A Conversation with Andrei Iancu on the Role of Innovation and the USPTO in Combating COVID-19

By Gene Quinn
August 24, 2020

“The American innovation system is working, and is working in overdrive, to solve this pandemic… [T]he fact is we wouldn’t be able to do what we are doing without the IP behind it to date.” – Director Andrei Iancu

Andrei Iancu speaking at the IPO Educational Foundation Awards Dinner in December 2019

I recently had the opportunity to conduct an interview with Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the United States Patent and Trademark Office, via WebEx. The focus of our conversation was the COVID-19 pandemic: USPTO efforts to work with stakeholders, the role of intellectual property in finding cures and treatments, and general thoughts relating to what the Office is observing. Our conversation also veered into Bayh-Dole and the the letter just sent by three-dozen state Attorneys General asking the federal government to use march-in rights against Remdesivir.

According to Director Iancu, trademark filings have exhibited a so-called V-shape recovery, where the front edge of the “V” represents a precipitous decline caused by some event (in this case the COVID-19 pandemic) and the trailing edge of the “V” represents a rapid bounce back to normalcy.

Trust in Trademarks

Patent applications are a lagging indicator of economic activity because of the inevitable innovation lag that occurs from the time the research is done and conception is made to when an invention is realized and a patent application is filed. Trademark applications, however, are more closely correlated with current economic activity, explained Iancu.

“Trademark filings are correlated with the general state of the economy, as measured by the growth of the Gross Domestic Product (GDP), and venture capital investment” Iancu explained. “Interestingly, Trademark activities tend to follow the S&P 500 index.”

That being the case, it is heartening to learn that the USPTO is seeing an increase in trademark activity, which traditionally quickly translates into economic activity, since trademark rights in the United States are use-based (i.e., they must be used in interstate commerce in order to establish rights). To obtain a trademark in the United States you must show that the mark is being used presently or that you have a bona fide intent to use it.

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Relief for Small Inventors 

In other good news, the Office has attempted to provide some relief to primarily independent inventors and small businesses, although it is applicable to anyone who has filed a provisional patent application. On June 11, the USPTO announced that they would allow applicants to file a nonprovisional patent application claiming the benefit of a provisional application for up to an additional two-months, without payment of a petition fee, if there were delays due to COVID-19. This is significant, but a bit byzantine. Applicants have only 12 months from the time they file a provisional patent application within which to file a non-provisional patent application claiming priority to the provisional. However, the Patent Law Treaties Implementation Act of 2012

(PLTIA) allowed for an additional two months in the case where there was an unintentional delay. Because of the flexibility given agencies under the CARES Act, the USPTO decided they could extend that additional two months for free due to COVID-19. So, if the 12-month period ended between March 27, 2020 and July 30, 2020, the two-month additional period to file is available.

There are a couple of things to note about this additional two-month period for filing a nonprovisional application, which many individuals, small businesses and start-ups have asked me about, and which I discussed with Director Iancu. First, according to Director Iancu the Office is assessing whether to extend this further, and if they decide to do so, another announcement will soon be made. Second, there is likely a limit to what the Office will be able to do because the 12-month period to file a nonprovisional patent application claiming benefit from a provisional is statutory. Therefore, while the Office is working to do what they can (per Director Iancu), inventors should speak with a patent practitioner or call the USPTO directly if they are contemplating going beyond 12 months from a provisional filing before they file a nonprovisional patent application.

Prioritizing Life-Saving Patents

In still other positive news, the USPTO announced on May 18, 2020, that the Office would allow for the free prioritization of COVID-19 related patent applications where one or more patent claims to a product or process that require approval by the Food & Drug Administration (so no software, for example). The program was authorized for up to 500 applications, and is working as designed, Iancu explained.

To date, nearly 25% of that original tranche of fast-tracked applications have been approved. Indeed, as of the time of my interview with Director Iancu, there had been 240 requests for COVID-19 prioritized examination, with 123 applications being granted prioritization and 31 applications being refused prioritization for failure to meet the requirements of the program for one reason or another. Another 86 applications are still pending decision in the Office of Petitions.

