Two Observations on Last Week’s Senate Hearings on Patent Eligibility Reform

By Gene Quinn
June 10, 2019

“Opponents of the 101 amendment have been referring to ‘human genes’ or ‘genes’ in a sloppy, unscientific manner without indicating whether they are talking about human genes in the body or isolated gene segments outside of the body. The distinction is critical…and confusion causes anti-patent hysteria. Sadly, confused anti-patent hysteria seems to be the goal, and how the opponents of thoughtful reform are poised to fight.”

https://depositphotos.com/192414674/stock-photo-close-view-change-word-made.htmlLast week, all eyes were on the first two days of historic Senate Judiciary IP Subcommittee Hearings, led by Senator Thom Tillis (R-NC), Chair of the Subcommittee, and Senator Chris Coons (D-DE), Ranking Member of the Subcommittee. The purpose of the hearing was simple: to determine a fix for the disaster foisted upon the industry by the patent eligibility jurisprudence of the Supreme Court of the United States.

The testimony of the first 30 witnesses has already been summarized, so there is no need for me to dive into the particulars of who said what here. Suffice it to say that the Subcommittee heard a range of opinions—some better supported than others.

Muddling Myriad

One issue that begs discussion is the extraordinary confusion over what the Supreme Court actually ruled in AMP v. Myriad during the two days of testimony. Indeed, at times it was difficult to determine whether there was simply confusion on the part of some witnesses, or an attempt to conflate and mislead the Subcommittee. With that in mind, a review of what the Supreme Court actually held seems to be in order.

Justice Thomas summarized the Court’s decision by saying:

[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring. 

Further, with respect to cDNA, Justice Thomas also explained:

[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

Myriad is often misquoted as saying that cDNA is patent eligible per se, but that obviously is not what the Court ruled. In fact, cDNA is patent eligible only so long as it is distinguishable from DNA. That may seem sound, but cDNA is only ever man-made. This more than anything else explains the depth of the Supreme Court’s lack of understanding of the science, and the issues.

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Creating the Crisis

The Supreme Court’s decision in Myriad seriously undermines the continued relevance of the Chakrabarty decision, given that something (i.e., cDNA) created in a lab by man may not be patent eligible. The very foundation of the Chakrabarty decision mandated a finding of patent eligibility when a person had engaged in activity to alter something. Clearly, a composite cDNA is created by man and is precisely the type of innovation the Constitution and laws of Congress envision being patent eligible. But the very fabric of the Chakrabarty ruling was shredded, overruled in fact, despite the Supreme Court continuing to say that it remains good law.

Of course, the fact that the Supreme Court overrules case after case without explicitly acknowledging that it has done so has created, at least in part, the patent eligibility crisis. It is also why the actual ruling in Myriad must be defined with great care. To wit:

  1. Human genes and DNA in the body have NEVER been patent eligible because they are not man-made and are not new. The Myriad decision did not change that. Opponents of the 101 amendment have been referring to “human genes” or “genes” in a sloppy, unscientific manner without indicating whether they are talking about human genes in the body or isolated gene segments outside of the body. The distinction is critical when discussing Myriad and matters of patent eligibility, and confusion causes anti-patent hysteria. Sadly, confused anti-patent hysteria seems to be the goal, and how the opponents of thoughtful reform are poised to fight. If they cannot win on the merits or science they will scare the public.
  2. The Myriad decision addressed whether isolated gene segments outside the body are patent eligible, and the holding is inconsistent with the language of 101 because an isolated material outside the body is due to human intervention and is thus man-made.
  3. The Supreme Court’s ruling in Myriad is based on the Court’s judicial exceptions to the statute, not the language of the statute as passed by Congress. Earlier this year in Henry Schein, Inc. v. Archer & White Sales, Inc., the current Supreme Court ruled 9-0 that there can be no judicial exceptions to a statute. Although not interpreting the Patent Act, such a declarative statement has to apply equally to all legislation if it applies to one Act of Congress.
  4. The Myriad decision threw out the baby with the bathwater, because it was interpreted to hold that all isolated natural materials are not patent eligible subject matter. These materials have played an essential part in the creation of medicines, such as antibiotics, anticancer agents, and in personal diagnostics. The downstream effect of Myriad has been devastating in all of these categories. As Sherry Knowles said in her testimony on June 4, research on isolated natural materials to cure diseases, including cancer, has come to a dead stop in the U.S.
  5. The Supreme Court in its Myriad decision stated that certain universities were not able to provide BRCA1/BRCA2 testing because of the Myriad However, there was NO evidence in the case that these universities had independently discovered the BRCA genes, their relationship to breast cancer, or developed the product and got FDA approval, i.e., carried out the “extensive effort” to create the invention and product. The universities wanted to tag team on inventions they did not create. Indeed, the Myriad case is a perfect example of a well-known and documented phenomena relating to the Supreme Court using facts not in the record to decide cases, which is antithetical to U.S. jurisprudence. Indeed, according to the NY Times, the Justices on the Supreme Court are “are quite receptive to this dodgy data” contained in amicus briefs.
  6. The Myriad Court thus made a fundamental error by skipping from the need to motivate basic research to later market accessibility, which was a theme on the second day of testimony when Senator Richard Blumenthal (D-CT) talked about his Affordable Prescriptions for Patients Act. This discussion has to unlink motivation to invent from prices and distribution, which are apples and oranges. Simply stated, as I have previously explained, drug prices in the U.S. are high not because of patents, but because foreign governments restrict access to markets, which force U.S. consumers to pay for R&D of drugs while patients around the globe do not contribute. See The Price of Price Controls. Of course, there will be nothing to price if nothing is invented because of insufficient motivation. Witness Bob Armitage and Senator Tillis ably emphasized this on the first day of testimony.
  7. Because of the human genome project and other publications, the human genome is now public. Therefore, there is diminishing value, if at all, in researching or getting a patent on isolated non-disease based naturally occurring gene segments out of the body. The only isolated gene segments of remaining interest are those linked to diseases, which we better be providing motivation to track down for all of our sakes. Any debate about isolated natural healthy genes is arguing to a quickly emptying, if not emptied, room. However, the downstream fallout of the decision is not going away.

