Introduction
In the recent European Patent Office (EPO) decision T 1356/21 concerning European Patent No. 2571517, the Board of Appeal upheld the patent for long-acting insulin formulations despite challenges regarding novelty and inventive step. This decision highlights the importance of technical effects and proper evidentiary support in patent disputes. It also clarifies how patent holders must demonstrate inventive contributions, while opponents must substantiate their objections with substantial evidence, especially when alleging bonus effects.
Summary of the Invention
The patent in question, owned by Sanofi, relates to aqueous pharmaceutical formulations of insulin glargine, a long-acting insulin analogue, aimed at treating diabetes mellitus. The core of the invention involves insulin formulations with concentrations of 270-330 U/mL, combined with a specific zinc range, designed to offer patients a flatter pharmacokinetic (PK) profile and prolonged insulin activity. This approach aimed to reduce the discomfort of injections by decreasing the volume, while also achieving a longer duration of insulin action, making it more effective for basal insulin therapy.
Key Arguments and Decision
- Opponent’s Argument: The opponent argued that the claimed concentration range of insulin glargine (270-330 U/mL) was not novel in light of prior art (D12), and that any effects related to the concentration change were merely bonus effects, which could not support inventive step. They also sought to introduce additional documents (A34, A35) as evidence.
- Patentee’s Argument: Sanofi, the patent proprietor, contended that the prior art did not specifically disclose the claimed concentration range. They further argued that the change in insulin concentration led to unexpected benefits such as a flatter PK profile and longer duration of action, which were not obvious from prior knowledge or teachings on similar insulin formulations.
- Board's Decision: The Board upheld the patent, agreeing with the patentee. They found that the claimed insulin concentration range was indeed novel over D12, as the concentration was sufficiently removed from what was disclosed in the prior art. Moreover, the Board rejected the notion that the observed technical effects were bonus effects. They emphasized that the opponent did not provide sufficient evidence to show that these effects were inevitable results of the concentration change. The Board also refused to admit the late-filed evidence, as it should have been submitted earlier.
Lessons to Be Learned
- Novelty in Narrow Ranges: Even when a concentration range appears within broader ranges disclosed in prior art, a narrow range can still be novel if it demonstrates distinct technical effects.
- Bonus Effects Doctrine: The Board clarified that not every additional effect from a known modification can be dismissed as a bonus effect. Substantial evidence is required to prove that a technical effect is merely a byproduct and not an inventive contribution.
- Evidentiary Standards: Parties challenging a patent must provide strong, early-stage evidence to refute the patentee’s claims, particularly when arguing technical effects. Late evidence is unlikely to be admitted unless justified by exceptional circumstances.
- Importance of Technical Effects: The decision emphasized that technical improvements, such as a flatter PK profile or extended insulin action, can be pivotal in establishing inventive step, especially in highly technical fields like pharmaceuticals.
Legal Basis
The decision cited Article 54(5) EPC for novelty related to medical uses and Article 56 EPC regarding inventive step. The Board also referenced G 2/08 concerning dosage regimens and novelty, and decisions like T 506/92 and T 21/81, which discuss the concept of bonus effects and inventive step.
Contact
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Legal Disclaimer
The information provided in this blog post is for generalinformational purposes only and does not constitute legal advice. The summary and analysis of the EPO case are based on publicly available information and are intended to offer insights into the decision and its implications. This content should not be used as a substitute for professional legal advice tailored to your specific circumstances. For advice related to any specific legal matters, you should consult a qualified attorney.