Eli Lilly v Actavis. Mark Engelman Head of Intellectual Property

Transcription

1 Eli Lilly v Actavis Mark Engelman Head of Intellectual Property mark.engelman@hardwicke.co.uk

2 Topics 1. Literalism 2. Ely Lilly v Actavis The Facts 3. Catnic Components Ltd v Hill & Smith Ltd [1982] RPC Improver Corpn v Remington Consumer Products Ltd [1990] FSR Kirin-Amgen Inc v Hoechst Marion Roussel Ltd [2005] RPC 9 6. Ely Lilly v Activis The Law 7. Ely Lilly v Activis The Effects

3 1. Literalism Definition of LITERALISM adherence to the explicit substance of an idea or expression 'The question is,' said Alice, 'whether you can make words mean so many different things. Alice in Wonderland Lewis Carroll

4 2. Ely Lilly v Actavis The Facts Pemetrexed - an antitfolate in a disodium salt for carcinoma side effects ameliorated with vitamin B12

5 2. Ely Lilly v Actavis The Facts Actavis intended to launch its drug with (a) pemetrexed diacid, (b) pemetrexed ditromethamine, or (c) pemetrexed dipotassium but crucially not the disodium salt,

6 2. Ely Lilly v Actavis The Facts Eli Lilly argued the Actavis s product : (a) as an equivalent infringed its patent because it fell within the claims or (b) because the disodium salt is created in the course of manufacturing pemetrexed.

7 3. Catnic Components Ltd v Hill & Smith Ltd Distinction drawn between: textual infringement and infringement of the pith and marrow of the invention. "A patent specification should be given a purposive construction rather than a purely literal one understanding language in accordance with what a reasonable person would understand the author to be using the words to mean

8 3. Catnic Components Ltd v Hill & Smith Ltd

9 4. Improver Corpn v Remington Consumer Products Ltd

10 4. Improver Corpn v Remington Consumer Products Ltd Patent covered a depilatory device having a curved "helical spring" driven by a motor. The spring when rotated gripped hairs between its coils and plucked them from the skin. The alleged infringement replaced the spring with a rubber rod having slits in its surface. The question was whether the slitted rubber rod was "a helical spring".

11 4. Improver Corpn v Remington Consumer Products Ltd the Improver Questions : (1) Does a variant (to an element of a patent claim) have a material effect upon the way the invention works? If yes, the variant is outside the claim. If no (2) Would this (ie, that the variant had no material effect) have been obvious at the date of publication of the patent to a reader skilled in the art? If no, the variant is outside the claim. If yes (3) Would the reader skilled in the art nevertheless have understood from the language of the claim that the patentee intended that strict compliance with the primary meaning was an essential requirement of the invention? If yes, the variant is outside the claim.

12 4. Improver Corpn v Remington Consumer Products Ltd On the other hand, a negative answer to the last question would lead to the conclusion that the patentee was intending the word or phrase to have not a literal, but a figurative meaning (the figure being a form of synecdoche or metonymy) denoting a class of things which included the variant and the literal meaning, the latter being perhaps the most perfect, best-known or striking example of the class.

13 Held: (i) (ii) 4. Improver Corpn v Remington Consumer Products Ltd the change to a rubber rod had no material effect on the way the invention worked; and it would have been obvious to an expert that the rubber rod would work in the same way; (iii) but (iii) the expert would have understood from the patent that the patentee meant to confine his claim to a "helical spring", in its primary meaning and not in a wide generic sense. For this last reason, the rubber rod did not infringe.

14 Art.69(1) 4. Improver Corpn v Remington Consumer Products Ltd should not be interpreted as meaning that the extent of the protection is to be understood as that defined by the strict, literal meaning of the wording used in the claims, the description and drawings being employed only for the purpose of resolving an ambiguity found in the claims.

15 4. Improver Corpn v Remington Consumer Products Ltd Art.69(1) Nor should it be taken to mean that the claims serve only as a guideline and that the actual protection conferred may extend to what, from a consideration of the description and drawings by a person skilled in the art, the patent proprietor has contemplated. On the contrary, it is to be interpreted as defining a position between these extremes which combines a fair protection for the patent proprietor with a reasonable degree of legal certainty for third parties.

