Familiar, but a little different - first experiences with patentability before the Unified Patent Court (UPC)

Familiar, but a little different - first experiences with patentability before the Unified Patent Court (UPC)

After a series of decisions relating mainly to formal issues at the UPC, it is finally time to take a look at the first decisions on patentability. Can we already see how the UPC deals with substantive legal issues of patentability?

The first decision ("Nullity 1")[1], which is of interest here, was issued by the Court of First Instance of the Central Division of the Unified Patent Court (Munich Section) on July 16, 2024 and concerned a biotechnology patent, EP 3 666 797 B1. The decision was issued in nullity proceedings ACT_459505/2023 UPC_CFI_1/2023 ("Sanofi v. Amgen") and is still subject to appeal.

The second decision ("Nullity 2")[2] was issued on July 19, 2024 by the Court of First Instance of the Central Division of the Unified Patent Court based in Paris and concerned a medical technology patent, EP 3 646 825 B1. This decision was issued in the context of nullity proceedings ACT_551308/2023 UPC_CFI_255/2023 ("Meril vs. Edwards Lifesciences") and is also appealable.

We recall that the UPC has exclusive jurisdiction for actions for revocation of patents and counterclaims for revocation of patents. Invalidity actions are heard by the central division (Art. 33 para. 4 UPCA), unless infringement proceedings have been initiated.

The main grounds for revocation are lack of novelty, lack of inventive step, insufficient disclosure, added matter and exclusion from patentability (Art. 65(2) Agreement on a Unified Patent Court (UPCA), and Art. 138(1) and 139(2)[3] EPC).

Consequently, in invalidity 1, the applicants claimed that the patent had been amended so that it contained subject matter which went beyond the content of the application as originally filed, that the invention was not disclosed so clearly and completely that it could be carried out by a person skilled in the art, that it was not novel and/or that it was not based on an inventive step.

In invalidity action 2, invalidity was based on an extension of the subject-matter beyond the content of the application as originally filed, the lack of enabling disclosure, the lack of novelty of claim 1 in view of WO 2012/48035 ("Levi"), WO 2011/109801 ("Benichou") and WO 01/28459 ("Dimatteo"); the absence of inventive step if the closest prior art is taken to be Levi or a combination of the Melody valve and its transcatheter system ensemble and the stent disclosed in the Fontaine article.

While it has - correctly - been stated in the literature that nothing has changed with regard to patentability when UP patents are granted by the European Patent Office (EPO), the question remains as to who really "decides" on patentability when it comes to nullity proceedings before the UPC.

To date, the UPC does not have a self-contained, independent system of procedural and substantive patent law. Articles 20 and 24 of the UPCA clarify that the court bases its decisions on: Union law, the UPCA, the EPC, other international conventions applicable to patents and binding on all contracting states (i.e. except the UK), and - to a limited extent - national law or even non-contracting states.

First, contrary to the statement above, it is very likely that there will be a largely independent system over time, as the UPC's decisions qualify as Union law and therefore take precedence. The UPC case law was cited in the invalidity decisions discussed below, e.g. UPC_CoA_335/2023, NanoString/10x Genomics, and CoA UPC May 13, 2024, VusionGroup/Hanshow.

Secondly, it must be seen whether "not much will actually change compared to current practice in the Member States", as some practitioners in this field have claimed.

In fact, it is unclear to what extent the UPC will take into account established national case law. As the aim is to achieve harmonization, the sometimes divergent national case law should ultimately not be the main basis for decisions. However, there is currently no reason why the UPC judges should not apply the principles of national case law when interpreting the new law until the Court of Appeal has developed its own case law.

The differences in the assessment of patentability between the EPO and the German Patent Court are a prime example of this. These differences can be particularly significant in the field of life sciences. For example, Section 1a (4) PatG requires that a claim directed to specific nucleic acid sequences must include specific industrial applicability. This requirement is not found in the EPC. Could this lead to a restriction of the scope of a UP before a German court with regard to the required harmonization? Would such a claim be invalid due to the lack of industrial applicability of the UP?

Somewhat more dramatic is a probable lack of novelty due to a national prior right under Sec. 3(2) PatG (similar to Art. 54(3) EPC). As mentioned above, Art. 139(2) EPC provides for the recognition of national rights, but the UP cannot be declared invalid or limited at national level only. It is completely unclear how this will be handled by the UPC, perhaps a unitary patent will not be enforceable in one of the member states.

Finally, and most importantly, according to German case law, a German patent court cannot (only) apply the EPO problem-solution approach when examining inventive step. The technical problem underlying an invention cannot be based solely on the advantages achieved by the invention. For example, even if the invention provides advantages that were previously unattainable, these advantages may not define the problem that the invention is intended to solve. Furthermore, depending on the field and circumstances, there may be several ways to address a technical problem and different solutions may be equally plausible (e.g. judgment BGH of 11.11.2014 - X ZR 128/09 - Repaglinid). Other decisions in Germany also reject the "static" and "ex post" application of the problem-solution approach.

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How did the UPC analyze the question of inventive step in the above-mentioned cases Nullity 1 (Central Chamber in Munich) and Nullity 2 (Central Chamber in Paris)?

