“Given the expanding uncertainty with the case law on U.S. patents—and whether, for example, they’ll protect the subject matter of a million (or even billion) dollar investment—U.S. investment in R&D has dropped. And perhaps most notably, it has dropped among innovative bio-pharmaceutical companies.”
The COVID-19 crisis has once more highlighted the need for incentivizing investment and innovation—and thus, for patent laws that duly “promote” and protect such “progress,” precisely as our Founders envisioned. See U.S. Const., Art. I., § 8, cl. 8. Indeed, those patent-based incentives over the years have helped produce life-saving medicines, tests, treatments, and cures; once-unimaginable computer technology, robotics, and nanotechnology; LASIK eye-surgery and cochlear implants; personal satellite-based navigation systems; handheld devices seemingly straight out of Star Trek; 3-D printer technology; and much, much more. Nevertheless, a series of judicial rulings over the past 15 years have steadily eroded U.S. patent protections. Consequently, once-innovative companies, including major innovative pharmaceutical companies, have divested in R&D, and investors more generally have diverted funding to non-inventive areas (like entertainment) or to countries (like China) whose patent laws offer protections more favorable than U.S. law. American innovation has fallen accordingly.
The Federal Circuit, specially created to serve as the patent law’s good steward, will have sound opportunities to fix this. And to fix it in a way that properly honors and serves the patent laws and Congress’s clear purpose. Otherwise, over the last few weeks alone, media accounts have repeatedly reported on the innovative shortcomings evident in the COVID-19 response. These included, for example, a cited need for better diagnostic tests. Just last summer, however, the Federal Circuit undercut incentives to invent in this field when it once again declined en-banc review of a ruling that U.S. patent protections do not extend to medical-diagnostic test kits and methods. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs, LLC, 927 F.3d 1333 (Fed. Cir. 2019). The Supreme Court recently declined review of this patent-eligibility issue as well, notwithstanding that the full Federal Circuit in Athena had issued eight separate opinions—each of which requested Court intervention. Id. Yet, in denying certiorari, the Court all but announced it was turning the patent-law reins back over to the Federal Circuit.
Will the court take them? In addressing that question, we first review the COVID-19 crisis amid the U.S. patent law’s current jurisprudence and its negative effects on R&D investment and innovation. In so doing, we show how Congress, to the contrary, designed the Patent Act to promote such investment and innovation, including with respect to its provisions on eligibility and invalidity, see, e.g., 35 U.S.C. §§ 101 & 103. Indeed, Congress later created the Federal Circuit for essentially this same reason, consistent with the Framers’ purpose of authorizing patent laws that “liberally encourage” innovation. Thereafter, however, we address the Federal Circuit’s recent decisions that have further weakened U.S. patent rights—including decisions on the “presumption-of-nexus” in obviousness cases and on indefiniteness. Last, we address the en-banc petition pending before the Federal Circuit in AAM, Inc. v. Neapco Holdings, expressing hope that the court will grant this petition and use it to properly clarify the court’s Section 101 case law. Perhaps now more than ever, the laws addressed to investment and innovation—and to the economic and technological strength they promote—must be properly interpreted.
The Status Quo Must Not Continue
Needless to say, no one involved in U.S. patent law or policy wants the pandemic or its multi-faceted consequences. Nor would a contrary ruling in Athena, supra, have meant that an innovator would have had at the ready the desired diagnostic testing for coronavirus. Nor a ready-made or known treatment, cure or vaccine. That said, the famous Burkean wisdom of course applies here. To paraphrase, “evil” or horrendous things can prevail if good people stand by and do nothing—and allowing bad precedents to go uncorrected has consequences.
Unfortunately, we are seeing those consequences play out with U.S. patent law in real time. For nearly 15 years, the Supreme Court’s IP opinions that have had the effect of de-valuing U.S. patent rights, making it increasingly difficult (for example) for U.S. intellectual-property owners to obtain injunctive relief against those who infringe, trespass on, or otherwise steal their patented ideas and property rights. See, e.g., eBay Inc. v. MercExchange, LLC, 547 U.S. 388, 391 (2006). (By contrast, the patent laws of China have made such injunctive relief available as a matter of course, with some reporting that prevailing patentees there obtain injunctions for nearly 90% of all requests.) And through the years, whether by Supreme Court precedent or other law-making, it has become increasingly easy to invalidate U.S. patents, see, e.g., KSR Int’l Co. v. Teleflex, Inc., 550 US 398, 415 (2007), and to render the subject matter of a patent ineligible for protection under §101. (We do not tackle here the separate pitfalls created by the 2011 America Invents Act.) This includes ineligibility not just for diagnostic testing, but for software, business methods, and quite possibly anything else in a patent claim that can be subjectively deemed “directed to” an “abstract idea, law of nature, or natural phenomena”; and doesn’t reflect an “inventive concept,” per the Supreme Court’s Mayo-Alice “framework” for Section101.
