Posted: October 15th, 2019
Teva Pharmaceutical Industries Ltd., and Teva Denmark A/S (“Teva”) v. Mylan AB (“Mylan”), the Danish Maritime and Commercial High Court, Case number BS-38788/2018-SHR, 15 March 2019
The case concerns infringement of the patents DK/EP 2 949 335, DK/EP 2 630 962 and DK/EP 3 199 172, which are owned by Yeda Research & Development Company, Ltd., and licensed by Teva (the “Patents”), which relate to a dosage regimen for the treatment of relapsing forms of multiple sclerosis, including by injection of 40 mg glatiramer acetate three times a week with at least one day between every injection.
Teva markets glatiramer acetate under the trademark Copaxone®.
In December 2017, Mylan obtained a marketing authorisation in Denmark for the follow-on medicinal product Copemyl 40mg/ml (“Copemyl”). Mylan registered a price for Copemyl in the Danish medicinal price register in February 2018, and subsequently won a public tender effective from 1 October 2018.
During the proceedings, Mylan claimed in chief that the Patents were invalid due to lack of inventive step and for insufficiency. Mylan did not dispute that if the Patents were valid, sale etc. of Copemyl would infringe the Patents.
On the merits, Mylan’s primary argument for invalidity was that since none of the Patents contain data from clinical trials proving the technical effect of the invention, it was not made plausible at the priority date that the technical problem was solved. Instead, Mylan argued, the person skilled in the art on the priority date would in fact have serious doubts about Teva’s invention as a formerly suggested every-other-day-regimen had proven to cause greater side effects. For the same reasons, Mylan argued that Teva could not make use of post-published evidence from after the priority date to show that the technical effect of the invention was indeed achieved.
Against this, Teva argued that there exists a legal presumption of plausibility. The Patent applications contain a well-outlined protocol for a phase III-trial, which Teva had filed an application for to the U.S. Food and Drug Administration one day before the priority date to prove the technical effect of the invention. Therefore, the person skilled in the art would have found it plausible that the technical effect of the invention could work. Hence, Teva should be allowed to include post-published evidence to document the technical effect of the invention.
In addition, Mylan argued that if the person skilled in the art on the priority date would have found the inventions described in the Patent applications plausible, the Patents would be invalid for lack of inventive step because they did not contain any clinical data themselves, i.e. Mylan argued that there existed a squeeze between plausibility for insufficiency and obviousness.
Against this, Teva argued that such a squeeze does not exist since the test of whether an invention is sufficiently inventive is to be carried out based on the information available prior to the priority date only, while the plausibility test also includes the information given with the patent application.
On 15 March 2019 the Danish Maritime and Commercial High Court granted a preliminary injunction against the sale etc. of Copemyl in Denmark.
Initially, the Court noted that since the Patents were granted by the EPO, a presumption of validity exists, and no decisions from the EPO had weakened this presumption.
Specifically, based on the extensive evidence produced during the proceedings, including 5 expert testimonies, the Court concluded that there was not sufficient basis to overturn the presumption of validity and establish that the Patents were invalid.
Accordingly, the Court concluded that Teva had rendered it probable that the Patents were valid and infringed by Mylan’s sale etc. of Copemyl.
The decision has not been appealed by Mylan.
Reported by: Mikkel Vittrup, Jeppe Brinck-Jensen and Nikolai Dokkedahl, Plesner Advokatpart-nerselskab, who advised Teva during the PI proceedings in Denmark.