Biosimilars vs Bad Patents: Accessibility, Key Court Cases With Ha Kung Wong

Ha Kung Wong, JD, an intellectual property attorney specializing in intellectual property law partnered with Venable LLP, discusses the patent system and biosimilar accessibility in an interview with The Center for Biosimilars^®. He acknowledges concerns regarding "bad patents" that could limit access to biosimilars but expresses confidence that the FDA and USPTO [United States Patent and Trademark Office] will refine the system to only grant good patents.

Wong highlights specific court cases involving biosimilars, including Eylea, Tysabri and Solaris. He advises stakeholders to follow these cases as they may have a significant impact on the biosimilar market. Despite the challenges of bad patents, Wong assures us that biosimilars are continuing to enter the market and driving down health care costs.

Transcript

How does the patent system impact biosimilar accessibility and how can it be improved to better balance investor interests and the need for more affordable health care options?

By and large, the patent system is really no different with respect to biosimilar accessibility, as it is to small molecule accessibility or any other areas of life sciences.

As outlined in the Constitution, good patents help protect innovation, which in turn provides incentive for development of new life saving treatments, as well as disclosure of information to promote continued development of those treatments. The problem we have is that not all patents are good, right? There are bad patents and they can be impactful in terms of limiting health care options.

The FDA and the USPTO [United States Patent and Trademark Office] have been collaborating to provide a more robust patent system for pharmaceutical patents and more robust in terms of making sure good patents come out and not bad patents.

For instance, they propose more training and time for patent examiner's during prosecution, better examination means better patents, and they have encouraged increased disclosure of regulatory materials during prosecution.

This proposal could help to avoid patents being issued that should not be either based on not properly meeting the patentability requirements or by inappropriately overlapping with earlier issued patents, which could in turn lower the number of bad patents that biosimilars would have to contend with.

That being said, the patent system as is hasn't necessarily negatively impacted biosimilar accessibility. Biosimilars are getting to the market and are bringing prices down and providing more affordable health care, even when they don't necessarily capture large market shares.

According to the quarter for 2023 report by Samsung Bioepis, the average sales price declined on average of 41% 3 years post-biosimilar launch and over 50% in the oncology space. There's a lot of benefit here from biosimilar launches and patents aren't necessarily stopping that from happening but we should be vigilant about bad patents. We don't want those to be allowed.

We’re starting to see some of the settlements for patent cases involving ustekinumab biosimilars as well as new cases regarding aflibercept biosimilars. What other biosimilar court cases should stakeholders be watching?

Well, there are a number of them and keep in mind that a lot of these biosimilars cases are fact specific so they won't necessarily result in something that will have wide ranging impact on the industry. But I do think there are a couple that we should keep an eye on.

First of all, Eylea has 5 pending lawsuits, a number of pending IPRs [Intellectual Property Rights] and at least 5 pending aBLAs [abbreviated Biologics License Applications]. This is definitely going to be a drug to watch in terms of decisions and market impact.

Solaris, they had a first litigation related to the proposed Solaris biosimilar, SB12, which was just filed on January 3 of this year by Alexion and again Samsung Bioepis. Samsung Bioepis provided its 180 day notice of commercial marketing over 6 months ago in July of 2023, which means it could launch at risk at any point after receiving FDA approval. It was a pending aBLA that was accepted by the FDA by July of 2023 so it's possible that launch could be soon if Alexion doesn't request supplementary injunction.

There's a lot of things here, a lot of moving parts here that we want to keep an eye on to see how that impacts the process when which a biosimilar might go through if they want to be aggressive and launch at risk. There's Tysabri, which has an ongoing litigation related to that Sandoz product, Tysabri, and there's a biosimilar Tyruko, which was FDA approved in August [2023].

The preliminary junction was denied in June, Sandoz has expressed a plan to launch at risk in the first half of 2024. This would be the first biosimilar launch for Tysabri which was approved almost 20 years ago so certainly something to keep an eye on there as well.