Q&A: Patent Attorney Provides Insight Into Biosimilar Legal Challenges

In an interview with The Center for Biosimilars^®, Geoff Biegler, JD, a principal at Fish & Richardson, an intellectual property law firm, expands on his presentation on biosimilar legal challenges throughout 2022, providing insight on the inner workings of the patent dance and how a Supreme Court decision could impact future cases.

You noted that the number of new Biologics Price Competition and Innovation Act (BPCIA) filings in 2022 was significantly lower than the peak of filing during 2018 but was an increase from 2021. Do you think 2023 is in store for even more filings than 2022, and do you think we may return to 2018 levels, especially as big products, like Stelara (ustekinumab), Simponi (golimumab), and Prolia (denousmab) are approaching their market exclusivity expiration dates?

Biegler: Obviously, none of us has a crystal ball to know what's going to happen, but if we're reading the tea leaves, it seems likely are going to see an increase in the number of cases next year and then potentially going forward. And I think the starting point for that is we did see an increase in the number of biosimilar applications. Last year, it was up to 11, which was more consistent with what we saw in 2018 and 2019, prior to the COVID-19 pandemic. And that, of course, is basically the prerequisite for lawsuits in this area. Without biosimilar applications, you don't have a lawsuit. So, that sort of points up.

We’ve also seen a number of big players in this space, like Teva Pharmaceuticals and Sandoz, signaling that they are working on a pretty hefty number of new biosimilars. I think they both were in the teens in what projects they've announced they're working on. So, I'd expect we're going to see more applications in the next few years. I think those numbers of applications will continue to go up, and then resulting litigation is likely.

In the longer term, you're right. We walked through in the webinar some of the molecules that are going to start to lose exclusivity in the next decade. There's a number of big money producing molecules in there, in addition to the few that you mentioned. For example, Keytruda (pembrolizumab), which I think is the biggest selling drug in the world right now, is going to be a challenge later this decade. So, there's a number of new molecules that have the potential to fuel more applications and resulting litigation.

The last thing is that could factor into this—that'll be really interesting to watch—is the Humira (adalimumab) market. We talked in the webinar about the number of biosimilars for Humira that are going to launch this year. And it's really the first drug for which we have this high of a quantity of biosimilars launching in a similar timeframe, and there's an interchangeable Humira biosimilar that's going to be included in that. So, I think that has the potential to affect the market dynamics.

On the one hand, if Humira maintains market share in the face of all that competition that might change the calculus a little bit for people who are looking at biosimilars of other molecules. And on the flip side, if there's really good adalimumab biosimilar uptake, it might sort of help the business case for some biosimilar manufacturers for future biosimilars. So, I think that's going to be something that'll be interesting to watch and see what the impact of that is.

When discussing the 4 main patent litigations that occurred in 2022, you described some parties as going through “some steps of the patent dance” and others as going through “the full patent dance.” What do you mean by this phrasing, and can you shed some light into the inner workings of these kinds of lawsuits cases?

Biegler: So, I've got to give you a little bit of context here to make sure that this makes sense, because the statutory schema is pretty complicated here. The patent dance is a series of exchanges between the biosimilar applicant and the reference product sponsor. It generally starts when the biosimilar applicant files its biosimilar application. Like with the Hatch-Waxman Act, the actual filing of that application is an artificial act of infringement. So, theoretically, the reference product sponsor can sue for patent infringement based on that.

But the statute here prevents the reference product sponsor from filing suit right away, until the reference product sponsor sees if the biosimilar applicant is going to engage in this patent dance the from the statute. And if the biosimilar applicant chooses to engage in the patent dance, it starts with the biosimilar applicant sending the reference product sponsor a copy of its biosimilar application, and then it proceeds.

The next step is the reference product sponsor provides a list of patents that it might assert against this biosimilar product. The biosimilar applicant comes back and provides contentions on noninfringement and invalidity for those patents. The reference product sponsor comes back with responsive contentions on those issues. And then the idea is that the parties negotiate the list of patents down to what will be asserted in the first wave of litigation.

