27/04/2016
It is probably fair to say that patent thickets are not universally popular. A 2011 UK-government-sponsored report (the Hargreaves report) stated that patent thickets “obstruct entry to some markets and so impede innovation.” Nevertheless they are here to stay – in the words of Sir Robin Jacob, a former Lord Justice of Appeal of the Court of Appeal in England and Wales who specialised in intellectual property rights: “Every patentee of a major invention is likely to come up with improvements and alleged improvements to his invention. By the time his main patent has expired there will be a thicket of patents intended to extend his monopoly. Some will be good, others bad. It is in the nature of the patent system itself that this should happen and it has always happened.” However, a recent UK decision has highlighted a way of opening up patent thickets.
Traditional approaches to patent thickets
In the electronic and computer-related fields, standardisation is commonplace and there is often a straightforward route for any company seeking to work in the area of the patent thicket – they pay up and take a licence, which is normally available on FRAND terms.
If the licensing route is not available, then a company seeking to work in the area of the patent thicket may be forced to ‘hack’ its way through the overlapping IP rights of the thicket, obtaining court orders for revocation and/or declarations of non-infringement in turn for each patent of the thicket. This is time consuming and expensive and might not even lead to commercial certainty if the patent proprietor maintains pending divisional applications.
However, a recent court decision in the UK has highlighted another option, where a clever form of declaratory relief might open up a patent thicket for competitors, regardless of the number of patents or the presence of still-pending divisionals in the thicket.
Declaratory relief
In Fujifilm Kyowa Biologics v AbbVie Biotechnology [2016] EWHC 425 (Pat), AbbVie is the proprietor of a number of patents and applications relating to the antibody adalimumab. AbbVie market adalimumab under the trade name Humira and it is approved for use by administration of 40 mg adalimumab every other week as a single dose via subcutaneous injection. AbbVie also own a number of later-filed patent families which claim 40 mg adalimumab subcutaneously every other week, the families including a number of still-pending divisional applications undergoing examination at the EPO.
Fujifilm Kyowa Biologics (FKB) intends to market a biosimilar adalimumab product once AbbVie’s basic adalimumab patent and SPC expire in 2018. In an attempt to ‘clear the way’, FKB applied to revoke two of AbbVie’s granted European patents in the UK claiming the 40 mg subcutaneous administration every other week. However, shortly after proceedings were begun in the UK, AbbVie abandoned one of the granted European patents in proceedings at the EPO in favour of one of AbbVie’s still pending divisional applications.
FKB thought this abandonment was a deliberate move to delay the entry of competing Humira biosimilar products by prolonging commercial uncertainty. In particular, FKB claims that the purpose of abandoning the patent was to avoid adjudication on its patentability by the UK court and the EPO Opposition Division, while seeking to ensure that the subject matter of the method of administration was maintained by a divisional application, with the object of preventing FKB from clearing the way in respect of its biosimilar after expiration of the SPC for the basic adalimumab patent. FKB complains that it will be now many years before the EPO will be in a position finally to adjudicate on the patentability of the subject matter of the divisional.
FKB asked to amend its claim before the courts to seek an unusual form of declaratory relief – it has asked the court to declare that, at the priority dates of AbbVie’s later-filed patents, it was either known or obvious to administer 40 mg adalimumab biosimilar (i.e. the FKB product) subcutaneously every other week.
If granted, a declaration such as this would be helpful for FKB because AbbVie would be prevented from asserting any of their later-filed patents covering the FKB product in the UK under res judicata or issue estoppel, including any future patents granted on AbbVie’s pending divisionals.
AbbVie did not like the sound of this at all. AbbVie argued that such a declaration is essentially an assessment of the validity of AbbVie’s pending divisional applications and that the UK courts do not have jurisdiction to examine European patents before grant.
The court decided that the declaratory relief was possible in this situation because the decision as to whether or not the FKB product was known or obvious at the priority date only concerns the specifications of the FKB product and makes no reference to AbbVie’s divisionals. Furthermore, such a declaration would not rule out valid granted patents deriving from AbbVie’s pending divisional applications.
Now that the UK court has decided it has jurisdiction to make such declaratory relief, it will proceed to full trial where the court will assess the novelty and obviousness of the FKB product at the priority dates of AbbVie’s later-filed patents.
Regardless of the eventual decision in the case between FKB and AbbVie, this case has been an important reminder for companies seeking to compete in and alongside patent thickets that it might not be necessary to knock out each patent individually or wait for every single pending application in the family to proceed to grant before it can be revoked. In some cases, the right form of declaratory relief might bring down the whole thicket.
If your company is faced with a competitor’s patent thicket and wonder whether declaratory relief such as that sought by FKB here is appropriate in your particular situation, or would like to discuss other options for working with (or around) patent thickets, please contact us.
This article is for general information only. Its content is not a statement of the law on any subject and does not constitute advice. Please contact Reddie & Grose LLP for advice before taking any action in reliance on it.
