“In prior times, the CAFC worked very hard to speak with a clear, consistent, stable, single voice and now it’s every panel for itself. You make the law in your image if you can get one other panel member to join your opinion; that’s not law, that’s just power plays.” – Retired CAFC Chief Judge Paul Michel
During IPWatchdog’s Life Sciences Masters 2022 today, Retired Chief Judge of the U.S. Court of Appeals for the Federal Circuit (CAFC) Paul Michel said a lot could be fixed by the CAFC itself with respect to patent eligibility law if it would just go en banc more often. “By my recollection the Federal Circuit hasn’t gone en banc on a major patent case in a decade,” Michel said. “And yet, all CAFC judges are on record saying that 101 law is a total mess and needs to be fixed.”
Michel was speaking on a panel moderated by Laura Smalley of program sponsor, Harris Beach, and including Mike Cottler of biosimilars company Alvotech and Thomas Stoll of Genentech. The panelists were discussing the effect of U.S. patent eligibility law on the life sciences industry, including the potential impact of current efforts to reform patent eligibility law, such as Senator Thom Tillis’ (R-NC) Patent Eligibility Restoration Act. While Michel said he believes it’s ultimately Congress’ job to make the kind of policy judgments the Supreme Court and Federal Circuit have been making in this sphere, there is still a lot more the Federal Circuit could be doing to help the situation:
“The job of the court is to police the uniformity of its own doctrine and its own case law by going en banc when there are inconsistent or conflicting decisions by individual panels. So, there’s been a tremendous failure on the part of the Federal Circuit, first to provide clarity and rigorous analysis and rationalism, but secondly to clean up disparate decisions and provide clarity by going en banc. They have the power to do that, they have the obligation to do that—they used to do that all the time in major cases, and in prior times, the CAFC worked very hard to speak with a clear, consistent, stable, single voice and now it’s every panel for itself. You make the law in your image if you can get one other panel member to join your opinion; that’s not law, that’s just power plays, and it’s really a very unfortunate development. We could make a lot of progress, whatever the Supreme Court or the Congress does or doesn’t do, if only the Federal Circuit would go en banc to do its job.”
As the self-proclaimed “contrarian” on the panel, Cottler said he believes Section 101 law is fair as is and noted that “for the most part, pharmaceutical patents have withstood 101 challenges,” pointing to Vanda v. West-Ward as one example. “Over time, even though there’s some uncertainty at first, the law balances out,” he added.
Cottler also told attendees that “diagnostic patents are still possible in the U.S.—not the broader claims but the narrower claims,” and dismissed all the focus on investment moving to China as hyperbole: “China’s used as a bogeyman when we talk about innovation,” Cottler said. “There are lots of hurdles to doing business in China. I don’t think a company will move its business to China simply because you can get a patent on a broad diagnostic claim there.”
Michel countered that assertion, explaining that the Washington cliché goes, “if you want to understand what’s really happening, follow the money.” Michel recited statistics that he said show 88% of U.S. venture capital money used to be spent on R&D and commercialization in the United States. “Now it’s dropped down to about 50%,” Michel said. “So, it’s migrating overseas like crazy to more friendly countries that are supporting, across the board, new technologies. It looks to me like we already see worrisome evidence that the money flows are going out of real technology into entertainment when it stays in the country and going out of the country to Europe and Asia where incentives are better. The conclusion to draw from that seems to me to be self-evident.”
Life Science Innovation Under Biden
Another panel today examined the state of incentives for pharmaceutical innovation under the Biden Administration and included Sherry Knowles of program sponsor Knowles Intellectual Property Strategies; former Acting Deputy Director and interim Director of the U.S. Patent and Trademark Office (USPTO), Drew Hirshfeld; Corey Salsberg of Novartis; and was moderated by Doreen Trujillo of sponsor Saul Ewing Arnstein & Lehr. Knowles and Hirshfeld implored all present to submit comments on the USPTO’s recent Request for Comments relating to continuations, terminal disclaimer practices and collaboration with the U.S. Food and Drug Administration (FDA), among other issues, which Knowles and the other panelists said suffers from some misguided and unrealistic suggestions. For example, one question, originally posed by the group of senators who asked the USPTO to look into this issue, asks whether six months should be the appropriate timeframe within which an applicant must file a continuation application. “You can’t possibly anticipate all the continuation or divisionals in that timeframe,” Trujillo said.
