UPC Life Sciences Injunctions: Key Patent Decisions and Strategy

Introduction : With the arrival of the Unified Patent Court (UPC) in June 2023, a drastic change occurred in the landscape of intellectual property within Europe. In the beginning, the life sciences sector approached the new legal framework with caution by assessing its strengths, such as pan-European injunctions and potential weaknesses, for example, central revocation of patents. However, these concerns were promptly dismissed. On the very first day, significant disputes like Sanofi v. Amgen and 10x Genomics v. NanoString Technologies were filed. Presently, the life sciences sector – encompassing medical devices, biologics, and small molecules – comprises more than 20% of initial filings and close to 50% of all preliminary injunctions (PI).

The speed and efficiency of the UPC have inspired worldwide healthcare organizations to reevaluate their tactics. In particular, the UPC seems especially favorable to the patent owners, with PI approvals exceeding 60% and average trial duration being only 80 days. In order to demonstrate a need for urgency, the court requires a greater “probability” that the patent is valid and infringed on, thus substantially differentiating itself from other significant jurisdictions. In particular, German Local Divisions seem especially favorable for the patent owners, offering them success rates ranging between 62% and 80% due to the combination of flexible process and quick resolution of cases. On the contrary, the United States features low success rates in terms of PI due to lengthy discovery process and strict requirements to prove the inability to avoid an irreversible harm, while the United Kingdom manages to achieve relatively high success rates due to adherence to American Cyanamid standards.

The interpretations made by the Court have become more complex as time progresses. Although the UPC is in a position to offer substantial relief measures, which would affect the market, it does not rush to its decisions. Rather, it conducts an objective analysis of the validity of the patent and gives an accurate interpretation of the claims in the patent, restricting injunctions for active patents.

Defining the Boundaries of Imminent Infringement

Given the highly regulated drug industry, discerning what constitutes permissible preparatory steps for regulation versus patent infringement poses challenges. In light of Article 62 of the UPCA, which allows courts to give orders prohibiting “imminent infringements,” the CoA had to establish criteria that would weigh the interests of originators against those protected by regulatory exemptions such as the Bolar exemption. One landmark case was that of Boehringer Ingelheim v Zentiva regarding the generic version of the drug Ofev (nintedanib), where Zentiva had obtained MAs and conducted pricing and reimbursement activities in Portugal more than one year prior to expiry of the patent held by Boehringer.

Affirming the Lisbon Local Division’s judgment, CoA created a three-pronged test of imminence of infringement: preparatory acts to commit infringement have to be done, all those preparatory acts have to be completely finished, and the only missing act is the start of the infringement. It was emphasized that even though requesting an MA is a part of regulatory exemption, doing national pricing and hospitalization procedures amounts to imminent infringement. Nevertheless, just having an MA will not always mean that there is enough of an infringement to issue an injunction. In Novartis/Genentech v. Celltrion case, the Düsseldorf Local Division refused to grant an interim injunction on Celltrion’s biosimilar. Having got an MA and promoting the product during the conference was not enough to prove the threat of infringement since price negotiations had not taken place yet.

The same requirement applies to the claims related to other medical indications of the drug. As it has been established in the Sanofi/Regeneron v. Amgen case, the Court of Düsseldorf (Central Division) requires that the claimants establish two things – the necessity for using the medicinal product because of its marketing in such a way that it is used for the patented indication, and the fact that the defendant was aware about this at the time in question.

The Limits of Preemptive Enforcement: The Fingolimod Precedent

Although the UPC provides very effective means for protecting inventions, the wider European practice demonstrates quite tough conditions for the grant of injunctive relief in case of pending patent applications. One of the most illustrative cases is the one of Novartis vs Viatris and others, in which Novartis filed suits against the generics manufactures of 0.5 mg dosing form of fingolimod (Gilenya), while the EPO was still considering granting the patent.

It should be noted that the Danish Maritime and Commercial High Court delivered a unique decision which indicated that the very filing of a patent application does not create an actionable legal interest, thereby depriving the claimant of standing to seek an injunction. Also, the case was rejected by the Patents Court of the United Kingdom because of the specific procurement process for the drug concerned in the UK. Since fingolimod is involved in the process of special secondary-care procurement in the UK, it has been decided that the reduction of its cost prior to the grant of the patent could be remedied through compensation. 

