Patent Doctrine (& Copyrightable) Subject Matter - IPSC 2016

Patent Doctrine (& Copyrightable) Subject Matter - IPSC 2016

Guest Post by Andres Sawicki, U. Miami

Are Engineered Genetic Sequences Copyrightable?: The U.S. Copyright Office Addresses a Matter of First Impression – Chris Holman, Claes Gustafsson& Andrew Torrance

Data-Generated Patents, Eligibility, & Information Flow –Brenda Simon

Inventive Application, Legal Transplants, Pre-Funk, and Judicial Policymaking –Josh Sarnoff

The Impact on Investment in Research and Development of the Supreme Court’s Eligibility Decisions – David Taylor

The Fallacy of Mayo’s Double Invention Requirement for Patenting of Scientific Discoveries – Peter Menell &Jeffrey Lefstin

 

Holman, Gustaffson, & Torrance—Are Engineered Sequences Copyrightable?: The U.S. Copyright Office Addresses a Matter of First Impression

Holman: Couple years ago, talked about why engineered DNA should be copyrightable. Big conceptual leap was extending c to software, so going to DNA no big deal. A lot of people have made this argument. Irving Kayton around the time when software was deemed copyrightable was shocked, perplexed when asked whether DNA should be too. And then wrote that it should be copyrightable. Drew Endy—synthentic biologist at Stanford—anyone who is involved in synthetic biology can’t understand why you can’t copyright genetic code. Holman worked with founders of DNA 2.0. It’s like Microsoft saying they sell plastic because they sell DVDs with software on it—DNA 2.0 doesn’t sell DNA, they sell the content encoded in it.

Holman and Torrance got the Prancer sequence from DNA 2.0 and submitted registration request to Copyright Office in July 2012. Received generic form rejection in August 2012. In November 2012, submitted appeal requesting reconsideration. Took 14 months until they heard from Director of Copyright Policy, apologizing for delay saying it’s a matter of first impression and an important issue. Director ultimately rejected registration with six reasons. Holman going to refute each.

Main argument from Copyright Office is that engineered sequences don’t fall with statutorily enumerated category. But statute uses “include” and legislative history shows the list is illustrative and not limitative. A lot of this came up in Bikram yoga case too. Nimmer similarly says if something is sufficiently analogous to existing subject matter, it should fit. Goldstein makes similar points, citing House Report.

Copyright Office says Congress amended statute to include software. Holman & Torrance draw analogy between software and genetic code. Amendment introduced limitations on software copyright, and defined computer programs. The CONTU report form 1979 is the basis for why Congress believed that software is copyrightable. Conclusion of report was that no legislative change required to make software copyrightable because it already was. Compare to architectural works amendment, which did add category. CONTU report was policy-based: large investment to create, cheap to copy, needs IP. Same applies to engineered DNA. History, in 1960s, Copyright Office took position software not copyrightable, but led to rule of doubt.

Office also said we can’t do prior art search. But Office doesn’t do searches for anything. Plus, it had no ability back in the 1960s with software. And it should be incumbent on Office to develop capacity.

Office also said no overlapping copyright and patent protection. But Oracle v Google and JEM v Pioneer to the contrary.

Office also said 102(b). But engineered DNA can be protected without violating 102(b).

Functionality arg. But so are copyrightable software programs, which don’t need artistic expression.

Bias against copyrightable expression in a biological system.

Q: Agree with first premise that software can be covered by both copyright and patent. But disagree with ultimate arg, and Oracle is mistaken. You can’t protect functional things under copyright. Software was done for anti-piracy benefits. CONTU retained idea-expression dichotomy. You can protect code, but not underlying functionality. Can you do that for DNA?

A: Yes, lots of redundancy in DNA.

Q: Oh so you can use junk code?

A: It’s not junk. There are an astronomical number of ways of coding for a protein.

Q: So if someone were to take our code for fluorescent protein and reverse engineer, you can prevent piracy of your version, but not their reverse engineered effort.

A: That’s exactly right. There is merger analysis and inoperability and a bunch of things you can import from software. The advantage over patent—imagine these in PAE hands. A troll asserted fluorescent protein patent. DNA 2.0 doesn’t want to prevent others from using function. They just want to prevent piracy.

Church wrote book in English letters and in DNA. So you can use DNA to encode English language.

Q: Why is life plus 70 the right regime?

A: I think it should be shorter, but I still think it’s not so bad because scope of protection isn’t terrible.

