Jones Day Talks Intellectual Property: Section 101, Life Sciences, and the Alice Two-Step
Section 101 of the U.S. Patent Act─which identifies four categories of inventions or discoveries that are eligible for patent protection─presents a number of challenges to companies working on innovations in the life sciences space. Jones Day's Patricia Campbell and Susan Gerber, who recently coauthored an article on this topic for The Intellectual Property Strategist, are joined by Meredith Wilkes in this edition of Jones Day Talks Intellectual Property. They discuss Section 101 and life sciences, and talk about what's coming up for Jones Day's Women in IP initiative.
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Dave Dalton:
Section 101 of the U.S. Patent Act specifies four categories of inventions or discoveries that are eligible for patent protection, but recent court decisions have raised serious questions about the correct application of section 101, especially in life sciences sector. Jones Day's Patricia Campbell and Susan Gerber recently published an article in the Intellectual Property Strategist that explains. They're joined by Meredith Wilkes, also of Jones Day, to tell us about it. I'm Dave Dalton. You're listening to Jones Day Talks Intellectual Property and Jones Day Talks Women in IP.
Dave Dalton:
Patricia Campbell is based in Jones Day's Silicon Valley office. She has more than 10 years of experience counseling clients in all aspects of patent portfolio development in the pharmaceutical and biotechnology sectors. Susan Gerber, based in Cleveland, practices in the area of intellectual property law, focusing primarily on patent infringement litigation and appeals. And Meredith Wilkes, a Jones Day partner also based in Cleveland, co-leads the firm's global trademarks, unfair competition and copyrights group. She chairs the firm's Women in IP initiative. Patricia, Sue, Meredith, thanks for being here today.
Meredith Wilkes:
Thanks for having us, Dave.
Dave Dalton:
Two things we want to accomplish. We're going to kind of give everybody an update on what's been going on and what's about to happen with the Jones Day's Women in IP initiative. We'll get to that in a second. We also want to talk about Section 101 of the U.S. Patent Act and the particular challenges it brings to life sciences space. Now we're lucky because some of those challenges were identified in a two-part article published in the Intellectual Property Strategist written by Patricia and Sue. That article is entitled Patent Eligibility Remains Uncertain, Especially for the Life Sciences, Even After Recent Federal Circuit Decisions and Efforts by the USPTO to Bring Clarity. That first part dropped January 2nd. Part two of the article is available next month.
Dave Dalton:
Let's start with Meredith. Give us some background. Talk about what Section 101 of the Patent Act is. I've got to imagine this is important because they didn't call it Section 538 or something. Section 101's right upfront. This has got to be something integral to understanding what's happening with patent law today. Give us some background.
Meredith Wilkes:
It is, absolutely, Dave. And thanks again for having us. And we're delighted to be kicking off the 2019 podcast season.
Dave Dalton:
I would not have started anywhere else.
Meredith Wilkes:
We're thrilled to be here. And our podcast today is particularly timely in view of the fact that on January the 7th, the United States Supreme Court asked the solicitor general of the United States, our former Jones Day partner Noel Francisco, to weigh in on the delicate issues of patent eligibility and patentable subject matter that Susan and Patricia are going to spend a lot of time talking about today. Our first program, our first Women in IP podcast is about Section 101 of the Patent Act and the particular challenges that are raised in the life sciences space. And you can imagine, and folks listening can imagine that this is an area that raises a lot of legal and practical challenges because we are trying to delicately balance here what some may consider competing interests to incentivize innovation and at the same time promote economic growth.
Dave Dalton:
That's always a tight rope. You don't want to stifle innovation or creativity, but you want to make sure people are playing fair, right?
Meredith Wilkes:
Exactly. On the one hand, we want to encourage companies to invest in research and development, to cure the most horrific diseases with the reward of a monopoly for their efforts. But on the other hand, we do not want to prevent development by giving somebody a monopoly over a law of nature or an abstract idea. And that's where Sue and Patricia offer unique perspectives on both the development and the protection of these rights and how to enforce them.
Dave Dalton:
All right, well let's swing over. Let's go to Sue first then. Talk about Section 101, and it talks about four specific categories of inventions or discoveries that are eligible for patent protection. Four different areas, right?
