Avi Toltzis is a litigation support solicitor at Powell Gilbert. He has worked on
contentious and non-contentious
intellectual property matters, and previously practised as an attorney in the US. Toltzis continues to assist with disputes involving parallel proceedings in overseas jurisdictions. He
can be contacted at:
avi.toltzis@
powellgilbert.com
Penny Gilbert is a partner at Powell Gilbert. She specialises in patent litigation, particularly in the life sciences fi eld. Her experience includes acting in the fi rst patent case to be heard by the UK Supreme Court and making referrals on the SPC regulation to the CJEU. She can be contacted at: penny.
gilbert@powellgilbert.com
the therapeutic indications covered by the MA. T e second part of the question asked whether article 3(b) precludes the grant of an SPC where the MA describes the substance as a “carrier protein”. T e CJEU had established in GlaxoSmithKline Biologicals (C-210/13) that excipients (which facilitate the formulation of a pharmaceutical product) and adjuvants (which enhance or modify the action of other active ingredients in a medication) may not be regarded as “products” under the SPC regulation, since they have no therapeutic eff ect. However, the CJEU concluded on the basis of the wording of the Synfl orix MA that protein D is neither an excipient nor an adjuvant, and that accordingly the CJEU’s restriction in GlaxoSmithKline Biologicals did not apply. Forsgren drew an analogy with Bayer CropScience
(C-11/13), where the CJEU held that a ‘safener’ in a plant protection product might have a protective activity in its own right, either directly or indirectly, meaning it could be classifi ed as an active substance. T e CJEU accepted Forsgren’s argument and therefore proposed that a carrier protein might also be characterised as an ‘active ingredient’ to the extent that it produces a pharmacological, immunological or therapeutic eff ect of its own. T e CJEU’s answer to this question expressly leſt it to the referring tribunal to determine whether, under the circumstances, protein D would meet this criterion.
It has become fashionable in recent years to disparage CJEU decisions on SPCs as obfuscatory.
Although in some respects the CJEU’s decision in Forsgren could be seen to lend further ammunition to the critics, a more productive view would be to focus on the clear message expressed by the Forsgren ruling: its emphasis on the identifi cation of an independent pharmacological, immunological or therapeutic eff ect in defi ning whether a substance is an active ingredient under the SPC regulation. In many cases applying this test will doubtless prove a diffi cult, highly fact-specifi c exercise. Leaving patent examiners to evaluate this issue on a case-by-case basis raises concerns that the CJEU’s decision is a step away from the guidance of the explanatory memorandum (COM[90] 101 fi nal–SYN 255), which envisages a harmonised, simple, transparent and non-bureaucratic application system for SPCs.
ROBODREAD /
SHUTTERSTOCK.COM
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