Irides: Weekly patent litigation update

The Irides Weekly Update is our round-up of patent litigation news highlights from around the world. Taking its name from the plural of “iris” - a nod to the ability of Irides to see what’s happening around the world.

Our latest edition - 23 February 2024 - is below:

UK

Court of Appeal upholds Patents Court decision on the meaning of “product” in the context of art. 3(b) of the SPC Regulation

As flagged in a “Stop Press” in last week’s Irides, the English Court of Appeal on 15 February 2024 handed down its decision in Newron Pharmaceuticals S.p.A. v The Comptroller General of Patents, Trademarks and Designs [2024] EWCA Civ 128. Birss LJ wrote the lead judgment, with which Moylan LJ and Lewison LJ agreed.

The appeal related to a treatment for Parkinson’s disease using safinamide (sold under the brand name Xadago). At first instance, the UKIPO hearing officer had noted that Newron’s patent claimed the use of “safinamide… in combination with levodopa/PDI” whereas the marketing authorisation was for safinamide alone. Although the summary of product characteristics (SmPC) at annex 1 to the marketing authorisation decision states that Xadago is indicated as an add-on therapy to levodopa and includes further references to levodopa and to PDIs, this did not change the fact that the medicinal product authorised was safinamide as a 50 mg tablet, not a combination. As the product in the patent and the marketing authorisation were different, a supplementary protection certificate (SPC) could not be granted under art. 3(b) of the SPC Regulation. This decision was upheld by Recorder Douglas Campbell KC, sitting as a Deputy Judge in the Patents Court.

On appeal, Newron referred to the opinion of AG Trstenjak in Medeva v Comptroller, which stated that a “broad or teleological approach to the definition of product and to the effect of art. 3(b) should be taken in order to achieve the purposes of the SPC Regulation”. The CJEU reached the same conclusion and its reasoning was essentially the same as that of the AG. However, the Court of Appeal held that Medeva had not altered the law as set out in the CJEU cases up to Santen. The strict approach in Santen, which rejected a Neurim-style teleological approach and held that the definition of “product” in the SPC Regulation is not dependent on the manner in which that product is used, is the correct one to use when examining what the “product” is for the purpose of the SPC Regulation. Even though the only therapeutic indication mentioned in the SmPC for Xadago-safinamide was as an add-on for therapy with levodopa, levodopa was an aspect of how the product safinamide was to be used, not an active ingredient in the medicinal product authorised by the marketing authorisation. 

The court also agreed with the submission from the Comptroller that the SPC scheme is meant to be relatively simple to administer by a patent office, and it should not require “minute analysis” of the annexes to a marketing authorisation to answer the relevant question. 

The Court therefore dismissed the Newron’s appeal and did not order the grant of the SPC.

CANADA

Federal Court of Appeal considers whether a sale is accompanied by an unrestricted implied licence to use

The Federal Court of Appeal recently handed down two decisions in the action of Pharmascience Inc. v Janssen Inc. and Janssen Pharmaceutical N.V. The first addresses the extent to which purchasing an article grants an implied right to use it without limitations. The second deals with the validity of the patent, taking into account unpatentable methods of medical treatment. Decisions here and here. 

The proceedings concern Janssen’s patent relating to its INVEGA SUSTENA product, a paliperidone palmitate suspension for the treatment of schizophrenia. The patent teaches a dosing regimen involving initial loading doses followed by monthly maintenance doses, with variations for renally impaired patients. Janssen sought a declaration that Pharmascience’s generic product would infringe the patent, which Pharmascience defended on the basis that the claims were invalid because, inter alia, they compromised unpatentable subject matter as methods of medical treatment. 

Implied licence

Pharmascience had sought a summary trial or, alternatively, dismissal of Janssen's infringement claim on the basis that its product did not provide one of the doses (75 mg-eq.) that was an essential feature of all of the claims. In the context of the summary trial, the Federal Court agreed with Janssen and determined that Pharmascience would induce infringement of the patent with its generic product based on its application of the three-stage test for inducement in Corlac v Weatherford Canada, 2011 FCA 228, which requires: (i) direct infringement by a third party; (ii) the inducer influencing the third party to the point that the infringing act would not have occurred without the influence; and (iii) the inducer knowing that its influence would bring about the infringing act. 

On appeal, Pharmascience took issue with the Federal Court’s application of the first prong of the test, arguing that there was no direct infringement resulting from the use of its generic product if the 75 mg-eq. dose was sourced from Janssen. Specifically, Pharmascience argued that sale of the 75 mg-eq. dosage form by Janssen included an implied licence to use that dose in any way the prescribing physician chose, including use according to the patented dosage regimen with other doses obtained from an unlicensed source like Pharmascience. In making this argument, Pharmascience relied on the Supreme Court decision in Eli Lilly & Co. v. Novopharm Ltd., [1998] 2 S.C.R. 129, 161 DLR (4th) 1, which established that the sale of a patented article without restriction includes the right to use that article as the purchaser pleases. 

