PI awarded following disagreement with EPO on added matter - Novartis v Dr Reddy's
The English Patents Court recently handed down a decision granting Novartis a preliminary injunction to prevent infringement of its second medical use patent protecting sales of its breast cancer drug everolimus (marketed as Afinitor) - Novartis Pharmaceuticals UK Limited v Dr Reddy's Laboratories (UK) Limited [2019] EWHC 92 (Pat). Dr Reddy's opposed the injunction on the basis that the patent in issue is invalid on the basis of added matter but did not otherwise dispute infringement.
What is interesting about the decision is that the High Court reached a "provisional but clear" view at the interim hearing that there is no added matter in claim 1 of the patent. This differs from the EPO's decision of September 2018 in opposition proceedings, where the patent was found to be invalid for added matter under Art 123(2) EPC (see EPO decision here). The EPO decision is currently under appeal.
Background
The patent in issue is EP(UK) 2 269 603 entitled "Treatment of breast tumours with a rapamycin derivative in combination with exemestane". It is a second medical use patent in EPC 2000 form, with claim 1 as follows:
"40-O-(2-hydroxyethyl)-rapamycin in combination with exemestane for use in the treatment of hormone receptor positive tumor, wherein in the hormone receptor positive tumor is a breast tumor." The compound 40-O-(2-hydroxyethyl)-rapamycin is also known as everolimus.
In July 2018, Dr Reddy's obtained a full label marketing authorisation for everolimus (i.e. it did not carve out a combination of everolimus in combination with exemestrane for use in breast cancer - see paragraph 4.1 of Dr Reddy's SmPC here). The SPC for everolimus per se expired on 17 January 2019, and Dr Reddy's intended to launch its full label generic everolimus after that expiry. Dr Reddy's only pleaded Ground of Invalidity in the UK proceedings is that the '603 patent is invalid on the basis of added matter because the combination and treatment claimed in claim 1 is not disclosed in the application as filed.
Novartis served expert evidence from Prof Johnston from the Royal Marsden Hospital in London to the effect that the claim was disclosed in the patent application as filed. Dr Reddy's did not object to the admission of the expert evidence, and did not serve evidence in response at the interim stage.
Decision of the EPO and Patents Court reasoning
What happened in the EPO opposition proceedings? The EPO applied the principle that selecting items from two lists means that a claim may contravene Article 123(2). This is expressed in the European Patent Office's case-law textbook in its current edition - see paragraph 1.4.2 of section II.E.1 Article 123(2) EPC). It reached the conclusion that there is no specific pointer to the specific combination therapy claimed (further detail can be found from paragraph 3.2 of the EPO's decision).
The Patents Court noted that English case law does not have the same principle expressed the same way as 1.4.2 of the handbook. It considered that "the better approach, at least in this jurisdiction, is to focus on the application of the legal test itself." [i.e. the Court should assess what is disclosed both explicitly and implicitly in the application as filed when viewed through the eyes of the skilled person]. "I do not accept that, as a general statement, it is true that a teaching which consists of a combination of two individualised lists, in other words two lists of individualised members, necessarily means that that combination is now to be treated as an un-individualised generic disclosure." The Court then assessed whether the claim was fact disclosed by the application as filed.
The Court acknowledged that the application as filed disclosed the use of rapamycin and derivatives of rapamycin for various indications, and that this involved a wide class of compounds and a wide disclosure in terms of their utility. However, the judge was of the opinion that everolimus was singled out, and was in fact the "paradigm example" to be used from that class, given that all of the in vitro and in vivo tests referred to everolimus, at least as an example. The application also disclosed the idea of using everolimus in combinations, including in combination with aromatase inhibitors for the treatment of breast cancer. Elsewhere, the specification mentions exemestane as one of a number of aromatase inhibitors. This provided the disclosure of the use of evorolimus + exemestane for the treatment of a breast tumour, and there was no added matter.
Undertakings and next steps
Dr Reddy's obtained the benefit of a cross-undertaking in damages. The undertaking would become relevant in the event that the patent is ultimately found to be invalid, and would seek to compensate Dr Reddy's for the award of the preliminary injunction. Although they did not take part in the hearing, the judge gave the Department of Health/NHS entities leave to apply for a similar cross-undertaking, and took it upon himself to write to the Department of Health/NHS to notify them of this possibility.