To be sure, this is not an article focused on Supreme Court Section101 precedent and the harms to innovation that it has wrought, though that has certainly played a major or even primary role in the harm to U.S. innovation. (And indeed, the proper analysis of that Section 101 precedent is a subject that warrants separate, in-depth treatment.) The larger point here is that, given the expanding uncertainty with the case law on U.S. patents—and whether, for example, they’ll protect the subject matter of a million- (or even billion-) dollar investment—U.S. investment in R&D has dropped. And perhaps most notably, it has dropped among innovative bio-pharmaceutical companies. See, e.g., Unpredictability in Patent Law and Its Effect on Pharmaceutical Innovation, by Christopher M. Holman, 76 Mo. L. Rev. 645, 663-64 (summer 2015) (“In recent years, major innovative pharmaceutical companies have experienced two pronounced and significant trends: a decreasing output of innovative new drugs and cutbacks in research and development (R&D) investment”). And innovation—the lifeblood of the American economy—has dropped with it. See, e.g., id. (explaining that the “high level of unpredictability in today’s patent law is a significant impediment to the development of new medicines” and cause of the “R&D crisis”); Bloomberg Innovation Index (2018); The U.S. Drops out of the Top 10 in Innovation Ranking, Bloomberg News (Jan. 22, 2018), by Michelle Jamrisko & Wei Lu, available at (visited March 28, 2020).
The U.S. Patent Laws “Liberal[ly]” Promote Investment-and-Innovation—and an Active Federal Circuit to Properly Interpret and Apply Those Laws
The Federal Circuit can fix this. And it can do so in a way that serves the text and goals of the Patent Act, and the legislation that created the court itself. Indeed, these sources of law reflect the American Constitution from which they emanate. Our Framers, so cognizant of history and of what had worked and failed in centuries past, were genius enough to repose in Congress the power to create such an innovation-promoting patent system. And for much of our history, that inventive spirit, fostered by our system of robust IP protection and free-market ingenuity, helped make America the most prosperous and powerful nation on earth. See, e.g., Max Roser (2020), “Economic Growth“. Published online at OurWorldInData.org.
And when we’ve had dips and confusion in the patent law—when courts across the country were applying different invalidity tests (“flash of genius!”), for example, and undermining patent rights—Congress responded. In 1952, it enacted the Patent Act that we more or less know today. Notable there was Congress’s ongoing emphasis that the Act extended eligibility for U.S. patent protection to “[a]nything under the sun that is made by man.” See, e.g., Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (citations omitted) (emphasis added). Congress thus put the law’s focus on the provisions that address whether an invention is indeed inventive, i.e., whether it is new, useful, non-obvious, and meets the Act’s disclosure and claiming requirements. See, e.g., id. As the Supreme Court has explained, the Act’s “broad” statutory language adheres to the Founders’ vision for “liberal[ly]” encouraging “ingenuity”:
The Patent Act of 1793, authored by Thomas Jefferson, defined statutory subject matter as “any new and useful art, machine, manufacture, or composition of matter, or any new or useful improvement [thereof].” Act of Feb. 21, 1793, 1, 1 Stat. 319. The Act embodied Jefferson’s philosophy that “ingenuity should receive a liberal encouragement.” 5 Writings of Thomas Jefferson 75-76 (Washington ed. 1871). See Graham v. John Deere Co., 383 U.S. 1, 7 -10 (1966). Subsequent patent statutes in 1836, 1870 and 1874 employed this same broad language. In 1952, when the patent laws were recodified, Congress replaced the word “art” with “process,” but otherwise left Jefferson’s language intact. The Committee Reports accompanying the 1952 Act inform us that Congress intended statutory subject matter to “include anything under the sun that is made by man.” S. Rep. No. 1979, 82d Cong., 2d Sess., 5 (1952); H. R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952).
E.g., id. at 308-09 (holding that a live, human-made micro-organism was eligible for patent protection under §101) (emphases added); see also Diamond v. Diehr, 450 U.S. 175, 184-88 (1981) (holding that a multi-step process that used a computer and other “conventional” steps to cure rubber was patent-eligible under §101). For nearly 30 years, these 1980-1981 Supreme Court cases stood as the last word on §101, bridging a period that oversaw so much of the remarkable innovation described above, as well as prolonged U.S. economic growth. And that made sense: The §101 text itself, after all, has remained unchanged.
As to invalidity, Congress adopted the Act’s provision on non-obviousness, 35 U.S.C. §103, to ensure that courts did not require a “flash of genius” moment in order to qualify as inventive or patentable. Rather, the provision made plain that a slow-and-steady analysis leading to the inventive solution could just as well merit patent protection. See 35 U.S.C. § 103, 66 Stat. 798 (July 19, 1952) (mandating that “[p]atentability shall not be negated by the manner in which the invention was made”). Even more, Congress created the Federal Circuit, precisely because it wanted a single court to “bring consistency to the patent field” and to “reinvigorate the patent and introduce predictability to the field.” E.g., Phillips v. AWH Corp., 415 F.3d 1303, 1330 (Fed. Cir. 2005) (en banc) (Mayer, J., dissenting); H.R. Rep. No. 312, 97th Cong., 1st Sess. 20-23 (1981).
Accordingly, the court has both statutory charter and authority to clarify—or to reverse via en-banc review—its perceived “anti-patent” rulings of recent years. In that way, an active en-banc Federal Circuit would be interpreting and applying the patent laws consistent with their foundation as the “liberally encouraged” driver of investment-and-innovation—the foundation that Congress, the Constitution and the Founders envisioned from the start. See, e.g., Diamond v. Chakrabarty, supra. Indeed, that is the main point for having a patent system. See U.S. Const., Art. I, §8, cl. 8.
