Introduction

The case of Regen Lab SA v. Estar Medical Ltd & Ors ([2019] EWHC 63 (Pat)) was adjudicated in the England and Wales High Court (Patents Court) on January 18, 2019. Regen Lab SA ("Regen") sought to enforce its European Patent (UK) 2073862 ("the Patent") against Estar Medical Ltd and other defendants ("the Defendants"). The Patent purportedly covered a method for preparing platelet-rich plasma (PRP), a substance used for wound healing and tissue regeneration.

The key issues revolved around allegations of patent infringement by the Defendants, who supplied kits allegedly infringing the Patent. In response, the Defendants counterclaimed for the revocation of the Patent, arguing that it lacked novelty, inventive step, and sufficiency of disclosure. Regen further sought to amend the Patent's primary claim to incorporate a use limitation, which was opposed by the Defendants.

The trial featured expert testimonies from both parties, including clinicians and polymer chemists, to substantiate claims of both infringement and invalidity.

Summary of the Judgment

The court thoroughly examined the allegations of prior disclosure and the inventive step of the Patent. Upon review, the High Court found that the claim 1 method of the Patent lacked novelty due to prior use in June 2005, where Regen's own operations had already disclosed the method. Additionally, the court concluded that the inventive step was absent, as the method was deemed obvious to a person skilled in the art at the priority date of the Patent.

Consequently, all claims within the Patent were invalidated on the grounds of lack of novelty and inventive step. Regen's application to amend claim 1 by introducing a use limitation was also dismissed, as it did not rectify the inherent invalidity of the claim. Furthermore, Regen did not argue for the independent validity of claim 2, and dependent claims (3-5) were similarly found invalid. As a result, infringement became a moot point.

Analysis

Precedents Cited

The judgment extensively referenced several key cases to substantiate its reasoning:

• Synthon BV v SmithKline Beecham plc [2005] UKHL 59: Addressed general principles of patent novelty.
• Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWHC Civ 819: Discussed the composition of the skilled person and inventive step.
• Generics (UK) Ltd v Warner-Lambert Company LLC [2015] EWHC 2548 (Pat): Explored the territoriality of common general knowledge.
• Coco v AN Clark (Engineers) Ltd [1968] FSR 415: Established the criteria for breach of confidence, relevant to prior disclosure.
• Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48: Reviewed the scope of patent claims and the doctrine of equivalents.

These precedents collectively informed the court's approach to assessing novelty, inventive step, and infringement.

Legal Reasoning

Inventive Step: The court analyzed whether the method was obvious to a skilled person. It concluded that, given the existing knowledge and Regen's own prototypes, the method lacked the necessary inventive step.

Common General Knowledge: The court adopted a territorial perspective, considering common general knowledge within the UK at the priority date. It found no evidence that specific aspects of the Regen kit were part of the general knowledge, thereby influencing the assessment of both novelty and inventive step.

Doctrine of Equivalents: In assessing infringement, the court applied the principles from Actavis, determining that even though the Defendants' product differed in chemical composition, it achieved the same result in a substantially similar way. However, since the Patent was invalid, this analysis was peripheral to the final decision.

Impact

This judgment reinforces the stringent requirements for patent validity, particularly concerning novelty and inventive step. It underscores the importance of unequivocally defining the scope of patent claims and ensuring that use limitations are explicitly articulated within claims rather than inferred. Additionally, the decision highlights the need for patentees to meticulously manage prior disclosures to safeguard their patents against invalidity challenges.

Future cases will likely draw upon this judgment when navigating the complexities of patent claims, especially in the biomedical field where iterative innovations are common. The emphasis on territorial common general knowledge may also influence how patentees approach international patent strategies.

Complex Concepts Simplified

Platelet-Rich Plasma (PRP)

PRP is a concentration of platelets derived from blood plasma, utilized primarily to promote healing in medical and dental procedures. The patented method aimed to optimize PRP preparation for therapeutic applications.

Thixotropic Gel

A thixotropic gel is a substance that transitions from a solid to a semi-liquid state when subjected to mechanical stress, such as centrifugation. In the patented method, this property facilitated the separation of blood components during PRP preparation.

Inventive Concept

The inventive concept refers to the core innovation of a patent, encapsulating the novel technical insights that differentiate it from existing knowledge.

Common General Knowledge

This encompasses the collective understanding and practices accepted by experts in a particular field at a given time. It plays a crucial role in determining the obviousness of a patent claim.

Doctrine of Equivalents

A legal principle that allows for a finding of patent infringement even when the infringing product or process does not literally fall within the patent's claims but performs substantially the same function in substantially the same way to achieve the same result.

Conclusion

The High Court's decision in Regen Lab SA v. Estar Medical Ltd & Ors serves as a pivotal reminder of the meticulous standards required for patent validity. By invalidating the Patent on the grounds of lack of novelty and inventive step, the court emphasized the necessity for clear and precise claim definitions and the safeguarding of proprietary methods against inadvertent prior disclosures.

This judgment not only affects Regen but also sets a precedent for how similar cases may be approached in the future, particularly in the biomedical and pharmaceutical industries where innovation is rapid and complex. Patentees must ensure rigorous protection of their inventions and avoid any actions that could compromise the novelty and inventive nature of their patents.

Ultimately, the case underscores the delicate balance courts must maintain between fostering innovation through patent protection and preventing monopolies on methods and technologies that are not sufficiently novel or inventive.