Patent Shift Predictions, Legal Landscapes of Biosimilars With Ha Kung Wong

Ha Kung Wong, JD, a partner at Venable LLP, brings a wealth of experience to the field of intellectual property law, specializing in patent and trade secret litigation. Beyond courtroom battles, his expertise extends to negotiating complex agreements for mergers, acquisitions, and collaborations across diverse industries, including pharmaceuticals, biologics, and cutting-edge fields like digital health and artificial intelligence. Wong's client roster boasts renowned names like Alkermes, Allergan, and the Bill & Melinda Gates Foundation.

The Center for Biosimilars^® delved into Wong's insights in an interview on proposed patent law changes poised to significantly impact the biosimilars sector. These changes encompass limitations on asserted patents, the potential elimination of interchangeability requirements, and increased scrutiny of pharmacy benefit managers (PBMs).

Transcript

Do you foresee any potential shifts or reforms in patent law that could positively or negatively impact the biosimilars sector in the near future?

Predicting whether there will be statutory shifts or reform in patent law is like trying to predict what will happen in the next Fast & Furious movie—you have no idea what specifically is going to happen but it's probably going to have some explosions that ultimately, will not be applicable to the real world. That being said, there are a few things I think that we might want to keep an eye on. I say "very few" only because we've seen a lot of things introduced and not a lot of follow through. There's a lot of good intentions out there, but there's not a lot of follow through. That being said, here it is.

First of all, Senators [Peter] Welch [D, Vermont], [Mike] Braun [R, Indiana], and [Amy] Klobuchar [D, Minnesota] introduced legislation in the Senate, and Representative [Jodey] Arrington [R, Texas] in the House on January 2024 that would limit the number of patents that could be asserted in a patent litigation. If this were to proceed, this may or may not have a practical effect because we've seen that most Bundled Payments for Care Improvement (BPCI) lawsuits that have been asserted are asserted on 10 or less patents. So, having an artificial limit may not make it any better. But it might. Who knows? It is certainly something to keep an eye on.

The Biosimilar Red Tape Elimination Act was introduced in July 2023 by Senators [Mike] Lee [R, Utah], [Ben Ray] Lujân [D, New Mexico], Braun, and [J.D.] Vance [R, Ohio]. That bill would eliminate the 2 separate designations of biosimilars and interchangables, which we know, exist in the US and we are the only country that does that. Every other country in the world only has 1 level of biosimilarity. It's possible if the interchangability requirement was removed, there could be greater uptake of biosimilars due to the possibility of automatic substitution at the pharmacy level, like we see with generic drugs. There may be increased confidence in biosimilars because they would be seen as perhaps closer to the reference product.

The problem is that when people hear there's a "biosimilar" but there's a higher level called "interchangable", their automatic reaction is, "Well that means biosimilars are garbage, why would I want that? I want an interchangeable. Oh, there's no interchangable? Then I don't want that product."

I think it will help with consumer confidence, patient confidence, and will help with health care provider confidence because a lot of doctors just don't know the difference.

In June 2023, Senators [Thom] Tillis [R, North Carolina] and [Chris] Coons [D, Delaware] reintroduced the Patent Eligibility and Restoration Act of 2023 to reform patentability requirements under Section 101. There, the bill seeks to clarify which inventions are eligible for patenting in the US. If that bill were to be passed, it would overturn Supreme Court decisions in Mayo, Alice, and Myriad, which we've all been talking about for 10 years. It would be really interesting to see how that would impact the pharmaceutical and biologics industry in particular.

Finally, there's been this increased congressional scrutiny of pharmacy benefit managers or PBMs. Congress has launched various investigations into PBM practices and while this isn't directly related to patent law reform, it could have a significant impact on biosimilar uptake given the preferential formulary coverage of biosimilars and how that plays a big role in whether biosimilars are used and whether cost savings are realized or not.

I've been on record saying this for a long time now. PBMs are middlemen that don't need to really be there, but at the end of the day, they end up increasing the cost for patients and it would be interesting to see if all this congressional scrutiny will lead to better cost savings for patients.