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 - 19 January 2024 - is below:

CANADA

Federal Court Upholds PMPRB decision on clinical similarities

On 11 January 2024, the Canadian Federal Court (FC) upheld a decision of the Patented Medicine Prices Review Board (PMPRB) which ruled that a patent could cover a medicine based on “clinical similarities” to the claimed invention. This was held to apply even if the patent does not actually specify the medicine itself. The effect of the PMPRB decision is that Galderma must file sales data and financial information to safeguard against excessive pricing.

The decision was in relation to Canadian Patent 2,478,237 (the 237 Patent) which covered use of the drug adapalene for the treatment of dermatological disorders such as acne. The patent was held by Galderma Canada Inc (Galderma), which marketed two products containing adapalene in varying amounts (marketed as Differin® (containing 0.1% adapalene) and Differin XP™ (containing 0.3% adapalene)). 

The patent for Differin® expired in 2009, while the 237 Patent, covering Differin XP™, lapsed in 2016. The PMPRB decided that the 237 Patent was capable of being “used for” Differin® according to s.79(2) of the Canadian Patent Act, and therefore Galderma should provide pricing information for this product.

Galderma had previously appealed the PMPRB’s decision and was successful in 2019. However, the decision was referred back to the PMPRB for redetermination and the PMPRB again concluded that the 237 Patent pertained to the lower concentration product (Differin®). Galderma again sought judicial review of the PMPRB’s decision, arguing that the PMPRB had been unreasonable in coming to its decision. The review was the subject of this FC decision, with file number T-906-20, neutral citation 2024 FC 46.

In its review decision, the FC held that the PMPRB’s conclusion that the two products were the same medicine, albeit in different concentrations, was reasonable. Galderma’s argument that the PMPRB had failed to assess whether the 237 Patent conferred an ongoing market benefit on the lower strength Differin® product was not accepted by the FC, and it said (at paragraph 58) that “it is clear from the jurisprudence that the mere existence of a patent that pertains to a medicine gives rise to a presumption of market power due to distortion of the competitive process.” 

There had been no evidence of market distortion before the PMPRB and in its decision, the PMPRB stated that “the fundamental question to consider was whether the invention is intended or capable of being used for the medicine, not whether there is the merest slender thread of a connection.” (see [57(a)] of the FC judgment). The PMPRB went on to say that there was no need for PMPRB staff to demonstrate actual market distortion (as well as there being no opportunity for a patentee to prove the contrary). There is a presumption that the mere existence of a patent would distort the marketplace by dissuading competitors from entering the market. Finally, the PMPRB said that  “a finding that, on its face, the patent is intended or capable of being used for the off-patent medicine is sufficient to establish the Board’s jurisdiction” and that the PMPRB did not need to go beyond the face of a patent in order to construe its use claims. The FC agreed with these points, and rejected Galderma’s argument of unreasonableness. 

At paragraph 62 of its decision, the FC said that both products produced similar clinical effects, the difference between these being the magnitude and speed of said effect depending on the concentration of adapalene. While the two medicines were not considered to be interchangeable, the indications that they were prescribed for were similar (in some cases they could in fact be substituted for each other).

The FC noted that the PMPRB had “found significant clinical similarities between Differin XP and Differin, and reasonably concluded that the invention of the 237 Patent pertained to, or could be used for, Differin”. As the FC agreed with the PMPRB’s decision, Galderma’s application was dismissed.

 JAPAN

Bristol-Myers Squibb granted preliminary injunction against Sawai Pharmaceutical shortly after generic  approval

On 28 November 2023, the Tokyo District Court issued a preliminary injunction against Sawai Pharmaceutical restricting producing and selling a generic version of Bristol-Myers Squibb’s (BMS) cancer drug, Sprycel® (dasatinib). 

By way of background, the patent in suit covers the dasatinib compound and had been granted an extension of protection until January 2024 based on the authorization of Sprycel® for treating chronic myelogenous leukemia, excluding cases resistant to imatinib.  In February 2022, Sawai Pharmaceutical (Sawai) were granted a marketing authorisation for dasatinib for the treatment of acute lymphatic leukemia, and applied for an authorisation for chronic myelogenous leukemia. BMS applied for a preliminary injunction against Sawai in July 2023. Japan has a patent linkage system, not prescribed by statute but nevertheless applied by the Ministry of Health, Labour and Welfare (MHLW), which assesses products for approval and should reject approval applications if the active ingredient is covered by a patent in force. In this case, contrary to the expectations of the parties, the MHLW approved Sawai's product for chronic myelogenous leukemia in October 2023.  Given the PI application had already been made, the court went on to examine the issue, notwithstanding the MHLW assessment. 

Pursuant to art. 68-2 of the Japanese Patent Act, the scope of a patent extension is limited to the identical product, including the same specific application, as the original approved product that warranted the patent term extension.  In this instance, BMS’s product contains "dasatinib hydrate", whereas "dasatinib anhydrate" is the API in Sawai's Product. The court concluded that for an extended patent relating to a pharmaceutical ingredient, even if there are minor differences in ingredients, quantity, dosage, or administration compared to the approved original product, the patent's protection may cover the new product if the differences are minor or merely formal and the new product is essentially identical to the original approved product. The court did not provide full details for its rationale, but it appears to have considered dasatinib "hydrate" and dasatinib "anhydrate" to be essentially equivalent. The court therefore granted the injunction to BMS.

CHINA

CNIPA announces the transitional measures regarding the newly-revised Implementing Regulations and releases revised Guidelines on Patent Examination

On 21 December 2023, after a two year deliberation period, the China National Intellectual Property Administration (CNIPA) published the finalised version of the revised Rules for the Implementation of the Patent Law, as well as the revised Guidelines for Patent Examination.  

The new rules and the guidelines on examination include prominent changes that will have an effect on both patent applications and the enforcement of patents. The changes that will come into effect are multi-faceted and include the following changes:

• The CNIPA will issue official notices in electronic form, and the issue date will be deemed as the date of receipt for any patent applications which are filed through the online system of CNIPA; 
• If an invention patent is granted more than 4 years from the application date and 3 years from the issue date of the Notification of Entering Substantive Examination Proceedings, the patentee can file a request for patent term compensation within 3 months from the grant announcement date of the patent; 
• The patentee, interested parties or any alleged infringers may request the CNIPA to issue a patent evaluation report after the grant announcement date of a utility model or design patent and the CNIPA must issue the report within 2 months of receiving the request. 

These changes will become effective on 20 January 2024.