The legal precedent set by the case of fingolimod is highly relevant for future UPC jurisprudence. It reveals a very important aspect of the European approach, according to which courts will respond promptly in cases where rights are being jeopardized but will be highly suspicious about speculative lawsuits launched prior to an EPO decision.

Strict Claim Construction and Independent Validity Scrutiny

In terms of the validity of the patent application, the UPC requires that there is a “more likely than not” probability of the patent being both valid and infringed. This has been evident in the independent nature of the court in relation to the EPO by the adoption of an inflexible and literalist method of claim interpretation. The above has been shown in cases such as Alexion v. Samsung Bioepis and Alexion v. Amgen, where Alexion had incorrectly listed a 22-amino-acid signal peptide in its patent relating to the development of the antibody known as eculizumab (Soliris). Alexion contended that the error could be identified and corrected by any expert because of the obvious nature of the mistake in the biological composition. However, the Court of Appeal (CoA) rejected the above argument and ruled that there should be certainty in the identification and correction of errors in the claims of a patent.

In terms of evaluating inventive steps, the UPC also applies the same independent stance. In 10x Genomics v. NanoString Technologies, the CoA overturned a PI ruling in view of the absence of inventive step in the patent for spatial molecular imaging. Instead of applying the rigid problem and solution approach followed by the EPO, the court adopted a “holistic” evaluation of the technical problem. The decision demonstrates how the UPC is ready to utilize the technical judges’ expertise to make a validity assessment regardless of the parallel EPO procedure.

Proportionality and Patient Interests: The Clinical Carve-Out

An important feature of the UPC’s case law in the life science sector is the inclusion of a proportionality defense as a means of protecting public interest in matters of health. Although according to Article 63 and Article 64 of the UPCA, a decision concerning patent infringement will normally be accompanied by the issuance of a permanent injunction, Article 3 of the EU Enforcement Directive provides for such measures to be proportional and not create any hindrance in trade. In the well-known case of Edwards v. Meril, this balance was struck. Having found the patent infringement on part of Meril’s prosthetic heart valves, the Court of Appeal (CoA) came to the conclusion that issuance of an injunction would adversely affect the patients who require a particular size of the valve which can only be provided by Meril. 

Nevertheless, the UPC is very careful when applying this exception to public health considerations. In the case of Insulet v. EOFlow, the defendant tried to defend itself against a preliminary injunction by saying that requiring the patients who have diabetes to change their equipment may put their health at risk. However, this line of argument was dismissed since the patients can switch to the alternative patch pumps. The UPC limits the use of proportionality only to the cases in which there will be an actual deficiency in the therapeutic regime.

Procedural Mechanics: Urgency, Confidentiality, and Defensive Strategies

The UPC’s procedural rules operate on highly compressed timelines, requiring intense discipline from both patentees and defendants.

The Calculus of Unreasonable Delay

Under Rule 211(4) of the UPC Rules of Procedure (RoP), an applicant’s unreasonable delay in seeking provisional relief can completely doom a preliminary injunction (PI) claim. The “clock” starts ticking the moment the applicant learns of the circumstances justifying the order, or when they reasonably should have known through proper due diligence. While the UPC lacks rigid statutory time limits, it strictly demands a rapid response. Local divisions may allow a flexible one- to two-month leeway to collect evidence, but any delay approaching three months is typically fatal to the requirement of urgency, as demonstrated in Mammut v. Ortovox.

The timeline for what qualifies as a “reasonable” delay varies based on the trigger event and the complexity of proving infringement. For instance, where establishing infringement depends on complex, time-consuming biological testing, an exceptional window of up to one year may be permitted to gather evidence, which was the case in Amycel v. Polish Farmer. Conversely, for generic drugs, the availability of bioequivalence data makes an immediate infringement assessment possible the moment price and reimbursement notifications become public. As seen in Boehringer v. Zentiva, courts expect immediate action once these market-entry approvals are cleared, leaving a strict timeline of just one to two months to file for provisional measures.

