Analysis: Kymab’s ‘patent bargain’ clarification and why it matters

Yesterday’s UK Supreme Court  decision in Kymab v Regeneron is expected to have profound implications for innovative life sciences companies, according to lawyers.

In a 4-1 ruling, the Supreme Court allowed Kymab’s appeal, declaring that two of Regeneron’s patents, which cover transgenic mice, were invalid for lack of sufficient disclosure.

The requirement for sufficiency lies at the heart of this decision, said Barbara Fleck, partner at  Appleyard Lees.

“The judgement emphasises that, for a product claim, sufficiency requires that the disclosure in a patent should enable substantially all products within the scope of a product claim to be made by the skilled person at the priority date, regardless of any ground-breaking contribution achieved by the invention,” said Fleck.

She added that the issue of sufficient disclosure is often contentious in proceedings relating to biotech patent applications or patents and “therefore, this decision on sufficiency by the Supreme Court is of great importance to the biotech industry”.

For Penny Gilbert, partner at  Powell Gilbert and part of the team representing Kymab, the case raised “fundamentally important questions of patent law” relevant to a wide variety of UK life sciences companies.

“It is reassuring that the UK court has confirmed that the law on sufficiency is in line with that of the European Patent Office (EPO),” said Gilbert. “The judgment also provides clarification that a principle of general application will only save a broad claim scope if it is likely to enable products across the range to be made.”

What does this mean for patentees?

According to Glyn Truscott, partner at  Elkington + Fife, yesterday’s judgment reduces the ability of a patentee to “save” a broad claim in the UK by arguing that the scope is justified by the broad impact of the invention.

“Although such a so-called ‘principle of general application’ can still be used to justify a broad claim, this is open to challenge that a significant and relevant part of the claimed range was in fact not enabled at the priority date,” he said.

The clear message from the judgment, said Nicole Jadeja, partner at  Pinsent Masons, is that applicants “take a risk if they file patent applications based on aspiration and which are not commensurate with their technical contribution”.

Practically speaking, the judgment reinforces the need for two things in a patent application with what might be viewed as broad claims, noted Truscott.

“First, as much exemplification as can realistically be included, with worked examples spread across the desired claim scope. Second, the need for carefully-crafted fall back positions in between the broadest desired claim scope and the fine detail of the particular examples,” he advised.

Beatriz San Martin, partner at  Arnold & Porter, added that, following the decision, “one of the challenges for patent attorneys crafting claims that rely on a principle of general application will be in ensuring that the claims will enable the whole range of products within the scope of the claim in order to avoid the claim being invalidated”.

To some extent, said Truscott, this reflects the age-old question of ‘when to file’—“file too soon and there may not be enough exemplification to enable the claims that you want, but file too late and run the risk of somebody else publishing the same or similar development before you file”.

He added: “This will remain a judgement call based on the facts of each particular case. Today’s Supreme Court decision is another piece of the puzzle to consider when making this call at the time of filing.”

The patent bargain

San Martin is surprised by Lord Brigg’s view of what is meant by the patent bargain.

A patent reflects a bargain between the inventor and the public, where the inventor gains a time-limited monopoly and the public gains the ability to make the product after the expiry of the monopoly, according to the court.

As part of the bargain, inventors must publish sufficient information to enable a skilled member of the public to make the product, ensuring that patent owners only gain legal protection which is proportional to their contribution to the art.

Briggs describes it as being “in the case of a product claim, the contribution to the art is the product which is enabled to be made by the disclosure, and not the invention itself”.

This contrasts with the Court of Appeal’s view that the patent bargain requires the reward given to the patentee should be commensurate with the contribution which the invention makes to the art.

“Indeed, it is in stark contrast to how most IP practitioners refer to the patent bargain—the reward being commensurate with the technical contribution made,” said San Martin.

There is a sense of unfairness to the decision for patentees with ground-breaking inventions, said San Martin, in that the reward may not necessarily be commensurate with the technical contribution.

“Lord Briggs accepts that the effect of the ruling will give the patentee ‘scant and short-lived reward for their efforts and ingenuity’. However, he considers it settled law that what matters is that the disclosure in the patent, together with the common general knowledge, is sufficient to enable the skilled person to make substantially the whole of the range of products within the scope of the claim,” she added.

Jadeja added: “This is the second judgment from the UK Supreme Court, in around 18 months, which focuses on the fundamental ‘bargain’ ... and is a stark reminder to patentees that any period of exclusivity is granted in return for disclosing enough information about the invention,” said Jadeja.

In November 2018, the Supreme Court  ruled in Warner-Lambert v Actavis, dismissing Warner-Lambert’s appeal in its pregabalin patent dispute with Actavis, while clarifying the role of plausibility in the sufficiency of patent applications.

EPO case

But, there may yet be a final twist to the story, said Truscott. The parallel appeal proceedings at the EPO for the European patent number 2,264,163 are ongoing and a hearing in that appeal has not yet been scheduled.

The Board of Appeal of the EPO’s decision won’t change the Supreme Court’s finding on the UK patent, but it “will determine whether there is a patent for the parties to fight over elsewhere in Europe”, he added.