Susan Gerber:
Sure. So Section 101 is a provision of the United States Patent Code that sets the boundaries for what types of inventions are going to be eligible for patent protection. And the code itself specifically says that processes, machines, manufacturers, and compositions of matter are eligible for patenting. The courts have looked at cabining in what those boundaries are to make sure that inventors aren't inappropriately claiming a monopoly over things like natural laws, natural phenomenon and abstract ideas.
Dave Dalton:
All right, we'll talk about some specific cases in a moment, but just generally, can you talk about historically where this may have happened or the kind of case that might've brought this to the patent office's attention or Congress's attention for that matter? What kind of confusion was there or where might've someone been taking advantage of the patent laws?
Susan Gerber:
Sure. So in some of those early cases, the concern was is that there might have been, say, a natural law, like for example, the formula that's integral to curing rubber, and those formulas played an integral role in the new discovery or the new invention. And so the courts were concerned that in giving the inventor rights to practice that invention for curing rubber, that they weren't also giving the inventor too much control over the underlying mathematical formulation. And so the courts tried to strike a balance in order to, again, encourage innovation and provide patent protection, but at the same time not to give too broad a protection and give exclusive rights to something that everybody should still have access to.
Dave Dalton:
Okay. I see, I see. It seems like a lot of the, I shouldn't use this word, but maybe some of the trouble sort of came about after two recent decisions. Mayo Collaborative v. Prometheus Labs, it goes 2012, and Alice Corp. v. CLS Bank International. Let's go to Patricia. Talk those two cases and how they've changed how patent eligibility may be determined.
Patricia Campbell:
Sure. So those two cases were really seminal in this area. The first one was Mayo Collaborative, as you mentioned. And the last one was a Supreme Court case Alice Corp. And as a result of these two cases, there's been a further narrowing of what, not only what the Federal Circuit and the Supreme Court considers is patent-eligible subject matter, but also, and what I'm going to talk about a little bit later on is what the USPTO considers to be patent-eligible subject matter when they examine patents.
Patricia Campbell:
So why don't we turn to the Supreme Court decision of Alice, which follows along from Mayo? So after Alice, the Supreme Court created what we call the two-step test in Alice to determine whether the claimed invention is patent-eligible. The first step of this so-called Section 101 inquiry is to determine whether the claims are, and I put this in quotes, "directed to a natural law or phenomenon or abstract idea." And if the claims are deemed to be directed to that natural law or phenomenon or abstract idea, then we go to the second step of the Alice test. And even if the claims were directed to that subject matter, they could still be found to be patent-eligible where, and I'm going to quote again, "the patent and practice amounts to significantly more than a patent upon the natural law itself." So significantly more is a bit of an abstract concept itself and has led to a lot of different jurisprudence in this area. But the Supreme Court itself cautioned that the court should tread carefully in construing this principle and in the event that it would swallow all patent law.
Dave Dalton:
It does sound like it's ripe for misinterpretation, confusion, being overly broad, but sidebar for a second. Sue, talk about patent owners who had patents that were issued before those 101 changes that Patricia was talking about.
Susan Gerber:
So I think that one of the challenges has been is that to get a patent and get it through the patent office takes some time, and there are quite a number of patents out there that were written long before the Supreme Court's guidance in Alice and Mayo, and then companies were litigating those rights after Alice and Mayo. And so their patents, that were written without any warning that the law was going to change, were being judged against the new standard. And so that's created some real challenges on the litigation side as patent owners are trying to enforce their pre-Mayo and Alice patents and then having to face challenges that these inventions aren't even eligible for patent protection. And that uncertainty has created quite a bit of litigation and quite a lot of for patent owners since then.
Dave Dalton:
I can imagine. In fact, when we were outlining this program, there's a whole section, it says, "Post-Mayo/Alice uncertainty." And I'm going to read something. You guys were kind enough to send some notes over. It sounds like people are concerned. This is right from your article actually. And you guys did a bang-up job on it, but I'm reading, I guess these are legal scholars, academic types, whatever, that are weighing in on the post-Mayo/Alice world. One person writes, and all the attribution is in your article, but one person writes, "Alice/Mayo have created a bumpy road ahead for pharmaceutical and diagnostic inventors in obtaining patent protection for their discoveries." Another person weighs in with, "The trend after Alice/Mayo has placed patient rights at risk while reducing the incentives and capital needed for innovation." The same person writes, "The law has created unacceptable chaos for inventors, innovators, business, and investors. Legal chaos is the exact opposite of what the U.S. economy needs."
