When an ANDA filer settles its PIV case with the brand company, they expect to have certainty as to how the parties proceed from there. In fact, the settlement should bring at least some certainty as to launch date into the PIV Market. But two recent cases suggest that maybe how the settlement plays out is not really according to plan. Perhaps settlements are more fragile than what they seem to be.

Development License Agreement

This story is common in the PIV Market:

• (1) A company (in this case Grünenthal) invents a patent(s) for a pharmaceutical product (Nucynta® ER(tapentadol));
• (2) Grünenthal prefers to license its patents and product to a US based firm (Janssen) and they execute a License Agreement in 2003;
• (3) Instead of Grünenthal, Janssen brings the product to market and sells it, profiting both Janssen and Grünenthal;
• (4) Years later, in 2015, Janssen sheds the product from its portfolio to Depomed by selling the License Agreement (who in turns sells it to Collegium) with the blessing of Grünenthal.
• Collegium “runs the product” for its waning years at the end of its product’s life cycle while sending along royalty payments to Grünenthal.

Authorized Generic Agreement

What is also a common story in the PIV Market: After a PIV cases have been filed, years of litigation, and continued anxiety for all parties, parties typically settle their cases. One of these settlement agreements may come in the form of an Authorized Generic Agreement. In this case, Collegium entered into such an Agreement with Hikma in 2024.

Authorized Generics have been around for 20+ years – the idea is that the brand company authorizes one generic company as a partner. The generic company sells the product as a generic and sends along some royalties to the brand company. Without them, brand companies would get nothing from the generic market, and, in their eyes, something is better than nothing. Sometimes, it means that the brand company simply repackages its own brand as a generic to sell it as a generic.

Under this Agreement, Hikma becomes an authorized distributor of the generic form of (Nucynta® ER(tapentadol).

No One Told Grünenthal

While not completely clear whether Grünenthal knew about the Authorized Generic Agreement, it apparently learned of an imminent launch of the generic of tapentadol when Collegium and Hikma issued a joint press release touting their partnership and its imminent launch. This Agreement has not set well with Grünenthal.

Shortly after the press release, Grünenthal filed a patent infringement suit against Collegium and Hikma. They seek to protect their two Orange Book patents which expire in 2028-2029.

Of course, though we don’t know the private conversations among these three companies, but it does beg the questions regarding communication amongst them. The suit makes it clear that Grünenthal believes its patents are still valid and hasn’t given up on them.