The Federal Circuit’s En-Banc Denials Continue to Diminish U.S. Patents and Inventiveness
Nevertheless, as the current COVID-19 crisis has continued, so too have the court’s en-banc denials on decisions that have once more weakened U.S. patent rights and innovation. That is, by not revising overreach in panel rulings, these en-banc decisions have put the capstone on a weakened U.S. patent law and system.
For example, as to obviousness and the often-critical “objective” evidence supporting a patent’s validity, the Federal Circuit has long required a nexus between the patent’s claim and the evidence pertaining (for example) to the patented product’s commercial success. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 1392 (Fed. Cir. 1988). But the case law also recognized a “presumption-of-nexus,” depending on (1) the patentee’s showing that its patent claim’s features were present in the commercial product; and (2) whether the accused infringer could rebut this prima facie presumption by showing that something other than the claimed invention—such as additional, unclaimed features or marketing—accounted for the product’s success. E.g., id. at 393-94. Further, and for at least 30-plus years, this patentee evidence for the presumption could alone suffice. That is, the patentee could still obtain this nexus-presumption even if (for example) the claimed product had “additional, unclaimed features.” E.g., PPC Broadband, Inc. v. Corning Optical Comm’ns RF, LLC, 815 F.3d 734, 747 (Fed. Cir. 2016) (reversing finding that the nexus-presumption was inapplicable; “[b]ecause the evidence shows that the SignalTight connectors are ‘the invention … claimed in the patent,’ we presume that any commercial success of these products is due to the patented invention. This is true even when the product has additional, unclaimed features.”) (citation omitted) (emphasis added); Ecolochem, Inc. v. S. Cal. Edison Co., 227 F.3d 1361, 1378 (Fed. Cir. 2000) (applying nexus-presumption even though commercial product had additional, unclaimed mobility feature); J.T. Eaton & Co. v. Atl. Paste & Glue Co., 106 F.3d 1563, 1571 (Fed. Cir. 1997) (presumption applicable even when product has additional, unclaimed features).
But that has now changed. In Fox Factory, Inc. v. SRAM, LLC, a Federal Circuit panel substantially tightened the requirements for obtaining this presumption, holding for the first time that the claim and its commercial product must indeed prove “essentially” identical, with no additional unclaimed features between them. See 944 F.3d 1366, 1374 (Fed. Cir. Dec. 18, 2019) (admittedly establishing this “unclaimed features” requirement for the first time and thereafter assessing whether the additional, unclaimed feature was “significant”). Judge Michel filed an amicus brief supporting en-banc review. Nonetheless, despite decades of precedent to the contrary, see, e.g., PPC Broadband; Ecolochem; J.T. Eaton, supra, the Federal Circuit declined the en banc request. Likewise, it has allowed other recent panel decisions to stand when those decisions have also made it easier to invalidate U.S. patents. In HZNP Finance Ltd. v. Actavis Labs, Inc., for example, the court again declined en-banc review for a decision that held certain composition claims indefinite, even when those claims used the well-established transitional phrase “comprising essentially of ….” –F.3d–, Nos. 2017-2149, 2017-2152, 2017-2202 (Fed. Cir. Feb. 25, 2020). Notably, four judges there voted for en-banc review, joining Judge Lourie’s dissenting (and well-reasoned) opinion.
A Time for Action—En Banc Action
Will this jurisprudence of shrinking U.S. patent rights end? One hopes as much, especially given concerns with encouraging innovation, maintaining competitiveness, and timely inventing the technology, vaccines, cures or treatments so vitally needed now, whether for pandemics or in any field of human endeavor “under the sun.”
And there is reason for hope. Pending before the court is an en-banc petition in AAM, Inc. v. Neapco Holdings LLC, 939 F.3d 1355 (Fed. Cir. Oct. 3, 2019), the panel decision for which extended §101 ineligibility to subject matter that seems entirely concrete and physical—namely, to an industrial process for making certain physical auto-parts (“drive shafts”). Id. The case has drawn substantial interest and prompted several amici filings (including Judge Michel’s) that have also supported en-banc review. And with good reason: The panel’s AAM decision, after all, would subject seemingly any technology to a §101-ineligibility attack, and would thereby expand the reach of an ineligibility test based on a provision that Congress cited as a basis for promoting inventiveness—indeed, as expanding U.S. patent protection to “anything under the sun that is made by man.”
AAM v. Neapco thus presents the en-banc Federal Circuit with the opportunity to properly fix, clarify or cabin its erroneous §101 rulings. We surely will face crises like COVID-19 again, to say nothing of the ongoing challenges with American competitiveness in the world marketplace and the growth of the U.S. economy and employment—all matters of grave importance. The question is whether the Federal Circuit will now cure its rulings that have hobbled U.S. innovation and once again “promote … progress” and invention.
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Join the Discussion
28 comments so far.
BApril 16, 2020 10:42 am
“As I have said before, in his opinion in the Ariosa case, he was not merely qualitatively wrong but quantitatively wrong by a factor of 1,000 to 1,000,000 on the face of his own opinion. But having seen him in person, I am utterly convinced of his decency and integrity and have no hesitation in attributing his unfortunate mistakes to lack of knowledge rather than rogue behavior.”
Ariosa is brilliant in that it exposes just how bad an opinion can be. That said, you should hang out at the CAFC for a few days of oral argument, then see if your opinion of the man changes.