In invalidity case 1, the Central Division concluded that the patent as granted was invalid because it was not based on an inventive step over Lagace. The skilled person interested in developing a treatment for hypercholesterolemia targeting PCSK9 would, based on and following Lagace's teaching, develop antibodies against PCSK9 that block the interaction of PCSK9 with the LDLR without an inventive step and would thereby arrive at the claimed subject matter in an obvious way.

Point 5.16 of the decision states: "Against the above background, the patent does not formulate a specific underlying problem. Notwithstanding this, it can be inferred from the description of the patent as a whole that the aim of the patent is to provide a treatment or prevention of hypercholesterolemia or atherosclerotic disease ...".

According to point 8.5, "the inventive step must be assessed from the point of view of a person skilled in the art on the basis of the entire state of the art, including the general technical knowledge of the person skilled in the art".

The court then looked for a "realistic starting point" in the prior art and pointed out that there could be several realistic starting points. It was not necessary to identify the "most promising" starting point (point 8.6).

According to points 8.9 and 8.10, a technical effect or advantage obtained by the claimed subject-matter in comparison with the prior art may also be an indication of inventive step. A feature which is arbitrarily selected from several possibilities cannot generally contribute to inventive step. The Central Division particularly emphasized that a retrospective view must be avoided. The question of inventive step should not be answered by retrospectively searching for (combined) prior art disclosures from which this solution could be derived, knowing the patented subject-matter or solution.

After a detailed analysis of the technological arguments and secondary factors, such as the prospects of success, the court summarized in point 8.82 that the skilled person, based on Lagace as a realistic starting point in the prior art, would arrive at the claimed subject matter without inventive skill. As a result, the patent was revoked in its entirety (point 9.8).

In invalidity case 2, the central division concluded that the patent as granted was legally valid in amended form. Interestingly, the court apparently applied a more generous standard under Art. 123(2) EPC than one might expect from some divisions of the EPO (point 70 of the decision).

As far as inventive step is concerned, no closest prior art was defined in invalidity 2. In paragraph 130 it is stated that it must be examined whether a person skilled in the art would have arrived at the technical solution claimed in the patent using his technical knowledge and simple manipulations in the given prior art. The inventive step is assessed on the basis of the specific problem encountered by the skilled person (referring to point 23.2 of the decision of the Paris Local Division of July 3, 2024, case UPC_CFI_230/2023)[4].

Following an analysis of the prior art, the granted patent was maintained in a modified "fully hexagonal" form of the heart valve prosthesis.

Of particular interest is that the court made "concluding remarks" on the inventive step analysis.

Paragraphs 153 to 155 state: "The Panel is aware that the EPO and some national courts apply the so-called 'problem-solving approach' when assessing inventive step. Under this approach, the judge determines the 'closest prior art', then defines the 'objective technical problem' to be solved and finally examines whether or not the claimed invention would have been obvious to a person skilled in the art on the basis of the closest prior art and the objective technical problem. This examination is not expressly provided for in the EPC and therefore does not appear to be mandatory. (emphasis added)

Irrespective of this, applying the 'problem solving approach' to the present process would not lead to a different result. Indeed, the panel identifies 'Levi' as the closest prior art because it addresses the same technical problem as the patent in suit and falls within the same field as the claimed invention.

It is true that the problem-solving approach is not explicitly provided for in the EPC, but its application seems to be mandatory at the EPO, as also shown by the case law of the Enlarged Board of Appeal (see e.g. point 24 of decision G2/21).

What can UPC users learn from the above decisions?

Firstly, invalidity proceedings at the UPC are indeed quite fast.
Secondly, it is indeed possible to lose a Unitary Patent in UPC revocation proceedings or at least to maintain it only with amendments.
Thirdly, it seems that the application of the rules relating to Art. 123(2) EPC is not applied as strictly as before the EPO.
Fourthly, in both invalidity 1 and invalidity 2, the problem-solution approach of the EPO was not applied. Rather, it appears that the analyses applied are very similar to the national approaches in Germany and France respectively. The Paris Central Chamber took the view that the application of the "problem-solution approach" would not lead to a different result in the present proceedings, but discontinued the comparison after determining the closest prior art.

In summary, the UPC does not appear to be strictly following the practice of the EPO in matters of patentability, but is rather on the way to creating its own standards. So far, these standards do contain elements of national law, perhaps even depending on the location of the chamber. Both patent proprietors and potential opponents must carefully consider these differences when deciding whether to grant a unitary patent, when opting out or when it comes to nullity and counterclaims.

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* Dr. Jan B. Krauss, Patent Attorney, European Patent Attorney, representative before the UPC, Partner Life Sciences at SKM-IP PartGmbB, Munich

[1] https://www.unified-patent-court.org/sites/default/files/ files/api_order/7BD3093D60CBD34C06940FCA0C598CEE_en.pdf

[2] https://www.unified-patent-court.org/sites/default/files/ files/api_order/21F793967A39FFC2BB1455CB3C788D2B_en.pdf

[3] It is still unclear how this fits in with Art. 3(2) of Regulation (EU) No 1257/2012 in the case of national prior rights (see also text below). The FAQ page of the UPC raises the question, but only answers it for prior use rights, Art. 28 UPCA (https://www.unified-patent-court.org/en/faq/sources-law-and-substantive-patent-law)

[4] https://www.unified-patent-court.org/sites/default/files/ files/api_order/8B08C53E1E2722DE9690B9C0BDAE0AEC_en.pdf

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