This article was first published in Who's Who Legal in April 2018.
Many of the cases before the English courts over the past year have dealt with the availability and scope of patent protection, in their attempt to achieve a fair protection for patentees while achieving sufficient certainty for third parties to enable them to go about their business free from the threat of patent infringement proceedings. How have the English courts approached this and have they got the balance right?
It has always been, and remains, a fact of the patent system in which we operate that patents are applied for and granted many years before they are litigated in the courts. In the English courts, litigation takes the form of invalidity or infringement proceedings – or, more typically, both invalidity and infringement are considered within the same proceedings. The dilemma that many patentees face at the outset is how to ensure that the patent is applied for late enough to enable the development to be sufficiently understood, so that the patentee can focus the application on the most promising aspect of the invention, while not leaving it so late that someone else has got there first. This is difficult to judge and it is not uncommon, therefore, for a court to be asked to construe a patent claim in such a way as to catch infringement, but at the same time avoid invalidity. The skill of the lawyer comes in understanding the invention sufficiently and finding the expert evidence to enable such a construction to be found. With this in mind, it is not surprising, therefore, that many of the cases before the English courts over the past year have dealt with the availability and scope of patent protection, in their attempt to achieve a fair protection for patentees while achieving sufficient certainty for third parties to enable them to go about their business free from the threat of patent infringement proceedings. How have the English courts approached this and have they got the balance right? In this article we consider how these questions have been resolved, and the issues they raise for the future.
Scope of Protection
The Supreme Court decision in Actavis v Eli Lilly  UKSC 48, handed down on 12 July 2017 dealing with claim construction for infringement, caused a significant change in the law of infringement in the UK. This has led to intense speculation as to its implications for validity, which the Supreme Court did not address. The decision, which introduced a new two-stage process for assessing infringement and changed the test for assessing whether an alleged infringement constitutes an immaterial variant, has already been followed by the lower courts. While the Supreme Court may have considered that holding the patentee too closely to the wording of the claim did not provide fair protection in accordance with the Protocol on the Interpretation of article 69, it has so far been alleged infringers who have attempted to take advantage of the change in the law. In Generics (UK) Ltd (t/a Mylan) & Synthon v Yeda Research and Development Co Ltd & Teva Pharmaceutical Industries Ltd  EWHC 2628 (Pat), Mylan and Synthon argued that a particular piece of prior art disclosed something equivalent to what was claimed in the patent. Mr Justice Arnold decided that it was not correct as a matter of law to take equivalents into account when assessing novelty, but he stated his view that if it had been correct, the patent would have lacked novelty over that piece of prior art. Meanwhile, in Fisher & Paykel Healthcare Ltd v Resmed Ltd  EWHC 2748 (Ch), Mr Richard Meade QC sitting as a deputy judge of the High Court commented: “The main dynamic in this case is, as is not uncommon, that the patentee, ResMed, is arguing for a narrower claim scope to avoid the prior art, and FPH is arguing for a broader claim scope”. The deputy judge in that case followed the approach of Mr Justice Arnold but, because of the uncertain state of the law, nonetheless stated his view on literal and purposive construction, and equivalents. Until a higher court decision settles the issue, it is likely that the potential for validity attacks of this kind will continue to be explored.
Understanding how a claim will be construed during litigation is increasingly critical for patent prosecution strategies developed and implemented many years before a patent even grants. On its face, the Supreme Court’s decision suggests that certain objections raised by the examiner during prosecution or encountered during opposition may not be worth opposing, as the courts will not place much weight on the views of the Examiner or the relevant European Patent Office body. In particular, the English courts seem sceptical of whether what is considered by the EPO or examiners as added matter is really sufficient grounds to invalidate a patent. However, the Supreme Court decision expressly allowed for the prosecution history to be considered in limited circumstances, so the context of a particular decision to limit a claim or any specific statement of reasons may still be submitted to be relevant by an alleged infringer. In Illumina v Premaitha  EWHC 2930 (Pat), Premaitha was unsuccessful in its attempt to rely on the prosecution history of one of the patents in suit to support its case for non-infringement, because Carr J found that the limitation added to claim one during opposition to avoid objections of insufficiency did not exclude the type of method practised in the allegedly infringing product. At this stage, the courts seem to be attempting to keep practice aligned with the law as it stood before Actavis, and so it is unlikely that patentees will feel confident in accepting narrower claims or not needing to pursue divisionals while such uncertainty prevails.
