Interpretation of the G2/21 decision by the national Courts: of the uselessness of the Enlarged Board of Appeal?
M. Dhenne (FR), Adj. Prof., PhD, Patent Litigator (Paris Bar and UPC)
Is it still necessary to present the famous G 2/21 decisionEPO, EBA, March 23, 2023, “Reliance on a purported technical effect for inventive step (plausibility)”. to the readers of this review? Certainly not in detail, but main points are worth recalling.
In this case, the Enlarged Board of Appeal (“EBA”) ruled on the admissibility of post-filing data in assessing the plausibility notion. The EBA considered that post-filing data submitted in support of inventive step should not be excluded as a matter of principle, even in cases where such post-filing data constitutes the sole means of proof of the alleged technical effect. However, “a patent applicant or proprietor may rely upon a technical effect for inventive step if the skilled person, having the common general knowledge in mind, and based on the application as originally filed, would derive said effect as being encompassed by the technical teaching and embodied by the same originally disclosed invention”Point 2 of the Order.. It seems three conditions arise from the criterion provided here in the Board’s Order: (i) encompassed by [the] technical teaching [of the application as filed]“, (ii) “embodied by the same originally disclosed invention”, and (iii) “[it] does not change the nature of the claimed invention”. To conclude the EBA states that it “is aware of the abstractness of some of the aforementioned criteria”Point 95 of the Reasons.. This is indeed the least we can say. Such “abstractness” that one might well question what the G 2/21 decision input is (like many other EBA decisions, unfortunately).
Here we didn’t have to wait for long before the uselessness of G 2/21 became apparent in practice. In fact, in the “APIXABAN” case, two different courts – British and French courts – have already succeeded in proposing two completely opposite interpretations of the decision. Let’s briefly study those decisions to clarify the plausibility situation after G 2/21.
The “APIXABAN” case: facts
Patent EP1427415 (“EP’415″) was filed on behalf of Bristol-Myers Squibb Company (“BMS Company”) on September 17, 2002, as international application PCT/US02/29,491 (WO 03/026652) (“WO’652”), under the priority of provisional application US 60/324,165 of September 21, 2001. It expired on September 17, 2022, and forms the basis of SPC FR11C0042, which will expire on May 20, 2026.
EP’415 claims apixaban (claims 1 and 2), the pharmaceutical composition comprising it (claims 3 and 4), the compound and the pharmaceutical composition for use in therapy, in particular to treat thromboembolic disorders (claims 5 to 22), optionally in association with a second therapeutic agent to treat thrombolytic disorders (claims 23 to 29).
Apixaban
(1-(4-methoxyphenyl)-7-oxo-6-[4-(2-oxopiperidin-1-yl)phenyl]-4,5,6,7-tetrahydro-1H-pyrazolo[3.4-c]pyridin-3-carbamide)
The “APIXABAN” case: proceedings
The patent has not been opposed. However, several invalidity proceedings have been initiated worldwide. For instance, the validity of the Canadian patent (CA2461202) has been challenged on several grounds, but without successFederal Court of Canada, January 12, 2021, Bristol-Myers Squibb vs. Pharmascience & Sandoz..
In addition, Sandoz and Teva sought a declaration of invalidity of the UK part of the applicationSandoz and Teva vs. Bristol-Myers Squibb [2023] EWCA Civ 472. for lack of inventive step, more particularly in view of international publication WO 00/39,131, lack of plausibility and extension beyond the content of the application as filed. The applicant obtained revocation of the patent, Arnold J having found that, in the absence of any theory based on the structure of apixaban or any data in the description, by way of example, nothing in the application supports the assertion that apixaban is a factor Xa inhibitor. As such, the assertion is not plausible, as the application gives the skilled person no reason to believe that there is a reasonable prospect that the assertion will prove to be true.
In contrast to the UK judge, the Paris High CourtParis High Court, June 2023, 8, 2023, Teva vs. Bristol-Myers Squibb, RG n° 21/12727. (i.e., “Tribunal Judiciaire de Paris”) ruled that the claim that apixaban is a factor Xa inhibitor was plausible for the purposes of assessing inventive step. According to the Court, the applicant was not in possession of the invention at the time of filing and filed on the basis of an idea or intuition. The Court notes, however, that WO’652 specifically discloses apixaban, which is then exemplified (no. 18), admittedly among 140 examples and the description of more than 100 product syntheses. That said, the Court notes that WO’652 discloses tests, resulting in the determination of “most preferred” compounds with very good affinity and in particular a Ki # 0.001 μM. WO’652 further states that the invention concerns a factor Xa inhibitor with improved pharmacological and pharmacokinetic properties. It also describes that 3.07 g of apixaban have been synthesized (page 178). This quantity unquestionably distinguishes apixaban from all other examples of synthesized compounds, in that it is by far the largest quantity synthesized according to the description (no other example reaches one gram, the other largest quantity synthesized being example 91:0.34 g). A person skilled in the art would necessarily have deduced, based on common general knowledge, that the patentee thought apixaban was a promising compound, if not the most promising.
In addition, BMS has submitted laboratory notebooks and reports from its researchers, predating the filing of WO’652, which indisputably demonstrate, and which are indeed not seriously disputed, that it was in possession of the invention, namely a factor Xa inhibitor, useful in the treatment of thromboembolic disorders, with improved pharmacological and pharmacokinetic properties. These elements fully confirm the research program as described by BMS, and the discovery of apixaban by Dr. Pinto and his colleagues before the priority date. The Court concludes that the plea alleging the lack of “plausibility” or “credibility” of EP’415’s contribution to the state of the art at the time of filing, and therefore the lack of inventive step of claims 1 to 4, is therefore rejected.
Comments
Both decisions adopt an extreme interpretation of G2/21.
The British decision certainly appears the more questionable. Stating that nothing in the application supports the assertion that apixaban is a factor Xa inhibitor is saying both one thing and its opposite in the same sentence. Indeed, in pharma the names are very specified. Here, for instance the Xa factor finds itself in the name ApiXaban. Not only does this position seem strange and contradictory to me, but it also fails to take account of the specificities of the pharmaceutical field, by reducing the notion of plausibility to almost nothing.
However, even if, in my opinion, the French position is better, we can’t ignore that this position is a bit extreme too. The Paris High Court adopts a flexible interpretation of plausibility. While it aligns itself with EPO decision G 2/21, adopting the more favorable position of implausibility ab initio, it nevertheless gives an interpretation opposed to that of the British judge. Whereas the latter considers that tests and data are compulsory, the French judge considers, conversely, that they are not, except in the specific case of a subsequent therapeutic application.
Therefore, whereas the British position reduces plausibility to almost nothing, the French position tends to set the plausibility threshold at a low level, which is unquestionably favorable to the patentee. It seems to me that the use of plausibility is intended to facilitate the assessment of patentability in a field marked by the random nature of the results obtained by the claimed inventions: the pharmaceutical field. However, we must be careful not to lower the assessment of this criterion, which is already intrinsically favorable to applicants. To do otherwise would be to give an undue advantage to an applicant who could reserve for himself the exploitation of an invention that falls more within the field of research than that of technology. In short, plausibility would only be set aside if the person skilled in the art had legitimate reasons to doubt it at the time of filing, so that applicants can claim an entire field of research for themselves without having yet started work on it.
In conclusion, as we have just seen, the criterion laid down in the G 2/21 decision can be considered from different angles, so that we can only hope that the new Unified Patent Court will genuinely help to unify, at least, European litigation in such situations, at the risk, otherwise, of encouraging forum shopping.