BApril 16, 2020 10:34 am
@ Paul Cole “I first heard the phrase “patent profanity” used by Tom Irving at a presentation that he gave at the AIPLA annual meeting some 20 years ago.”
Interestingly enough I heard the term “patent profanity” early in my first law job. The first word we were taught never to use was “invention.”
AnonApril 16, 2020 10:31 am
Your opinion is always yours to have.
As with other patent topics, I do hope that you are able to grasp that sometimes ‘being nice’ is not the necessary answer. As with other patent topics, I do hope that you are able to grasp that sometimes “practitioners should write better” is not the necessary answer.
When you prescribe things that get in the way of the necessary answers, you become part of the problem, no matter how good your advice may be in and of itself.
Paul ColeApril 16, 2020 09:44 am
Following your comments, I have consulted the Wikipedia entry for Judge Reyna, I have found that he majored in history and also the following:
“Reyna was nominated to the Federal Circuit on September 29, 2010. When nominated, he received the highest rating possible by the American Bar Association Standing Committee on the Federal Judiciary: “Unanimously Well Qualified.” On April 4, 2011, the U.S. Senate confirmed his nomination by a roll-call vote of 86-0.”
It was from the outset and continued to be the case until 2010 that a high proportion of the cases before the Federal Circuit involved patents. Given his character and distinguished career, it is very apparent that Jimmie Reyna was “well qualified” for a judgeship where the cases coming before him might involve trade or contractual issues or other matters of a non-technical nature and that appointment as a judge of one of the circuit courts of appeal would have been both appropriate and deserved. But the appointment of an international trade practitioner to the Federal Circuit raises the issue of how the members of the ABA standing committee could POSSIBLY have concluded that he was “well qualified” for this specialised position or how the US senators could POSSIBLY have concluded that this was indeed the case. There was, I think, an obligation on him to investigate the specific work that the court was tasked to do, possibly to read a number of its recent decisions to obtain a better idea of the work and then consider whether e.g. the obviousness of a pharmaceutical composition was something he would be well placed to decide. If there was a mistake, I think it might have been acceptance of President Obama’s offer without sufficient attention to the detail of the position being offered.
But on the whole, I will stick to my opinion. And, to my great sorrow, I do not have the agility to contact my arse with my head,
AnonApril 16, 2020 07:04 am
Your response to patent profanity is basically to take one of two options, neither of which are effective for the US domain:
stick your head in the sand and proclaim ‘it’s not that bad.”
(sorry, but it IS that bad – you do not get to select the facts)
Here, wear my glasses, they work for me
(problematic with MANY who operate in a different Sovereign, and related to not properly acknowledging the fact that there is NO ‘One World Order.’)
Further, your willingness to bend over backwards to someone who admits a deficit (at the onset) and who still later makes material mistakes – just because you think he is a ‘nice guy,’ shows a serious flaw in your ability to be critical. It is NOT a mistake to take a view that someone may be a ‘nice guy’ and still be malevolent to a certain position.
The reality is that there are multiple forces, multiple philosophies that ARE malevolent towards strong patent rights.
You appear to be an advocate for excellent practice in patent practice for practitioners.
You appear to be an extremely weak advocate for reform in the larger scope of patent law.
That is decidedly not good.
Excuse the colloquial and somewhat crass statement, but please take your head out of your arse.
Paul ColeApril 16, 2020 02:35 am
About 3-4 years ago Judge Reyna gave a short talk at the AIPLA annual meeting in which he mentioned his background and admitted that when he joined the Federal Circuit he had little or no knowledge of science and no knowledge of patent law. If you look at his biography, you will find that his former practice was in the field of economics, and that he was a part-time US university lecturer which marks him out as an individual of enthusiasm and benevolence in the fields where he was formerly practising. Very unfortunately he took no questions at the conclusion of his talk and left immediately with no opportunity for anyone to talk to him as I would like to have done.
As I have said before, in his opinion in the Ariosa case, he was not merely qualitatively wrong but quantitatively wrong by a factor of 1,000 to 1,000,000 on the face of his own opinion. But having seen him in person, I am utterly convinced of his decency and integrity and have no hesitation in attributing his unfortunate mistakes to lack of knowledge rather than rogue behavior.
Paul ColeApril 16, 2020 02:16 am
I first heard the phrase “patent profanity” used by Tom Irving at a presentation that he gave at the AIPLA annual meeting some 20 years ago.
There is, I think, a divide between life science practitioners and those practicing in the electrical/mechanical arts. In life sciences it is still common to find background art discussed, sometimes with the detail and length that might be expected for a PhD thesis. In the electrical/mechanical arts bland short introductions referencing no prior art are more common. The disadvantages of that practice are amply demonstrated by the UK Windsurfer litigation discussed in my paper downloadable from
and from my drafting book.
In my view the gold standard is ONE reference in the Background section, being the closest prior art known to the inventor at the time of filing. That provides a reference point from which differences incorporated into the invention can be identified. The starting point should in my view be named or identified especially in the case of a published document and so far as possible the actual words of the prior art document should be reproduced but no more. If James Drake and Hoyle Schweitzer had identified Sailfish/Sunfish as the best prior art and ideally included a drawing of it in their specification, many unfortunate mistakes would have been avoided and they would have had a better chance of obtaining valid and enforceable patent protection.
