10 Points on US Patent Law Developments Focusing on Biotech

This is based on a talk given by David Resnick at the CIPA Life Sciences Conference on 15 November 2013.  Points 1 to 6 relate to patent eligible matter.  Points 7 to 10 relate to general patent matters.

1.  The most important developments have been in the area of patent eligible subject matter.  Section 101 is now an important ‘gatekeeper’ being used by the USPTO and the Courts to decide on what can be patented.  Essentially laws of nature and abstract ideas cannot be patented.  Recent cases have overturned settled practice in the areas of diagnostic tests and compositions of biological matter.

2.  The Labcorp, Bilski, Prometheus and Myriad cases have changed the situation dramatically for judging patent eligible matter.  The US Supreme Court decided in Labcorp v Metabolite that a claim to assaying body fluid for diagnosis was not patentable because this was a natural phenomenon.  The Federal Circuit introduced the ‘machine or transformation’ test in Bilski to determine what was patentable in such a situation, but the Supreme Court on the same case said this was not the only test, without actually defining what the test should be.  In Prometheus again a diagnostic test relating to measuring the level of a substance in the body was held to be unpatentable.  These three cases have left a lot of uncertainty as to the boundaries of eligible subject matter in the diagnostic area.

3.  Myriad held that DNA isolated from the natural state is not eligible matter.  However changing it to cDNA makes it different from nature and so cDNA is eligible matter even though the sequence of cDNA is dictated by nature.  This has led to uncertainty for other important biological materials, such as antibiotics, enzymes, isolated cells, and protein drugs.

4.  In order to overcome section 101 objections against product claims to it may be helpful to add the features of being ‘synthetic’ or ‘recombinant’.  Pairs of primers might be patentable.  Chemically modified versions of naturally occurring DNA might be patentable.

For diagnostic claims the following may be helpful

- adding a treatment step

- limiting to testing a subpopulation (e.g. a person with a particular symptom)

- using the word ‘measure’ instead of ‘determine’

- testing multiple markers

- referring to an ‘assay comprising’

- specifying the test in more detail, e.g. allowing antibody to bind, washing… etc.

- specifying a type of sample or timepoint at which it was taken.

5.  The Courts are looking at ‘law of nature’ very broadly.  In Perkin Elmer v Intema the Federal Circuit rejected as patent ineligible a test which compared first and second trimester samples to detect the likelihood of the foetus having Down’s syndrome.  In Ariosa v Sequenom a test looking at nuclei acids from a foetus in maternal blood was held to not be eligible matter.  However Myriad is presently in litigation with several parties and that should give more clarity to the law in this area.

6.  In regards to strategy for applicants, for issued patents it is probably not a good idea to go for reissue to rewrite claims in view of the uncertainty in the area.  For pending applications it would be a good idea to limit claims to make them more specific, perhaps focusing on the specific product at point of care that needs to be protected.  When filing new applications it might be a good idea review what information might be kept as a trade secret.  In addition it is worth keeping an eye on trends in what claims the USPTO is allowing to proceed to grant.

7.  It must be remembered that anything said in prosecution can be used in a claim construction proceeding.  In Biogen v GSK, Biogen failing to challenge the characterisation of the invention by the Examiner was important in claim construction.  Responding to a restriction requirement can also lead to arguments being on file that can be used against you in subsequent proceedings, as happened in Uship v United States.  It may be a better strategy to either not respond or respond without using technical arguments.

In Teva v Sandoz the average molecular weight could be measured in different ways and so the Federal Circuit invalidated certain claims as insolubly ambiguous.  Across a portfolio one needs to have a consistent approach, and perhaps also use different terms in different cases.

8.  In Hamilton Beach Brands v Sunbeam it was found surprisingly that the on-sale bar under pre-AIA rules applied even in the case of a supplier selling ‘privately’ to the company that had developed the product.  This could be different under AIA because an offer to sell also has to be ‘available to public’ under the new rules.

9.  It must be borne in mind that there are circumstances where old cases will be treated under the new law.  In particular if new claims are added which are not entitled to a pre-AIA filing date.  If such claims are introduced when bringing an application into the US national phase then it is something that cannot be fixed, and so it is better to amend claims later as a preliminary amendment.

10.  Whilst it is possible to speed up examination using prioritised examination, in practice the requirements on the applicant are onerous, and it is better to use PPH instead if possible.

You may also be interested in the related articles Top 10 Points on Patent Developments and Case Law in the US in 2013 and Top 10 Observations on US Restriction Requirements.