The Supreme Court has now refused 43 petitions seeking further clarification and guidance on patent eligibility since Alice v. CLS Bank, with the Court most recently refusing Villena v. Iancu. While there are some who want to stop sensible reform based on scare tactics and misinformation, the truth is the Supreme Court has made a mess of patent eligibility law and is continually refusing to clean it up. Congress must act, and the time is now.


Image Source: Deposit Photos
Photo by VadimVasenin
ID: 192414674 

 

The Author

Gene Quinn

Gene Quinn is a Patent Attorney and Editor and President & CEO ofIPWatchdog, Inc.. Gene founded IPWatchdog.com in 1999. Gene is also a principal lecturer in the PLI Patent Bar Review Course and Of Counsel to the law firm of Berenato & White, LLC. Gene’s specialty is in the area of strategic patent consulting, patent application drafting and patent prosecution. He consults with attorneys facing peculiar procedural issues at the Patent Office, advises investors and executives on patent law changes and pending litigation matters, and works with start-up businesses throughout the United States and around the world, primarily dealing with software and computer related innovations. is admitted to practice law in New Hampshire, is a Registered Patent Attorney and is also admitted to practice before the United States Court of Appeals for the Federal Circuit. CLICK HERE to send Gene a message.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 18 Comments comments. Join the discussion.

  1. anon19 June 10, 2019 6:47 pm

    I’ve sent my comments to Sen. Tillis. For any of you who care about the state of Section 101, please do the same. NOW is the time to make our voices heard.
    IntellectualProperty@tillis.senate.gov

  2. Joachim Martillo June 11, 2019 10:36 am

    I sent the following comments Sen. Tills.
    Preface: Fixing 101 Requires Fixing 100 — Section 100 is a complete mess.

    Title 35 Changes

    Note to anon. I fixed some typos. I will reply to your comments later.

    I am working on some comments on Section 112.

  3. Anon June 11, 2019 2:55 pm

    Joachim,

    I saw your reply on the other thread, as well as this one, and at this point only wanted to say that I appreciate the fact that you appear to be going about sorting this out in an earnest and honest manner.

    I may not agree with your aim, or your choice of vehicles through which your aim is conducted, but at least you have been open, consistent yet amenable to suggestions, and do not have some pre-conceived [“X” type of innovation should not be protected under the laws providing protection to innovation].

    I look forward to your evolving views (even as I may continue to disagree with elements, parts, or general tactics).

  4. Greg DeLassus June 11, 2019 3:53 pm

    I was gratified, in listening to today’s hearings, to see that the panel of diagnostic medicine industrialists were mostly unwilling to be played in a “biotech vs. high tech” game. Drs. Hill and Merino were insistent that it is not enough to revise the statute to clear up the mess affecting biotech. We must also deal with the mess that affects AI innovators if we are to realize the full fruition of contemporary research efforts.

  5. Joachim Martillo June 11, 2019 5:54 pm

    anon@3, Article I Section 8 | Clause 8 is so scant that I doubt it will ever be possible to get rid of the judicial exceptions, and I predict any statute that tries will be declared unconstitutional. Thus I wrote the judicial exceptions into the statute according to early modern epistemological thought. At the very least, SCOTUS may have to spend some time in studying Kant if it wishes to declare the proposed statute unconstitutional in any credible manner.

