When the referring board’s written decision was issued in the case underpinning the “plausibility” referral (G 2/21) late last year, it provided much-needed certainty about how the EPO would apply G 2/21 in the future. However, that certainty has been short-lived because the opponent in that case has filed a petition for review of the decision by the Enlarged Board of Appeal.
The US Federal Circuit has given a decision that blocks a potential form of “evergreening” that pharmaceutical companies might have used to prevent launch of generic versions of their drugs through asserting later-filed method-of-use patents for the drug.
When the EPO’s Enlarged Board of Appeal issued its decision in G 2/21 (the “plausibility” referral) earlier this year, many were left wondering what the requirements were for a patent applicant/proprietor to be able to rely on post-filed evidence in support of inventive step. The referring board in the case underpinning the referral (T 116/18) has recently issued a decision setting out its interpretation of G 2/21 in detail, offering new insight into how the EPO is likely to apply this important decision in the future.
EPO Enlarged Board of Appeal set to consider in G 1/23 the degree to which enablement impacts the status of a commercially available product as state of the art
Central to the assessment of patentability at the EPO is the definition of ‘state of the art’. Article 54(2) EPC defines the state of the art as ‘everything made available to the public’ before the effective filing date of a patent application. But when the thing made available to the public is a product with a defined chemical composition, how much of that composition is made available to the public by the simple disclosure of the product? G 1/92 provided an answer but as the current referral to the EPO’s EBA shows, there are gaps that need filing.
T0435/20 demonstrates the limit of obviousness of the “standard” procedure of generating antibodies for peptide epitopes. T0435/20 also serves to teach us that non-routine methods for generating antibodies for rare or “challenging” epitopes must be fully disclosed and apply to all of the antibodies that are claimed.
The UKIPO confirms that an SPC is for the product in the marketing authorisation on which it is based and not further uses for the product
It is well known that a pharmaceutical product can find alternative uses than the application for which it was originally developed. Furthermore, further patents can be granted to additional usage and dosage regimes for such pharmaceutical products. The question considered by the Hearing Officer in this case was whether a marketing authorisation for a single active compound (safinamide) was also sufficient to support a supplementary protection certificate (SPC) application for the use of safinamide in combination with levodopa/PDI for the treatment for Parkinson’s disease.
The Court of Appeal has issued a decision in the case of Neurim and Flynn v Mylan  EWCA Civ 699 finding that the plausibility of a therapeutic effect for treating a particular form of insomnia has been demonstrated using subjective data obtained by questioning the users of the pharmaceutical product.
There has been a new referral to the CJEU from the Supreme Court of Ireland on the interpretation of Articles 3(a) and 3(c) of the European SPC Regulation in relation to combination products.