On July 14, 2023, Gilead filed two PIV cases in Delaware which were similar, yet curiously different. They both involve its $2B product Genvoya®(elvitegravir, cobicistat, emtricitabine, tenofovir) Tablets and one ANDA filed (ANDA 218575).

The First Complaint

Gilead filed its first Complaint against two defendants Apotex and MSN Laboratories over the 10,039,718 patent (# 1:2023cv00774). Paragraph 8 alleges: “Apotex, along with MSN, together and with subsidiaries, affiliates, agents, and partners, prepared and filed ANDA No. 218575…” It goes further to elaborate that “Apotex and MSN collaborate with respect to the development, regulatory approval, commercial manufacture, marketing, sale, offer for sale, and/or distribution of the Genvoya ANDA Product….” In addition, Gilead mentions that both defendants sent it the PIV Notice Letter.

Simple enough. It appears from the first Complaint that Apotex and MSN Laboratories collaborated on this ANDA. Collaborating with another generic company to support an ANDA happens often enough.

The Second Complaint

But then, Gilead filed a second Complaint against only Apotex and over two different patents than its first Complaint (# 1:2023cv00775). Paragraph 8 alleges: “Apotex, alone and with subsidiaries, affiliates, agents, and partners, prepared and filed ANDA No. 218575…” Gilead further mentions that Apotex sent it the PIV Notice Letter. In fact, there is not one mention of MSN Laboratories in the second Complaint.

Huh? Gilead first alleges that Apotex and MSN collaborated, then, second, states that Apotex acted alone. Both of these allegations can’t be true. (Editing note – “alone and with subsidiaries, affiliates, agents, and partners” really isn’t alone, is it?)

Clever Legal Strategy?

Having researched PIV cases for nearly 20 years, I believe that this is a first: two Complaints filed simultaneously, alleging two different origins of an ANDA. The first Complaint provides some details about MSN providing manufacturing support which may explain why there are different patents involved in the two cases and perhaps two cases, but not the ANDA origins.

It’s possible that there is genuine confusion on the part of Gilead on its origins and the true involvement of MSN. It is also possible that the two generic companies for strategic, market, or legal purposes did not want to clarify, either. Filing two cases enables Gilead to cover the two possibilities. As these cases roll along, clarity will likely surface.