Q: Analogy to software a great start, but need to talk more about merger discussions. The premise was that if you can’t implement functionality another way, no protection. For the moment, we don’t know how to code DNA functionality multiple ways. What are the implications of locking up DNA code?

A: Think about Monstano—a farmer saving seeds. That’s piracy. They aren’t changing the code. But, if you have another company with a lab that does same function with different code, that should be permitted. For a small protein, because there are multiple ways to code, if you tried to make the identical protein, there are so many redundancies, if you make one code, there isn’t enough matter in universe to make all possible versions of that function.

Q: In software, I started my career talking about tailoring for software. I think software is a different animal because of functionality and interoperability. I think you’d be better off following a hybrid or sui generis proposal like semiconductor. If industry wants to support you, they might be able to get it. It’s just DNA is not close enough to other copyrightable stuff aside from software.

A: Yeah, when I got the rejection from the Office, DNA 2.0 didn’t want to appeal to federal court. But we are getting a lot of interest from lawyers who are pushing for these kinds of cases. And yeah, I agree that semiconductors and other countries’ fashion design protections might be a better model.

 

Simon—Data-Generating Patents, Eligibility, and Information Flow

Simon: I’ll discuss intersection of patent eligibility and info flow. Sup Ct has expressed concern about patent exclusivity impeding flow of info. Sichelman and I introduced idea of patents that generate data. They are patents that by design generate valuable data. Will talk about Sup Ct language reflecting info-flow concerns. Will discuss whether those decisions express concern not only about downstream tech, but also downstream data. Will also talk about unintended consequences of restricting eligibility.

Examples of data-generating patents. Genetic testing, sleep trackers, heart-rate monitors. True, ordinary use of patented inventions might generate data about ways to improve the design of that invention—e.g., garden hose. Data-generating patents different because data about users or world itself distinct from information about the patented invention. When these patents are issued, might create market power over not only invention, but data as well. Unlike trade secret law that has safeguards like reverse engineering or independent discovery. Tech advances in big data era have made this protection even more valuable.

Sup Ct decisions have expressed concern about some patents impeding flow of info. Karshtedt has a nice paper on Breyer’s parallels between copyright and patent. In Mayo, Breyer pointed to possibility that exclusivity might impede flow of info, and provided some examples. Raising price of using ideas. Cost of searching. Costly licensing agreements. Court later describes ways that patents on laws of nature can impede technology on later discovered features of metabolites, and individual patient characteristics. This latter stuff is something that the patent holder may have exclusive access to because of its data-generating patent.

AMP v. Myriad denied patentability to naturally-occurring genes and the info they encode. Thomas referred back to Mayo, balance between incentives and impeding info flow. Emphasizing info flow characteristics may show court’s concern with patentee leveraging patent exclusivity to exercise power over data gathered as a result of its patent. Myriad refuses to contribute patient data to public databases. That means competitors have limited data to use for their own research. Myriad reaped a bunch of lead-time advantages.

Final decision is Breyer’s LabCorp dissent from cert dismissal. Even way back in 2006, three Justices were commenting that patents can restrict flow of information. Also note that more recent case—Bilski—used similar language. Methods of hedging risk unpatentable. Stevens concurrence cited LabCorp and expressed concern with “Information Age” issues. Patent on foundational technology—sequencing or internet search—that provides for preclusive effect can prevent competitors from generating or accessing data.

Typically, concerns about info flow in patent seem puzzling. Disclosure is the quid pro quo, although we can argue about how effective it is. Data-generating patents raise a distinct issue—the patent allows for the generation of data that is then protected via trade secret.

Primary factor for determining whether they restrict info flow is whether they have a preemptive effect on marketplace competition for data. Contact lens with info about diabetes wouldn’t have preemptive effect because there are other ways to get the info about diabetes. May be problematic from ethical or privacy perspective, but not from info flow perspective.

Unintended consequences. Even if we can narrowly tailor restrictions, we have a problem that we will reduce disclosure overall because inventors will keep these inventions as trade secrets. Maybe we can counterbalance by imposing some data disclosure requirements. Might need some data exclusivity period to ensure that incentives are maintained. Prizes and rewards and sui generis protection possible too.

Q: Will this be industry-specific? Could imagine in software or electronics patents, the data re sales, usage, etc would be valuable in the same way that patient data might be valuable, so unless you want all of the data, you will have to limit by industry.