So, those are all the steps if you go through the full dance. But the Supreme Court has told us that that's all optional on the part of the biosimilar applicants. So, the biosimilar applicant can do all of that, some of that, or none of that and not even provide their biosimilar application. The effect of that is if the biosimilar applicant either doesn't dance at all or somewhere through the process decides it doesn't want to participate anymore, the ability to control the scope of the litigation as far as what patents, the number of patents, and the timing of the litigation reverts to the reference product sponsor, who then can file suit with much less limitations.

With that kind of backdrop, what we saw this year was 1 party that went through all the steps of the dance; that was in the Biogen vs Sandoz case. We saw another case where the biosimilar applicant provided its application, got the list of patents from the reference product sponsor, and then basically bowed out at that point. And then, we saw a third case, Janssen vs Amgen, where Amgen declined to give Janssen its biosimilar application, which just allowed Janssen to sue on whatever it wanted to. So, we're seeing various approaches.

As far as the inner workings, there's just a lot of strategic considerations here. From the perspective of the biosimilar, who is controlling a lot of these decisions as to what to participate in. There's a balancing act and considerations between getting certainty as to the scope of the patents that could be asserted and potentially limiting the remedies that the reference product sponsor can obtain on those patents vs as a biosimilar applicant, you are giving a lot of information very early in the process.

You could be giving them application details of your manufacturing process or your contentions on the other party's patents. These are things that in normal litigation, even in Hatch-Waxman litigation, you don't typically provide until after lawsuits have been filed and you're well into the case. So, you're giving a lot of information early that you normally would not. So, I think depending on the size of the portfolio, whether there are key patents that the biosimilar applicant thinks need to be cleared and might resolve the dispute more broadly and other considerations, there's a lot of strategy that goes into deciding whether to dance and how far in the dance to proceed.

You also mentioned during the webinar that the majority of BPCIA cases have been filed in Delaware courts. Why is this?

Biegler: You see that with a lot of patent litigation generally, but the main reason is because so many companies are incorporated in Delaware. And there's a guarantee that you can sue a company in its state of incorporation. There's been a lot of developments in venue law over the last 5 to 10 years, which basically establishes where can I sue somebody and if they don't have a presence there, is it fair that I can sue them. Delaware is one place where if companies are incorporated there, you can definitely sue them there. So, that's one reason.

The second reason is one of familiarity. The Delaware courts just have a long history of litigating patent disputes and hearing Hatch-Waxman cases and now biosimilar cases. And so I think there's a familiarity with the judges there and I think a lot of litigants feel like the judges there are a little bit more of a known quantity than perhaps judges in other districts who don't hear as many of these cases and may not have as much experience with them.

During the webinar, you brought up the Supreme Court’s preparation to weigh in on the Amgen vs Sanofi case regarding a PCSK9 antibody, saying that while it isn’t a BPCIA case, it could have implications for biosimilars. How might this decision impact biosimilars, and why should the industry keep its eye on it?

Biegler: So, this decision has the potential to impact patent law generally, significantly, depending on how it turns out. This is the first case on the enablement defense that the Supreme Court has taken, at least in the modern era. And the question the Supreme Court has taken up here relates to the full scope of the invention and whether that has to be enabled, and if so, what the standard is to show that. And this has the potential to change how we view the enablement defense, generally, but it's been particularly relevant in the biotech area over the last decade as well as a related defense called written description.

The case itself is actually about biologics. It's about Amgen's Repatha (evolocumab) and Sanofi's Praluent (alirocumab). They're both antibodies, and they both target the same antigen in the body, which is PCSK9. And the story is that Amgen made certain antibodies that bound to this PCSK9, including Repatha, but they effectively claimed all antibodies that bind to PCSK9, and that would encompass Praluent, even though I think there's no dispute that Amgen never actually made that exact antibody.

Sanofi basically convinced the district court and then the Federal Circuit that Amgen had claimed too much or claimed too broadly, more than invented, and that it hadn't enabled sort of the "full scope of the claim." In other words, the patent might teach you how to make and use Repatha, but it didn't teach you how to make and use general antibodies that bind to this particular target. So, that was the holding below. And now the Supreme Court is going to consider whether, in fact, the decision of the patent was not enabled or that didn't teach how to make antibodies generally that bind to this target.

So, this could have a huge impact in competitor biotech cases, where you often don't have the same antibody or protein that your competitor does, but you might be trying to target the same target in the body. That's basically what happened here. And when one company claims broadly and if those patent claims are okay, they often will go after competitors who are pursuing a drug to the same target even though it's a different drug.

