At the UK High Court, administering judge Richard Meade has actually discovered 2 NuCana patents void for included matter, and for an absence of commercial applicability and plausibility. EP (UK) 2 955 190 B1 and EP (UK) 3 904 365 B1 are from the very same family and are really comparable, regardless of EP 365’s claims being rather narrower. The judgment marks a win for Gilead, specifically combined with a recent EPO choice likewise revoking EP 190.
NuCana had actually counterclaimed for violation, which the judgment notes would have been promoted, had the court discovered the patents legitimate. Although EP 190 initially covers a drug compound for dealing with cancer, NuCana does not utilize the patent for HCV treatment, nor does it market any pharmaceuticals in the location of cancer treatment.
However, the patents cover sofosbuvir, which is a main component in medication utilized to treat liver disease C. As such, Gilead markets numerous drugs to cover the latter wider indicator, including its anti-viral Sovaldi, Harvoni, Vosevi and Epclusa items.
Gilead sees success
In the most recent UK procedures, which started in February 2021, the court revoked both patents. NuCana had actually used to modify some claims covered by EP 190, specified by the so-called Markush formula. This formula covers main component sofosbuvir. However, Gilead assaulted the patents on numerous premises, consisting of included matter, declaring that the initial application does not ‘clearly and unambiguously’ divulge the Markush meanings in the patent claims.
The business likewise argued for invalidity based upon commercial application, and absence of plausibility, consisting of deficiency and obviousness over the ‘Shepard’ previous art (United States 2003/0109697). It likewise argued that NuCana’s proposed modifications to EP 190 were not allowed.
The EPO just approved EP 365 in September 2022, suggesting it is presently still in the opposition duration. Regarding EP 190, the EPO’s Technical Board of Appeal heard an opposition case simply 2 days after the High Court hearing. The EPO likewise withdrawed the patent on the basis of innovative action and included matter.
Judge thinks about plausibility
Furthermore, the judgment referrals the then-pending G 2/21 EPO choice on plausibility. On 24 March, the EPO’s Enlarged Board of Appeal validated its recognized case law needing that, in order for the inspectors to represent information sent after submitting a patent, it needs to be possible from the application as submitted, in mix with typical basic understanding, that the technical result was already attained at the date on which the patent was submitted.
Given that the EPO had actually not yet launched its choice prior to the Gilead vs. NuCana judgment, Meade acknowledged he was bound by previous nationwide case law coming from Warner-Lambert vs. Actavis (case ID: [2018] UKSC 56]. However, the judge did reference the possibility that the pending EPO G 2/21 choice might affect nationwide case law while acknowledging its significance for future plausibility cases.
EPO and Germany weigh in
In 2021, Gilead had actually challenged EP 190 prior to the EPO Opposition Division, although it later on turned down Gilead’s arguments to maintain the patent in changed form.
Patrick Kelleher
While EP 190 remained in opposition, Gilead started cancellation procedures in the UK. NuCana likewise took legal action against Gilead for violation at the Regional Court Düsseldorf.
In July 2022, the court validated that Gilead infringed EP 190, while likewise turning down Gilead’s ask for a stay pending the EPO appeal and the action concerning the ask for a mandatory licence (case ID: 4c O 18/21). Gilead had actually submitted these demands a couple of weeks prior to the hearing in Düsseldorf.
In credibility procedures, the Regional Court Düsseldorf backed the Opposition Division’s choice to maintain EP 190. Interestingly, Gilead likewise presented a disproportionality defence, which the court turned down in its whole, leading to an injunction.
According to JUVE Patent sources, it was among the very first cases in Germany to completely take a look at the brand-new disproportionality defence, as set out under § 139 I stipulation 3 of the German Patent Act. However, considered that the EPO has actually withdrawed EP 190, procedures in Germany worrying the patent will concern an end.
Market leaders, head-to-head
In UK procedures, the London workplace of worldwide company Bird & Bird acts for Gilead, with partners Patrick Kelleher and Jennifer Jones leading the group. The representation extends cross-border, with the company likewise standing for the worldwide pharmaceutical business. Here, Oliver Jan Jüngst and Michael Alt lead the group.
Penny Gilbert
European patent lawyer company J A Kemp led EPO opposition procedures for Gilead, with partner Chris Milton taking charge.
London-based IP shop Powell Gilbert represents NuCana, led by partner Penny Gilbert. She has an outstanding market credibility for pharmaceutical cases. In Germany, blended IP company Hoffmann Eitle stands for the business, with partners Niels Hölder and Thorsten Bausch taking the lead.
NuCana is a fairly brand-new customer for the German company, this being the very first direction for its partners. The company’s patent lawyers likewise led procedures for NuCana in the EPO invalidity procedures.
For Gilead
8 New Square (London): Michael Tappin, Tom Moody-Stuart, James Whyte
Bird & Bird (London): Patrick Kelleher, Jennifer Jones (partners); partners: Henry Elliott, Ning-Ning Li, Patrick Brown, Josh Price
For NuCana
11 South Square (London): Piers Acland
Three New Square (London): Tom Mitcheson
One Essex Court (London): Andrew Lomas
Powell Gilbert (London): Penny Gilbert, Joel Coles, Bethan Hopewell (all partners); partner: Daniel Down
UK High Court of England and Wales, London
Richard Meade (administering judge)