    I consider the issue of 112 (f) a more serious problem. The sense of existing jurisprudence indicates 112 applies differently in the predictable vs the unpredictable arts. To control the courts the distinction must be written into the statutes.

    Who decides which technological art is predictable and which is unpredictable?

    It may be necessary to hand some substantive rule making authority over the USPTO as loathe as I am to write such a statement.

  6. Anon June 12, 2019 9:44 am

    Joachim,

    I invite you to go back and review the dialogue on that “the Court will find it UNconstitutional” angle that you want to hang your hat on.

    You are on infirm legal ground there.

    As to other aspects of the current Tillis initiative, I concur that 112 is fraught with peril. I also would reject some of the key attempts to change the US Sovereign “Useful Arts” system into a lesser “Technical Arts” system evidenced in the proposed 35 USC 100 changes.

  7. TFCFM June 12, 2019 10:39 am

    >>>While there are some who want to stop sensible reform based on scare tactics and misinformation, the truth is the Supreme Court has made a mess of patent eligibility law and is continually refusing to clean it up. Congress must act, and the time is now.<<<

    It is, of course, hardly news that the current state of the law regarding the boundaries of patent eligibility is confused (at best), and that something ought to be done to clarify those boundaries. However, as any hungry camper can tell you on a misty morning far from home, an egg in the frying pan beats an egg that has gone out of the frying pan and into the fire any morning.

    With that observation in mind, we should temper our desire to "Do Something!!!!" with recognition that supposed "cures" can sometimes prove worse than the condition they are intended to treat. So, it seems to me, may be the case with proposals to amend section 101 to declare that "everything" is patent-eligible. Far from being "scare tactics" or "misinformation," trying to revise section 101 in a sensible way seems to me an advisable course of action – and one that is better done right than merely done quickly.

    cDNA as an Example

    Mr. Quinn cites cDNA as an example of a molecule that is "always made by man."

    As an initial matter, this is simply not accurate. Cells infected with various viruses (ones which express "reverse transcriptase" – the same protein used in most man-mediated cDNA syntheses – produce cDNA. So too do cells (including substantially all eukaryotic cells, including human cells) include retrotransposons which produce cDNA. Plant cells, in particularly, are positively riddled with retrotransposons which produce cDNA. So cDNA is not remotely "always made by man."

    More substantively, though, focusing on the origin of cDNA misses the point.

    cDNA is, unquestionably, a molecule and thus a "composition" of the sort which plainly falls within one of the statutorily-designated classes of patent-eligible subject matter. Thus, cDNA (like all other molecules) is patent-eligible UNLESS some exception to the statutory classification applies.

    What is interesting – and potentially patentable – about cDNA molecules (and other nucleic acids) is not that they are polymers made from a small set of monomers, or any particular chemistry regarding how the monomers are connected. Instead, essentially ALL that is interesting/potentially-patentable is the SEQUENCE of the monomers in a cDNA. That sequence is merely information encoded in a molecule, just like information can be encoded on a magnetic medium by altering the physical dipole arrangements of the medium. Similarly, just as information embodied on a medium like a memory chip or a floppy disk does not become patentable merely because it is encoded in the medium, so too should genetic-sequence information become patentable merely because it is encoded in a cDNA molecule medium (or any other nucleic acid medium).

    Understood on this level, it can be appreciated that cDNA is merely a storage medium for information, and that this is so regardless of whether the cDNA is generated by a human, by a virus, by a retrotransposon, or by any other source.

    There is no credible reason why patent law ought to treat mere genetic information differently than other types of mere-information when assessing patent eligibility. Applying long-held patent-eligibility principles: The mere fact that a process may involve manipulation of information does not deprive the process of patent-eligibility. However, where a process involves nothing more than manipulation of information (regardless of the physical form of the medium encoding the information), U.S. patent law has consistently held such processes unpatentable.

    The practical effect of treating genetic information like other information has been seen already: bare-bones 'medical diagnostic' methods based on the mere discovery of a naturally-occurring correspondence between certain genetic information and a disease state have been held not-patent-eligible without more. This may have the effect of preventing an early discoverer of such a mere-correspondence from erecting a "toll booth" from which the discoverer can thereafter profit from practical advances (i.e., therapy or "doing something about" the correspondence) which are later made by others. However, even (especially?) if this is so, it will also have precisely the converse incentive for development of those practical advances – the ones which often will have far greater practical significance to patients, anyway. Assurance that their inventions will not be held hostage to one who merely discovered some information gives developers confidence that they may be able to recover the costs of their development efforts.

    Setting a clear and sensible boundary for patent-eligibility is an important goal. Getting that boundary right matters much more than does re-drawing the boundary quickly. A patent eligibility standard that permits patenting of mere information recorded on a storage medium (even a man-made storage medium, such as a floppy diskette or a cDNA molecule) will serve to inhibit use of that that information for practical purposes. Until and unless that information is employed in some practical application (i.e., not just "thinking about the information and its potential significance"), it should not be, by itself, patentable. Accordingly, patent eligibility of processes that involve use of information stored on a medium must look to more than the trivial detail of whether the medium (i.e., cDNA) is "made by man."