However, the Court of Appeal rejected this argument. In this case, the 75 mg-eq. dose sold by Janssen was not the whole patented article but merely a component of the patented invention, and previous case law relating to combination inventions had established that the sale of a single component was insufficient to grant the implied right to use an entire combination. Further, there was no reason to conclude that either Janssen or its customers would have understood that the purchase of paliperidone palmitate in a single dose from Janssen would include an implied licence to practise the entirety of the patented dosage regimen in combination with other doses obtained from unlicensed sources. The appeal on this point was therefore dismissed.

Methods of medical treatment

The Supreme Court decisions in Tennessee Eastman v Commissioner of Patents [1974] S.C.R. 111, 33 D.L.R. (3d) 459, Shell Oil v Commissioner of Patents [1982] 2 S.C.R. 536, 142 D.L.R. (3d) 117 and Apotex v Wellcome [2002] 4 S.C.R. 153 establish that a method of medical treatment is not patentable because it does not fall within the definition of “invention” as contemplated in the Canadian Patent Act. In particular, a method of medical treatment does not relate to trade, industry or commerce and concerns non-economic professional skills. 

At first instance, Pharmascience had argued that the dosage range for the maintenance dose (from 25 to 150 mg-eq. according to the product monograph for INVEGA SUSTENNA) indicates that no particular dose will work for every patient and a claimed dosage regimen that does not work for all patients constitutes an unpatentable method of medical treatment since it requires skill and judgment from the prescriber. However, the Federal Court rejected Pharmascience’s argument, noting that professional skill and judgment was not required to practise the relevant claims: a physician could choose whether to prescribe the claimed dosage regimen or not, but no skill or judgment was involved in implementing it. 

On appeal, the Court of Appeal considered the jurisprudence of the lower courts, which has evolved to focus on whether the invention comprises a "vendible product”, distinguishable from the skilled work of a physician and hence outside the realm of methods of medical treatment. Much of the case law had also focused on whether claimed dosage regimens were fixed or variable. However, the Court of Appeal noted that the assessment of whether a claimed dosage regimen relates to a method of medical treatment cannot be based exclusively on whether its dosing and schedule is fixed or not. The proper question is whether use of the invention requires the exercise of professional skill and judgment; the burden remains on the party challenging the patent and the assessment will generally turn on the particulars of the case and the evidence on the record.

The Court of Appeal saw no reason to interfere with the Federal Court’s assessment that certain flexibilities in the claimed dosing regimens, such as the injection site or precise timing windows (for example intervals of “± X days”) did not have clinical implications and did not inherently interfere with a physician’s exercise of skill and judgment. A single sentence referring to the possibility of titration up or down in view of a patient’s condition within the broader context of the patent was also not enough to turn the claims into method of treatment claims.

The Court of Appeal therefore upheld the decisions of the Federal Court and held Janssen’s patent to be valid and that Pharmascience had induced direct infringement of the patent.

EUROPE

Draft SPC Regulations approved by Parliament’s JURI Committee

Following our update in April 2023, in which we discussed the European Commission’s publication of its long-awaited proposed reforms of the existing legal regime governing supplementary protection certificates (SPCs), the amendments to the four draft SPC regulations have been approved by the European Parliament’s JURI Committee. Of note is the proposed introduction of both a unitary SPC (to complement the unitary patent) and a centralised examination procedure for SPCs (implemented by the EUIPO in close cooperation with national patent offices). According to the current draft, a centralised application can be filed in any official EU language and will be examined by one member of the EUIPO and two examiners from the national patent offices. The amendments will now proceed to be read before the European Parliament on 26 February 2024, whilst the EU Council continues its review in parallel.  The approved amendments can be found here, here, here and here.

EPO 

Amended EPC Guidelines released

The EPO has released a preview of the newly revised EPC Guidelines, which enters into force on 1 March 2024. Key changes reflect recent decisions by the Enlarged Board of Appeal (EBA), as well as practical adjustments in relation to patent applications and the Unified Patent Court (UPC).

The proposed amendments provide clarity on priority claims. Following G 1/22 and G 2/22, a presumption of entitlement to priority now exists where priority is claimed under at. 88(1) EPC. The examining division, opponent or third party challenging entitlement to priority will now have the burden of proving otherwise.

In relation to AI, the Guidelines stress the need for detailed disclosure of AI inventions, including mathematical models and training datasets, and confirm that the EPO will check whether the designated inventor is a natural person, reflecting the outcome of the decision in J 8/20 (DABUS).

More information on the amended Guidelines can be found here.