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 - 07 June 2024 - is below:

CJEU - STOP PRESS

AG Opinion delivered on Art. 3(a) and 3(c) of the SPC Regulation in Joined Cases C-119/22 and C-149/22.

On 6 June 2024, Advocate General Emiliou delivered an Opinion on the conditions for granting SPCs for medicinal products in response to a requests from the Market Court, Finland (Teva v Merck Sharp & Dohme) and the Supreme Court, Ireland (Merck Sharp & Dohme v Clonmel Healthcare). The joined cases involve SPCs granted for combinations of active ingredients in medicinal products where a previous SPC has been granted for one of those ingredients. The Opinion addresses the interpretation of Art. 3 of Regulation (EC) No 469/2009, which sets out the conditions for obtaining an SPC, including that the product be "protected by a basic patent in force" (Art. 3(a)) and that it "has not already been the subject of a certificate" (Art. 3(c)).

In brief summary, the Advocate General has suggested abandoning the teleological approach to Art. 3(c) as laid down in Actavis I and Actavis II and adopting a literal approach to that provision. In relation to Art. 3(a), the Advocate General has provided his own interpretation of the criteria laid down in Teva v Gilead, suggesting that, in relation to SPCs for combination products, it is not enough that the combination is expressly mentioned in the claims of the basic patent in suit. To satisfy Art. 3(a), the combination must also be part of the invention of the basic patent as determined by reading the claims in light of the teaching of the specification.

A full report will follow next week. The Opinion can be accessed here.

CA

Proposed amendments to the Patent Rules to implement patent term adjustment.

Proposed amendments to the Patent Rules (SOR / 2019-251) were published in the Canada Gazette for consultation on the implementation of patent term adjustment by January 2025. This follows the entry into force of the Canada-United States-Mexico Agreement (CUSMA) on 1 July 2020, according to which the parties agreed to provide an additional term to compensate patent owners for unreasonable delays in the issuance of patents.

Amendments to the Patent Act to provide a framework for an additional term received royal asset in June 2023. According to the amended Patent Act, subject to certain conditions, an additional term for a patent may be granted if the patent was issued more than 5 years from a date to be defined in the Patent Rules for divisional applications and national phase entry applications, and the filing date of the application in any other case, and 3 years from the date of the request for examination (whichever is later). In Canada, the substantive examination of a patent application only occurs when requested by an applicant. For most applications, examination must be requested within 4 years from filing of the patent application.

The proposed changes to the Patent Rules would support the additional term framework in the amended Patent Act. These include:

• The additional term determination process to be followed by the Commissioner: an initial assessment of eligibility, a preliminary determination of the duration of any additional term, a 2 month observation period for receiving submissions from the patentee and third parties and a final determination, and a final determination of the additional term.
• Specification of the number of days to be subtracted in determining the duration of an additional term, including days when the patent applicant must take an action or pay a fee and days in periods initiated by the patent applicant, such as requesting continued examination after certain events occur during patent examination.
• A mechanism for the reconsideration of additional term determinations.
• Fees for an application for an additional term and for an application for reconsideration of an additional term ($2500 as standard and $1000 for small entities).
• Fees for maintenance of patents and applications for the 20th and subsequent anniversaries of the patent filing date ($1000 as standard and $400 for small entities).

The first patents eligible to benefit from patent term adjustments according to the proposed Patent Rules would be those granted on or after 2 December 2025. The Canadian Intellectual Property Office estimates that there will be approximately 1100 applications for additional term over the next 10 years.

The consultation is open until 3 July 2024.

WIPO

WIPO member states adopt new Treaty on Intellectual Property, Genetic Resources, and Traditional Knowledge.

WIPO member states have approved a new Treaty at a Diplomatic Conference held from 13 to 24 May 2024 in Geneva. The Treaty addresses the intersection of IP, genetic resources and associated traditional knowledge.

