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 - 8 December 2023 - is below:

UK

UKIPO temporarily removes examination guidelines on AI Inventions

Following the recent decision on 21 November 2023 in Emotional Perception AI v Comptroller General of Patents [2023] EWHC 2948 (Ch) reported previously here, the UKIPO has made a decision to temporarily remove examination guidelines on AI inventions.

EPO

Technical Board of Appeal (TBA) rules on availability of prior art which is not catalogued

Technical Board of Appeal (TBA) rules on availability of prior art which is not catalogued. By decision dated 4 October 2023, the board in T 0364/20  considered a patent application of a Finnish company, Neste Oyj (respondent), which was opposed by another Finnish company, UPM-Kymmene (appellant).  The appellant sought to rely on a university Master’s thesis (D4), which had been submitted before the priority date of the patent but only catalogued in the university library after the priority date.

In decision T 314/99 (relied upon by the respondent) where a thesis was submitted to a German university before the priority date of the patent in that case, but not catalogued until after, the TBA concluded that the document: "did not by its mere arrival in the archive become publicly available, since that did not mean it was as of that point in time catalogued or otherwise prepared for the public to acquire knowledge of it, and because without such means of information the public would remain unaware of its existence".

The instant decision diverges from this precedent apparently in view of the Finnish constitutional provision that: "[d]ocuments and recordings in the possession of the authorities are public, unless their publication has for compelling reasons been specifically restricted by an Act”.  In this case, the TBA concluded:  “Master’s theses such as D4 are documents in the possession of universities.  Thus, they must be public unless an act restricts their publication.  There is no evidence that the publication of D4 was restricted.”

The TBA justified the divergence from T 314/99 by noting that D4 was deemed to be public by virtue of Finnish law and no similar legal provision  is mentioned in T 314/99.  The TBA accordingly considered the matter related to a case-specific question, not a fundamental point of law, and refused permission to appeal to the Enlarged Board of Appeal.

The same case also considered admissibility of auxiliary requests filed “after expiry of the time limit set under Rule 79(1) EPC and before expiry of the time limit set under Rule 116(1) EPC”.  The TBA considered that these requests were not automatically admissible, but it was reasonable in the circumstances of this case to admit the auxiliary requests.

CANADA

FCA dismisses appeal, patent not listable against STELARA SNDS

On 21 November 2023, the Federal Court of Appeal dismissed an application by Janssen Inc. (Janssen) to the Office of Submissions and Intellectual Property (OSIP) who had refused to accept a patent list for a Supplemental New Drug Submission (SNDS). Decision here. 

By way of background, Janssen submitted two requests for approval to OSIP regarding its drug, STELARA: one in 2019 for a new use in ulcerative colitis and another in 2020 for updated safety data. OSIP denied listing one of the requested patents, CA 3,113,837 (837) on the Patent Register for both submissions. Janssen applied to the Federal Court for a judicial review of the OSIP’s decision.  At first instance, the court upheld OSIP's decision, stating that the 837 patent wasn't filed until after the 2019 submission and lacked specificity for the 2020 submission. In relation to a further patent, the OSIP's rejection of the submission's "change in use" claim was deemed reasonable, as it focused on the approved use with no time based limitation. The court also supported OSIP's decision on product specificity and patent list requirements. The Canadian filing date requirement for patent listing was considered reasonable to ensure timely market entry of generic drugs. Consequently, the court dismissed Janssen's application.  OSIP had also refused to accept the patent list for the first submission, citing non-compliance with the 30-day submission period from the issuance of the 837 Patent, as specified in subsection 4(6) of the Regulations. Janssen’s judicial review was dismissed by the Federal Court.

Janssen appealed to the Federal Court of Appeal, before which the primary issue was whether OSIP's refusal to accept the patent list was reasonable.  OSIP argued that the patent list did not meet the requirements of subsection 4(4) of the Regulations as it did not identify the submission. OSIP rejected Janssen's claims that the subsequent submission could alter the nature of the initial patent list. The Court of Appeal agreed with OSIP's reasoning, emphasising that the 30-day deadline for submission had lapsed.

The Court of Appeal also rejected Janssen's interpretation of subsection 4(7) of the Regulations, stating that it does not permit the addition of a different SNDS to an existing patent list. The information on the initial patent list was up to date, and Janssen could not add a different SNDS under the guise of updating.

The court found no reviewable error in the Federal Court's conclusion that OSIP's refusal was reasonable. Consequently, the appeal was dismissed with costs.

BRAZIL

Food and Drug Agency passes new regulations approving skinny labelling

The Brazilian Food and Drug Agency (ANVISA) has passed new regulations amending Article 14 of Collegiate Board Resolution No. 47/2009 (Rule No. 47/2009). This amendment includes an exception to allow generics and biosimilars to carve-out patented uses from their labels.

Skinny labelling was not previously permitted under the Brazilian Federal legislation, which set out that generics or biosimilars must have the same therapeutic indication as the reference drug. The proposed amendment states that “the package leaflets of generic and similar medicines may differ from their respective Standard Package Leaflets with respect to patented therapeutic indications or indications claimed in published patent applications”.

This amendment was subject to a public consultation, which closed in April 2023. It was subsequently approved by ANVISA during the voting session on 6 December 2023. The amendment will come into force 60 days after the amended text of Rule No. 47/2009 is published in the Federal Register.