Posts by: Mikael Henriksson | (2) posts

New EPO practice on the patentability of surgical methods

The Enlarged Board of Appeal of the European Patent Office has in its latest decision G 1/07 of 15 February 2010 provided guidelines on the exception to patentability on methods for treatment of the body by surgery. The purpose of this exclusion is to free the medical profession from constraints by patents. The context of this decision relates to methods for MRI imaging of lung and heart vasculature, involving as one of many steps the administration of an imaging agent to a patient’s body. One embodiment involves injection of the imaging agent into the heart.

It has been questioned whether the current practice that the presence of a single surgical step in a multi-step method excludes this method from patentability is appropriate. The present decision makes it clear that a method is excluded from patentability if it involves at least one method step for treatment of a body by surgery or therapy.

Until now, the lower instances have developed two different lines of interpreting the exception to patentability on methods for treatment of the body by surgery. The first, and dominating, interpretation has been that it is the nature of the intervention that is decisive, i.e. what actual operations are performed on the body. The second, dissenting interpretation has been that it is the purpose of the intervention that is relevant, or more precisely whether or not the method is intended to, or suitable for maintaining or restoring health, physical integrity or physical well-being.

The present decision emphasizes that it is the nature of the intervention that is decisive, but it is also recognized that this should not be so broadly interpreted so as to exclude safe routine techniques, such as hair removal by optical radiation, from patentability. When determining its nature, a guiding factor may be the complexity of the invasive step, including the required medical expertise and the health risks involved. In this particular case, however, the invasive step represents a substantial physical intervention on the body, which requires professional medical expertise to be carried out and which entails a substantial health risk even when carried out with the required professional care and expertise. This step is therefore of a surgical nature regardless of its purpose, and methods comprising this step are as a consequence excluded from patentability as methods for treatment of the body by surgery.

Although some remedies, such as disclaimers, may be available if a claimed method is held to be a method for treatment of the body by surgery, this decision reinforces the rather strict European view on the patentability of inventions involving a step that is surgical in its nature. It therefore remains of key importance to word the specification and the claims carefully when setting out to protect such inventions by a European patent.

Mikael Henriksson, European Patent Attorney

When is sixty days from now? – Cheap and expensive strategies when being late

Ever been late? Then you know that there are two basic types of strategies for handling the situation: I Was Not Late and It Was Not My Fault. These two strategies are well illustrated in some recent cases concerning applications for patent term extension before the US Patent and Trademark Office, one of them involving AstraZeneca.

I Was Not Late
Calculating deadlines is not always straightforward. One problem is when to start counting, i.e. what day is day no. 1? In patent law, it is common practice that a term in days shall start counting on the following day. This is also how AstraZeneca, and many others at that time, interpreted the deadline of within sixty days from the date of governmental approval when they filed their applications for patent term extension concerning Prilosec OTC (US patent 5,817,338) and Symbicort (US patent 5,674,860) on the very last day.

The US Patent and Trademark Office denied these applications, one of the reasons being that the applications were filed one day late. The Office explains that this specific statute (35 USC §156) requires that the application is submitted “within the sixty-day period beginning on the date the product received [the relevant approval]“. Applying the I Was Not Late strategy, AstraZeneca have challenged these decisions. They argue that the US Patent and Trademark Office has suddenly and retroactively changed their practice of calculating the deadline, and thereby deemed timely filed applications as being late.

It Was Not My Fault (also known as The Dog Ate My Homework)
So, what if you realise that you are already late? The standard remedy in patent law is to pay a fee, and sometimes explain the unintentional delay. The fee is typically considerable, but not unreasonable (currently in the range of €210-550 at the European Patent Office). The Medicines Company filed their application for patent term extension concerning Angiomax (US patent 5,196,404) 61 days after the date of governmental approval (which in view of the AstraZeneca cases may be regarded as day 62).

The application was dismissed by the US Patent and Trademark Office as being late filed, but the Medicines Company have certainly explored their options for changing this outcome and protect their yearly sales of above $300 million for Angiomax. After intensive lobbying by The Medicines Company, the House of Representatives has recently passed an act with the suggestive name “Responsive Government Act of 2008″ (H.R. 6344), also known as “Dog Ate My Homework Act”. If passed by the Senate and signed into law by the President, this act retroactively allows late filing of an application for patent term extension for three days against a fee, provided that the delay can be explained as unintentional.

And the fee? $65 million. Being late can be costly too!

Mikael Henriksson, European Patent Attorney

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