In summary, if a claimed invention in a patent application is based on "genetic resources", applicants shall be required to disclose the country of origin or source of the genetic resources. "Genetic resources" are defined as genetic material (any material of plant, animal, microbial or other origin containing functional units of heredity) with actual or potential value.

If the claimed invention is based on traditional knowledge associated with the genetic resources, applicants will be required to disclose the Indigenous Peoples or local community who provided the traditional knowledge.

The Treaty does not have retroactive effect so, without prejudice to existing national laws on disclosure, contracting parties may not impose obligations in relation to patent applications filed prior to the Treaty entering into force.

UPC

The UPC turns 1!

Saturday 1 June marked the first anniversary of the opening of the Unified Patent Court.

The Court can also celebrate the addition of a new Contracting Member State. Romania deposited its instrument of ratification of the UPC Agreement on 31 May 2024. In accordance with Art. 89(2), it will become the 18th Contracting Member State on 1 September 2024.

During the past year, the Court has seen 134 infringement actions and 35 revocation actions filed, with the majority of cases filed in German divisions. Despite German starting out as the dominant language, 50% of all cases before the UPC are now being conducted in English.

UPC

Court of Appeal denies a stay pending opposition proceedings.

On 28 May 2024, the UPC Court of Appeal upheld a decision of the Paris Central Division in Carrier v BITZER not to stay revocation proceedings before the UPC pending parallel opposition proceedings before the EPO concerning the same patent. In line with previous Court of Appeal decisions, this non-technical appeal was adjudicated by a panel of three legally qualified judges without technically qualified judges.

The Appellant, Carrier Corporation (Carrier), had lodged a request pursuant to r. 295(a) of the Rules of Procedure seeking a stay of the UPC revocation proceedings pending the outcome of opposition proceedings before the EPO. Shortly prior to their request to stay the UPC proceedings, Carrier requested acceleration of the EPO opposition proceedings.

R. 295(a) states that "[t]he Court may stay proceedings where it is seized of an action relating to a patent which is also the subject of opposition proceedings or limitation proceedings (including subsequent appeal proceedings) before the European Patent Office or a national authority where a decision in such proceedings may be expected to be given rapidly". When there are accelerated proceedings before the EPO, r. 298 states that "[t]he Court may stay its proceedings in accordance with Rule 295(a) pending the outcome of such request and any subsequent accelerated proceedings".

In their appeal, Carrier argued that "rapidly" in r. 295(a) should denote relatively quick proceedings compared to either the typical pace of opposition proceedings or the expected pace of the UPC proceedings, or both. However, the Court of Appeal determined that, as a general principle, the Court will not stay proceedings. The mere fact that revocation proceedings before the UPC relate to a patent which is also the subject of opposition proceedings before the EPO is not sufficient to allow an exception to this principle.

The Court also stated that decisions in which the UPC and EPO reach different conclusions on the revocation of a European patent are not irreconcilable. The latter decision will prevail, having taken the earlier decision into account, including whether an appeal against a revocation is still possible. The term "rapidly" in r. 295(a) is to be interpreted in light of this principle.

The term "may" in r. 295(a) means that the Court has a discretionary power to stay the proceedings when a rapid decision may be expected from the EPO, which will depend on the balancing of the interests of the parties. Acceleration is relevant to this assessment, but the mere fact that the EPO has granted a request to accelerate opposition proceedings is not sufficient to stay revocation proceedings before the UPC.

In this case, despite the acceleration of EPO opposition proceedings, the fact that the scheduled date for oral proceedings at the EPO was over four months after the scheduled date for the oral hearing in the UPC revocation proceedings led to the Court finding that no rapid decision from the EPO was expected, and no stay was granted.

UPC - STOP PRESS

Hamburg Local Division rejects PI.

On 3 June 2024, the Hamburg Local Division rejected a PI request from Dutch company Ballinno based on its patent to a "method and system for detecting an offside situation". The PI request was filed on the basis of alleged patent infringement by UEFA and Kinexon relating to the use of a microchip that will feature in the Adidas match balls for Euro 2024.

We will provide a further update when the written decision is published.