Dave Dalton:
Patricia, how did we get here? And what do we do? There's a lot of uncertainty out there. These people, I think, probably understand patent law as well as anybody, and they're concerned, based on what they're writing.
Patricia Campbell:
Yeah, I think we got here because there's been a conflation in Supreme Court jurisprudence between Section 101 of the statute and other sections of the statute that speak to the requirement for the invention to be non-obvious and to be novel. A Section 101 was always meant to be rather narrow as defined in the statute, but with case law, as it's gotten broader and broader, and we have a whole set of jurisprudence that defines judicial exceptions, it's tended to swallow up anything that has some sort of a correlation, what we would call a natural algorithm, if you will, that's recited in the claim.
Patricia Campbell:
So for example, you speak about the diagnostic inventions. A diagnostic invention would be something to the effect that the patient would have measured in their blood or serum some level of a biomarker. And if the biomarker is present or absent, then that patient would be a good or a poor candidate for a certain type of therapeutic. So you can see what the algorithm would be. It would be something to the effect that if the diagnostic is measured or is present above a certain amount, then you administer the therapeutic. So it's really, if, then administer. And because the natural law has really entered into the diagnostic space, we have had a problem with diagnostic companies getting patents and/or even valid patents that can stand challenge in the courts.
Dave Dalton:
Well, let's go to that. I think maybe this is the kind of case you're referring to. Ariosa Diagnostics v. Sequenom, that was a federal circuit case, and there was a denial of a rehearing. Talk about that case and how it factors into the post-Mayo/Alice world.
Patricia Campbell:
Sure, and I'm going to turn this over to Sue in a minute, but one thing I do want to say about the Ariosa decision is that I think everybody was in agreement that this invention was a significant invention, it's a noninvasive way of detecting problems with the fetal DNA, doesn't require that you do amniocentesis, wonderful invention, and yet it was found to be patent-ineligible. And I'm going to turn this over to Sue because she's a litigator in the group, but this was an unfortunate decision and she can speak to that.
Dave Dalton:
Yeah, please comment, Sue.
Susan Gerber:
So I think one of the things about Ariosa, and really it's kind of turned the patent bar on its head, was that because it was such an innovative and valuable innovation, that people were very surprised that the court would strike down as being not eligible for patent protection, and that that extension of the Supreme Court's decision in Mayo caused a lot of consternation for patent owners, for the bar, as well as for the court itself. And the parties in Ariosa and Sequenom, they asked for the Federal Circuit to rehear the case, what's called en banc, to have the full court weigh in on this issue. And the court as a whole decided not to rehear the case, but several of the judges wrote separately because they were very concerned with what was going on.
Susan Gerber:
In particular, Judge Newman dissented from the denial of rehearing, because she really felt that the panel's decision in that case had improperly extended Supreme Court precedent to the detriment of inventors. And Judge Lourie, who was joined by Judge Moore, that he also wrote separately and he said, and I'll quote, that "neither the traditional preclusions of law of nature or of abstract ideas ought to prohibit patenting of the subject matter in this case," and further noted that the whole category of diagnostic claims was put at risk. And he even characterized it as a crisis of patent law and medical innovation and said that may be upon us.
Dave Dalton:
Do judges usually... That's strong language. Do judges usually write like that in an opinion? That sounds alarmist almost.
Susan Gerber:
I think it is fairly rare for judges to weigh in like that, and I think it just highlights the concerns that the court had, the direction that Section 101 law was going at that point.
Meredith Wilkes:
Dave, it's Meredith. Let me just-
Dave Dalton:
Please.
Meredith Wilkes:
I wanted to jump in on something that Sue and Patricia both highlighted in their comments and in their article. And it's in response to the question you asked a minute ago about how did we get here? Some folks would say it's because of Hurricane Alice, the Supreme Court's decision in the Alice case, because that's when the courts started to take the patent eligibility determination, I want to say into their own hands, as opposed to allowing the issues to go to a fact-finder. And so if we're looking at it at 100,000 feet, the patents that are being litigated in the district court, and then that make it up to the Federal Circuit and then ultimately to the Supreme Court.