While the “patent profanity” doctrine makes some valid points, it tends to be carried to an unhelpful extreme in the US, somewhat like the ineligibility doctrine discussed here.
BemusedApril 15, 2020 07:05 pm
Paul [email protected]. Relax, Francis. No one particularly cares about your CV or your background. The posting was about your statement that in your entire illustrious career you’ve never met a federal judge that did not issue a decision that was not based on the “material facts and the relevant law”.
Let me make it simple for you: If you truly believe that, then notwithstanding your self-aggrandizement, you suck at being a lawyer.
AnonApril 15, 2020 06:04 pm
Are you operating with a bit of lack of understanding of the patent profanity in the US?
I ask because you lean on the PCT statement of “and state the advantageous effects, if any, of the invention with reference to the background art.” in a day and age when ANY inclusion of art is a P00R practice.
Only under the most dire (or at the opposite extreme, the most benign) instances should one include anyone else’s art in a background section today.
Don’t like this? Blame the courts. But don’t blame practitioners.
BApril 15, 2020 01:49 am
@ Paul Cole “If there is a choice between ignorance or misjudgment and malice, I will personally go for ignorance or misjudgment every time.”
The CAFC has, in a number of cases, deliberately lied in their feckless opinions about the factual record. Thus, between ignorance or misjudgment and malice, I will attribute malice and hubris.
It is my personal theory that certain judges, e.g., Reyna and Taranto, are trying to make a name for themselves as “the judge who clarified the issues and saved the world from bad patents by virtue of their singular brilliance.” Others, such as Judges Stoll and Chen, just lack the intellectual capacity to render an opinion that passes the laugh test, and so shamelessly lie about the factual record.
“And you are utterly right about my ignorance and lack of touch with reality.”
Paul, having worked with you in the past, I fully respect your knowledge of U.S. case law and have been impressed with certain unique insights. However, I think Bemused is correct in that you have, in that polite way the British have, chosen decorum in the face of rogue behaviour. This really is no different than the decorum of the various prestigious counsel, such as the attorneys who represented Chamberlain, in the face of absurdity.
Me, I know decorum is useless at the CAFC. I can’t even shame a single Federal Circuit judge into defining the term “inventive concept” in some meaningful fashion that doesn’t involve complete capriciousness.
Paul ColeApril 14, 2020 02:50 pm
Again @ Bemused
In appropriate circumstances it enhances rather than belittles a person to apologize.
Paul ColleApril 14, 2020 02:44 pm
I agree with B that the CAFC has gone rogue on eligibility. But I suspect that this was based on early post Alice decisions where they over-broadly interpreted and effectively gold plated what were meant to be cautious and conservative SCOTUS decisions, possibly for fear of another SCOTUS reversal. If there is a choice between ignorance or misjudgment and malice, I will personally go for ignorance or misjudgment every time.
And you are utterly right about my ignorance and lack of touch with reality. I have totally ignored all the relevant decisions discussed on this or other blogs. My ignorance of statute and case law concerning section 101 is profound. I know nothing about the CAFC or its procedures. Were I to be tasked with writing a brief for the CAFC or Scotus, I would be totally at sea because I know nothing about relevant US patent law or the rules applicable to a brief. I never authored a brief in the Ariosa, Athena or Recognicorp cases as you would know if you follow the relevant blogs including the SCOTUS blog where if you search for me you will not find my name mentioned.
I can only marvel at how well informed you are and how sound your judgment is.
BApril 14, 2020 09:05 am
@ Bemused “Bluntly, you should be embarrassed to have written such a nonsensical (and I’m really trying hard to be polite here) response to my posting.”
I do like Mr. Cole, but I agree with you on this issue. The CAFC has gone rogue on the 101 issue.
Also, FYI, last time I was at the CAFC I talked to an attorney who did Veteran Affairs cases. It was his opinion that the CAFC’s decisions were highly problematic.
Finally, has anyone here read the last two 101 cases that came out of the PTO? Simpering decisions looking for an “inventive concept.” “Oh, look, those claims preempt something!” Yes, all claims preempt something, but our CAFC judges are too retarded to know this.
BemusedApril 13, 2020 08:26 pm
Paul [email protected] “Whatever the personal philosophies of the CAFC judges, their duty is to hand down correct decisions according to the material facts and the relevant law, and I have yet to meet a federal judge who does not adhere to those standards.”
Paul, in light of that statement I have to assume you’ve never had a case before the CAFC because no one can be that ignorant or so out of touch with reality. I have to further assume that you really don’t read this blog given the dozens and dozens of CAFC decisions profiled on here (many by Gene Quinn) repeatedly illustrating the anti-patent bias of many of the judges on the CAFC.
Bluntly, you should be embarrassed to have written such a nonsensical (and I’m really trying hard to be polite here) response to my posting.
BApril 13, 2020 08:15 pm
@ Model 101 “Based on the fact that about 1000 cases were decided without any evidence and 50 plus cases for cert were denied by the Supreme Court… should the new 101 be decided retroactively?”
I say “yes” because Alice/Mayo is an unConstitutional taking. No evidence and no legal standard. One cannot mock the CAFC to the point where they will tell you what an “inventive concept” is. I know this first-hand.
Also “yes,” because rubbing the courts’ noses in their past vapid mistakes is just bonus.