A: Most concerning patents at first blush are medical for public health reasons. But some of the data you are talking about, there’s a little bit of a blur. Imagine a deep brain stimulator measuring information from consumers. Is that commercial data? For some of these implementable devices or similar things like fitbit—how many hours of sleep you get—how much of that is health data? I would hesitate to implement strong industry-specific limitations. I would focus on preemptive character.

Q: To extent you identify a different class of invention, maybe there is an enablement angle. Maybe some of the data has to be accessible? That would need a significant rethinking of enablement, but it suggests that the standard might be different by data-generating patents.

A: But we’d have to dramatically change enablement requirement because it’s set at time of filing. Some have proposed something like this—maybe at time of maintenance fees. I can only imagine can of worms. It’s an interesting suggestion though.

Q: Can make the case that a lot of data wouldn’t be generated at all. Myriad a great example. Patients’ complaint was that medical community said patients shouldn’t be able to look at their own data.

A: Ted and I wrote a bit about prospect theory and coordination considerations. I think the conclusion to draw from this is that information flow concerns might be undercut by overly limiting patentable subject matters.

 

Inventive Application, Legal Transplants, Pre-Funk, and Judicial Policymaking –Josh Sarnoff

Sarnoff: Lefstin has a very good and thorough discussion of Neilson. Established line between principles in the abstract, which weren’t patentable, and applications, which were patentable. I think Lefstin does a great job of explaining that this is a practical application. From brief, legislative record says no inventive application hurdle. Not sure I agree. Might be overstated, especially with respect to composition of matter. LeRoy and O’Reilly. O’Reilly in particular brings Neilson to US. Two years before these cases was Hotchkiss,

which had human creativity and ingenuity requirement. So question is what do we do with the discovery itself—is that part of the creativity or not? My view is that when the dicta comes to US, we have the inventive application requirement.

I don’t think the true origin of inventive application is Funk Bros. I think Jeff does great job with 1952 Act legislative history, which decided not to overturn Funk. So if that case was inventive application, it would still be the law post-1952. Cases shortly after the Act made clear they understood inventive application is part of the law. Question whether it’s a good thing. And Congress didn’t eliminate ability of courts to modify law, subject to one constraint.

Flook relied on Funk too. Congress hasn’t reputed Funk. Should courts repudiate inventive application? I argued before, Ansonia Brass has the non-analogous use requirement, Reisenfeld said it too; non-analogous use is there for a good reason. We don’t want to lock up what the previous world of human inventions has given us. We want creative advances. There are earlier strains on non-analogous uses. Robinson and Leck say discovery of what nature can do is good, but lock up with patent rights only things that nature doesn’t itself do. Non-analogous things of what nature does. If new use is inventive in the other sense, it is non-obvious.

Why should we care? Mostly non-utilitarian moral views from 18th century. McCleod says this is God’s gift and locking up is a moral sin. Lockean view that we owe equal concern for each other. I think this is a better way to put it. Science itself shouldn’t be protected by patent rights. We can allow patents for inventive applications that aren’t just the world itself. If there are applications that allow you to effectively lock up the natural thing, then just do away with restriction on locking up natural thing.

Comparative perspective—scientific results are the common property of all mankind.

Prior art treatment dicta are followed, inventive application is required. Courts remain free to establish eligibility rules regarding applications of nature according to best policy.

Q: Under your view, you give Morse a claim—why not recognize that a lot of this area is overclaiming, and that was something potentially at issue in Neilson. Having a practical application is good. When you have a scientific law or principle, implicit in that is some fairly substantial scientific advance. What we don’t have is when is a discovery eligible?

A: If we’re gonna allow non-practical application, we might as well allow patenting discovery. If that stuff should be free for all to use, then granting a limited application just because you were the first makes no sense. If you can write the seventeen applications, that makes no sense too.

Q: Does statute matter at all? Two points. At time of Funk, for many authors, ingenuity was tied to [didn’t catch this]? How do we deal with Federico, finding a new property of a substance is ok—why?

A: You still had to have a non-analogous use. In terms of statute, it matters as a presumption. Once you recognize Funk was the law, Congress didn’t reverse, courts after

recognize it, then the answer is the law. Since then, other courts have played around and changed it. Now the Supreme Court is changing too. If you care about fidelity to 1952, fine. But I think Congress left it open in 1952. Didn’t change it but also didn’t prevent changes. Only question if there is a constitutional constraint on treatment of scientific discoveries. I don’t think Court will go there, esp post Eldred, but there’s a non-frivolous argument.

