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1 February 2018Americas

LSIPR webinar: BSKB dissects antibody patents

When it comes to patenting antibodies, “written description seems to be the big issue these days”, according to Gerald Murphy, IP partner at law firm Birch Stewart Kolasch Birch (BSKB).

Speaking during an  LSIPR webinar held on Tuesday, January 30, Murphy and BSKB associate John Heithaus discussed the issues around obtaining and enforcing patents on antibodies.

Many antibody patents have been invalidated in the US courts over the past decade, often for lack of written description. Of the requirements for a successful patent application – novelty, non-obviousness, and written description – the latter is the real challenge, explained the BSKB lawyers.

With regard to determining the novelty of antibodies, Heithaus said the question really being asked is whether the nature-based product is “not” directed to a law of nature of a natural phenomenon.

He gave the example of a beverage containing pomelo juice with an effective amount of added preservative. This new beverage will be patent eligible if it has markedly different characteristics to its natural version.

The bar for testing for obviousness was raised after the KSR case. Heithaus said the Patent Trial and Appeal Board is increasingly rejecting antibody claims on the grounds that the claim is simply the application of a known technique, or an improvement of the same. For example, decreasing the regularity of drug ingestion needed is an obvious improvement.

The main issue, according to the BSKB lawyers, is written description.

Different antibodies have different structures, so there could be a lot of different results depending on “how you put the different pieces together”, explained Murphy. Previously it was acceptable to broadly claim a genus of antibodies, as disclosing the related antigen would satisfy the written description.

But you can no longer acquire a patent with broad claims to cover these different combinations. Since  Noelle the description requires a fully categorised antigen to support the claim to an antibody, where the target antigen itself is novel.

The courts’ newly categorised antigen means that applicants can claim antibodies simply by describing the related antigen, rather than the antibody invention to be patented. This goes against the statutory quid pro quo of the patent system which “relies on one describing an invention”, according to Heithaus.

As a practitioner he sees two ways forward: either written direction requirements evolve and adapt, or examiners and the courts will continue to define antibody patents by the antibody’s relationship with the antigen.

He hazards a guess that it will go towards the latter, and said it’s “really important to see how that develops” – particularly for pharmaceutical companies, which may find their older antibody patents invalidated due to their broad claims.

In future, when companies apply for antibody patents, Murphy advises them to claim something “a little bit broader than the antibody, but don’t expect to get the world”.

Click here to listen to the webinar.

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More on this story

Americas
28 September 2017   Unlike in Europe, the lack of a plausibility threshold in the US means that those applying for patents there are more likely to be granted a broader claim.
Europe
22 March 2018   Late-filed documents will come under greater scrutiny in light of changes to the European Patent Office’s opposition procedure.
Big Pharma
6 August 2020   Antibody patenting can be a minefield for IP practitioners if they lack the most up-to-date knowledge about the best way to approach a patent application.

More on this story

Americas
28 September 2017   Unlike in Europe, the lack of a plausibility threshold in the US means that those applying for patents there are more likely to be granted a broader claim.
Europe
22 March 2018   Late-filed documents will come under greater scrutiny in light of changes to the European Patent Office’s opposition procedure.
Big Pharma
6 August 2020   Antibody patenting can be a minefield for IP practitioners if they lack the most up-to-date knowledge about the best way to approach a patent application.