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13 September 2018Big Pharma

LSIPR webinar: HGF delves into personalised healthcare patents

Personalised healthcare is a rapidly developing field, not just because of medical advancements, but also because the criteria necessary to secure second medical use patents has similarly evolved over the years, an industry webinar heard.

Laurence Gainey, patent director at HGF’s Manchester office, UK, considered the history of personalised healthcare inventions and second medical use patents in Europe during a joint webinar between LSIPR and HGF on Tuesday, September 11.

Personalised healthcare involves targeting a treatment for the right patient, at the right time, with the right dose—sparing other patients the time, expense, and side effects of an unsuitable treatment, said Gainey.

Gainey said that the patenting of personalised healthcare inventions can be “quite problematic” in Europe, as the new product must still meet the criteria of medical use claims.

In the EU, novelty of purpose for first medical use was enshrined in article 54 of the European Patent Convention (EPC), 1973. As explained by Gainey, this provision did not allow for a second or further medical use to the one specified.

But, in 1984, the Swiss Federal Institute of Intellectual Property issued an adopted statement of practice. It said that a claim to the use of an active ingredient for the manufacture of a medication may be allowed, even where it relates to the second application of a known pharmaceutical composition.

Gainey said that the European Patent Office’s (EPO) Enlarged Board of Appeal endorsed the Swiss office’s communication shortly afterwards, and from then on, patent applications were often drafted “in the Swiss format to stretch the boundaries of what is permissible under second medical use”.

Eventually, legislation caught up with legal practice, and article 54 of the amended EPC 2000 (implemented in 2007) confirmed that second medical uses are patentable as “purpose-limited product claims”.

Under the amended law, a specific use in a method of manufacture can be novel if that use was not part of the prior art, Gainey explained.

The Enlarged Board of Appeal widened the scope of second medical use patents again in 2010, when it determined that the specific use does not need to be limited to the treatment of a new illness.

Gainey said that under that decision, a different treatment of the same illness may count as novel; for example, an alternative dosage regime to that claimed by the first patent.

Finally, Gainey went on to explain that an additional hurdle to overcome when looking to obtain second medical use patents in Europe centres on what counts as a new patient group.

He said that the EPO used to adopt a “very strict stance” on this, but it has relaxed its approach over the years.

For example, in an early decision of 1987, the EPO held that the claimed patient group of a second medical use patent could not overlap with that of the prior art.

But, in 2003, the EPO held that in some circumstances, the patient group can be the same, so long as the mechanism of treatment is “completely distinct”, Gainey said.

He noted that more recent cases, such as one in 2013, have confirmed that an overlap is acceptable as long as the groups were pathologically or physiologically distinct.

Gainey concluded that, although it can be challenging to protect personalised healthcare-based inventions, European patents are obtainable and can have a significant commercial benefit—making it a worthwhile pursuit.

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More on this story

Europe
22 March 2018   Late-filed documents will come under greater scrutiny in light of changes to the European Patent Office’s opposition procedure.
Big Pharma
16 October 2018   The case of Actavis v Eli Lilly introduced “a real change in the law” and the way in which it addresses the doctrine of equivalence, according to Douglas Drysdale, partner at HGF in Glasgow, UK.