Q: Court has tended to lump all the excluded categories together. And Mayo suggests it doesn’t matter how narrow or specific your principle is.

A: Science and nature is pre-existing. Abstract ideas—we have no idea what that means. I view it as some abstract ideas are fundamental to how the world works. I am more sympathetic to smaller things that should be treated as human creativity. But we have no theory of abstract ideas so it’s a total mess. Still doesn’t tell you most important question—what level of incremental creativity, which requires some theory of difference. If we went to invention, we would have some theory. That’s something courts can build over time. Preemption makes no sense. I think Breyer has made a hash of the law. I would rather see us fund scientific discovery through taxes, but who knows.

 

The Impact on Investment in Research and Development of the Supreme Court’s Eligibility Decisions – David Taylor

Taylor: Haven’t done the empirical work on this yet, but just getting started. Interested in impact of 101 on R&D. We all know the two-part test. Caveat that I am reporter for AIPLA 101 task force, and this doesn’t represent their views. But lots of people view the current test as bad and are thinking about going to Congress. Would be nice to have data about extent to which Court’s decisions have impacted investment. I want to study that by surveying VC to test hypotheses. First hypo: four recent decisions have impacted decisions. Second: Impact significant. Third: Impact negative.

Want to look at diverse firms at various stages of VC funding and tech areas. Two types of questions. Have Court decisions impacted, including knowledge of decisions. And then indirectly without mentioning decisions, how has decision-making changed over time. I want database of VC firms from 2016 and from 2009. Plan to ask about activities from 2006-15. Survey only about US.

Some ideas. “In your opinion” questions about effect of patents on investment in invention and marketing. Meat of survey—on the left are tech areas and then effect on each area. Next question is on effect on each industry area. Are they aware of the decisions by name. Effects of particular cases on financing. How much, which decisions, and what has impact been—direction, tech, and industry. Between which tech areas—out of which and into which. Some broad questions about type of financing in time period. Then, if willing, amount of money invested by year. Want to go to 2006 to get behind Fed Circ Bilski decision. Can also look at size of investor.

Where it gets difficult and ugly is to ask particular questions about type of tech are by percentage by year. And then more complicated by industry. That’s it.

Q: Useful to get more granular to ask about whether decisions change to ability to get patent, changes to likelihood of getting sued, and then changes to uncertainty?

A: I like that. Especially the question about uncertainty.

Q: A question to get a bead on—decision of VC to fund a company is hugely complex. Questions to get directly at that? How do patent eligibility cases affect your decisions?

A: Maybe ask some sorting or ranking of factors about relevant importance?

Q: I’d change order of questions. You raise salience of decisions at the outset. I’d ask questions about investments first. And make them coarser so your response rate goes up. And then you will want to bury salience of eligibility. Also, you should do a five-point scale rather than three-point.

A: Great. Thanks.

Q: Narrow point—is patent protection important at all? And why? Often hear that it is part of an exit strategy. Broader question—why should we care? Real question is substitution effects. Ask legislators if they are going to change funding decisions in response.

A: Also why limit to patents?

Q: That’s my question too. Ask about non-patent appropriability mechanisms. For the people who answer no, this isn’t important to me. Question if that’s because they have substitutes available.

Q: You can still ask patent-specific questions, just do it at the end, and don’t let them go back.

A: Thanks.

 

The Fallacy of Mayo’s Double Invention Requirement for Patenting of Scientific Discoveries – Peter Menell &Jeffrey Lefstin

Menell: Want to fully credit Josh for his influence on Mayo. This is unusual for me because I usually do normative work, but this is historical, and Jeff is great with that. So we are doing a historical, interpretive paper. We agree that biosciences is an area where patents have been relatively successful. Four points. First, not explicitly in brief, when you peel back layers of Mayo, you realize Josh wrote it. Second, we don’t have any briefing or cases on a key word in the statute: “discovers.” Then we’ll go to a couple of historical points.

One q I have come to appreciate, it would be amazing if Justices could figure out everything on their own. This idea of omniscience is under-addressed. But they are human. Opening brief and petitioner briefs, mostly short. Most influential was Josh’s. Then a bunch on either side, including the government, saying this patent is just garbage on 102 or 103, and leave it at that. When we get to the outcome, the Court got the language from Josh. He talks about the requirement of prior art treatment, from O’Reilly. I think it was a mistake, though.