BApril 13, 2020 08:08 pm
@ TFCFM “Athena did not REMOTELY hold that “patent protections do not extend to medical-diagnostic test kits and methods,” as the authors suggest. (If my assertion is inaccurate, please copy the court’s holding here, so we can all see it.)”
Go back to playing fireman on another blog. You are not an attorney, and you are certainly not a patent attorney or agent. You constantly misrepresent every holding you ever comment upon, and Judge Paul Michel’s knowledge of eveything 101 is profound. Posting anything for your edification is a waste of time. You’ll just run in circles and deny what’s before you.
BRW, I spend my spare time tearing apart the holdings of various judges, and to date I can think of no judge with a better record of understanding all the 101 issues than Judge Paul Michel.
“Athena could have made their discovery a trade secret. However, they chose to patent their discovery, and as a result, the world learned about that discovery. Would the world be a better place if every diagnostic test was a trade secret?”
His holiness Judge Richard Taranto, who has yet to figure out that there are other parts of the Patent Law than 35 USC 101, has openly stated that trade secrets are the appropriate route.
bApril 13, 2020 07:47 pm
@ Paul Cole “Support for these propositions would be informative: in the absence of such support they degenerate into mere invective.”
I’ve written various articles on the dishonesty of the CAFC and documented said dishonesty in detail. However, even if I had not, the vast stupidity that is the Alice/Mayo jurisprudence of the CAFC is no accident.
Model 101April 13, 2020 04:45 pm
Thanks Judge Paul Michel for your article. I seriously doubt any case will be heard en banc. It’s up to Congress. Based on the fact that about 1000 cases were decided without any evidence and 50 plus cases for cert were denied by the Supreme Court… should the new 101 be decided retroactively? No inventor would ever file another patent application In the US after losing because of 101. They’d be foolish to do so.
Paul ColeApril 13, 2020 04:38 pm
Whatever the personal philosophies of the CAFC judges, their duty is to hand down correct decisions according to the material facts and the relevant law, and I have yet to meet a federal judge who does not adhere to those standards. If things go wrong it is up to us to improve our drafting and advocacy and help them reach correct decisions.
Your suggestion that I have been attempting to excuse the Supreme Court’s role in the current eligibility mess based on your purported study of my comments suggests an inability to read – see what I have said about Athena and the TRIPS treaty. Attention to detail is an important attribute of any advocate.
Support for these propositions would be informative: in the absence of such support they degenerate into mere invective.
A new way of producing an old result would be perfectly acceptable under the EPC. But subject matter that can satisfy the technical problem test is also likely to be stronger in the US. Famously the application for the Alice patent was thrown out by the EPO notwithstanding that it was prosecuted by the late Keith Beresford who was not only the most able UK patent attorney of my generation but also a noted proponent of software eligibility before the EPO. If he could not identify a solved technical problem, the decision to take the US case to the Supreme Court looks less than wise.
It may be helpful to quote Judge Lourie in the recent decision in Illumina v Ariosa: “Under Mayo, we have consistently held diagnostic claims unpatentable as directed to ineligible subject matter. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, 927 F.3d 1333, 1352 (Fed. Cir. 2019) (Moore, J., dissenting from denial of rehearing en banc) (“Since Mayo, we have held every single diagnostic claim in every case before us ineligible.”) …” The distinction between Athena and Illumina is rather thin since in Athena the patentees used chemical steps for precipitating an autoantibody from blood and enabling its presence to be detected by radioactive counting.
And with reference to Ariosa try telling an expectant mother concerned about possible problems with the foetus that she can either have a blood test at 12-14 weeks or an amniocentesis at 18 weeks plus with attendant risk to the developing foetus from the invasive needle procedure and that the Oxford researchers who enabled that test invented nothing. Similarly in Athena, another Oxford-originating invention.
TernaryApril 13, 2020 03:01 pm
Detecting “… a newly-recognized natural phenomenon…” Yep. Should be patent eligible. Like detecting COVID19 virus or any of its natural phenomena. You make it sound like Athena claimed “the world” and what is beyond. But the claim is actually focused on a disease and a particular (previously unknown) phenomenon.
Many detection methods (and therapeutic/ preventive substances) of COVID19 are “directed” to known properties of corona viruses, which are actually well known. At this stage, most of us would agree that a novel COVID19 test/therapeutic/vaccine is an invention, and a very valuable one. Leave it to pseudo-methodologists and lawyers to argue that no invention was done, and if done it is patent ineligible and if it is patent eligible it was obvious anyway.
Your assertion of “folks who “invented” nothing” is incorrect. The Court did not hold that “nothing was invented” in this case. They merely decided the invention was patent ineligible. A bureaucratic decision. Nothing more. A power delegated to them. But not on the basis of their inventive/scientific skills. I would not trust the court to be able to decide if an invention was made, even when it was staring them right in the face. Even the USPTO does not assert that an inventor “did not invent” the claimed invention in an application, if rejected.
You are mixing up a misguided opinion of a Court with what an invention actually entails.
You are looking for inventions that are “genuinely new and non-obvious.” What are those? Even Newton admitted that he was standing on the shoulders of giants. That doesn’t make his invention(s) obvious.
