UPC delivers first judgment on Validity and Infringement of a Second Medical Use Claim

Sanofi Biotechnology SAS & Anor v Amgen, Inc., & Ors– Thomas, Thom, Kupecz and Dorland-Galliot – [UPC_CFI_505/2024]

The Dusseldorf Local Division (LD) has delivered the UPC’s first Judgment on second medical use claims. The case concerns EP 3 536 712, exclusively licensed to Sanofi by Regeneron. Sanofi and Regeneron sued Amgen for infringement, while Amgen counterclaimed for revocation of the patent. Although the LD agreed with the EPO Opposition Division that the patent was valid, the LD did not find infringement in favour of the claimants. On the contrary, the court was not convinced that Amgen had placed the product on the market in such a way that would have knowingly led an alleged infringer to the claimed therapeutic use. In arriving at this conclusion, however, the court cautioned against deciding on the infringement of second medical use claims in an abstract manner and emphasised the need to analyse all relevant facts and circumstances of the alleged infringement. In the case in question, the product’s Summary of Product Characteristics (SmPC) associated the drug with the claimed use; however, there was found to be insufficient evidence demonstrating physicians would have prescribed Amgen’s drug for the claimed therapeutic use of Regeneron’s patent.

Background

This case relates to a dispute between the claimants, Sanofi and Regeneron, and the defendant, Amgen, in connection with Amgen’s cholesterol-lowering drug, evolucumab marketed under the tradename Repatha®. The claimants sued Amgen for infringement under a second medical use patent directed to the composition comprising a PCSK9 inhibitor for reducing Lp(a) levels in a particular patient group.

Unlike patent claims to a pharmaceutical composition per se, a second medical use claim is not necessarily infringed simply by the sale of the composition according to the claim without the patent owner’s consent. This is because the claims in second medical use patents are limited to the particular use (e.g. dose, therapeutic indication, patient subgroup, mode of administration) specified in the claim and do not encompass all uses of the drug. Despite the purpose-limited nature of second medical use patents’ scope, they can prove very valuable to innovator companies, commonly driving market exclusivity towards the end of a drug’s patent life when sales are typically largest.

A significant example involved Warner-Lambert pregabalin patents. Their compound patents to pregabalin per se and its use for treating epilepsy had lapsed, and they launched actions around the world to stop the sale of pregabalin based on their medical use patents covering the use of pregabalin for the treatment of neuropathic pain. While third parties should have been free to sell pregabalin for epilepsy following the expiry of the relevant patent, they had to avoid benefiting from the still-patented use for neuropathic pain. Whether or not a third party’s sale of pregabalin presented a risk of infringement depended on the circumstances of the sale. Courts in different countries applied different tests for assessing infringement. The LD of the UPC has now had its first opportunity to grasp this thorny issue.

Issues in this Case

The claimants’ position was that Amgen’s activities amounted to inducing infringement by encouraging the use of Repatha® for the claimed use of reducing Lp(a) levels. Amgen’s SmPC, mentioned that Repatha® reduced Lp(a) in clinical trials and, in the claimants’ view, this demonstrated inducement as a prescriber would recognise Repatha®’s effect on Lp(a) from the SmPC and understand that a significant group could benefit from this effect.

As well as questioning the validity of the patent, Amgen argued that the mere mention that Repatha® lowered Lp(a) in the SmPC was not relevant to a prescriber’s decision to prescribe Repatha®. Neither Repatha® nor Sanofi/Regeneron’s own product, Praluent® were approved for the reduction of Lp(a). On the contrary, the SmPC listed several therapeutic indications for Repatha®, and most of these were associated with the risks associated with elevated LDL-cholesterol levels. They alleged none of the indications mentioned in the SmPC involved reducing Lp(a) even implicitly. Amgen’s position, therefore, was that the claimants had not established infringement.

