As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions.  We recently reviewed the Unified Patent Court (UPC) first decision – invalidating EP Patent No. 3,666,797 B1 – and provided a summary of that case. This analysis will focus on how the same patent disclosure has been evaluated before two courts – the U.S. Supreme Court and the UPC – and what applicants should consider, in view of the recent jurisprudence, when preparing patent applications.

Please note that our firm specializes in U.S. patent law.  The analysis provided herein, including regarding the EPC Sanofi-Aventis v. Amgen decision, is for informational and educational purposes only.  We suggest that parties seeking guidance on European patent matters consult with a qualified European patent attorney for authoritative advice and/or representation.

Background

In May 2023, the U.S. Supreme Court invalidated U.S. Patent Nos. 8,829,165 and 8,859,741, holding that Amgen’s functionally claimed genus of monoclonal antibodies lack enablement, and stating, “[t]he more one claims, the more one must enable.” Amgen Inc. et al. v. Sanofi et al., 143 S. Ct. 1243 (2023).  Reinforcing the need for specific disclosures and leaving less room for “trial-and-error-discovery,” the Court reiterated the basic tenet of enablement to be: “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.  In other words, the specification must enable the full scope of the invention as defined by its claims.” Id. at 1254. 

The Court did not close the door to all functional genus claims – the strict standard expressed by the Court is couched in the clarification that “it may suffice to give an example (or a few examples) if the specification also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose.” 143 S. Ct. 1243, 1254 (quoting Incandescent Lamp, 159 U. S., at 475). That is, “[i]n some cases, disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset.” Id. Even so, the Court made it clear that, in evaluating enablement, “courts cannot detract from the basic statutory requirement that a patent’s specification describe the invention ‘in such full, clear, concise, and exact terms as to enable any person skilled in the art’ to ‘make and use’ the invention [under §112(a)].  Judges may no more subtract from the requirements for obtaining a patent that Congress has prescribed than they may add to them.” Id.  Though the Court did not evaluate obviousness of the claims, the decision nevertheless sent a shockwave through the patent law world by seemingly raising the threshold for satisfying the enablement required. 

In July 2024, a three-judge panel of the UPC Central Division in Munich revoked EP Patent No. 3,666,797 B1 (the EP ‘797 patent) – a corresponding European patent to those contested in the U.S. – as invalid for lack of inventive step.  Sanofi-Aventis v Amgen (CFI 1/2023). In reaching this decision, the UPC held that “the skilled person … would have followed-up on the explicit suggestion in [lead reference] Lagace and would have developed anti-PCSK9 antibodies as a treatment for hypercholesterolemia and – doing so – would have arrived at the (uses of) antibodies as claimed . . . .  The unknowns and uncertainties that were brought forward by the Defendant, none of which are clearly voiced in the many prior art documents relied upon in this case, in any event do not outweigh the clear incentive provided by Lagace to develop anti-PCSK9 antibodies that block the interaction between PCSK9 and LDLR for treatment.” Opinion at 8.81-8.82.

We note that, while this is the first invalidation ruling to issue from the UPC, the court presented its analysis in a manner echoing that of the EPO’s so-called “problem-and-solution” approach, including identifying the closest prior art document (Lagace), considering the underlying problem (in short, providing a treatment for hypercholesterolemia or related conditions by targeting PCSK9 to regulate levels of LDLRs, and thereby LDLs), evaluating whether the claimed solution would have been obvious (which the court ruled it was, on a theory that where the target antigen is known, producing antibodies that bind the target is routine and not inventive), and considering whether the skilled person would have had a reasonable expectation of success (which the court ultimately ruled they would have).  The UPC thus found that, starting from the teachings of Lagace, a skilled artisan would have pursued antibodies blocking the PCSK9/LDLR interaction without the need for an inventive step.  The court did not, however, opine on the enablement of the claims at issue.

One Disclosure, Two Standards

Thus, in the span of just over a year, substantively similar claims of patents having the same disclosure were invalidated on distinctly different grounds. 

