PHARMACEUTICAL IP

Pharmaceuticals

Evolve is a pharmaceutical specialist IP firm, offering comprehensive intellectual property services built on the experience of our attorneys in both in-house and private practice settings. We provide strategic counsel throughout the innovation lifecycle, from drafting and portfolio management to licensing, due diligence, and contentious matters.

Evolve is built on the deep expertise of our qualified attorneys in the pharmaceutical and biotech sector. With our personalized approach, scientific backgrounds and industry insights, we deliver tailored and pragmatic IP solutions for our pharmaceutical and biotechnology clients.

Sector insights...

Commercial success is a nothing-burger for the EPO in Wegovy patent inventive step analysis (T 1701/22, Obesity treatment with semaglutide)

In recent years, Novo Nordisk’s weight loss drug semaglutide, marketed as Wegovy for obesity and Ozempic for diabetes, has become a pharmaceutical phenomenon. As with most successful pharmaceutical products, the remarkable success of semaglutide means we can also expect some high profile IP disputes. In jurisdictions lacking provisions for patent term extension, semaglutide is expected to face generic challenge…

IP strategy for AI-assisted drug discovery

AI has been hailed as a potentially revolutionary tool for accelerating and enhancing the difficult and expensive process of drug discovery. Medicine perhaps represents the field in which AI has the most to offer humanity. However, the nascent field of AI-assisted drug design also highlights the need for IP strategy to be as forward-looking and…

Beyond the process: Securing robust IP protection for cell therapies

Unlike traditional pharmaceuticals, these “living medicines” present unique IP challenges that can make or break a biotech’s future…

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

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 this ingredient, the generic…

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

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 a process claim and…

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

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 Appeal that it was…

The benefits and pitfalls of drug manufacturing IP (T 2543/22)

The Board of Appeal decision in T 2543/22 relates to a manufacturing method for preparing a therapeutic peptide. The Board of Appeal found that whilst various methods were known, the skilled person would not have had a reasonable expectation of success in applying them to produce the specific claimed peptide. The case highlights some interesting aspects of pharma…

The description of a patent should “always” be used to interpret the claims (DexCom vs. Abbott, UPC_CFI_230/2023)

The Paris Local Division of the Unified Patent Court (UPC) first substantive decision on patent validity in DexCom v Abbott (UPC_CFI_230/2023), provides some interesting commentary on how much the description should be taken into account when interpreting the claims. Claim interpretation is the subject of the highly anticipated referral to the EPO’s Enlarged Board of Appeal, G1/24…

A new mode of administration is a new specific medical use (but not necessarily inventive) (T 0295/22)

The Board of Appeal decision in T 0295/22 tackles the question of whether a new mode of administration of a drug should be considered a new medical use. The Board of Appeal concludes that the current EPO Guidelines for Examination are wrong on this point, and that mode of administration may be considered a specific new medical…

Functional claims for pharmaceutical formulations: Validity versus enforcement (T 2130/22)

The Board of Appeal decision in T 2130/22 considered the inventive step of a pharmaceutical formulation in which the technical effect relied upon for inventive step was also a functional feature of the claim. The decision confirms that when a technical effect is specified as a functional feature in a claim, arguments regarding lack of demonstration of the…
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