  8. Anon June 12, 2019 1:46 pm

    Your logical flaw is in the reduction of an actual object to being MERELY information.

    This not only confuses the statutory categories, it does not pay attention to the other part of 35 USC 101, in that the utility is to be of the type belonging to the Useful Arts.

    Your premise then is seriously flawed – quite in fact bringing to mind the quote attributed to Wolfgang Pauli: “Not even wrong.”

    The “but it’s information” argument is nothing more than a red herring.

  9. TFCFM June 12, 2019 2:15 pm

    >>>Your logical flaw is in the reduction of an actual object to being MERELY information.<<<

    A floppy disk with a computer program on it is an "actual object," and yet not, by itself patent-eligible.

  10. Anon June 12, 2019 7:22 pm

    A floppy disk with a computer program on it is an “actual object,” and yet not, by itself patent-eligible.

    Wrong.

    Ever hear of Beauregard claims?

  11. TFCFM June 13, 2019 10:01 am

    A Beauregard claim is merely a type of claim — not a rule of patent eligibility.

    Without more, a floppy disk with a program, a data file, an image file, or nothing at all is not per se patent eligible. As always, it is a claimed invention that must be considered for patent eligibility, not merely the medium upon which a claimed invention may be embodied.

  12. Anon June 13, 2019 11:13 am

    TFCFM,

    You are attempting to move the goalposts. The counterpoint presented defeats your assertion.

    The place you attempt to move the goal posts has already been addressed by me at post 8: utility within the Useful Arts. Your “without more” and “per se” fall to the quote that I provided you: Not even wrong.

  13. Joachim Martillo June 13, 2019 12:09 pm

    I added the introduction quoted below to my document entitled Fixing § 101 Requires Fixing § 100 to explain to logic behind this § 100-based proposal to defang § 101 eligibility doctrine.

    Because the clearer explanations are based in the philosophy of Kant,

    • who was a contemporary of Jefferson and Madison,

    • who consistently summarized the early modern Enlightenment epistemological concepts suffusing the Patent and Copyright Clause, and

    • who is a paragon of systematic logical thought in law,

    SCOTUS will have difficulty in declaring either the changes to § 100 or the implications of these changes for § 101 to be unconstitutional under said clause of the US Constitution.

  14. TFCFM June 13, 2019 1:17 pm

    >>>You are attempting to move the goalposts…<<<

    If you don't wish to discuss the point I raised in my original message, why bother raising all your other nonsensical tangential "points" instead? Perhaps you confuse childish name-calling for discussion.

  15. Anon June 13, 2019 4:42 pm

    TFCFM @ 14,

    I discussed your points raised in your original message. It was your reply to my discussion in which YOU moved the goalposts.

    Please do not stoop to your own childish name-calling when YOU are the one misbehaving (and I am the one calling for that misbehavor to stop).

    Joachim @ 13,

    That’s a nice touch – it reads much more powerfully now. I still invite your to the exchange between myself and Night Writer awhile back in which I laid out the multi-prong counter to his view of “the Court will find it UNconstitutional” angle.

  16. TFCFM June 13, 2019 5:30 pm

    >>>I discussed your points raised in your original message<<>>A patent eligibility standard that permits patenting of mere information recorded on a storage medium (even a man-made storage medium, such as a floppy diskette or a cDNA molecule) will serve to inhibit use of that that information for practical purposes. Until and unless that information is employed in some practical application (i.e., not just “thinking about the information and its potential significance”), it should not be, by itself, patentable. Accordingly, patent eligibility of processes that involve use of information stored on a medium must look to more than the trivial detail of whether the medium (i.e., cDNA) is “made by man.”<<<

    That one can write, apply a label ("Beauregard claim") to, and argue with patent examiners about a claim to information which merely happens to be embodied in an "actual object" (or molecule) does not resolve the question of whether the information (with or without object/molecule) represents patent-eligible subject matter.

  17. Anon June 13, 2019 9:16 pm

    TFCFM,

    Read again my post at 8.

    Statutory category is but one part of 35 USC 101.

  18. Model 101 June 18, 2019 11:06 am

    anon19 – good advice! Now is the time! I went to the hearings on June 4 and 5. I wouldn’t have gone if I thought the patent system was honest. I reviewed the written testimony and videos from all the hearings. I was wrongly accused to be an abuser of the patent system. My case was noted a couple of times in the record. Although the record is large, it can’t hurt to contribute.

    Maybe, just maybe, truth will break through, and stick it’s head out of the swamp here.

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