The standards articulated by the US and EP courts create  two competing – even contrasting – conditions to be met for patentability and for invalidating existing patents.  Taken at a high level, an applicant may be faced with a conundrum: cater to the U.S. enablement standard, and prepare a specification laden with working examples – and risk demonstrating obviousness, by showing the Examiner the myriad developmental, analytical, or otherwise preparatory steps that could theoretically lead to the claimed invention to be routine?  Or err on the side of unpredictability, highlight an unexpected technical effect and the difficulty of generating said invention – and risk limiting claim scope by enabling only a portion of the subject matter, severely limiting the functional breadth of the disclosure?

To meet the heightened enablement standard of the U.S. Supreme Court decision, an applicant is incentivized to bolster the detailed description of the specification, including the inclusion of comprehensive, detailed examples, specific embodiments, and experimental data, where relevant, so as to avoid being considered “research assignments.”.  Moreover, an applicant may wish to draw both narrow and broad claim scopes, wherein the broad claims are supported by detailed descriptions of the full scope of the invention, and the narrow claims relate back to specific embodiments.  Of course – and as was at issue in the U.S. Amgen decision – claims reciting functional limitations must be backed by sufficient guidance to achieve the claimed function across the full scope of the claims (“The more one claims, the more one must enable”).  Amgen, 143 S. Ct. at 1254.

Meanwhile, to meet the inventive step standard recited in theUPC opinion, an applicant must show that the claimed invention is not obvious to one of skill in the art, considering the state of the art – that the invention involved a clear inventive step in response to an existing problem.  To meet this threshold, an applicant may want to highlight significant technical contributions (including, as considered in the UPC opinion, techniques which go beyond those which “the skilled person would have routinely employed”).  Opinion at 8.72.  An applicant may further wish to include comparative data, demonstrating the advantages and/or unexpected results of the invention, compared to prior art solutions, which the UPC acknowledged in that “[a] technical effect or advantage achieved by the claimed subject matter compared to the prior art may be an indication for inventive step,” but noted that a “feature that is selected in an arbitrary way out of several possibilities cannot generally contribute to inventive step.”  Opinion at Headnote 5.  In view of the UPC opinion echoing the EPO considerations for inventive step, an applicant may also want to frame the invention in the context of “problem-solution,” and in so doing clearly state the problem and the means by which the claimed solution differs from and improves upon existing technologies.

What’s an Applicant to Do?

Striking a balance between providing a sufficiently detailed disclosure and avoiding building a roadmap to an obvious invention is no easy feat.  A rich specification which provides copious details, examples, structures and data may inadvertently provide something – perhaps an allegedly routine method, or admission or evidence of motivation – which could be used to argue that the invention lacks inventive step before the UPC, especially if the description outlines potential variations and optimizations of said invention that could appear routine and within the general level of skill in the art.  All the while, a specification lacking such details and disclosures is at risk of heightened scrutiny in the U.S., especially in more complex arts, for while “a specification may call for a reasonable amount of experimentation to make and use a patented invention,” the Court reiterated that “[w]hat is reasonable in any case will depend on the nature of the invention and the underlying art.” 143 S. Ct. 1243, 1255.

These differing standards could further conflict in the case of broad claims.  For example, in the U.S. a broad claim may be permissible if (as suggested by the Supreme Court) a diligent applicant layers the patent’s specification with examples and embodiments so as to enable a person skilled in the art to make and use the full scope of the claims.  However, such broad claims may face immediate challenge before the UPC, especially if each claim – however well supported – does not demonstrate am unexpected technical contribution over the prior art, with the examples and data serving as basis to allege a routine path for a skilled artisan motivated to create an alternative to the prior art. 

In navigating the matrix created by the respective Amgen cases, patent applicants may want to consider various aspects of their patent applications. 

