Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, discusses the differences between patent litigation for biologics and biosimilars under the BPCIA and small-molecule drugs and their generics under the Hatch-Waxman acts.
What are the key differences between the process for resolving patent disputes under the Biologics Price Competition and Innovation Act (BPCIA) and under Hatch-Waxman?
I’m a regulatory attorney, so I’m going to address it from the perspective of a regulatory attorney. [Intellectual property, IP] attorneys could give you a number of different answers, but I think there’s really 4 main differences.
The first one is for biosimilars, there’s no patent linkage. What I mean by that is, the approval of the application does not depend on the patents. For Hatch-Waxman, there is patent linkage. If a company does not want to challenge a patent, they have to get what’s called a paragraph 3 certification and they cannot get approval for that application until the patent expires. Even if they want to challenge the patents, there’s something called a 30-month-stay, which delays approval of the application until the patent litigation runs.
For biosimilars, there’s no patent linkage. There are processes for resolving patent disputes, but those are completely separate from whether or not FDA will approve the product. That difference is something that FDA specifically requested when the legislation was passed because one of their biggest headaches is the whole Hatch-Waxman patent process. For biosimilars, they just wanted to stay completely out of that.
The second big difference is that there’s no list of patents for biosimilars. So, for small molecule drugs, you’ve got the FDA orange book. In that publication, the FDA lists all of the patents that apply to the brand product. For biosimilars, FDA has what’s called a purple book, but that does not include any of the patents. The idea is that the patents will be identified and litigated through the process that Congress set out. That’s another main difference.
I guess I said there were 4, now I’ve only got 3 [laughter]. But the third difference I would say is the BPCIA, the biosimilar patent process, is actually much more complex than the Hatch-Waxman requirements. I actually didn’t think Congress could come up with something more complex, because the Hatch-Waxman provisions are extremely complex, but they exceeded my wildest expectations and they’ve included an unbelievably complex process for biosimilars.