In the final of our reports from the AIPPI Annual Congress that took place in Milan in September, we look at IP issues currently facing the pharmaceutical sector. This was an industry much discussed at the event from the possible implications for Supplementary Protection Certificates (SPCs) in the UK post-Brexit to new regulations on ‘skinny labels’. Below is an overview of the points discussed.
Manisha Desai, assistant general patent counsel at Eli Lilly (US), spoke of the impacts on patentable subject matter of the US landmark rulings of Bilski v Kappos (2010), Majo v Prometheus (2012), Molecular Pathology v Myriad Genetics (2013) and Alice Corp v CLS Bank International (2014).
These Supreme Court decisions led to a two-part test for patent eligibility in the US: (1) are the claims directed to patent-eligible subject matter; and, (2) do the claim’s elements , considered both individually and as an ordered combination, transform the nature of the claims into a patent-eligible application?
Desai referenced some of the controversial decisions that had stemmed out of this approach (such as in Ariosa Diagnostics v Sequenom where a revolutionary medical test was not deemed eligible for patent protection), and suggested that the way the test was being applied was confusing, not just for the courts, but also for those drafting and examining patents.
What next for skinny labels?
Recent cases in the UK and Germany concerning skinny labels were also on the agenda on AIPPI’s ‘Pharma Day’. Here, panellists discussed two recent decisions involving Warner-Lambert Company and Actavis Group, which had provoked considerable discussion in the industry last year when the UK High Court denied an interim injunction aimed at preventing pharmacists from dispensing the generic product without making ‘reasonable endeavours’ to ensure it wasn’t being prescribed for the use claimed in the patented product.
‘Skinny labels’ (the practice of launching a generic with clear packaging that mentions only the permitted indications) and ‘Swiss-form claims’ (which also contains a medical indication with a statement of purpose) is an area of law that requires greater discussion and clarification, argued the panellists, calling for more certainty in this area.