IP Law Daily, PATENT NEWS: Harvard's analyte detector patent succumbs to NanoString’s revocation challenge at EU’s Unified Patent Court, (Oct 30, 2024)

By Saurabh Kashyap, B.A., LL.B., LL.M.

Patent invalidated across Germany, France, and Netherlands; parallel infringement litigation continues at UPC’s Munich local division.

Following a revocation petition filed by NanoString Technologies, the Central Division (Munich Section) of the Unified Patent Court (UPC) revoked European Patent 2 794 928 B1 (the "Patent") owned by the President and Fellows of Harvard College ("Harvard") and licensed to 10x Genomics, Inc. The court ruled that the claims lacked novelty and inventiveness, aligning with NanoString Technologies Europe Limited’s arguments. The revocation is a significant development in multi-jurisdictional patent disputes, especially given ongoing litigation in Germany and parallel infringement proceedings involving 10x Genomics (NanoString Technologies Europe Ltd. v. President and Fellows of Harvard College, No. UPC 252/2023 (Oct. 17, 2024)).

Background. The claimant, NanoString Technologies Europe Limited, is a subsidiary of NanoString Technologies, Inc., a U.S.-based life sciences company specializing in molecular diagnostics and translational research. The disputed patent involves advanced multiplexed biological detection methods relevant to diagnostics and scientific research.

The defendant, Harvard College, is a vital part of the Harvard University system. It manages an extensive intellectual property portfolio. In recent years, it has actively collaborated with 10x Genomics, Inc., a biotechnology company focused on gene expression and molecular analysis tools. As part of these collaborations, Harvard and 10x Genomics co-own or license patents, including the divisional patent EP 4 108 782 B1 (EP ‘782). The relationship between Harvard and 10x Genomics underscores the competitive nature of the molecular diagnostics field, which plays out through litigation against competitors like NanoString.

10x Genomics is also a party to parallel infringement proceedings. Alongside Harvard, it sought provisional relief against NanoString in UPC’s Munich Local Division. However, this request was denied on October 10, 2023, primarily due to uncertainties around the validity of Harvard's patent.

NanoString Technologies Europe Limited initially filed this revocation action on July 27, 2023 seeking invalidation of the Patent across Germany, France, and the Netherlands. The dispute, however, originated earlier when NanoString’s German subsidiary filed a similar revocation action on July 29, 2022, in the German Federal Patent Court (BPatG). The German court found the Patent invalid on May 7, 2024, revoking it entirely. Harvard appealed this decision to the German Federal Court of Justice (Bundesgerichtshof), where the matter is still pending.

The German litigation paralleled infringement claims filed by Harvard and 10x Genomics in the Local Division of the Munich UPC. However, provisional relief was denied due to the uncertainty surrounding the Patent’s validity, weakening Harvard’s and 10x Genomics' enforcement strategy.

The EP 2 794 928 B1 at the center of these disputes relates to compositions and methods for detecting analytes using optical detection techniques. It is of high value in molecular diagnostics, particularly in research involving multiple biological targets within complex samples. NanoString contended that Harvard’s claims were not innovative, citing prior art disclosures to challenge the Patent's validity.

Prior art. Nanostring based its revocation challenge primarily on Göransson. - a prior art scientific publication in molecular biology focusing on methods for detecting and analyzing biomolecules through sequential hybridization. The technique described involves using optical labels, such as fluorescent tags, to identify multiple target molecules in a sample by hybridizing complementary probes sequentially. This approach allows researchers to detect several analytes, such as proteins or nucleic acids, even when working with complex samples or limited color channels for detection.

Nanostring’s arguments. NanoString claimed that the Patent failed to meet the core requirements for patentability under the European Patent Convention (EPC). It asserted that the lacked novelty as defined under Article 54 EPC, contending that the patented technology had already been disclosed by prior art, specifically Göransson. Additionally, NanoString challenged the patent on the grounds of inventive step under Article 56 EPC, maintaining that the claimed methods represented obvious modifications of pre-existing techniques that any skilled practitioner could derive without creative ingenuity.