Meredith Wilkes:
And some of these cases are patents that have issued, meaning that a patent examiner has looked at the subject matter and made the 101 analysis and determine, "This is patent-eligible subject matter, and all the other statutory criteria have been met," and a patent is issued. And then years later, the patent is being litigated, and a United States district court judge, who may or may not have a scientific background, is starting to make determinations at the pleading stage, so no development of discovery, no expert testimony, making these determinations at the very earliest stages of the case, invalidating patents. And so that's why we're seeing this widespread panic at some level, and this call for better guidance from the PTO that Patricia was alluding to and some of the case law that that Susan was talking about, and then the strong language that we're seeing from the courts.
Dave Dalton:
Well, you bring up two very good points. Some of these patents have been enforced for years sometimes, correct? And then you have a judge who probably has, I'm sure has a brilliant legal mind, but maybe isn't the most qualified person in terms of a science or technical background to be able to make that kind of decision. And it seems wrong to me as a lay person that the patent's been in force, and this can be brought out again, years later, am I wrong? Or am I being too pedestrian in my thought process there?
Susan Gerber:
So Dave, if I can weigh in on that point, you are exactly right. And in fact, this was highlighted in a recent decision out of the Federal Circuit. The court issued two decisions in Burkheimer v. HP, as well as Aatrix v. Green Shades Software. And again, those cases were considered for rehearing en banc, and the court again denied to rehear them, but again, a number of members of the court wrote. And one of the opinions that came out with the denial of rehearing made exactly the point you're making, which is when judges are evaluating claims for eligibility, they should be looking at it as what we call the person of ordinary skill in the art, the technical person, and not through the eyes of an ordinarily skilled judge.
Susan Gerber:
And those two decisions were critical because they made the point that while eligibility is a legal determination, there are underlying factual issues. And if those facts are in dispute, that eligibility should not be determined on the pleadings or on summary judgment, but rather should be decided after a fully-developed record. And if you fully develop the record and get to summary judgment, and there still are factual disputes, then eligibility should only be determined at a trial.
Dave Dalton:
You just mentioned two of the cases that we'd hoped to get to. A third in this, I guess, context for this part of the discussion is Vanda Pharmaceuticals v. West-Ward Pharmaceuticals. How does that play in?
Susan Gerber:
So I think that Vanda as well as two other decisions that have been recently decided CellzDirect v. Rapid Litigation and Exergen v. Kaz make the point that I think we're starting to see the court trying to get back some of the protection for life sciences inventions in that they have emphasized that when the claims are an application of whatever this natural law or natural phenomenon that's been identified, that those types of inventions are eligible.
Susan Gerber:
So for example, in Vanda, when the inventors recognized this correlation between a certain enzyme in the blood and a drug dosage and a condition, and they figured out this correlation, but then they applied it to come up with a specific therapy, then the court was willing to say that that invention was patent-eligible even though inherently there was this natural correlation that underlied it. It was the application that made the difference. And the same was the case in Rapid Litigation, where it was a situation about freezing liver cells. And because the fact that the cells would survive multiple freezing and thawing, that sort of was a natural law or correlation, but the lab method that applied it, that was patent-eligible.
Susan Gerber:
And in Kaz, it was a method for taking one's temperature, and certainly body temperature is a natural phenomenon. That is what it is. But because they applied that notion of body temperature in a new and innovative way, then the court said that that was patent-eligible.
Dave Dalton:
Is there any other part of the law, even intellectual property law, where the stakes are higher? I mean, the things you're describing here are literally life-saving, or they could be, they have the potential to be. The stakes are so high, and yet the patent laws in some cases are so lacking clarity that it could be impeding development in innovation and advancement. Am I right?
Patricia Campbell:
I think in particular, it's the diagnostic businesses that have really suffered under the 101 jurisprudence. I mean, these are important inventions that allow detection of diseases and to determine whether the patient or patient subpopulation is particularly favorable for that type of therapeutic. And these types of inventions are not being able to be patented. If a biotechnology company can't patent an invention or their technology, they can't recoup the enormous cost of developing the invention in the first place.
Dave Dalton:
Millions.