The judge, Birss J., also proposed writing to the EPO to notify it of the UK infringement proceedings and to request expedition of the EPO appeal. He noted that Dr Reddys are not prevented from raising additional arguments on validity at the UK trial.
What is interesting about the decision is that the High Court reached a "provisional but clear" view at the interim hearing that there is no added matter in claim 1 of the patent. This differs from the EPO's decision of September 2018 in opposition proceedings, where the patent was found to be invalid for added matter under Art 123(2) EPC (see EPO decision here). The EPO decision is currently under appeal.
Background
The patent in issue is EP(UK) 2 269 603 entitled "Treatment of breast tumours with a rapamycin derivative in combination with exemestane". It is a second medical use patent in EPC 2000 form, with claim 1 as follows:"40-O-(2-hydroxyethyl)-rapamycin in combination with exemestane for use in the treatment of hormone receptor positive tumor, wherein in the hormone receptor positive tumor is a breast tumor." The compound 40-O-(2-hydroxyethyl)-rapamycin is also known as everolimus.
In July 2018, Dr Reddy's obtained a full label marketing authorisation for everolimus (i.e. it did not carve out a combination of everolimus in combination with exemestrane for use in breast cancer - see paragraph 4.1 of Dr Reddy's SmPC here). The SPC for everolimus per se expired on 17 January 2019, and Dr Reddy's intended to launch its full label generic everolimus after that expiry. Dr Reddy's only pleaded Ground of Invalidity in the UK proceedings is that the '603 patent is invalid on the basis of added matter because the combination and treatment claimed in claim 1 is not disclosed in the application as filed.
Novartis served expert evidence from Prof Johnston from the Royal Marsden Hospital in London to the effect that the claim was disclosed in the patent application as filed. Dr Reddy's did not object to the admission of the expert evidence, and did not serve evidence in response at the interim stage.
Decision of the EPO and Patents Court reasoning
What happened in the EPO opposition proceedings? The EPO applied the principle that selecting items from two lists means that a claim may contravene Article 123(2). This is expressed in the European Patent Office's case-law textbook in its current edition - see paragraph 1.4.2 of section II.E.1 Article 123(2) EPC). It reached the conclusion that there is no specific pointer to the specific combination therapy claimed (further detail can be found from paragraph 3.2 of the EPO's decision).
The Patents Court noted that English case law does not have the same principle expressed the same way as 1.4.2 of the handbook. It considered that "the better approach, at least in this jurisdiction, is to focus on the application of the legal test itself." [i.e. the Court should assess what is disclosed both explicitly and implicitly in the application as filed when viewed through the eyes of the skilled person]. "I do not accept that, as a general statement, it is true that a teaching which consists of a combination of two individualised lists, in other words two lists of individualised members, necessarily means that that combination is now to be treated as an un-individualised generic disclosure." The Court then assessed whether the claim was fact disclosed by the application as filed.
The Court acknowledged that the application as filed disclosed the use of rapamycin and derivatives of rapamycin for various indications, and that this involved a wide class of compounds and a wide disclosure in terms of their utility. However, the judge was of the opinion that everolimus was singled out, and was in fact the "paradigm example" to be used from that class, given that all of the in vitro and in vivo tests referred to everolimus, at least as an example. The application also disclosed the idea of using everolimus in combinations, including in combination with aromatase inhibitors for the treatment of breast cancer. Elsewhere, the specification mentions exemestane as one of a number of aromatase inhibitors. This provided the disclosure of the use of evorolimus + exemestane for the treatment of a breast tumour, and there was no added matter.
Undertakings and next steps
Dr Reddy's obtained the benefit of a cross-undertaking in damages. The undertaking would become relevant in the event that the patent is ultimately found to be invalid, and would seek to compensate Dr Reddy's for the award of the preliminary injunction. Although they did not take part in the hearing, the judge gave the Department of Health/NHS entities leave to apply for a similar cross-undertaking, and took it upon himself to write to the Department of Health/NHS to notify them of this possibility.
The judge, Birss J., also proposed writing to the EPO to notify it of the UK infringement proceedings and to request expedition of the EPO appeal. He noted that Dr Reddys are not prevented from raising additional arguments on validity at the UK trial.