16 4. Improver Corpn v Remington Consumer Products Ltd Art.69(2) - Equivalents For the purpose of determining the extent of protection conferred by a European patent, due account shall be taken of any element which is equivalent to an element specified in the claims.

17 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd Technologies employed by the two parties for producing the hormone erythropoietin

18 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd C: a DNA sequence for use in securing the expression of EPO in a host cell versus D: TKT method did not involve using a "DNA sequence for use in securing expression (of EPO) in a host cell"

19 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd D made EPO by an endogenous DNA sequence coding for EPO in a human cell into which an exogenous promoter sequence has been inserted

20 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd to adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming.

21 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd Interpreting the claims of the Amgen patent in the context of its specification, the claims were concerned with the expression of EPO by a gene which is exogenous to the cell. But the genes which express EPO in cells by the TKT process are not exogenous.

22 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd The HL rejected literalism over a purposive construction (adopting Catnic): to adopt a principle of construction which actually gave effect to what the person skilled in the art would have understood the patentee to be claiming. (not what the author of the words thought them to mean cf Alice)

23 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd Additionally, if a claim is intended to cover products or processes which involve the use of technology unknown at the time the claim was drafted, then the patent specification and claims based thereon should be drafted so that a person skilled in the art would understand the description in a way which was sufficiently general to include the new technology.

24 5. Kirin-Amgen Inc v Hoechst Marion Roussel Ltd But Kiren-Amgen was not really an equivalents type case.

25 6. Ely Lilly v Activis The Law Activis is: Does K2=Na2?

26 6. Ely Lilly v Activis The Law Claim 1: Use of pemetrexed disodium in the manufacture of a medicament for use in combination therapy for inhibiting tumor growth in mammals wherein said medicament is to be administered in combination with vitamin B12 or a pharmaceutical derivative thereof [which it then specifies].

27 6. Ely Lilly v Activis The Law The central contention between Eli Lilly and Actavis was whether the words pemetrexed disodium were to be read literally or purposively? If the latter, they include either a pemetrexed diacid or a pemetrexed salt with vitamin B12, which represents the essence of the patent.

28 Neuberger LJ: 6. Ely Lilly v Activis The Law (i) does the variant infringe any of the claims as a matter of normal interpretation; and, if not, (ii) does the variant nonetheless infringe because it varies from the invention in a way or ways which is or are immaterial? (iii) If the answer to either issue is yes, there is an infringement; otherwise, there is not.

29 6. Ely Lilly v Activis The Law What does immaterial mean? Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

30 6. Ely Lilly v Activis The Law Now applying the facts: Question 1: Does the variant infringe any of the claims as a matter of normal interpretation;

31 6. Ely Lilly v Activis The Law Now applying the facts: Answer 1: No

32 6. Ely Lilly v Activis The Law Now applying the facts: Question 2: Would it be obvious to the person skilled in the art, reading the patent at the priority date, but knowing that the variant achieves substantially the same result as the invention, that it does so in substantially the same way as the invention?

33 6. Ely Lilly v Activis The Law Now applying the facts: Answer 2: The chemical variants in Actavis' product: (a) pemetrexed diacid, (b) pemetrexed ditromethamine and (c) pemetrexed dipotassium were equivalents of the disodium salt. They did not have a material effect upon the way the invention works.

34 6. Ely Lilly v Activis The Law Now applying the facts: Answer 2, Rule 1: Lord Neuberger drew upon references in its specification to the words other anti-folate drugs which have a similar effect to pemetrexed disodium.

35 6. Ely Lilly v Activis The Law Now applying the facts: Answer 2, Rule 2: He refused to take into account any exchanges between the patent office and the patentee during the prosecution of the patent.

36 6. Ely Lilly v Activis The Law Now applying the facts: Question 3: If the answer to either issue is yes, there is an infringement; otherwise, there is not. Thus, there was an infringement.

37 7. Ely Lilly v Activis The Effects The doctrine of equivalents is alive and well The prosecution history is irrelevant The wording of the specification remains important Invalidity might be dealt with the same way is this patent claim invalid because the prior art has an equivalent