A “biological truth” does not exist. A “truth” is a logical/human concept. It only exists in the human mind. A “truth” as per Kant, exists a priori to empirical verification. The claimed invention of Athena only exists after empirical verification. That is the nature of invention. It only exists after you have taken action. That is the whole scientific basis of clinical trials. Nothing is admitted as effective (and safe) a priori to testing. Of course, in hindsight, etc…. The concept of “truth” is introduced as a rhetorical trick to incorrectly imply abstractness. History of science has enough examples of how shaky our “scientific truths” actually are.
CuriousApril 13, 2020 02:07 pm
monopolization of biological truth
Said by someone who doesn’t understand what the terms “monopolization” or “biological truth” mean or what those terms mean in the context of what was invented.
Also, let’s remind everybody what the Federal Circuit stated:
The named inventors of the ’820 patent discovered that many of the 20% of MG patients without acetylcholine receptor autoantibodies instead generate autoantibodies to a membrane protein called MuSK.
While we are at it, let’s remind everybody what is stated in the US Constitution:
“To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries.
We’ve got a discovery, as admitted by the Federal Circuit, and we’ve got the US Constitution speaking about exclusive rights for discoveries. Looks like a disconnect to me.
Then, we’ve got the following statement by the Supreme Court that was cited by the Federal Circuit:
These exceptions exist because monopolizing the basic tools of scientific work “might tend to impede innovation more than it would tend to promote it.” Id. at 71.
The “might tend to impede innovation” has got to be one of my most favorite utterances by the Supreme Court. Weasel words on top of rampant speculation.
What many commentators and the courts fails to appreciate is that impeding innovation (as described by SCOTUS) and the promotion of progress (as described by the Constitution) are not mutually exclusive. Patents (and by extension, patent law) can do both at the same time. Patents rights are exclusionary, and consequently, all patents might tend to impede innovation directed to similar technology. However, this impeding of innovation is more than balanced out by what patents do to promote progress. Patents promote progress via two major mechanism: (i) public disclosure of inventions and (ii) rewarding inventors for their disclosure.
Athena could have made their discovery a trade secret. However, they chose to patent their discovery, and as a result, the world learned about that discovery. Would the world be a better place if every diagnostic test was a trade secret? The problem with such a world is that the credibility of these diagnostic tests would be questioned as the results cannot not be independently confirmed. Additionally, in keeping these discoveries trade secrets, the amount of collaboration with other researchers would be greatly diminished. While these discoveries could serve as seeds for other lines of research, in a trade secret regime, these other lines of research will lie fallow because very few will know to pursue them.
Let’s say that trade secrets are impracticable for these types of discoveries. Who is going to do the research to identify these types of discoveries when there is no money to be made off of them? Sure, there may be some universities that will continue to do that type of research. However, there won’t nearly be as much impetus from the for-profits to do that kind of research. As stated by Newman in her dissent, “the public interest is poorly served by adding disincentive to the development of new diagnostic methods.”
jacekApril 13, 2020 01:45 pm
Isn’t a little bit naive to expect sudden reviewal of good corporate citizenship, putting the greater good of the nation above (Google, Facebook, Apple….etc. ) greed? Judges who suddenly actually know, and rule in line with real intent of the law…. etc…
“Words are like Grass.” Hope is for fools.
What is your proposition?
We need real action.
TFCFMApril 13, 2020 11:18 am
Article: “Just last summer, however, the Federal Circuit undercut incentives to invent in this field when it once again declined en-banc review of a ruling that U.S. patent protections do not extend to medical-diagnostic test kits and methods. See Athena Diagnostics, Inc. v. Mayo Collaborative Servs, LLC, 927 F.3d 1333 (Fed. Cir. 2019).”
Dishonestly mis-representing the holding in Athena v. Mayo fools no one, and only undercuts the credibility of this blog.
Athena did not REMOTELY hold that “patent protections do not extend to medical-diagnostic test kits and methods,” as the authors suggest. (If my assertion is inaccurate, please copy the court’s holding here, so we can all see it.)
Instead, the court held that the generic diagnostic method claimed in Athena (claim 1, claiming any and all methods of detecting in any mammal any auto-antibody to any epitope of any of a particular class of proteins) is merely claiming all embodiments of a law of nature, and that adding well-known assay steps and reagents (Athena claims 2, 3, and 6-9) does not add anything inventive to that. Athena stands for no deeper proposition than that use of a well-known method to observe a natural phenomenon is not eligible for patenting. A third-grader could tell you that this is the proper conclusion (even if the third-grader, doubtless, could not put his or her finger on precisely why this should be so).
Patent rights should be used to reward genuine invention — not simply to make a pile of money for the first monopolist to use others’ ideas to generate a useful tool.
Medical science, especially, will continue to reveal the natural phenomena that we call “biology” and “medicine” without monopolists’ profiteering. The authors do a severe disservice to all medical pioneers, major and minor, by suggesting that ONLY the naked pursuit of profit has driven advances in medical care and biological knowledge. The opposite is more nearly the case.
Where technologists develop genuinely techniques, reagents, or devices that are genuinely new and non-obvious over biological truths (“natural phenomena”), they should rightly be rewarded for their efforts. However, when they seek (as in Athena) simply to lock out all others from the practice of medicine and biology merely because they were able to file legal papers prior to the announcement of a newly-recognized biological truth, their efforts to profit from excluding all others from that truth ought to be denied.