• Scope of the Claims: In the past, many applicants aimed to obtain similar claim scope across various jurisdictions, from the same specification.  However, in the current legal landscape, there are different approaches to consider when evaluating claim scope, as follows:
  • US: Include broad and narrow claims alike, with independent claims of varying scope, and ensure that the broadest claims are supported by the detailed description, experimental data, and working examples. While not every claimed embodiment necessarily needs a corresponding example, the court has stressed that embodiments must be closely tied together by a general quality of a given class.  See Amgen, 143 S. Ct. at 1255, quoting The Incandescent Lamp Patent, 159 U.S. 465, 474 (1895) (“it may suffice to give an example (or a few examples) if the specification also discloses ‘some general quality … running through’ the class that gives it ‘a peculiar fitness for the particular purpose.’”)
  • UPC: Prioritize claims that clearly demonstrate or are supported by a technical advancement or effect (see UPC Opinion at 8.76-8.79, commenting on the lack of demonstrated technical effect for the limitation “[b]inds to the catalytic domain”).  Further, include language in the specification specifically supporting the problems solved by claims related to distinct improvements and explain the technical challenges that were overcome so as to distinguish inventive acts from routine acts of an alleged POSA at that time (see id. at 8.6, explaining that “[a]starting point is realistic if its teaching would have been of interest to a skilled person who, at the priority date of the patent at issue, was seeking to develop a similar product or method to that disclosed in the prior art which thus has a similar underlying problem as the claimed invention.”)
• Specification: While each portfolio – and each invention – will be approached with a different strategy, it is possible that the “standard” practice of nationalizing a shared specification in multiple countries may need reconsideration.  That is, it may be helpful for applicants, under the right circumstances, to file different specifications, on the same day, in order to ensure proper support and avoid the myriad problems described above. An applicant may wish to consider whether to:
  • US: Draft a comprehensive and detailed description to meet the heightened enablement standard of Amgen, in particular emphasizing variations, alternatives, and differing examples to support each species of a genus (for example) – with the aim to meet the Court’s description that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” Amgen, 143 S. Ct. at 1254.
  • UPC: Emphasize aspects of the invention that clearly step away from routine experimentation, and instead demonstrate a technological contribution, or distinct solution to a problem in an unexpected way.  Avoid extraneous details that could suggest a motivation or routine work in the field (See UPC Opinion at8.54 and 8.56, describing that “generating and selecting such antibodies was a matter of routine for the skilled person,” and that “the Defendant has not put forward any (technical) problems that the person skilled in the art would not have been able to overcome on the basis of their common general knowledge at the relevant date;” see also id. at 8.72, noting that “the Central Division is not convinced that the immobilisation techniques employed by Defendant go beyond techniques that the skilled person would have routinely employed at the relevant date.”)
• Functional and Structural Language: As was at issue in the Amgen patents across both jurisdictions, claims which describe inventions functionally may need different treatment from those which describe inventions structurally. Practitioners must carefully consider the following issues:
  • US: A specification can recite functional language provided the specification provides sufficient detail to enable a skilled artisan to perform the function across the entire scope of the claim.  The court is wary of allowing broad “roadmaps” of functional limitations.   See Amgen, 143 S. Ct. at 1257 (“Through trial and error, imagine that an inventor finds and discloses 26 different successful lock combinations. But imagine, too, that the inventor tries to claim much more, namely all successful combinations, while instructing others to randomly try a large set of combinations and then record the successful ones. … Sure enough, that kind of ‘roadmap’ would produce functional combinations. But it would not enable others to make and use functional combinations; it would instead leave them to ‘random trial-and-error discovery.’”) (Internal citations omitted).  Structural claims seem less problematic, but should be supported by detailed descriptions, chemical structures, and/or amino acid or nucleotide sequences, where applicable, proportionate with the breadth of the desired claims.
  • UPC:  While functional claims can be used, recent case law makes clear that functional limitations must be backed by concrete embodiments demonstrating a non-obvious contribution or effect.  (See UPC Opinion at 8.67, stating that “it is sufficient [but also necessary] for denying inventive step that the skilled person would without inventive contribution arrive at a result which is covered by the claim. In the present case, ending up with antibodies that fall under the scope of the claims of the Patent, including antibodies that bind to the catalytic domain of PCSK9, was obvious.”) With structural claims, reliance on specific feature-based limitations may help satisfy the inventive step requirement by clearly differentiating the invention from the known problem and existing solutions.

It will be interesting to see how patent applicants and practitioners adapt and evolve in response to these recent decisions, as well as what ramifications these decisions will have globally.  Because certain patent offices in other jurisdictions closely follow EP decisions to set their own examination standards, while other jurisdictions follow US standards, and some jurisdictions have followed both US and EP standards, these decisions will have ramifications beyond just the US and Europe.  Undoubtedly, patent drafting and prosecution strategies will change and practitioners will need to stay vigilant to navigate the differing standards between the U.S. and UPC.