Sequenom case leaves pharma confused over patent law

By Fiona BARRY contact

- Last updated on GMT

The US Patent and Trademark Office and case law have created confusion around IP
The US Patent and Trademark Office and case law have created confusion around IP

Related tags: Patent

US intellectual property (IP) rules and a string of recent court cases are reducing the types of inventions pharma companies can patent, and “calling into question entire portfolios,” says a specialist lawyer. 

A Federal Circuit decision this month struck down Sequenom’s patent for a diagnostic test, because "patent claims should not prevent the use of the basic building blocks of technology - abstract ideas, naturally occurring phenomena, and natural laws.​" This is the latest incident to narrow the scope of pharma IP claims, following interim guidance published by the US Patent and Trade Office (USPTO) last December​ and February,​ as well as high-profile cases like Myriad ​and Mayo ​(see our guide below).

The legal changes aim to solve the question of when an invention becomes different enough from a naturally occurring object to be patentable. The answer will affect the pharma industry’s ability to patent antibodies, isolated APIs, and dosage and diagnostic methods.

But the area is still a mess of confusion and contradictory decisions which the pharma world is impatient to see cleared up by further USPTO regulations and future case law, according to Eli Loots, a partner at IP firm Knobbe Martens.

What counts as ‘significantly more’?

Current USPTO rules state patent claims must amount to “significantly mor​e” than laws of nature, physical phenomena, or abstract ideas. But what counts as more is still “in the eye of the beholder,​” until more cases are tried, said Loots.

‘Can I patent it?’ in-Pharmatechnologist.com’s guide to current regulations:

For the pharma world, these patent issues make diagnostic systems unpatentable if they are considered the same as natural laws.

This affects paired diagnostics – testing patients for a gene which predicts whether a therapy will be successful – as well as algorithms around dosage. Rulings may prevent pharma companies from patenting desired thresholds of metabolites in the bloodstream after drug administration, which help decide dose regimens and whether to supplement with other medicines or halt treatment.

The upheaval goes beyond diagnostics and also affects nature-based products, from antibodies to isolated small molecules.

Under USPTO guidelines, “a generic claim to some antibodies might not be patentable,​” Loots told us. “The guidelines specify that claims to an antibody with a specific sequence, where the sequence is not known out there, could be patentable under the right decisions.​”

‘A smaller slice of the pie’

Until final guidelines are known, biopharma is narrowing the scope of its claims – an onerous task for an industry used to pursuing broad patents very early on in R&D to cut off rivals from “design-arounds​”.

Instead, companies are moving away from “trying to pre-empt the space around this natural phenomenon and more towards something that is a working commercial product.”

But these narrower claims can lower patent value and raise costs. Loots predicted the USPTO may also start shifting the burden of proof onto the applicant company, which will have to show its antibody is not the same as one among tens of thousands found in nature - essentially, “trying to prove a negative.​”

For now, the law firm is recommending to clients that they increase their number of claims when filing, and keep cases pending until courts and the USPTO settle on an interpretation of the rules. 

Related topics: Regulatory & Safety, Regulations

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