Opening the final session of today's conference, Marius Schneider (Ipvocate) addressed the topic of "Policing and enforcing IP", on how the counterfeiting industry has changed. Gone are the good old days when fakes came in by container. Now they mainly enter the European Union via post and courier services, the result of purchases made from websites. This was effectively the atomisation of counterfeit trade.
Marius gave a summary of the current state of play in terms of the scope of the new Customs Regulation and the scale of the problem it was designed to address. The destruction of small consignments of infringing goods, with minimal paperwork and bureaucracy, is the desired end -- and the law has had some success in dealing with both these goods and items entering the EU in the luggage of their owners. Marius discussed procedures, the exchange of information relating to infringing goods, and international cooperation.
Marius then described the simplified procedure for the destruction of goods -- originally optional, where the owner of the goods did not object. Further changes are on the way under the EU legislative package, particularly with regard to transit of goods that are not ostensibly destined to be put on the market in the EU.
"Second medical use claims: why are they so difficult to understand?" was the contribution of Darren Smyth (EIP). This was a fast-changing field, Darren noted, referring the ongoing pregabalin litigation and the continuing uncertainty regarding Swiss form claims. Broadly speaking, he explained, this litigation concerned an expansion of an exception to an exception.
Darren then gave a lovely, thoroughly intelligible explanation of what Swiss claims were, how they came into existence, and how they were relevant to the pregabalin patent infringement suit. He addressed the concept of "skinny labelling", where a prescribed patented medicine lists all indications except for that for which a particular use has been patented. Skinny labels have very little meaning in the real world, since the absence of an indication on the label doesn't stop the product so labelled from being prescribed for it ("off-label" use). What usually happens is that the doctor prescribes a generic product; the pharmacist then supplies the cheapest version, which is usually the generic version bearing the skinny label, which is given to the patient for treatment of the patented indication. This didn't make the patent owner very happy.
There are mental elements at play here, involving both what might be intended and what might be foreseen. But surely the doctor doesn't care which version of the right medicine the patient gets, and the pharmacist doesn't know what in particular the doctor intended the patient to be taking the medicine for. A ruling of the Court of Appeal may be needed for the clarification of this.
Who is responsible for infringement and non-infringement? If the patent owner has an obligation to allow competition for the supply of the drug for off-patent purposes, then competition law may be relevant too. Sir Richard Arnold's cunning plan is that, since the patent owner and alleged infringer can't do it all themselves, the National Health Service should be invoked, issuing instructions as to how the product should be prescribed. This may not however be welcomed by doctors, who are responsible for their own budgets too and who therefore prefer to prescribe generic products.
Jeremy Phillips then closed with his summary, "The Big IP Picture: is there one?" and we all went off for a drink ...
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