Salsberg also took issue during the panel with some of the data relied on heavily by many in the Biden Administration, as well as others, to justify the needed changes—particularly the Initiative for Medicines, Access & Knowledge (I-MAK’s) assertions about the numbers of patents covering major drugs. Salsberg explained that the numbers are often inflated by pending and abandoned applications. As an example, Salsberg said Congress cited 73 patents on Novartis’ drug, Gleevec. “But there are only six,” he added. “They get to 73 by counting 44 abandoned patent applications as patents. Of the remaining 29, one was pending, and of the other 28, they don’t read on the drug at all.”
IPWatchdog Founder and CEO Gene Quinn said industry needs to “swing back” at such misinformation more often and more aggressively. “This to me screams of racketeering or tortious interference with business relations,” Quinn said. “I don’t understand across the spectrum in the patent world why people are not more aggressive at going back at these liars?”
Salsberg noted that he has presented the same information to the FDA and that Senator Tillis has been a huge champion in fighting back with letters to both I-MAK and the USPTO this year. “I really hope the Office will do something,” Salsberg said. “Before we make changes to the patent system [based on this data], we better make sure the information is accurate.”
Other panels today examined the future of the written description requirement, strategic considerations for claim drafting in life sciences, price fixing and antitrust liability as a way to control drug prices; and best practices for obtaining investment for life sciences companies.
IPWatchdog Hall of Fame
Today also marked the first three inductees into the IPWatchdog Hall of Fame: Judge Michel, Phil Johnson and Sherry Knowles were honored with awards by Gene Quinn for their significant contributions to IP law and practice through the years.
Life Sciences Masters 2022 is the first live program to be held at IPWatchdog’s brand new headquarters in Ashburn, Virginia. Learn more about attending upcoming programs here.
Join the Discussion
15 comments so far.
concernedOctober 28, 2022 09:16 am
I just read B’s draft brief asking for CAFC en banc hearing of my case. Brilliant arguments.
Considering the CAFC has made law into their own image, no way the full CAFC would address our arguments. It would be too embarrassing.
The rage in this nation, in part, must be the observation that common people play by the rules and really have no recourse. Their recourse to correct the situation only exists in theory, hence, the ensuing rage that their matter is hopeless even playing by the rules.
One common contributor calls such situation “Power without recourse” or something to that effect. No authority should exist without recourse. Going through the so-called ‘due process’ drill where law was made in the CAFC panel’s image is hardly due process.
A jury of my peers would immediately find the evidence dodge suspicious. One critic on this forum says my evidence is irrelevant, however, the CAFC has not written the same. Neither did the examiners or the PTAB. Just a complete “due process” dodge of the evidence and a poster creating an excuse in his own image to justify the dodge.
B has worked extremely hard on my appeal, has been all in, and B has given me every shot to win my appeal. That is, assuming the playing field is level which a lot of people on this forum question.
AnonOctober 28, 2022 08:20 am
Respectfully B, Academia already is subject to a “ some boardroom of administrative knuckleheads silence said…”
It has been that way since at least the ’00’s (when I investigated a potential career change into Academia).
That “boardroom” is the entrenched (and typically FAR Liberal Left) ideologies to which all coming up (if you are making a career of it) MUST bend their knee to.
Objective critical thinking (and meritocracy) are disdained — and even punished.
While I applaud your notion of academic freedom – such (as such) exists in only microscopic bits and pieces.
Having a strict code of ethics would (then) actually promote a better environment for your notion.
BOctober 27, 2022 02:52 pm
I fully appreciate your position on the problem. I am more hesitant on the proposed solution given the current idiotic political climate where “misinformation” is merely true information (or at least a debatable position) that people in power don’t like, and the difference between a “conspiracy theory” and accepted and verifiable news is three to six months.