According to NanoString, Göransson disclosed the essential elements of the claimed technology, including sequential detection methods with optical labels. NanoString contended that the claimed invention merely adapted well-known in vitro techniques to in situ applications, which would have been obvious to a person skilled in the art.

Furthermore, NanoString alleged that the Patent did not sufficiently disclose the invention (Art. 83 EPC), making it challenging for others to replicate. NanoString also argued that the patent's subject matter extended beyond the original application's content, violating Art. 123(2) EPC. These deficiencies, NanoString maintained, justified the Patent’s complete revocation.

NanoString opposed Harvard’s auxiliary requests for amendments, asserting that these were improperly delayed under Rule 50.2 of the UPC’s Rules of Procedure. The company claimed that Harvard should have submitted these amendments earlier, especially given the German litigation results.

Harvard’s defense and role of 10x Genomics. Harvard defended the Patent's validity, asserting that it introduced a novel method for detecting analytes by leveraging sequential detection of optical signals. Harvard argued that its technology overcame the limitations of previous methods by offering improved sensitivity and accuracy in biological assays. It further maintained that Göransson's prior art did not disclose the claimed invention's unique features, particularly the temporally sequential detection process.

In response to NanoString’s revocation request, Harvard sought to amend the Patent by narrowing the claims. It submitted auxiliary requests to address the novelty and inventive step challenges, aiming to distinguish the invention from Göransson. Harvard also argued that its amendments were necessary following the unfavorable German decision.

Initially, Harvard filed a motion to stay the UPC proceedings, citing lis pendens under the Brussels I recast Regulation. It argued that the German case, filed earlier than the UPC action, should take precedence. However, Harvard withdrew this motion at the oral hearing, signaling its preference for resolution at the UPC.

Jurisdiction and refusal to stay proceedings. The UPC first addressed its jurisdiction and Harvard’s withdrawn lis pendens objection and confirmed its jurisdiction under Articles 24(4) and 71a of the Brussels I recast Regulation. It noted that the parties' preference to proceed indicated their submission to the court's authority. Given the advanced stage of the UPC case, the court declined to stay proceedings, emphasizing the need for efficiency and legal certainty.

The court applied principles from Tatry (C-406/92) and Mala Technologies/Nokia Technologies to distinguish between related but separate legal entities in the parallel German and UPC proceedings. Although NanoString’s German subsidiary had initiated the earlier revocation action, the UPC found that the parties were not identical for purposes of lis pendens, allowing the UPC action to continue independently.

Novelty and inventive step. On the merits, the UPC concluded that Harvard's claims lacked novelty under art. 54 EPC. The court found that Göransson disclosed substantially similar methods for sequential detection of analytes using optical signals. Harvard's auxiliary amendments did not introduce any inventive features beyond what was already known in the field. The court emphasized that adapting Göransson's in vitro methods for in situ applications would have been obvious to a skilled person, rendering the Patent invalid for lack of an inventive step. The court’s analysis also referenced Mala Technologies/Nokia Technologies in determining inventive step requirements, emphasizing that minor modifications or predictable applications do not meet the EPC's inventive threshold.

Harvard’s auxiliary requests. Upon analysis, the UPC also rejected Harvard’s auxiliary amendment requests, citing procedural rules that require parties to submit their complete case early in the process. The court held that Harvard’s amendments, filed in March 2024, were a belated response to the German decision and should have been raised sooner. Allowing these amendments would have undermined the UPC’s front-loaded procedural framework.

Costs and judgment. Additionally, the UPC ordered Harvard to bear the costs of the proceedings under Article 69(1) of the UPC Agreement, given NanoString’s success in securing the Patent’s revocation. The judgment applies across Germany, France, and the Netherlands.

The Case is No. UPC 252/2023.

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