Navigating Confidentiality

Procedural confidentiality should be stringently observed by litigants as well. For instance, during the litigation between Insulet and EOFlow, the CoA gave EOFlow a lesson in dealing with trade secrets. EOFlow was required to divulge commercial data concerning its supply chain and prices. EOFlow had based its case on Rule 262.2 RoP, which bars public access to information in the court registry alone. Therefore, EOFlow did not make any application under Rule 262A RoP requiring Insulet not to make use of the information it would disclose. The CoA found that the commercial information ceased to be a trade secret after being disclosed because there was no rule 262A order.

The Rise of Protective Letters (Schutzschrift)

As the UPC has the power to issue ex parte provisional orders without giving an opportunity to the defendant, Protective Letters (Schutzschrift) pursuant to Rule 207 RoP have turned into an indispensable tool for defense. The submission of arguments for non-infringement, invalidity, or urgency prevents the issuance of an order by the court by making it review the defense beforehand. In this way, it is possible to dispel the element of surprise and, most likely, the hearing will be convened. For manufacturers of generic drugs intending to market in Europe, submitting a Protective Letter becomes an obligatory action.

Global Trade Implications: Long-Arm Jurisdiction and the EU-India Dynamic

The implications of the UPC do not end at the boundaries of this institution owing to the fact that it has “long-arm jurisdiction.” In case the defendant is a citizen of one of the states which form part of the UPC, then the UPC will have jurisdiction over the violation of patents in Europe even in the cases of countries which are not members of the UPC such as the United Kingdom and Spain. 

This extensive impact has huge implications for the international pharmaceutical distribution chain, especially for India, which manufactures nearly 20% of the generic medicines globally. At the same time, the European Union has been working on the Critical Medicines Act in order to promote local production and cut its dependency on active pharmaceutical ingredients and medicines from Asia. Nevertheless, negotiations for the European–Indian Free Trade Agreement are likely to make the European policy less effective. This free trade deal will remove 8% to 11% of the tariff rate, making it extremely economical to sell their $2 billion biosimilar and complex generic pharmaceutical market in Europe. Thus, Indian pharmaceutical firms will have to implement very advanced legal and market approaches due to a combination of the decreased trade barriers and potential injunctions imposed by the UPC.

Conclusion

The creation of the Unified Patent Court has completely revolutionized patent litigation in the life sciences industry within Europe. Unlike the fragmented approach to patent protection used in the past, the UPC allows patentees the opportunity to have their patents upheld through fast and continental injunctions. However, this is by no means an easy court to navigate through, as it demands that there be a sense of urgency in terms of the patent application, that it assesses patents on their own merit in determining their validity, applies strict and literal claim construction while issuing harsh penalties for any drafting faults, and even makes exceptions where the health of patients is at stake.

For pharmaceutical companies worldwide, from originators to generic drug exporting companies, understanding how to effectively utilize all the procedural intricacies of the UPC, whether it entails issuing Protective Letters or filing pricing and reimbursement applications, is now crucial in order to maintain market exclusivity.

Author:- Kumar Harsh, in case of any queries please contact/write back to us at support@ipandlegalfilings.com or   IP & Legal Filing.

Endnotes

1. Unified Patent Court, Agreement on a Unified Patent Court (UPCA), arts. 62–64 (2013), available through the official UPC legal framework.
2. Unified Patent Court, Rules of Procedure of the Unified Patent Court, Rules 207, 211(4), 262 and 262A (latest consolidated version), governing protective letters, urgency, confidentiality and provisional measures.
3. Unified Patent Court, Court of Appeal, Boehringer Ingelheim International GmbH v. Zentiva Portugal, Lda., UPC_CoA decision interpreting “imminent infringement” under Article 62 UPCA.
4. Unified Patent Court, Court of Appeal, 10x Genomics, Inc. v. NanoString Technologies, Inc., UPC appellate decision discussing inventive step analysis and revocation of a preliminary injunction.
5. European Commission, Directive 2004/48/EC on the Enforcement of Intellectual Property Rights (IP Enforcement Directive), art. 3, requiring that enforcement measures be effective, proportionate and dissuasive.