Claim Interpretation

As has become the norm with substantive UPC decisions, the LD provided a detailed discussion on the scope of protection of the claims before analysing validity and infringement. EPO practitioners keenly awaiting the EPO Enlarged Board’s decision in G1/24 may be intrigued by the reference in the decision[1] to the “primacy of the claims” in paragraph 86 of the decision. However, whereas the EPO has sometimes used this phrase while interpreting the claims without reference to description, the LD reiterated the principles established in NanoString v 10x Genomics [UPC_CoA_335/2023]. In the LD’s view, “primacy” did not relate to the claims in isolation. Instead, the LD concluded that the description[2] always played a role in establishing the primacy of the claims.

Notwithstanding the above, the LD was aligned with the EPO in concluding that a composition for any specific use in a method of treatment of the human body can be patentable, and that novelty of medical use claims can derive from the claimed therapeutic use alone.

In their counterclaim for revocation, Amgen placed emphasis on the need for the claimed use to be therapeutic in nature and argued that, here, the reduction Lp(a) levels was not a therapeutic indication. Had Amgen been successful, the claims would be interpreted as merely “suitable for” the claimed use rather than specifically limited to that purpose, and so the patentee would not have been able to rely on the claimed use for novelty.

The LD looked to the description of the patent to dismiss Amgen’s arguments.  The LD concluded that, in the light of the description, a skilled person would understand the reduction of Lp(a) as a therapeutic intervention in its own right with the ultimate goal of treating or reducing the risk of cardiovascular disorders. Amgen’s counterclaim for invalidity was unsuccessful.

Infringement

In Amgen’s favour, however, the LD also found that there was no infringement. The LD noted that there are as yet no statutory provisions regarding the infringement of second medical use claims. The LD held that, to find infringement, the claimants had to prove that the allegedly infringing product fulfilled the “use” features of the claim. To consider this the LD applied the test that the alleged infringer:

• must offer or place the medical product on the market in such way that it leads or may lead to the claimed therapeutic use (the so-called “objective element”)
• of which the alleged infringer knows or reasonably should have known that it does (the so-called “subjective element”).

For example, had there been a prescription for lowering Lp(a) levels or circumstances showing that such use may be expected to occur, it may have been difficult for the alleged infringer to avoid a finding of infringement as they should reasonably have known that sale of the product would have led to the claimed use.

The LD also highlighted that the following may be important in assessing the relevant facts:

• the extent or significance of the allegedly infringing use,
• the relevant market including what was customary on that market,
• the market share of the claimed use compared to other uses,
• what actions the alleged infringer had taken to influence the respective market,

1. either positively, de facto encouraging the patented use,
2. or negatively by taking measures to prevent the product from being used for the patented use.

The LD acknowledged that the SmPC of the product might be important. However, it was not the only decisive factor. In the SmPC of the case at hand there was no indication that Repatha® had been approved for the claimed indication, but Repatha® was indicated for a range of other disorders. Amgen had also applied a “skinny label”, avoiding labelling their product for the claimed use. Furthermore, Amgen’s experts provided convincing reasons as to why the Lp(a)-lowering effect described in the SmPC would not have influenced their prescribing decisions and the claimants were unable to demonstrate (e.g., by showing prescriptions) that Amgen’s placement of Repatha® on the market would have led to the claimed use.

Conclusions

Although this is a first instance decision, the LD has made clear that the infringement of second medical use claims is a complex matter requiring detailed analysis of the facts. While “skinny labelling” carving out the still-patented use may assist a defendant’s position on infringement, the full circumstances under which the product is placed in the market should be taken into account and, as well as subjective matters, such as what the defendant knew or should have known.

Many will be watching closely for an appeal to the UPC Court appeal. This will bring greater clarity on second medical use claims in courts across the EU and may influence the practice elsewhere.

[2] Article 69 EPC and its protocol

This article was prepared by Partner & Patent Attorney Hsu Min Chung and Patent Attorney Robert Scanes.