MCC: We just passed the three-year anniversary of the Supreme Court’s ruling in Mayo v. Prometheus. How much of a game-changer is this case?
Maslowski: The law tends to be a slow-moving animal, so at this point, it’s still hard to say whether Mayo is a big game-changer. Its impact continues to evolve, and with the subsequent Myriad and Alice decisions, we're still getting guidance from the Supreme Court on the Section 101 issue. What is clear, however, is that Section 101 has become a big issue not only in the computer and electrical arts, but it is also taking a more prominent role in the chemical and biological arts.
In the personalized medicine diagnostic area, which is what Mayo was about, we've certainly seen decisions on some fact patterns, but they don’t yet draw a definitive boundary line as to patentable and unpatentable subject matter. We're still waiting for new cases to more clearly define that boundary, and to be honest, even the U.S. Patent and Trademark Office, with its ever-changing guidelines on Section 101, seems a bit uncertain. So, there’s a lot to learn in the coming years.
MCC: Give us some of the context leading up to the Supreme Court’s rulings in Mayo and Myriad.
Maslowski: The full context for the Mayo decision and the line on patentable subject matter goes back quite a number of years – more than 150 to be more precise. The O'Reilly v. Morse and Nielson v. Harford decisions from the mid-1800s are still cited on the issue of patentability, with each of these cases on opposite ends of the spectrum. Preemption, which is an important consideration in Section 101 cases, has at least part of its genesis in the O'Reilly case, and in view of that, it stands to continue to play an important role going forward. It set the precedent against the patentability of a general method for transmitting information by use of electromagnetic force, reasoning that patenting a method with such broad application would preempt others from using the idea, even for applications that the inventor Morse never imagined.
I tend to think of Nielson as the counterbalance of O'Reilly. It is importantly distinguishable by virtue of its more limited (and successful) claim in patenting a blast furnace, meaning an apparatus for blowing hot air, rather than the simple idea of blowing hot air. So, the runway leading up to Mayo and Myriad has been quite a long one, but I don’t think anyone would say we are anywhere near the end of it. And I might add that it’s truly impressive that 150-year-old cases still have a place in today’s decisions from the Court on patentable subject matter.
MCC: Keeping our focus on the Supreme Court level, what does Mayo add to the current Section 101 analysis?
Maslowski: By my reading of the decision, Mayo brings us a step closer to identifying a more formulaic approach to the 101 issue. Certainly, the later Myriad and Alice cases attempted to apply this Mayo test, and there are others coming down the pike that will shine light on the relevant test. In that sense, it's obviously a real positive that the Court is attempting to provide boundaries around this idea. But it’s equally obvious that we can’t pretend that any court-created test will always fit well into future inventions. We’ll just have to wait and see how the test holds up as we go forward.
MCC: The USPTO released guidelines a few months after the Mayo decision, and then revised guidelines came out in December. How is this guidance playing out on the ground?
Maslowski: The guidelines are helpful in their attempt to explain recent Section 101 cases and then provide concrete examples as to the Patent Office’s views on patent eligibility, all of which should help in close-call situations. As patent litigators, we have to recognize that we don't yet know whether the Federal Circuit and/or Supreme Court will agree with the way the Patent Office has written the guidelines, and, obviously, the application of the test will vary from examiner to examiner. While those in the industry don’t welcome the uncertainty, we do recognize that this is how the law can work.
In the life sciences field, Section 101 issues are slowly creeping outside their usual scope. For example, outside the area of diagnostic and personalized medicine, I've seen attempts by patent lawyers to creatively import Section 101 into what I'll call “traditional” biotech or pharmaceutical cases. They are implicating Section 101 under the current law, even though the subject treatments aren’t new – in fact, many have been around for decades. So, we’re seeing a lot of litigation around these issues.
MCC: It’s been five years since passage of the Affordable Care Act and the amendments to the Public Health Services Act, creating the abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. What was the intent of the amendment, and what is its impact on manufacturers of FDA-approved biological products?
Maslowski: My understanding of the intent of the amendment is twofold. First, it was to enable generic-like competition and provide a lower-cost way for follow-on manufacturers to seek approval to make copies of an already-approved biologic drug. Secondly, there was also an incentive to protect the investment that companies make in developing these new drugs by providing a period of market exclusivity.
One thing that is nearly certain is that biosimilar drugs are coming. In fact, one has been approved but is not yet launched for marketing in the U.S. So the overall impact on the branded side with these biologics remains to be seen, for instance, in terms of how pricing will be affected by the introduction of biosimilar drugs. And it’s important to understand that the new biosimilar versions are not necessarily the exact same biologic drug that the innovator company is selling.
Taking that point a step further, a small molecule drug is basically a chemical compound that can be made in a test tube. If you make a small molecule drug just like an established branded drug, you can represent that they're essentially identical. Biologics, on the other hand, are made from living organisms; they are proteins manufactured by cells. Antibodies are a good example of this kind of large molecule, and they can be very different from small molecule drugs that can be reliably replicated. For instance, while the biosimilar may purportedly have the same amino acid structure as its branded counterpart, it may have different glycosolation patterns that may not be completely understood in terms of drug effectiveness. So, this really is an evolving area.
MCC: From a litigator's perspective, what kinds of challenges are you seeing with these new drugs? Are different issues being contested versus a traditional infringement case?
Maslowski: At this point, much of the litigation around biosimilars seems to be focused on interpretations of the Act. For example, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) contains some triggering dates that are hotly contested, with parties debating the exact meaning of the language in terms of the biosimilar approval process. Other deadlines, such as the 12-year period of marketing exclusivity, seem to be less contested at this point because the first challenges are to established products that have already been marketed for more than 12 years.
From a high level, the general patent issues are similar to those in an Abbreviated New Drug Application (ANDA) Hatch-Waxman case. But there certainly tends to be a focus on different defenses in cases related to biologics. For example, in the world of biologics, a big defense for an accused infringer tends to be Section 112, and, within that, “written description” is an especially contested issue in many biologic cases, as distinct from small molecule ANDA cases. My feeling is that once we put aside the BPCIA-specific issues, including deadlines, many cases will look like a standard biotech patent infringement case.
Having said that, companies with branded products will have to prepare specifically for these disputes as they are incredibly complex. While there may be similarities to other pharmaceutical cases, the legal issues and defenses that arise in a biologic case can be dramatically different from those in the standard ANDA case, and you need patent lawyers with actual trial experience handling biologic cases.
MCC: It seems that you need more than lawyers in this context. In closing, tell us about Akin Gump’s team and the full complement of expertise you bring to the table.
Maslowski: That's absolutely right. I believe our team at Akin Gump is the foremost IP litigation group in the biotech area. One of our strengths includes our attorney litigators with Ph.D. degrees in the relevant scientific areas who can dig down into the minutia of these inventions. Having team members with this qualification is absolutely necessary in the context of dealing with the defenses in these cases, including the written description as well as enablement defenses. Successful outcomes require a massive understanding of the technology and the details behind a product.
Not many cases have gone to trial in this area lately, but we've taken some of the biggest ones through verdict and have been lucky enough to win some. This practice is a sweet spot for the firm, and we look forward to continuing that as these biologic cases grow and become more critical for our client companies.
Published June 3, 2015.