In biosimilar cases, typically there's less ability to actually change the structure of the protein. Usually, you have to have the same one. But it has the potential to significantly impact how broadly reference product sponsors (RPSs) can claim inventions related to their product generally. So, this could carry over to, for instance, formulation patents, manufacturing patents, and a whole host of other patents and affect how broadly the RPSs are allowed to claim relative to exactly what it was that they made and disclosed in in their patent.

So, it's going to be really impactful in the entire patent world, depending on how it comes out. But I think particularly in biotech and in biosimilars litigation, it's going to be significant potentially.

In August 2022, an antitrust claim against AbbVie’s practices using patent litigation to postpone adalimumab biosimilar competition in the United States was dismissed. The case claimed that AbbVie was creating patent thickets and pay-for-delay deals to prevent competition from entering the market, but the court said AbbVie’s actions did not count as anticompetitive practices. What were the reasons for the court’s decision, and what implications could it have for future anticompetition claims?

Biegler: There's a lot to unpack with this one. I'll try to keep it fairly brief. So, the plaintiffs here had basically argued that AbbVie violated antitrust laws by using what are called thickets of patents to block biosimilar competition. And in this case, AbbVie had over 130 patents that it said covered Humira that it could potentially assert against the biosimilar maker. So, what the plaintiff said was, "Look, the sheer number of patents here deterred biosimilar competition improperly." And within that large group of patents, a lot of them are really "weak." That's the way that they were characterized.

So, the argument was, it wasn't just the fact of having the patents that was how AbbVie was preventing competition; it was the sheer size of their portfolio and their ability to get patents that were not particularly strong just to deter biosimilar competition. Just the sheer amount of work that the biosimilar manufacturers had to do to get past all these patents was the activity that was alleged to be anticompetitive.

The Seventh Circuit said, essentially, that they relied on the Noerr-Pennington doctrine, which protects companies from liability from antitrust litigation when the party petitions the government, which has been understood to mean also getting a patent and asserting a patent as long as it's not a sham litigation. What the Seventh Circuit said here basically was the number of patents doesn't matter. I think, as the Court said, "What's wrong with having a lot of patents?" The patent laws do not set a cap on the number of patents any one person can hold. So, the court was not moved by the argument that the sheer number could be anti-competitive.

The court also did not buy into the idea that it mattered if some of the patents were "weak." The court said, "Look, patents are either valid or invalid. They're broad or narrow. And there's not really any such thing as a weak patent. It's either valid or invalid, and it might be narrower if it's weaker. But in any event, the First Amendment protects AbbVie and others' rights to assert patents, weak or not weak." So, that was the basic structure of the opinion on patent thickets.

As to what it means going forward, I don't know that it's going to mark the end of arguments about patent thickets. What it seems to have done, unless another circuit goes in a different direction, is anyone who's going to raise a challenge like this is going to have to do more probably than point to sheer numbers, because that is really what the court was not buying—that the sheer number was a problem. The court basically said, "How do we know when we're at one too many? Where is the line? It's not something that we can actually determine." There might be more challenges to these large portfolios that some of these companies hold on their biologics, but the theory is going to probably have to change.

On the other piece, on the pay-for-delay, the scenario was that AbbVie had allowed particular biosimilar manufacturers earlier entry into the EU market, then into the US market, and the allegation was that letting them in the EU market was essentially a reverse payment, that AbbVie was giving biosimilar manufacturers something of value, that was getting into the EU market early, in exchange for delaying their entry into the US market. And the Seventh Circuit said, there's differences in patent laws between the 2 jurisdictions and that different dates could be a result of that. And basically, it was too speculative to say that this was some actual reverse payment, as opposed to just the result of a good faith or arm's length negotiation between the parties, where they ended up giving an earlier date in one jurisdiction than in another.

So, on that piece, again, this is just 1 decision from 1 circuit, and other circuits can always go in a different direction. But the takeaway, at least in the Seventh Circuit, is that if parties simply agree to entry dates in different places, that's probably not going to be enough to constitute a payment. I think the court here seemed like it wanted to see a more concrete payment as the basis of a reverse payment claim, as opposed to just the party selecting entry dates in different places.

To read more about the webinar, click here.

To view the full webinar on the Fish & Richardson website, click here.