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Generics (t/a Mylan) v Yeda Research Doctrine of equivalents does not [yet] apply when assessing novelty

Date: 14 May 2018

By Dr. Janet Strath

 

Actavis v Lilly; The Madness Begins

 

In Autumn 2017 Patent issues we reported the introduction, in the UK,  of a doctrine of equivalents by the Supreme Court in Actavis v Eli Lilly. 

 

One of the questions opened by such a doctrine is how far to open up the claims to equivalents when the boot is on the other foot and one is considering validity of a patent.

 

This question has been considered in Generics  (t/a Mylan) v Yeda Research, in which the Patents Court held that the doctrine of equivalents does not apply when assessing novelty.

 

This represents a significant change from the previous position in English patent law, namely that claims must be construed the same way for purposes of assessing patent validity and patent infringement.

 

The patent at issue covered a dosage regimen for the administration of glatiramer acetate (GA) for the treatment of relapsing forms of multiple sclerosis (MS).

 

  • The dosage regimen consisted of three subcutaneous injections of 40 mg GA every seven days with at least one day between each injection (“40 mg TIW”).
  • Previously, GA was approved for administration in a regimen consisting of a daily subcutaneous injection of  20 mg (“20mg QD”). 
  • There was also a prior art patent reference (referred to as “Pinchasi”), that taught administration of 40 mg GA via subcutaneous injection every other day (“QOD”).

 

The claimants, Mylan and Synthon, contended that the patent was invalid on the grounds of lack of novelty, lack of inventive step and insufficiency.  The claimants had previously introduced a 20 mg GA generic product, and wanted to clear the way for the launch of a 40 mg GA generic product for which they had obtained a marketing authorisation.

 

There was no dispute that the claimants’ intended acts in relation to the claimants’ product infringed the patent if validity was upheld. 

 

Mr Justice Arnold found the patent was novel but invalid for obviousness, as the dosage regimen was nothing more than a small and simple variation on the teaching of a prior art patent. 

 

The patent of Yeda Research was exclusively licensed to Teva Pharmaceutical Industries Ltd.   Teva markets GA for the treatment of MS under the trade mark Copaxone.

 

Worldwide sales of Copaxone in the year ending 31 December 2016 were about $4.2 billion, representing nearly a fifth of Teva’s worldwide sales and a significantly higher percentage of its profits. 

 

A large proportion of prescriptions of GA were written for the 40 mg TIW regimen following the authorisation of administration of GA in accordance with the 40 mg TIW regimen.

 

Interpretation

 

For 35 years, the principles of “purposive construction” has been applied to patent claims and, since 2004, the ultimate question has been what the person skilled in the art would have understood the patentee to have used the language of the claim to mean, which involved interpreting the claim having regard to the fact that the patentee’s purpose was to describe and claim an invention. 

 

The defendants (patentees) argued that, in light of Actavis v Lilly, these decades of law should be set aside and a patent claim should be interpreted literally – in the same manner as a clause in a commercial contract – and without regard to the patentee’s purpose.  Arnold J disagreed.

 

Patents differ from commercial contracts in two key ways.

 

First, a contract is (at least in principle) a bilateral statement agreed between the contracting parties, whereas a patent is a unilateral statement made by the patentee and addressed to the class of persons represented by the person skilled in the art.

 

Secondly, whereas a contract is a document containing promises by the contracting parties to each other (in some cases for the benefit also of third parties), a patent is a document which describes and claims an invention for the purposes of establishing a legal monopoly with regard to that invention.

 

A patent [is] to be interpreted through the eyes of the person skilled in the art and [the exercise involves] interpreting the words of the claim in context. The context must include the very purpose for which the document exists, namely to describe and claim an invention.

 

Novelty

 

Mylan and Synthon argued that it remained the law that a claim lacked novelty if the prior publication disclosed subject-matter which, if performed, would infringe the claim, and that, applying Actavis v Lilly, it was sufficient that the subject-matter would infringe the claim applying the doctrine of equivalents. 

 

The defendants submitted that the claim would only lack novelty if the prior publication disclosed subject-matter which fell within the claim on its proper interpretation, i.e. it was not sufficient that the subject-matter would infringe the claim applying the doctrine of equivalents. 

 

Arnold J concluded that the defendants were correct. The Supreme Court had been concerned with infringement and not with validity. It would require another decision of the Supreme Court to supply a definitive answer to the question of whether the law of novelty had changed.

 

On the basis of normal construction, Arnold J held that a skilled person would regard the administration of 40 mg GA via subcutaneous injection every other day (“QOD”), as taught by Pinchasi, to be distinct from the 40 mg TIW regimen claimed in the patent.  Accordingly, the patent was novel. 

 

(In case the case should go further, he considered what the position would be if it was legally possible for a claim to be deprived of novelty by virtue of the doctrine of equivalents. In such circumstances, and assuming that the skilled person would consider it plausible that 40 mg TIW was efficacious as claimed by the ‘335 patent, he held that the claims would lack novelty over Pinchasi.)

 

Inventive step

 

The difference between the administration of 40 mg GA QOD as taught in the prior art patent and the 40 mg TIW regimen claimed amounted to just one dose every fortnight. 

 

Overall, Arnold J found that this was obvious to try and that the skilled person would have had a fair expectation of success.

 

No need for an Arrow declaration

 

Teva’s patent in suit was a divisional of another patent, and there were two pending divisional applications which covered the 40 mg TIW regimen for administration of GA. Mylan and Synthon sought an “Arrow” declaration “to clear the way”, but when asked why an Arrow declaration should have any greater persuasive value than a reasoned judgment on the validity of the patent in suit, they had no real answer.

Arnold J declined to grant such a declaration, finding that the defendants had not improperly sought to shield the subject-matter of the patent from scrutiny by the courts (to the contrary, they had vigorously defended the validity of the patent at issue), and an Arrow declaration would not have any greater persuasive value than his reasoned judgment on invalidity.

 

Comment

 

As the judge noted, this decision could represent a radical departure from English patent law which had dictated, prior to 12 July 2017, that a claim should be interpreted in the same manner, and had the same scope, for the purposes of considering both novelty and infringement, thereby ensuring that the patentee could not maintain a broad scope of claim for the purposes of infringement, but a narrow one for the purposes of validity.

 

 

 

 

 

 

 

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