I’ll talk about the statute. There is this word “discovers.” I was taught to start with text, then structure, and then go higher up if you like. It is in Constitution, and then in patent acts throughout the years carry the language. Order has changed, but we’ve had discoveries throughout. Then a finding from Senate Report in 1836, that talks about much has been discovered but much unrevealed, and the mysteries of nature unfolded. He was talking about science. So no question at beginning of industrial revolution we are talking about science. And then it’s not discussed until the Plant Patent Act of 1930.

Lefstin: Assuming we care about statutory text, if you go to legislative history, a lot of concern about whether discovery of plant was constitutionally patentable. The meaning of invent at time of Constitution included discovery. For Plant Patent Act, we get some examples of what it means to invent or discover. Includes finding a plant in your backyard. Why do we care? Because Congress uses utility patent statute as home for Plant Patent Act. It reads “invented or discovered.” Maybe text doesn’t matter. Or maybe conventional propagation was in first and second. Or maybe they mean different things in the two places it comes up in statute, which I don’t think is tenable. 1952 reports indicate no change. I am less convinced than Josh about Funk Bros implications—don’t think Congress knew about it.

Menell: Another great discovery. Credit Jeff for discovering true meaning of Morse case. He claimed all uses of electromagnetism. In doing so, they cite to hot blast cases. The language is we must treat the case as if the principle was well known. Why? Out of context, Stevens and Breyer are making a plausible interpretation, but it’s completely incorrect. They were using this to postulate that if this were the same as the Minter case, it would still fit within the category of a machine. Morse got it right—unlike Neilson, where all methods of pre-heating improved blast furnace, not all methods of electromagnetism communicate at a distance. Stevens found that same language out of context in Flook and said treat the algorithm as unknown. We forgot about this because Diehr, which we thought overruled it.

Then we get to Mayo. Quotes the same passage. The question was: did Neilson inventively apply pre-heating? Yes, says Breyer, here are the unconventional steps. Jeff points out that Neilson case rejects inventive application argument.

Jeff: Main challenge of Neilson was enablement problem.

Menell: Treating the principle as well-known was about whether this qualifies as a machine. Under the Minter case, which had to do with self-adjusting chair, they decided it was a machine. We wanted in Sequenom to realize they misread the case. If you look at district courts now, it’s a disaster. And Patent Office is worse. So now algorithms are no longer relevant to invention. Go ask Forsyth Hall people. Can’t do AI without algorithms. I would take view that let’s take software out. But I think we’re going to spend another decade chasing our tails with a dysfunctional system.

Q: Quick point. I totally agree with Jeff on discussion of English cases. Clearly, they didn’t understand language they were reporting. They didn’t have substantial novelty requirement. We had just gone to non-obviousness. Then what do we make of the import of the language into our system, which was different from the other system. Who knows? But we did build on it in a variety of ways. Point is Congress hasn’t adequately addressed. Courts

have gone back and forth, and it’s really an open question. Courts are free to enforce inventive application, Congress is free to get rid of it entirely.

A: If Court wants to adopt the rule, then that would be fine. But they have to deal with text. Yours was the only brief with any substance on this issue. There is no case dealing with “discovers.” There are people who think—I don’t think religion solves the problem. A lot of my students say E=mc2, but the annealing patent is just understanding the properties of copper.

Q: How much has to do with the loss of a real utility requirement in patent law? In terms of practical application, seems that we’re just talking about utility requirement. Why aren’t people pushing the reinvigoration of that doctrine? One of the old cases talked about practical utility. That gets rid of a lot of the abstract idea problems.

A: But that creates the problems of State Street. A useful Arts test with utility req might work. Even in Alice, there was concurring opinion that said Stevens was right. Court should’ve taken State Street. Unfortunately, Court isn’t selecting cases right. I’m really upset they took Apple v. Samsung on the wrong issue. And then they take the cheerleader case, which is much worse if you want to define functionality. They aren’t getting the right issues. Maybe there were other things about Sequenom that troubled them. We need to error correct. But I don’t think the Court will.

Industrial utility highlights for me that these are legislative determinations.

Q: Alex Kasner piece in Stanford is great. What did they mean by “discovery”? And he does a long historical analysis.

A: When I think about Sequenom, I am astounded that the Supreme Court didn’t want to take this on. It is a breakthrough. It is a woman’s health issue. I’ve been told by Ariosa representatives that the patent was poorly drafted. But why wouldn’t it make sense to at least say this is the kind of breakthrough that is eligible. I don’t see that the Court has a good grasp of how people will respond. Seems odd to say if you do Nobel quality research, you are ineligible.