Full judgment on patent infringement case, found in favour of Lilly

The UK Supreme Court (UKSC) has released its full judgment on the long running court case involving the product infringement of Eli Lilly and Company’s Alimta vitamin regimen patent — Actavis v Eli Lilly Case.

This news follows the unusual release of the outcome of the case in advance of the full judgement notification last week.

The full judgement shows that the UKSC found in favour of Lilly for each of the points set forward for consideration. The end result is that Actavis’ product is infringing Lilly’s patents in the UK, France, Italy and Spain.

Emma Fulton, one of the Hogan Lovells lawyers leading the case said: “Today's decision puts more emphasis on considering the invention in the patent when assessing whether a competitor infringes. It also brings UK law more closely in to line with the law in other key European countries.”

“Although the case arose in the context of pharmaceutical technology, it applies across the range of patented technologies,” added Stephen Bennett, partner at Hogan Lovells. “This is good news for patent owners who want to catch infringers that make small changes to their products to try to avoid infringement.”

“We are pleased with the UKSC’s key conclusions that confirm the Alimta vitamin regimen patent would be infringed by these generic pemetrexed products in the UK, France, Italy and Spain prior to June 2021,” confirmed Michael J. Harrington, senior vice president and general counsel for Lilly. “We continue to emphasize that protection of intellectual property rights is extremely important to the biopharmaceutical industry and the patients we serve. Intellectual property rights provide assurances of market exclusivity that help support the development of the next generation of innovative medicines to treat unmet medical needs.”

As a result of the outcome of this case new ‘Improver’ questions have been formulated through the update to the test for equivalent infringement. The new questions will ask whether the variant achieves substantially the same result in the same way as the invention; whether it is obvious to the informed reader that the variant achieves the same result in substantially the same way as the invention; and whether the reader of the patent would have concluded that there was an intention of strict compliance to the literal meaning of the claim(s) as an essential requirement of the invention.

“Importantly, the decision makes it clear that assessing the scope of protection of a patent is a two stage process: first work out what the patent claim means; and then consider whether any variant infringes by equivalence,” said partner Dan Brook of Hogan Lovells.

“This conclusion vindicates Lilly's position after five years of hard-fought litigation… We are delighted at the outcome for our client,” Brook concluded.

Background to the case as supplied by Hogan Lovells

Lilly's patent concerns the safe and effective use of a cancer drug, pemetrexed, in co-therapy with vitamin B12. Actavis' proposed products differed only in relation to the salt form of the pemetrexed. Actavis sought declarations of non-infringement in relation to the UK, French, German, Italian and Spanish patents in the UK courts.

Actavis removed the German patent from the UK litigation in 2014 after the Düsseldorf Court found that it would be infringed by Actavis. In the UK High Court, Mr Justice Arnold held that the remaining patents were not infringed and granted declarations of non-infringement to Actavis.

On appeal, the Court of Appeal refused to grant the declarations sought by Actavis on the grounds that Actavis' proposed products would indirectly infringe Lilly's patent. However, the Court of Appeal found that the patent would not be directly infringed.

As well as overturning the Court of Appeal's decision on direct infringement, the Supreme Court has upheld the Court of Appeal's decision on indirect infringement – that is Actavis' appeal was unsuccessful.

The Hogan Lovells IP team was led by London partners Daniel Brook and Stephen Bennett, with London lawyer Emma Fulton and support from Hogan Lovells French and Italian patents teams and Clifford Chance's Madrid patent team. The barrister team from 3 New Square chambers was Tom Mitcheson QC, Andrew Waugh QC and Stuart Baran.