A recent judgement handed down by the UK’s highest court in a dispute between two major pharmaceutical companies is set to have potentially significant consequences for patent holders and those seeking to steer clear of granted patents.
On 12 July 2017, the Supreme Court of the United Kingdom handed down a judgment that allows greater leeway for those seeking to establish infringement of patents in the UK. In overturning the decisions of two lower courts, the judgement means that a product or process that is physically distinct from a patented product or process can still infringe a patent, if the difference is immaterial.
Lord Neuberger, acting as presiding judge, found that Actavis would infringe Eli Lilly’s patent EP(GB)1313508 by making three products (pemetrexed diacid, pemetrexed ditromethamine, pemetrexed dipotassium), even though the products were acknowledged to be chemically distinct from the compound in Lilly’s patent claims (pemetrexed disodium).
Lord Neuberger found that infringement should be assessed by addressing two issues:
i) Whether the claims are infringed as a matter of normal interpretation; and
ii) if the answer to (i) is no, there is nevertheless infringement because a product or process differs from the claimed invention in an immaterial way.
In considering the question of immaterial variation, Lord Neuberger outlined that the aspects which should be taken into account are;
i) whether, even if it is not embraced within the literal scope of a claim, a variant achieves the same result in the same way;
ii) whether a skilled person (knowing the variant achieves the same result) would find it obvious that the variant works in the same way; and
iii) whether a skilled person would regardless believe that the patentee intended that strict compliance with the literal claim meaning was an essential element of the invention.
In the case in question it was found that Actavis’s three products did not ‘literally’ infringe the claims but that they related to immaterial variations and that Lilly did not intend to exclude any pemetrexed salts.
In finding infringement, despite there being an acknowledged distinction between a product and the literal meaning of a patent’s claims, Lord Neuberger has taken steps to give effect to a ‘doctrine of equivalents’ in UK patent law, aligning the UK more with legal practice in other European jurisdictions such as Germany. Furthermore, it was also found that the corresponding French, Italian and Spanish patents would similarly be infringed.
This decision gives significantly more latitude to patentees seeking to establish infringement in situations where a competitor comes close to, but does not literally fall within, the wording of a claim.
Those seeking to steer clear of granted patents are now faced with an extra step of assessing whether their activities could be considered an “immaterial variant” of the claimed invention.