Generic vs Generic : Glatiramer - Another Battle Ground in Making?

Momenta's Patents and Mylan's ANDA

Momenta, a wholly owned subsidiary of Johnson & Johnson, was the first to get the FDA-approval for a generic version of Teva’s Copaxone? (glatiramer acetate injection). Momenta also owned two patents which they claim relate to ways to manufacture the complex glatiramer product and which helped them gain the regulatory approval for their generic version. Momenta has now sued the other generic – Mylan/Viatris, Natco & Gland for infringement of the said patents.

The Plaint

As per the complaint available in public domain, the suit has been initiated on the basis that the plaintiff believed that the Mylan Glatiramer Acetate Products are made by a process that infringes the patents-in-suit. The complaint asserts that in-order to get the regulatory approval, the defendants would have required to adopt a manufacturing process that would infringe the patents.

Discussion

Here the first ever question that came to my mind was the maintainability of the suit. That is because, the plaintiff, not being the sponsor of the NDA to which the ANDA is referenced, but the holder of another ANDA product referencing the same RLD, shall not be entitled to the benefit of the ‘artificial infringement’ doctrine under HW provisions to initiate and maintain a suit on the basis of the ‘paper application’, without having to require to produce actual proof of infringement.

At least, the said complaint does not discuss having done any of the activity of collecting and/or generating evidence of infringement like obtaining and testing the impugned product and the like. The apparent assertion in the complaint is, the plaintiff believed that the defendants, in order to meet the regulatory requirement, would have to adopt a process that would (necessarily…???) infringe the patents-in-suit. [relevant paragraph is reproduced hereinafter]

"...66. Upon information and belief, both the 20 mg/mL and 40 mg/mL forms of the Mylan Glatiramer Acetate Product are believed to be made by a process that infringes the claims of the patents-in-suit."

Another assertion in the complaint, is the fact that Generics [UK] Ltd. (“trading as Mylan”) and Synthon B. V. (a partner of Mylan for development of their Glatiramer product for Europe) have filed oppositions before the EPO to corresponding patents in Europe. Therefore, as Mylan is allegedly actively involved in challenging the validity of the plaintiff’s patents in Europe, through their partner/subsidiary, they had the ‘knowledge’ of the patents in suit. [Reading of relevant portions of the complaint suggests to me that the fact is pitched as both – the knowledge of the patents (to a great extent) and an indirect indication that 'they infringe' (to a small extent), too].

The timing of initiation of the suit may also add to the complexity to some extent, because the later of the two patents-in-suit, was granted since Jul-2016 and the impugned product was launched in Oct-2017; while the suit has been initiated now - nearly four and a half years later.

The complaint also contends that the parties imported glatiramer products in US in quantities ‘greater than that is necessary for regulatory approval' and the parties were doing 'preparation for launch' activities not covered under safe harbor. In what context the complaint tries to correlate this with the infringement issue is not clear, except that the plaintiff may be trying to assert the patent for the pre-launch activity too.

Summary

So the question is - Shall a suit be admissible in the first place without the express evidence of infringement in or with the complaint? Are the ‘information and belief’ standard and the act of challenging the validity of a corresponding patent in foreign jurisdiction (to some extent, as discussed above), independently or together with one another, enough to institute a suit?

It is also not clear - i) if there is/can be any means or process by which a generic glatiramer product can be prepared, without having to infringe the patents-in-suit; or ii) whether the plaintiff have evidence of infringement which they have separately submitted or may produce at the later stage of the suit.

Answers to these questions may be obtained, most probably, through trials, but does this fact weigh on maintainability of the suit? Can the defendants be sent notice and be asked to appear based on the facts asserted in a plaint which does not discuss evidence of infringement? [The plaint also does not discuss any pre-suit notice being sent to the defendents.]