Academic freedom must entail being able to make a complete fool of oneself – or in the alternative envision things no one else yet sees. I’d rather let a law school professor sink his own reputation rather than have some boardroom of administrative knuckleheads silence said law school professor.
“When a true genius appears, you can know him by this sign: that all the dunces are in a confederacy against him” — Jonathan Swift
AnonOctober 27, 2022 11:11 am
Night Writer and B,
I hear your dialogue and would add that the points being presented is one reason why I have pushed for there to be an even stronger code of ethics for law professors than the one that exists for attorneys.
Everyone knows that attorneys must operate under a code of ethics.
But when you turn around and look at just whom is — at the first instance — training NEW (and thus impressionable) attorneys, AND** have those same people attempting to influence the courts through their Amicus briefs, how is it that these folk have less ethical constraints than attorneys?
** The general rot of the US Academic system – with its kowtowing to entrenched views as opposed to any sense of true meritocracy has very much infected US legal academics. Further, given that “general” (and thus, the vast numbers) of wanna-be attorneys do NOT come from undergraduate programs that have true rigorous critical thinking (as would come from engineering programs), we have both a “teacher” and a “student” bias problem, disposed to the NON-critical thinking modes of the Liberal Left.
As can be seen in Elon Musk’s XKCD type of “Sprint Left,” as well as the “Left push down the stick figure in the center and accuse the center of being Far Right” comics, the Liberal Left bias has NO tolerance for any view that does not (strictly) adhere to what they want.
Night WriterOctober 27, 2022 10:31 am
Just think that the Supreme Court referenced Lemley’s journal article to support the holding in Oil States case that patents are a public right. His article was used to make a finding of fact on how the privy court in England had invalidated patents.
Just think about that. A journal article without peer review and with NO consequences if Lemley acts unethically in writing the journal article (there is tremendous evidence that nothing happens to law professors when they lie in journal articles.) And there was contrary evidence.
Just let that sink in. The most important case arguably for patent in 100 years and it was decided based on a non-reviewed journal article where the author does not have to hold himself to ethical standards.
BOctober 27, 2022 09:10 am
@ Night Writer “Lemley is held up as perhaps the most respected academic in patent law. The rot is deep.”
Unfortunately, like the vast majority of judges, most “academics” have never participated in the real world and live in a paper fantasy. I remember one paper from Lemley speaking about how most patents will never be licensed and are worthless. Certainly, there are many patents that have little or no market value, but that’s how competition and innovation works. That said, such patents are harmless except to their owners’ financial status.
I’ve certainly turned down $$$ for writing worthless patent applications, and I’ve forgotten how many times I’ve told people about the laws of thermodynamics aren’t likely to be broken. That said, such patent applications are harmless except to their owners’ financial status.
What Lemley gets wrong is that patents aren’t a gamble. They’re insurance as well as a form of capital that investors demand before investing their fortunes. Having seen THE CORRUPT CAFC lie to destroy one small business after another, I think the phrase “tremendous failure” (of the above title) is the wrong term. It’s a tremendous success given the clear goals of the CAFC.
concernedOctober 27, 2022 07:16 am
Judicial activism is a generous term. Throughout my patent prosecution I wonder how the system would get around my evidence. The system always finds a way to not address the evidence. The latest argument was the evidence was not preserved.
One poster on this forum calls my evidence irrelevant. Then the judges should write the same in their opinion and provide an explanation as to why the evidence is irrelevant. However, the judges making statements in their opinions that are troubling only adds to the suspicion of their motives.
I may not get my patent, but I know when I have been had by very questionable means. The system writes I met the law as it was written, not the law’s interpretation.
What interpretation number is the system at now and what MPEP guidance? Changing the rules ongoingly on a law that was written in 1952, seventy years earlier.
Bring in a new set of judges. Perhaps their interpretation, forged in their own image, will give me a patent. Certainly an act of (1952) Congress could not do it for me.