Pretending that the court in Athena did anything more than preventing the monopolization of biological truth by folks who “invented” nothing and who merely sought to use techniques described by others to monopolize a newly-recognized natural phenomenon dishonors and discredits they who assert that pretense.
CuriousApril 13, 2020 10:09 am
If a patent specification discloses no new result, the question arises which has perplexed philosophers: Does absence of evidence amount to evidence of absence? The pragmatic answer is that patent attorneys are or should be trained to look for new function or result, and if the relevant claim is not supported by such evidence disclosed in the specification itself that is affirmative (though not necessarily conclusive) evidence of absence.
There is no requirement, in US law, for a new result. For example, you can obtain a patent on something that provides an old result (but performed differently).
BApril 13, 2020 09:06 am
Dear Judge Michel,
The CAFC is determined to break 101 and keep it broken. AAM v. Neapco will be denied en banc b/c the majority of that panel violated due process and made a number of misrepresentations. The CAFC doesn’t admit mistakes and doesn’t admit intentional misconduct.
AnonApril 13, 2020 07:53 am
Shall we visit again the limitations of your attempt to excuse the US Supreme Court’s role in the current mess of eligibility Common Law-scrivened chaos?
You do no one any favors with such attempts.
While there is certainly nothing wrong — per se — with your calls for critical thinking and application of law, your confined own lack of critical thinking aimed at the body of the Supreme Court itself perpetuates the problem at its roots.
How many times must we engage before you grasp and amend your advocacy?
Paul ColeApril 13, 2020 05:01 am
” …indeed, the proper analysis of that Section 101 precedent is a subject that warrants separate, in-depth treatment.” Amen to that!
It is highly probable that careful and detailed analysis of the Supreme Court decisions on section 101 would reveal significantly narrower legal rules flowing from recent decisions than commentators and the CAFC judges suppose. Students of law are taught the analysis of court decisions in law school, identifying the material facts that were relevant to a decision and the rule of law that flows from these facts. For example in Prometheus v Mayo the only novel features were information about the upper and lower boundaries of the therapeutic window for thiopurine drugs. The claim did not require anything to be done with that information and the hand of man was not involved in any way with that information because there were no features in the claim requiring it to be used. The allegedly novel features were therefore in an ineligible category of mere information, and the remaining features were not novel on the face of the patent specification itself and therefore excluded under section 101 as well as 102. The rule of law flowing from the decision is clearly that eligibility cannot be derived from ineligible features, and no more than that.
The CIPA brief to the Supreme Court in the Athena case argues that the categorical exclusion for diagnostic methods identified in the en banc refusal decision in that case and recently reaffirmed in another CAFC decision places the US in breach of its obligations under the TRIPS treaty to grant patent protection in all fields of technology. Placing the US in breach of the of such an important international treaty initiated by the US, or even the possibility of such a breach, must surely be regarded as a national disgrace. It is incomprehensible why this point is not more noticed by the US profession and the courts, and why the Supreme Court was not sufficiently concerned to grant certiorari for that reason alone.
On obviousness, the remark of Mr Justice Jackson in Great Atlantic & Pacific Tea Co. v Supermarket Equipment Corp is of enduring and inspirational value: “A patent for a combination which only unites old elements with no change in their respective functions, such as is presented here, obviously withdraws what already is known into the field of its monopoly and diminishes the resources available to skilful men.” The inspiration comes from appreciation of the converse: if there is identifiable new function or result then the exclusion does not apply and there is potential for invention. Even more inspirational is a statement of Mr Justice Bradley in Webster Loom v Higgins: “It may be laid down as a general rule, though perhaps not an invariable one, that if a new combination and arrangement of known elements produce a new and beneficial result, never attained before, it is evidence of invention.”
If a patent specification discloses no new result, the question arises which has perplexed philosophers: Does absence of evidence amount to evidence of absence? The pragmatic answer is that patent attorneys are or should be trained to look for new function or result, and if the relevant claim is not supported by such evidence disclosed in the specification itself that is affirmative (though not necessarily conclusive) evidence of absence.
That analysis is supported by PCT Rule 5.1(a)(iii) which requires that the description shall: “disclose the invention, as claimed, in such terms that the technical problem (even if not expressly stated as such) and its solution can be understood, and state the advantageous effects, if any, of the invention with reference to the background art.” It may be from this rule that the technical problem test applied by the EPO has been derived, the technical problem being a reconstruction from identification of the difference between the invention and the closest prior art and the new result that flows from that difference. Very unfortunately in the US the emphasis in recent years appears to be on background factual enquiries and not on new result which is often forgotten or downplayed.
BemusedApril 13, 2020 04:01 am
With all due respect to Judge Michel (whom I greatly admire for his steadfast support of the U.S. patent system and American innovation), this is a fantasy. The CAFC will NEVER (as presently constituted) be a supporter of patent rights and inventors. The previous administration (at the direction of its paymaster, Google) made sure to appoint judges to the CAFC that have time and again expressed their absolute disdain for patent rights and independent inventors.
The underlying problem with the CAFC’s current anti-patent jurisprudence isn’t a matter of statutory (mis)interpretation. Rather, it is a matter of personal philosophy and how the (anti-patent) judges on the CAFC “feel” about patents and patent rights.
Stated simply, the current composition of the judges on the CAFC will not ever change their tune because they just don’t like patents. Not a particularly shocking revelation. After all, that’s how they got to the CAFC in the first place.