Key recent developments in the United Kingdom and Europe relating to patents and the pharmaceutical sector
The CJEU has provided its preliminary ruling in Teva v Gilead on the meaning of Article 3(a) in the context of a medicinal product composed of several active ingredients. It has also clarified principles of IP rights exhaustion applicable to parallel importation of medicinal products from “new” Member States that acceded to the EU after 2003. Closer to home, English courts have handed down some interesting decisions around claim construction, confidentiality clubs and delays in raising new arguments. Finally, as the UK moves closer to the March 2019 Brexit deadline, questions remain as to whether the Unified Patent Court will be set up in time for the UK to participate in the Unitary Patent system. The UK Government has made some progress in setting out its approach to various IP issues in the event of a “no-deal” Brexit by recently publishing several technical notes.
CJEU sets out new test in Teva v Gilead Art 3(a) SPC reference
The CJEU has not adopted the test proposed in Advocate General Wathelet’s opinion in Teva v Gilead. Instead it has ruled that a product composed of several active ingredients is ‘protected by a basic patent in force’ if the patent claims relate necessarily and specifically to that combination, even if it is not expressly mentioned in the claims of the patent. This means, from the point of view of a skilled person at the priority date of the patent, the combination of the active ingredients must necessarily fall under the invention covered by the basic patent, with each of those active ingredients being specifically identifiable in light of all the information disclosed by the patent.
CJEU clarifies law applicable to parallel trade of medicinal products from “new” EU Member States
In interpreting the Specific Mechanism, the CJEU clarified in Pfizer v Orifarm that the correct date for comparing patent protection regimes between the EU Members States and “new” Member States was the date at which patent protection was originally sought in the EU. Therefore, Pfizer was able to enforce its SPC in Germany against parallel imports from the “new” Member States because there was no equivalent patent protection in the later states when Pfizer originally applied for its European patent designating Germany.
Are prior art references the blueprint to your claim construction?
Recent English court decisions have addressed claim construction taking into account prior art references in patent documents. In OCV v Jushi, the Court of Appeal held that a patent that compares certain parameters against a prior art example could not be construed as having claims that would include the prior art parameters. Interestingly, the English Patents Court in construing patent claims in Chugai v UCB under US law noted that prior art references could be used in construing claims only when they remained ambiguous after considering all other intrinsic and extrinsic evidence.
Other issues relevant to patent litigation
The English court has considered issues relating to confidentiality clubs and delays in raising new arguments. In TQ Delta v Zyxel Communcations, Carr J noted that although parties could agree to an “external eyes only” tier in confidentiality clubs, the court would generally be reluctant to grant such an order since it undermined the ability of a restricted party to fully understand the case against it and participate at trial. A series of decisions have seen the court assess whether a party may be permitted to adduce further evidence at a later stage of proceedings. The outcomes in these cases suggest that parties should be minded to plead their cases not just as clearly and sufficiently as possible, but also as soon as possible.
Bulgaria ratifies the UPCA Provisional Application Protocol but delays still in store for the UPC
In late July, Bulgaria ratified the UPCA Provisional Application Protocol, which enables the provisional application of the institutional, financial and administrative provisions of the UPC Agreement in order to undertake the preparatory steps towards the establishment of the UPC. However, in order for this Protocol to come into effect, five more countries (including Germany), which have or are ready to ratify the UPC Agreement still need to accept or ratify it. Since it is estimated that there needs to be a 6 – 8 month preparatory period once the Protocol is in force before the UPC can commence operations, it is increasingly looking unlikely that the UPC will be established before March 2019. However, in its recent round of “no-deal” technical notices, the UK Government has declared its intention to stay in the UPC and the Unitary Patent system post-Brexit.
The UK Government has recently published a series of “no-deal” technical notices that are relevant to IP rights and the pharmaceutical sector. These deal with issues that arise in the event there is no Brexit deal struck between the UK and the EU and span a wide range of topics including patents, SPCs, licensing, medical devices and clinical trials, the UPC/Unitary Patent, marketing authorisations and Horizon 2020 research funding.
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