in the way countries apply patent law. This has especially been the case with the UK and German courts. There is a high level of communication and cooperation between the judges in both countries when faced with the same disputes, increasing judicial acknowledgment of each other's jurisprudence and the insights offered, and the adoption of common positions on a number of legal issues by the UK and German courts with the Technical Board of Appeal of the European Patent Office.

   Yet some differences in approach still remain on a number of important patent issues despite this general trend of harmonisation. These can make all the difference between success and failure. This article considers some of the current key patent litigation trends in the UK and Germany. It also sets out in tabular form the overarching approaches taken in both countries to how patents are interpreted, given the importance this can have on the issues of infringement and validity; although broadly harmonised and based on the same basic law, there are nonetheless fine nuances in application between the countries which can lead to different results in practice.

2. UK Life Sciences Trends

   (a) Interim Injunctions

   The ability to obtain an interim injunction against a competitor is one of the most potent weapons in any litigant's armory. The price the patentee pays for this is the contingent liability - should the patent ultimately be held not to infringe or to be invalid - to recompense the defendant for any damage it has suffered as a result of the injunction.

   The English Patents Court has considerably raised the price of this contingent liability by holding in life sciences cases that the patentee's customers can also claim the benefit of this so-called cross-undertaking in damages.1 The underlying rationale is that they are entitled to be compensated if it turns out that they have paid too much for the patentee's drugs during the pendency of the injunction.

   The practical significance of this is that given that the principal customer in the country is the state, in the form of the National Health Service, then this can act as a significant deterrent to applying for an injunction. The sums involved may potentially be vast.

   The result is that in practice the courts are granting speedy trials more readily than before, and patentees are more likely to agree to trade off an interim injunction for a speedy trial. Speedy trial in this context means a process typically taking under 9 months from commencement through trial and to judgment. It should also be noted that patentees are now being faced with a trade-off themselves - if they are granted an interim injunction they may also have to agree to a speedy trial as well as agree to be potentially at risk should the injunction be set aside.

   (b) Medical Use and Dosage Regimes

   It is trite law that the first inventor of a new product suitable for use in medical treatment is entitled to patent that product. This can cause difficulties where this is a known product and where the invention lies in the discovery of a new medical use (the so-called "first medical use'') or where - although already known for medical use - the invention lies in the discovery of a new second medical use (see for example "New Uses for Old Products - SPC Applicants Get Boost From Advocate General Opinion'' [26 WIPR, 7/1/12]). Such claims form an important part of the life science industry's patent portfolio.

   The UK law position used to be that new ways of delivering non-novel drugs for non-novel uses could not be patented because their novelty lay in mere methods of treatment.2 Fortunately for life sciences companies, the difficulties posed by first and second medical use patents have been addressed over the past few years, with the result that these are in principle no longer objectionable under UK law.

   First medical use patents have been expressly permitted as the result of a specific enabling amendment to the Patents Act. This now provides that first medical use patents are permitted provided any medical use of the product does not form part of the state of the art, and the use is otherwise inventive.3

   The position on second medical use patents has been resolved by the Court of Appeal decision in Actavis UK Ltd v. Merck & Co Inc.4 There it was held that new dosage regimes and other methods of administration of a drug are not excluded from patentability as methods of treatment.

   As a result, second medical uses are therefore permissible even if the novelty relates solely to a dosage regime or a method of drug administration. That said, the English courts' approach is nonetheless to examine such cases robustly:

   If on proper examination the invention is for a mere discovery about an old use which is dressed up as a second medical use, then it will be rejected. Second medical use patents will only be upheld if the active ingredient is actually effective to achieve a new treatment. If it is not, or if it is not discernibly effective, then it is not a proper second medical use, and will be rejected. The Patents Court has recently extended the scope of second medical use patents when considering the interface between second medical use claims and enantiomers. In Ranbaxy (UK) Ltd v. AstraZeneca AB5 the Patents Court held that a claim to the use of a single enantiomer of an active ingredient (omeprazole) was not infringed by the importation of a medication containing a mixture of two enantiomers, even though the manufacturing process used the single enantiomer as its raw material.

   Given the importance of medical use patents to the life sciences industry, these developments are to be welcomed.

   (c) Claim Interpretation and Infringement

   The UK Supreme Court or House of Lords as it then was comprehensively restated the correct approach to claim interpretation and infringement in 2005 in Kirin-Amgen v. Hoescht Marion Roussel6 where it held that the fundamental question was:

   "[W]hat [would] the person skilled in the art have understood the patentee to be using the language of the claim to...