Part 3: Axinn Attorneys Discuss Patent Exclusivity and the BPCIA

The Center for Biosimilars^® (CfB): Hello, I'm Matthew Gavidia today on the MJH Life Sciences News Network, The Center for Biosimilars^® is pleased to welcome Ted Mathias, a partner with Axinn, Veltrop and Harkrider LLP, and Stacie L. Ropka, also a partner with Axinn, Veltrop and Harkrider LLP.

Stacie, the BPCIA [Biologics Price Competition and Innovation Act] grants 12 years of exclusivity to originator biologics. Why was this thought necessary in light of patent protections?

Ropka: Well, prior to the BPCIA act of 2009, there were numerous bills directed to providing an abbreviated pathway for the approval of follow-on biologics. And these were debated over several years starting in about 2006. Until the BPCIA came along, each of those bills just languished in Congress.

One of the hotly debated provisions of those bills was in fact the amount of exclusivity that should be provided to reference product sponsors outside of any patent protections. The various bills proposed anywhere from 5 to 14 years of exclusivity.

Reference product sponsors basically argued that the cost is so high and the time involved with developing a biologic medication is so long that patents would be insufficient to provide enough of an exclusivity period to encourage development of biologic medications, because with competition, they would not be able to make a sufficient return on their investment.

That is, patents would either expire soon after a new biologic was approved, or if there were any remaining patents, they would be more susceptible to things like design-arounds, or even invalidity challenges, and thus they would not be providing much protection from competition, and selecting 12 years was basically a compromise.

As it turns out, the vast majority of biosimilars do face patent litigation well after the expiration of the 12-year exclusivity period, making some people question whether a 12-year exclusivity period is necessary.

CfB: Stacie, additionally, can you speak on if Congress is pursuing any legislation that is related to the BPCIA in its current form.

Ropka: Yes, there are several bills pending in Congress that are intended to encourage biosimilar development and help biosimilars gain market share once they are approved and launched. One of these is called the Purple Book Continuity Act of 2019. This is a House bill that was introduced back in March 2019 by Rep Anna Eshoo (CA-D).

The bill, HR 1520, has 5 co-sponsors and enjoys bipartisan support. This bill is directed to codifying the availability of information about approved biological products that may in turn support the development of biosimilar products, and one of the provisions involves creating a list of patents available for litigation.

Now, the Hatch-Waxman Act and the BPCIA are conceptually similar, and both provide a pathway for this patent dispute resolution. Both the Hatch-Waxman Act and the BPCIA consider the submission of an abbreviated application to be what they call a technical act of infringement, which allows for the reference product sponsors to assert their patent rights by filing a complaint and starting patent litigation. This is pretty much where the similarities end.

Patent dispute resolution under Hatch-Waxman is fairly straightforward, at least because the patents that will be at issue in litigation are listed in a database known as the Orange Book. Under the BPCIA, there is no Orange Book, and the patent list is created by the reference product sponsor, and the biosimilar developer follows a series of steps prescribed by the BPCIA, which is known as the "patent dance." This patent dance is time consuming and expensive.

Now in 2014, FDA decided on its own to create a database known as the Purple Book, which currently provides a list of approved biologics and, if there are any, approved biosimilars. The Purple Book Continuity Act would, among other things, require FDA to include a list of patents in that Purple Book. This bill passed the House in May of 2019, but it has stalled in the Senate. The Biologic Patent Transparency Act is a bill in the Senate that also includes provisions for a patent list to be included in the Purple Book. It was introduced by Sen Susan Collins (ME-R) in March of 2019 and it has yet to pass the Senate.

Both the House and Senate bills are looking to encourage biosimilar development by providing the would-be biosimilar developers a heads-up regarding the potential scope of any patent litigation. There are also a number of bills intended to restrain anticompetitive conduct by the reference product sponsors, so that any biosimilars that launch will not face extra hurdles in gaining market share or market acceptance.

There are a number of these—they're both in the Senate and in the House. They've been introduced by Republicans and Democrats. One is called the Affordable Prescriptions for Patients Act. Another is called Protecting Consumer Access to Generics Act. There's probably another half dozen along this same line.

And then finally, there are a few bills directed to ensuring that biosimilar developers can obtain enough samples of the reference product to support the development of efforts for the abbreviated application for the biosimilar. When a biosimilar developer wants to pursue a biosimilar of a biologic product, they need to obtain samples of the actual biologic from the reference product sponsor.

The reference product sponsors have found many ways to prevent the exchange of those samples. If you can't have samples, you can't file an abbreviated application and there will be no biosimilar. So, Congress is stepping in, and they have a few bills that are pending right now.

There's Creating and Restoring Equal Access to Equivalent Samples; there is both a House and Senate version of that bill. There's the Fair Care Act; that's a House bill. There's the Fair Access for Safe and Timely Generics; that's also a House bill.

What all of these bills share in common is they have been introduced in their respective chambers in 2019 over the months of February to June, but they haven't gone much further, except, as I discussed, for the HR 1521 bill, regarding the Purple Book.

CfB: Lastly, Ted, do you have any thoughts on what would replace the BPCIA?

Mathias: I wouldn't expect Congress to reinvent the wheel. Congress will be under a lot of pressure to act quickly, and the path of least resistance is really just to reenact the BPCIA in its current form. But there are a number of changes based on our 10 years of experience with the BPCIA that Congress is likely to at least consider. Stacie has outlined a couple of bills that Congress has considered, such as the Purple Book bill. But in terms of really big-ticket items, there are 3 potential changes that come to mind.

The first is the 12-year exclusivity period that Stacie referred to. There's certainly an argument to be made that the period should be shortened, and although there would be a lot of opposition to shortening it, it would certainly help strengthen the market for biosimilars.

Second, there is the interchangeability designation and whether we should just get rid of it. No interchangeable has been approved, and Europe has done just fine without any sort of interchangeability designation. They just have the singular biosimilar designation. There is some evidence that biosimilar uptake in the US has been slowed by doctors having doubts about the safety of biosimilars—doubts that are not supported by the data, but just simply because they aren't deemed to be interchangeables.

So, third, there's a question whether there should be exclusivity for the first biosimilar applicant. Exclusivity has been a powerful incentive for generic drug manufacturers under the Hatch-Waxman Act, and the question is, why not for biologics? If we're looking to spur more investment in the biosimilars market, an exclusivity period is 1 way to do that.

But I think what is clear is that if the BPCIA is invalidated along with the rest of the ACA [Affordable Care Act], Congress is really going to face an interesting reckoning. It's going to have to decide whether the BPCIA struck the right balance between innovation and cost savings or whether changes need to be made in order to spur follow-on development.

CfB: To learn more, visit our website at centerforbiosimilars.com. I'm Matthew Gavidia, thanks for joining us.