Night WriterOctober 27, 2022 06:30 am
If you actually read the cases and look at what the judges are doing, it is clear that many of their concerns is to try and limit patents through judicial activism. That is what they care about. Probably the best way to understand this is to read Lemley’s papers. Lemley twists reality and law in every manner possible to provide arguments to limits patents. And Lemley is held up as perhaps the most respected academic in patent law. The rot is deep.
AnonOctober 26, 2022 01:47 pm
Thanks B (interpretation).
Certainly, there are some ‘Judicial Branch IS THE Supreme‘ apologists out there that view the Judicial Branch (and especially the Supreme Court portion of that branch) as being actually ABOVE the Constitution.
To these folk, the more liberal (not the same as Liberal Left) view of “common law” is that the judges can do whatever they want to do (interpretation means ANYTHING).
To those that know and respect the foundations of THIS country (including both the Constitution and the Declaration of Independence, as well as the Federalist Papers), Judicial Tyranny is a very real danger, and we have both Separation of Powers and cross checks of each Branch by the other Branches for a reason.
Add to this the fact that patent law is expressly delegated to (and only to) the Legislative Branch, and ANY legislating from the Bench should be strictly frowned upon.
BOctober 26, 2022 11:58 am
“Quinn said. ‘I don’t understand across the spectrum in the patent world why people are not more aggressive at going back at these liars?’”
Gene, when one points out the CAFC’s “inconsistencies” to the CAFC, the CAFC ignores the issues and, as happened in In re Killian, engages in the most outrageous lies imaginable to the point of fabricating quotes, misrepresenting the record, and misrepresenting case law.
I thought Chamberlain and American Axle were bad. Killian is the new gold standard in judicial dishonesty.
BOctober 26, 2022 11:50 am
@ Anon “1) the judicial branch is re-writing law (NOT using common law properly to fill in the gaps — that is, legislating from the bench) – that duty of writing law belonging to Congress[.]”
There are notable voices on this forum that call this nonsense “interpretation.”
BOctober 26, 2022 11:45 am
Dear Judge Michel,
It’s worse than you think. Half of the CAFC is actively trying to confuse the law on patent eligibility while the cluelessness of a few other CAFC judges acts as a crazy catalyst.
The remaining few (Moore and Newman being the sometimes exceptions) won’t call out their fellow judges
AnonOctober 26, 2022 09:32 am
To the respected retired Judge’s comments of regarding [__] Michel said he believes it’s ultimately Congress’ job to make the kind of policy judgments the Supreme Court and Federal Circuit have been making in this sphere, there is still a lot more the Federal Circuit could be doing to help the situation, I will note that I was among the first in the patent blogosphere to make BOTH of those points:
1) the judicial branch is re-writing law (NOT using common law properly to fill in the gaps — that is, legislating from the bench) – that duty of writing law belonging to Congress; and
2) (perhaps having been brow-beaten by the Supreme Court), the CAFC has only continued to
— add rope to the Gordian Knot of (the Supreme Court’s making of) 101 jurisprudence that is simply internally inconsistent —
with its LACK of following through on its own procedural ‘respect for prior panel decisions’ (noting that the very first cases after the Supreme Court muckery validated a more expansive – and proper — view of eligibility.
concernedOctober 26, 2022 05:38 am
Quinn said. “I don’t understand across the spectrum in the patent world why people are not more aggressive at going back at these liars?” My attorney has been saying the same thing since I have known him.
“You make the law in your image if you can get one other panel member to join your opinion; that’s not law, that’s just power plays, and it’s really a very unfortunate development.”
Another observation my attorney made to me. I even have one such CAFC decision named after me. The preceding decision is hard to analysis, or is it hard to comprehend? Maybe the next CAFC panel will be able to decipher or perhaps encompass. Or maybe the next CAFC panel will just fall down and hit their “chin” again.
Pro SayOctober 25, 2022 07:51 pm
Notorious C.A.F.C., meet notorious S.C.O.T.U.S., meet notorious P.T.A.B., meet notorious C.O.N.G.R.E.S.S. . . . say hello to American innovation.
The American innovation you all crippled.