(Updates with additional lawyer comment in fourth paragraph.)
Nov. 24 (Bloomberg) -- The European Union’s highest court backed extended patent protection for drugs and vaccines that are effective against multiple diseases.
“The fundamental objective” of the EU rules in question “is to ensure sufficient protection to encourage pharmaceutical research, which plays a decisive role in the continuing improvement in public health,” the EU Court of Justice, based in Luxembourg, said in a ruling today.
The case seeks to provide the pharmaceutical industry with clarity on how to interpret EU rules on so-called supplementary protection certificates, or extended patent protection, for multidisease drugs or vaccines. The value of even a few months of extra protection for a blockbuster drug can’t be understated, said Jonathan Radcliffe, a lawyer at Mayer Brown LLP in London.
The EU court “confirmed a relatively broad scope of SPC protection covering all combinations of a particular active ingredient with others, providing that the active ingredient is supported by the underlying patent,” said Will James, a lawyer at Marks & Clerk Solicitors in London. “The circumstances where you cannot obtain an SPC are now clearer.”
Extending patent protection would help drugmakers just as the competition from generic drugs reaches its peak. Through 2016, drug companies face loss of exclusivity on products with more than $170 billion of sales, according to Bloomberg Industries research. Next year drugs producing almost $50 billion in revenue face potential competition.
The extended patent protection, or SPC, can only be given to the company that owns the patent on a drug’s active ingredient. Today’s case arose after a unit of Medeva Holdings BV, which belongs to Celltech Pharma Europe Ltd., was refused such SPCs in the U.K. for multidisease vaccines that consisted of patented and non-patented active ingredients. A judge in London sought the EU court’s guidance on how to interpret the region’s SPC rules.
In a less narrow view of SPC protection than “was feared,” the EU court confirmed that SPC protection shouldn’t be possible for active ingredients “that owe nothing to the disclosure in the underlying patent,” said James.
The EU court clarified that only one SPC can be given per patent, Radcliffe said in a phone interview.
“It could have a chilling effect on the strategies life- sciences companies will have to adopt, and on their revenues,” said Radcliffe, adding in some cases multiple SPCs have been granted per patent.
The cases are: C-322/10, Medeva BV v. Comptroller-General of Patents; C-422/10, Georgetown University, University of Rochester, Loyola University of Chicago v. Comptroller-General of Patents, Designs and Trade Marks.
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