Patricia Campbell:
If there's no possibility to recoup that, then there's no possibility for that business. And there's a great fear that that whole area of diagnostics will just basically die on the branch. So I think that Vanda in particular is a case that's really moving in the right direction, and the Federal Circuit is moving in the right direction, and later on we're going to talk a little bit about how we think the PTO is moving in the right direction.
Dave Dalton:
We're going to talk about that in just a minute, as a matter of fact. I'm fascinated by this stuff, and really, and Meredith knows this, I love our IP podcasts, but again, the stakes here in life sciences are so different because if there's no investment, if there's no capital applied, if people aren't working on this, if there's not innovation because they can't get patent protection, everybody loses, right? This is a very important part of the law, and I think we need to talk more and more about this. Let's talk about PTO guidance, Patricia.
Patricia Campbell:
Sure.
Dave Dalton:
Tell me what's developed there and where we're standing.
Patricia Campbell:
Well, one of the things to talk about a little bit is to go into the past a bit. So in the immediate aftermath of the Myriad decision in 2013, the USPTO released a set of guidance documents in March of the next year, 2014, explaining how it planned to apply these new Section 101 precedents. And many in the industry, in the life sciences industry, were very dismayed by this new set of guidance as going too broad and really wiping out the ability for a lot of biotechnology companies, especially diagnostic companies, to get patents in the space. And so there was a huge amount of criticism. The USPTO responded to this significant criticism by releasing new set of guidance documents in December of 2014. And those followed the Supreme Court's 2-step Mayo/Alice test.
Patricia Campbell:
So since then, the USPTO has been updating as new Federal Circuit case law has developed. And last year there were two sets of guidances that were issued by the USPTO in view of the Berkheimer and Vanda decisions, and can speak about those a little bit if you would like.
Dave Dalton:
Please.
Patricia Campbell:
In April of last year, following the Berkheimer decision, the USPTO issued a memorandum to the examining core that instructs how examiners should approach the Mayo/Alice step two analysis. So as you will recall, step one was, are the claims directed to some sort of judicial exception, like some sort of algorithm? Step two is, if they are directed to that type of algorithm, is there something in the claim that recites significantly more? And Meredith touched on this in the sense that significantly more is really a factual decision. And so therefore when examiners pick up cases and they want to make a rejection under 35 U.S.C. 101, they have to back up their rejection for significantly more as a factual determination, and a factual determination that the significantly more piece is well-understood, routine, and conventional.
Patricia Campbell:
The four types of categories of evidence the examiner has to provide are, one, a citation to an expressed statement in the specification for the patent application or a statement made during prosecution by the applicant that the element in question is in fact well-understood, routine, and conventional, or, two, a citation to a court decision, which [inaudible 00:24:03] the well-understood routine or conventional nature of the elements in question, or number three, a citation to a publication that demonstrates the well-understood routine or conventional nature of the elements, or number four, a statement that the examiner is taking quote, unquote official notice, and this can be challenged by the applicant.
Patricia Campbell:
So in other words, no longer can USPTO examiners say, "I'm rejecting these claims as lacking subject matter eligibility under 35 U.S.C. 101," without making some sort of a factual determination.
Dave Dalton:
Talk about how guidelines changed after the Vanda decision.
Patricia Campbell:
That has actually been probably more exciting for those of us in the life sciences area. So following the Vanda decision in June of last year, the USPTO issued a second memorandum again to the examining core, providing guidance for inventions in the areas of what we've been talking about, diagnostics and personalized medicine. So just to step back a little bit and talk about the Vanda case in a little bit more depth, in Vanda, the claims at issue were cited a method of treating a patient, having schizophrenia with a specific type of drug called iloperidone. And iloperidone is something that's known to cause heart problems. And so it's important to identify patients that have a particular genotype associated with poor drug metabolism, because you don't need patients administered iloperidone to die of a heart attack, cardiotoxic reaction to the drug.
