Additional post-filing data is often crucial to confirm
the technical effect of pharmaceutical patents. On 1 February 2017
the Board of Appeal of the European Patent Office will be deciding
the fate of Bristol-Myers Squibb's (BMS) patent directed to
dasatinib. The decision could have far-reaching implications on
patentability of pharmaceuticals in Europe and the usefulness of
Background to the case
The original patent application filed by BMS identified a range
of compounds by means of a general formula and include dasatinib in
a list of example compounds. Assays for the identification of
protein kinase (PTK) inhibitors were described and it was stated
that the example compounds had shown activity in one or more of
those assays, but no data for individual example compounds was
provided. In the opposition proceedings, prior art documents were
cited disclosing that other compounds falling within the general
formula are PTK inhibitors, and the claims were narrowed to focus
solely on dasatinib as a single compound and its use in treating
cancer. BMS argued that the application made it plausible that
dasatinib is a PTK inhibitor useful in the treatment of cancer and
referred to post-filing evidence verifying that fact.
First Instance Findings
The novelty of dasatinib as a single compound was never in
doubt. However, in revoking the Patent, the Opposition Division
decided that as the original application did not include data
demonstrating the activity of dasatinib, its utility was not
sufficiently disclosed and no technical effect could be attributed
to the compound. The post-filing data could not remedy that defect
and was not admitted. Thus, the medical use claims were found
insufficient and the compound per se claims found to be
directed to an obvious arbitrary selection that could have been
arrived at by trial and error and so lack an inventive step.
Admissibility of Post-filing data
It is generally accepted that supplemental post-filing data is
admissible in support of a technical effect when the application as
filed goes beyond mere speculation and instead makes it plausible
that a problem has been solved. The European Federation of
Pharmaceutical Industries and Associations (EFPIA) has commented
that in this case "the application most certainly renders
it plausible or credible that the problem of providing alternative
anti-cancer agents or alternative PTK inhibitors has been
solved." Thus, the Opposition Division's decision not
to admit the post-filing data undermines established practice for
the patenting of pharmaceutical compounds.
If the Opposition Division's findings are upheld and become
widely adopted, there could be profound implications for the
patentability of pharmaceutical inventions in Europe. Should the
ability of an applicant to file additional supporting data later be
substantially curbed, it will become essential to include
comprehensive data at the time of filing in order for the
patentability of novel compounds to be established. While, some
corporations may have the ability to delay filing patent
applications until data on all potential lead compounds has been
obtained, many others including SMEs and universities may not be in
a position to do so: it may be necessary for them to file patent
applications and publish at an early stage, i.e. as soon as the
activity of a group of compounds has been rendered credible, in
order to secure the funding for further investigations that verify
the initial findings. Also, any delay in the filing of patent
applications risks relevant information being published that
renders the innovation non-patentable. For all parties, the risks
associated with conducting research into pharmaceutical innovations
will be increased, having a knock-on effect on the availability and
price of new medicines.
The outcome of the Appeal hearing on 1 February 2017 is awaited
with bated breath by the pharmaceutical industry. We will report on
the outcome as soon as it is known.
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The UK government has not yet invoked Article 50 of the Treaty on European Union (this is likely to happen by the end of March), and the UK's actual exit from the European Union is at least two years away.
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