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Strict US written description requirement applied to CAR-T-cell therapy (Juno v Kite)

  • 29th April 2025
The decision in Juno v Kite is not a surprise in light of the recent CAFC case law on written description for antibodies, and represents yet another nail in the coffin of functional genus claiming for biomolecules in the US.

Beyond the process: Securing robust IP protection for cell therapies

  • 29th April 2025
Cell therapy represents one of the most exciting fields of innovation, with the potential to provide long-term cures for previously incurable diseases. However, unlike traditional pharmaceuticals, these “living medicines” present unique IP challenges that can make or break a biotech’s future.

Securing market protection for cell therapies: Patents versus regulatory exclusivity

  • 29th April 2025
Conventional approaches to LoE fail to capture the complex reality of cell therapy products. IP strategy for cell therapy needs to be adapted to take account of these realities.

Too broad, too early? AI platform for cell analysis found to lack technical character and sufficiency (T 0660/22, Cell analysis/NIKON)

  • 29th April 2025
This decision highlights some of the challenges associated with trying to broadly protect software-based platform technology for biological research.

No back-pedalling on prosecution disclaimers (Azurity v. Alkem, Fed. Cir. Case No. 23-1977)

  • 22nd April 2025
Originally posted on IPKat. In Azurity v. Alkem  the US Court of Appeals for the Federal Circuit (CAFC) affirmed the District of Delaware’s ruling that Alkem’s antibiotic formulation did not infringe patent claims owned by Azurity. The CAFC found that Azurity clearly and unmistakably disclaimed the presence of a key ingredient from the claimed formulation during prosecution. Given that Alkem’s formulation included…

Beware of boilerplate: Practical lessons for patent drafting from G1/24 (Claim interpretation)

  • 11th April 2025
Originally posted on IPKat. Following the high profile hearing last month, we are now waiting for the written decision of the Enlarged Board of Appeal (EBA) in G 1/24. Readers can catch-up on the full background to the case here. There is also still plenty to discuss while we wait.  G 1/24 relates to the question of…

Use versus process patents: Implications for novelty and scope (T 1913/21)

  • 9th April 2025
Originally posted on IPKat. The recent decision T 1913/21 highlights a crucial differentiation between second non-medical use claims and process claims. The Board of Appeal found that, according to the established case law, claims in which the technical effect of the invention occurs only as part of a process for producing a product, must be regarded as…

Excluding a technical feature is not inventive without evidence of a technical effect (T 1865/22)

  • 21st March 2025
Originally posted on IPKat. The recent Board of Appeal decision in T 1865/22 considered the inventive step of a composition where the only distinguishing feature was a lower concentration of a component compared to the closest prior art. The prior art taught that higher concentrations of this component were advantageous. The Board of Appeal found that simply excluding…

The UPC’s approach to added matter and functional claims (Abbott v. Sibio Technology, UPC_CoA_382/2024)

  • 13th March 2025
Originally posted on IPKat. The recent decision in Abbott v Sibio Technology (UPC_CoA_382/2024) offers valuable insights into the UPC’s approach to the interpretation of functional claim language and the ever-contentious topic of added matter. On both issues, the UPC broadly appears to have followed the EPO approach. However, the lack of any explicit indication from the Court of…

To infinity and beyond! The sufficiency requirements for open-ended ranges (T 1977/22)

  • 4th March 2025
Originally posted on IPKat. The recent Board of Appeal decision in T 1977/22 related to the patentability of claims defining subject matter with open-ended parameter ranges. The question before the Board of Appeal was whether a claimed open range, and its numerically infinite scope, could ever be said to be sufficiently disclosed (Article 83 EPC). The Board of…

CJEU clarifies jurisdiction rules for European patent enforcement: BSH Hausgeräte vs. Electrolux AB

  • 1st March 2025
Originally posted on IPKat. Earlier this week the CJEU provided its ruling in the highly anticipated case of BSH Hausgeräte v. Electrolux (Case C-339/22, February 2025). The case addressed longstanding questions about the jurisdiction of European courts when patent invalidity is raised as a defence in an infringement case. The CJEU found that national courts maintain jurisdiction over infringement…

The UPC’s first decision on infringement by equivalence (Plant-e v Bioo, UPC_CFI_239/2023)

  • 28th February 2025
Originally posted on IPKat. In Plant-e v Bioo the UPC provided its first decision addressing the doctrine of equivalents in patent infringement proceedings (UPC_CFI_239/2023). The Local Division of the Hague set out a novel four-part test for assessing equivalence drawn from various national jurisdictions. The test appears relatively patentee-friendly, with the Local Division finding infringement of the claims despite…
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