Patricia Campbell:
So in the Vanda decision, the Federal Circuit evaluated the claims at issue as a whole and found in fact that they were not directed to the judicial exception. Remember that the directed to inquiry is step one of the Alice inquiry because they were method of treatment claims, even though they applied a natural relationship. So they're not directed to the natural relationship, they're directed to a method of treating. And so this is really hopeful for those of us that prosecute in the space, because it gives us hope that if we have claims that are actual method of treatment claims, even though they might recite some sort of natural correlation or algorithm, that these claims would not necessarily be found by the USPTO to be directed to the natural correlation, and therefore one wouldn't have to establish when you prosecute the case that the claims in addition to not being directed to the algorithm also would need to satisfy step two of the Alice inquiry, which is a showing non-routine or unconventional steps.
Dave Dalton:
So a good positive development on that front. The name of the article was Patent Eligibility Remains Uncertain, Especially for the Life Sciences. Part one showed up in the January edition of the Intellectual Property Strategist. Part two is coming out in February. Sue, what can we look for in part two?
Susan Gerber:
In part two, we're going to talk a lot about how the PTO has responded to some of these changes from out of the judiciary and the PTO's independent efforts to try to bring clarity to this area of patent eligibility. And I think it's interesting to note that we're going to also see in the courts some overlap between what's happening in the patent office and what's happening in the judiciary. Just this week, yesterday, and then coming up later this week, there were two cases that the Federal Circuit is hearing that involve issues of deference to the Patent Office guidelines, which once those decisions come forward will show how much weight courts are going to give to Patent Office determinations and to patentees who say, "Well, I followed the guidelines, my patent should be judged in light of those guidelines." So it'll be interesting to see what the Federal Circuit does there.
Susan Gerber:
And then the other interesting sort of interplay between the two parts of our article and the judiciary and the PTO is the Supreme Court's asking for the solicitor general to weigh in on the Berkheimer decision, which because then the PTO will get its opportunity to tell the court how it feels about Berkheimer and all of the things that have happened in the last year and developments in 101 law.
Dave Dalton:
Huh, interesting. Meredith Wilkes has been suspiciously quiet over there. So I'm going to go to her real quick before we wrap this up. What is going on with the Women in IP initiative at Jones Day? What can we look forward to, say, in the first couple months of 2019?
Meredith Wilkes:
Dave, I thought you would never ask. I was sitting here, waiting my turn patiently.
Dave Dalton:
Oh, no.
Meredith Wilkes:
Oh no, we're really excited. You're going to hear a lot more from Women in IP this year. Obviously, we're thrilled and delighted to start off with Sue and Patricia's article and their discussion about 101 in the life sciences space. Obviously in view of the Supreme Court's request earlier this week, the January 4 new guidelines, the deference that may or may not be given to them, there's a lot more to talk about in this space, for sure.
Dave Dalton:
Absolutely.
Meredith Wilkes:
The Supreme Court has granted cert in a copyright infringement case, and it's going to have oral argument on January the 14th on issues surrounding the costs to a prevailing party in the copyright space. So for certain, you'll hear from the Women in IP on that front. As you and I were talking about over the weekend, the Supreme Court has also granted cert on a scandalous trademark matter.
Dave Dalton:
That's right.
Meredith Wilkes:
We love a scandal in the trademark space. So you'll hear from our Women in IP in a podcast on the outcome of that decision, if and when it happens this year. Also, you'll hear from Dr. Cary Miller and Dr. Jen Chheda on Women in the IP PTAB arena. So we're really excited about the podcasts that we'll be working up with you.
Dave Dalton:
That's a nice segue, and that'll take us out of this because I wanted to say for more information on intellectual property law at Jones Day, just go to jonesday.com, find the practice page, and go to intellectual property. You can also find complete biographies for Meredith Wilkes, Susan Gerber and Patricia Campbell. Subscribe to Jones Day Talks on Apple Podcasts, Google Play, Stitcher, and Android. And while you're there, check out some of our previous podcasts. Hey, thanks to you three, Meredith, Sue, Pat. It's been great. We'll do it again soon.
Meredith Wilkes:
Thank you.
Dave Dalton:
I'm Dave Dalton. You've been listening to Jones Day Talks Intellectual Property. We will talk to you next time.
Speaker 6:
Thank you for listening to Jones Day Talks. Comments heard on Jones Day Talks should not be construed as legal advice regarding any specific facts or circumstances. The opinions expressed on Jones Day Talks are those of lawyers appearing on the program and do not necessarily reflect those of the firm. For more information, please visit jonesday.com.
