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27 April 2021GenericsAlex Baldwin

UK High Court upholds Alcon glaucoma patent

The UK High Court has refused to invalidate an Alcon glaucoma treatment patent in a judgment handed down on Friday, April 23.

Justice Richard Meade rejected the arguments from a group of generics manufacturers that Alcon’s patent was invalid as either obvious or anticipated.

The patent-in-suit, EP 1 920 764, protected the drug Travoprost until August 2014, with a supplementary protection certificate (SPC) expecting to cover the patent until May 2017.

The ‘764 patent relates to the use of Travoprost for the treatment of glaucoma and ocular hypertension.

Both the patent and SPC had expired but the trial was made necessary because interim injunctions were obtained.

Two of the generics manufacturers acting as defendants— Accord UK and Aspire Pharma—had already started to develop their own versions of Travoprost so submitted to infringement, instead seeking to invalidate the patent.

Justice Meade ruled that the allegations over obviousness and anticipation had failed and upheld the patent’s validity, claiming there was no need for amendments.

Validity arguments

The generics companies accused Alcon’s patent of obviousness, referencing prior art publication ‘Stjernschantz’ as its reasoning—a paper on Phenyl substitution for Glaucoma treatment published in 1992 in Drugs of the Future co-authored by Drs Stjernschantz and Resul.

There was a disagreement between the parties as to whether Stjernschantz was significant or not. Alcon’s pharmacology expert Dr Krauss claimed that Dr Stjernschantz “was not known in the field”, but later accepted that he had personally followed Stjernschantz’s work closely.

Alcon claimed there were three key differences between its Fluprostenol Isopropyl Ester (FIE) compound and the “most promising” of the future compounds outlined in Stjernschantz.

“Taking all these matters together I reject the obviousness attack over Stjernschantz,” said Justice Meade.“I have done so on the basis of the defendants’ view of the skilled team. The defendants’ case would only have been more difficult on Alcon’s view of the skilled team.”

Alcon was represented by Andrew Waugh QC and Anna Edwards-Stuart of Bristows  and the defendants were represented by Justin Turner QC and Daniel Selmi of Innovate Legal.

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More on this story

Europe
14 April 2014   The UK High Court has invalidated two patents covering Roche’s breast cancer drug Herceptin (trastuzumab) after a challenge by generic drug maker Hospira.
Big Pharma
23 July 2019   The English High Court has ruled that a patent owned by Roche should be revoked on grounds of insufficiency.