“Keep in mind that it is only for small and micro entities; we did not make this program available for large entities who can better afford the prioritized examination fee,” Iancu said. “We want to focus resources on small and micro entities, and individual inventors, to help them out as much as possible to bring their inventions to market.”

What is lurking in those patent applications? Are there great cures, treatments, vaccines that can turn the tide? While Director Iancu is in as good a position to comment on that as anyone, including the surprisingly and instantly famous Dr. Anthony Fauci, patent applications must be maintained in secrecy until they are published. That is the law, and I wasn’t going to ask that question despite it being the question that all Americans, and really all citizens of the world, really want to know. Nevertheless, I tried to phrase the question in a way that Director Iancu could comment, if he wanted to comment:

“So, Dr. Fauci opines all the time, and you are the one with your finger on the pulse of innovation and with access to all the patent files. Are you optimistic? Dr. Fauci seems to make a lot of predictions—would you care to make a prediction?”

After giving me the famous Yogi Berra quip about predictions being difficult to make, especially about the future, Director Iancu demurred and didn’t want to make any predictions. He did, however, talk about the importance of intellectual property in the fight for the vaccines, cures and treatments the nation and world so desperately want and need.

“The American innovation system is working, and is working in overdrive, to solve this pandemic,” Iancu told me. “Intellectual property is proving to be critical as we are working to create tests, treatments and cures for this virus. And the fact is we wouldn’t be able to do what we are doing without the IP behind it to date.”

To put an exclamation point on his message, Iancu finished his thought: “All of what is being accomplished today is the result of years of innovation; it is important not to lose track of that.”

A Measured Approach to Marching In

Indeed, it is important that we not lose sight of the fact that the innovations that are allowing multiple companies to race to a vaccine in unprecedent time frames are because of the vast amounts of research and development that have taken place in the years leading up to this COVID-19 pandemic. Intellectual property is the engine behind innovation, and without intellectual property there could be no justification to prospectively spend the many trillions of dollars on healthcare related R&D that has been collectively spent leading up to this pandemic.

And yet, a bipartisan group of three-dozen or so State Attorneys General are now imploring the federal government to exercise march-in rights relative to Remdesivir. Save for a moment that march-in rights do not apply to Remdesivir, something the State AGs overlooked. The attempt to strip IP rights using march-in rights is roughly equivalent to exercising power under eminent domain and strikes me as foolish.

“Bayh-Dole has been a very important piece of legislation that has opened the door for amazing research and lab-to-market activity over the last few decades,” Iancu told me after I concluded my rant on the then recently sent letter by State AGs. “Before we talk about taking drastic measures to use march-in rights, we really have to be careful that there is actual evidence that such measures are appropriate and need to be taken. At a minimum, there needs to be evidence such as that the invention is not being commercialized.  As far as I know there is no such evidence, and indeed the evidence is currently to the contrary. IP facilitates innovation and enables access to technologies. So, we have to be very careful before we disrupt decades old, or centuries old norms.”

 

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 14 Comments comments. Join the discussion.

  1. Pro Say August 24, 2020 8:11 pm

    Thanks guys. Always nice to hear Andrei’s thoughts.

    Mine:

    1. It’s heartening that the Director and his colleagues continue to work so hard to restore our patent system to its formally world-leading position.

    With the unconstitutional Alice / Mayo eligibility limits — and their improper application by the CAFC — we are in no better than 3rd place in the world — at best. No amount of hand-waving or dust-kicking changes this.

    The Office’s only mistake so far — though it’s a critically important one — is the permitting of allegations by Examiners and unconstitutional PTAB “judges” of multiple judicial exceptions being contained in one claim.

    As a careful analysis of Alice and Mayo makes clear, this is improper. SCOTUS said one and meant it. Not two, not three, not four or more exceptions. One.

    The CAFC is equally guilty of this misapplication.

    2. I would advise anyone considering taking advantage of a / the 1-year provisional-to-non-provisional extension to think twice before doing so.

    Because such extensions are extra-statutory, you can rest assured that should such inventor/s attempt to assert such “extended” non-provisional/s in the years to come, any infringers will likely argue in court (assuming intervening prior art) that such extension/s is / were improper.