Having a clear approach and understanding of how a claim will be construed gives both patentees and third parties certainty. Even so, uncertainty can still arise in circumstances where it is far from clear whether patents that are yet to be granted will be asserted against a third party’s product at some point in the future. In particular, the trend for multiple patents relating to a particular product or treatment, whether a divisional of the same patent application or patents relating to different aspects of the treatment such as a dosage regimen or formulation, can make it difficult for companies to be confident of freedom to operate. These are all legitimate and common strategies, but the courts have been concerned with protecting third parties in particular circumstances where the practices may give rise to abuse of the patent system. While revocation (or a declaration of non-infringement) is the necessary route to clearing the way for granted patents in the English courts, one option that has recently become popular for potential infringers in the UK in relation to pending applications is to seek a so-called Arrow declaration. This is a declaration by the court that a particular product or process would have not have been new, or would have been obvious as at a particular date, such that a patent alleged to be infringed by that product or process must itself be invalid. Arrow declarations made a comeback in 2016 and the test of how the court’s jurisdiction should be applied continued to be developed in 2017. In Fujifilm Kyowa Kirin Biologics Company Ltd & Samsung Bioepsis UK Ltd & Biogen IDEC Ltd v Abbvie Biotechnology Ltd  EWHC 395 (Pat), Fujifilm and Samsung were successful in obtaining a declaration as the result of a very unusual set of facts, including Abbvie’s conduct in abandoning patents that were the subject of validity proceedings before a decision could be given, and in threatening to sue for infringement throughout the world. However, in the case of Generics UK v Yeda, mentioned above, Arnold J refused to grant a declaration and held that the reasoned judgment of the court would be sufficient without a declaration being necessary. The remedy therefore seems set to continue to be available only in limited circumstances.
Patent Protection and Clinical Trials
One of the key aims of the patent system is to incentivise research, and in general, courts have this in mind when making decisions. However, a pressing issue for many life sciences companies will be the potential for a report of an ongoing clinical trial for a new treatment to render a use patent relating to that treatment obvious. The risk makes it difficult for patentees to decide when is the right time to file their first application – there needs to be sufficient information in the application to render the invention plausible, but if data from the clinical trial are awaited, it becomes difficult, if not impossible, to keep the existence of the clinical trial out of the public domain. This issue exists in all jurisdictions, but is also dependent on the laws on confidentiality, as well as the regulatory environment which affects how much information has to be disclosed regarding ongoing clinical trials. The EPO does not take a consistent approach to the effect of a disclosure of an ongoing clinical trial on the validity of a patent covering that regimen. In some cases the Technical Board of Appeal has recognised an assumption of confidentiality for certain disclosures, for example, in T 906/01 and T 152/03; but in T 7/07 it was held that the distribution of the drugs as part of the clinical trial rendered them available to the public. In the English case of Hospira UK Ltd v Genentech Inc  EWCA Civ 1185, the Court of Appeal upheld the first-instance decision that the disclosure of the design for a clinical trial in a review article did render the patent obvious. The case concerned Genentech’s trastuzumab (brand name Herceptin), which is used in the treatment of HER2 positive breast cancer. The Court considered that the report of the relevant clinical trial design and the review paper overall made the treatment obvious to try with a reasonable expectation of success. Significantly, the Court of Appeal rejected the argument that the expectation of success should be higher in the case of claims that include a therapeutic effect as part of their technical subject matter, such as second medical use claims. The Court held that there should not be a special standard applied in such cases and that there was already flexibility built into the obviousness test which allowed all the relevant circumstances to be taken into account. The developing case law from cases such as Hospira v Genentech, coupled with case law regarding routine clinical trials, such as the Court of Appeal’s decision in Actavis & Others v ICOS Corp & Others  EWCA Civ 1671, which held that the clinical trials leading to the claimed dosage regimen invention would be carried out as a matter of routine, raises questions about the longer-term role of patent incentives in encouraging the conduct of clinical trials.
It is common practice in many jurisdictions for a non-domiciled patentee to put in place an exclusive licence with a local entity before the litigation is commenced. All too easily overlooked, formalities can have a dampening effect on whether a party is able to enforce their patent rights, or recover damages in full. In Illumina Inc v Premaitha, the defendants made challenges to the validity of the exclusive licences in place between the patent proprietor, Sequenom and the licensee, Illumina. The key point considered related to how the licence handled affiliates. In his judgment, Mr Justice Carr considered the requirements of section 130 of the Patents Act 1977 in relation to being an “exclusive licensee”. He found that the wording used in the relevant licence agreement, “Sequenom … hereby grants to Illumina and its Affiliates an exclusive … licence”, enabled Illumina’s affiliates to operate the licence in their own right, without needing authorisation from Illumina. It did not matter that Illumina controlled all its affiliates because the licence was still relevant to a number of persons and did not comply with the requirement for an exclusive licence to be “to the exclusion of all other persons (including the proprietor or applicant)”. The decision did not affect standing to sue (as the proprietor was a party to the action) but it was argued that it could be of relevance to the level of damages available. Licensing structures are always complex for life sciences companies, and this case highlights the need to consider the specific requirements of patent law in the jurisdiction of litigation, in addition to all the commercial circumstances.
English case law continues to shape how life sciences companies should decide their product and patent strategy – from product development to licensing and commercial agreements, from designing clinical trials to patent prosecution. Legal advisers need to be alert to the wider implications for later, often unanticipated patent litigation.