Case Name: Actavis UK Ltd v Eli Lilly & Co [2017] United Kingdom Supreme Court 48

Citation:  [2017] UKSC 48

Court: Supreme Court of the United Kingdom

Corum/Judges: Lord Neuberger, Lord Mance, Lord Clarke, Lord Sumption, Lord Hodge

Introduction

Patents balance invention drive with public access to new technologies. This equilibrium depends on claim construction-interpreting patent claim scope. The environment changed in 2017 when the UK Supreme Court adopted a more comprehensive and purposeful infringement assessment process in Actavis v. Eli Lilly. The case assessed whether Actavis’ proposed generic cancer treatment drug infringed Eli Lilly’s patent, despite chemical differences. This ruling reestablished the idea of equivalents in UK patent law and realigned it with the European Patent Convention (EPC).

Facts of the case

Eli Lilly owned a patent for folic acid, vitamin B12, and pemetrexed disodium cancer treatment, this mixture decreased chemotherapy adverse effects. Actavis intended to sell generic drugs in Europe and the UK. It wanted dipotassium, ditromethamine and pemetrexed diacids instead of disodium.

Actavis argued their medication did not breach Eli Lilly’s patent since it lacked pemetrexed disodium. Actavis requested the courts rule that their products did not breach Eli Lilly’s patent. Eli Lilly rebutted. Actavis stated that their drugs performed like their patented drug despite employing different chemical salts. Actavis was reportedly violating its patent, but not exactly.

The UK Supreme Court heard this case. Although Actavis employs different chemical salts, do its medications breach Eli Lilly’s patent? Simply put, the court had to evaluate if a similar product that performs the same task in the same way violated the patent, even if it is not covered.

After the case, courts evaluate patent infringement differently, especially when the accused infringing object works similarly.

Issues

1. Determining whether Actavis’s products, utilising various salt forms of pemetrexed, are encompassed by the scope of Eli Lilly’s patent claims based on a literal interpretation.
2. Determining whether these products violated Eli Lilly’s patent under the law of equivalents, although not constituting literal infringement.
3. What is the appropriate methodology for claim construction under UK patent law, particularly considering Article 69 of the European Patent Convention (EPC) and the accompanying protocol on its interpretation?
4. Should UK courts implement a unified European methodology for equivalence and purposive interpretation of claims?

Judgment of the UK Supreme Court

Resolution Date: July 12, 2017

Delivered by: Lord Neuberger (President)

Regarding Literal Infringement

The Supreme Court concurred with the lower courts that Actavis’s products did not violate the patent. The assertion identified “pemetrexed disodium” a specific chemical component, while the Actavis products utilise other salts. Therefore, based on the rigorous literal infringement of the claims, no infringement occurred.

Regarding Infringement by Equivalents

This encapsulates the essence of the Supreme Court’s groundbreaking decision. The court determined that:

Infringement may arise even if the variant does not conform to the literal interpretation of the claim, provided it is deemed an equivalent. The Court established a novel three-part criterion to ascertain if a product or procedure violates a patent through equivalence:

Three-step test for equivalence: 

1. Does the variant provide a substantially identical outcome through a substantially similar method as the invention?
2. Indeed, all the salt formulations of pemetrexed utilised by Actavis exhibit the same therapeutic efficacy.
3. Would it be apparent to a person proficient in the field that this variant attains the identical outcome? A proficient individual would discern that several salt forms would fulfil the same biological role. 
4. Would the individual have determined that strict adherence to the precise language of the claim (pemetrexed disodium) constituted a requisite condition? No. The explicit reference to “disodium” was not intended to preclude all other types of salt.

Consequently, Actavis’s products were determined to violate Eli Lilly’s patent by equivalency, although not employing the precise terminology.

Alignment with the EPC

1. The Court underscored that its revised methodology is consistent with Article 69 of the EPC and the Protocol of its Interpretation, which seek to achieve equilibrium between equitable protection for the patentee and legal certainty for third parties.
2. This result aligned UK law with the treatment of equivalents by Courts in Germany, the Netherlands, and France, facilitating the harmonisation of patent law across Europe

Effect on Prosecution History Estoppel 

The Supreme Court additionally dismissed the notion that statements made during patent prosecution (prosecution history) should often constrain claim interpretation, save when:

1. The assertions are unequivocal, and
2. They explicitly limit the extent of the claim.
3. This limits the applicability of prosecution history estoppel in the UK.
4. The Supreme Court rejected Actavis’s appeal.

Actavis’s products were determined to infringe upon Eli Lilly’s patent designations in the UK, France, Italy, and Spain by equivalence.

The Doctrine of Equivalence has been restored in UK law, having been dormant since the house of Lords ruling the Catnic v. Hill & Smith Ltd. (1982), and is now explicitly included in the infringement analysis.

Conclusive Judgement

Redefining infringement in Actavis v. Eli Lilly (2017) was a turning point in UK patent law.

Substantial functionality may outweigh literal distinctions in some cases, increasing patentee protection. However, it challenges generic producers and raises concerns about claim interpretation predictability. The UK Supreme Court resolved the dispute and redefined patent enforcement by complying with European Standards.

References

1. Actavis UK Ltd v Eli Lilly & Co [2017] UKSC 48, UK Supreme Court Judgement: http://www.supremecourt.uk/cases/docs/uksc-2017-0005-judgement.pdf
2. European Patent Convention (EPC) – Article 69 and Protocol on Interpretation: http://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar69.html
3. Catnic Components Ltd v Hill & Smith Ltd [1982] RPC 183 (HL)
4. Lord Neuberger, speech on patent interpretation (2017): http://www.supremecourt.uk/docs/speech-170706.pdf
5. Analysis by Chartered Institute of Patent Attorneys (CIPA): “Actavis v Eli Lilly” http://www.cipa.org.uk