    Is a couple / few more months worth such a risk?

    3. Sadly, because the Federal Circuit has unconstitutionally virtually barred diagnostics from patent eligibility, no one should expect to be able to protect Covid diagnostic innovations against being readily stolen by others.

    Diagnosing Covid is of course critical in the battle against this world-wide scourge.

  2. MaxDrei August 25, 2020 7:48 am

    Pro Say, given that totalitarian regimes like China and Russia can use their own people as involuntary guinea pigs, and then skip Stage III clinical trials and thereby bring their effective vaccines to market much quicker than the world’s democracies can, I would incline to reticence about the extent to which “march in” rights, or “defence of the realm” special measures, or “compulsory licence” mechanisms, are going to be needed, to save the population from premature death by COVID.

  3. Anon August 25, 2020 10:20 am

    Pro Say,

    Your rather odd penchant for “single judicial exception” does your credibility more harm than good.

    You miss the (much) bigger picture or whether or not THIS TYPE of legislating from the bench has any propriety in the first instance. You seem to want to ‘rely’ on SCOTUS, while you miss the FACT that the scourge STARTS with SCOTUS.

  4. Pro Say August 25, 2020 10:34 am

    Max, to insure clarity, my # 3 concern is that techniques of diagnosing the virus will be difficult to protect with patents in the U.S. Which is dangerous for U.S. citizens and those who live here.

    I’m against march in, etc. “rights” ; except in cases where our gov has made material monetary and / or other resource contributions to such innovations.

    And as you say, the totalitarian regimes will do whatever they want to do.

  5. MaxDrei August 25, 2020 12:33 pm

    Pro Say, can you enlarge upon your assertion that difficulty patenting diagnostic methods is “dangerous for U.S. citizens”?

    I ask because I’m in Germany where methods of diagnosis performed on the human or animal body have been ineligible for patent protection since 1978 but that doesn’t leave me feeling that life here is dangerous.

    Consider methods of surgery. They too are ineligible here. I’m glad about that. I should think that the dangers to me would not fall but rather rise, in proportion to the degree to which life-saving methods of surgery are routinely patented.

    The innovative pharma firms closest to the end of Phase III clinical trials of COVID-19 vaccine seem to be here in Europe. I can understand that you are preoccupied with COVID-related dangers to residents of the USA, but not why you think it is because of the patent-eligibility jurisprudence of the USA.

    Would you like to say more?

  6. Pro Say August 25, 2020 1:36 pm

    My good friend Anon,

    Odd penchant it is not. Instead, it is my pointing a way forward for my fellow inventors and their counsel . . . in the non-statutory alternative eligibility universe SCOTUS has transported us all into.

    Rest assured, you have my full concurrence that they have with their Mayo and Alice decisions usurped that which is the exclusive purview of our legislators.

    That is indeed the biggest problem.

    But, if and until either they or Congress restores eligibility to all areas of innovation as our country’s Founders and Congress itself intended, we must in the meantime insure that the CAFC and Patent Office operate as SCOTUS intended . . . in the alternative eligibility universe SCOTUS conjured up . . . from thin air.

  7. Pro Say August 25, 2020 1:50 pm

    Max: “‘… can you enlarge upon your assertion that difficulty patenting diagnostic methods is “dangerous for U.S. citizens’?”

    The danger is that the U.S. may never benefit from better (e.g. more accurate, quicker, simpler, less expensive) diagnostic methods without the patent protection some of the potential inventors of such would necessarily need / require in order to make the substantial investment/s (and / or to obtain the necessary venture financing) necessary in order to bring such methods to market (noting, e.g., the withdrawal of the Cleveland Institute from such inventing).

    How many U.S. (and world) lives could have been saved / better outcomes realized were such innovations available?

    We’ll never know.

  8. Benny August 26, 2020 12:41 am

    ProSay,
    That still doesn’t explain why the US may never benefit from improved diagnostics while I, and MaxDrei, do.
    Perhaps because Max and I have universal healthcare insurance, while the US, in it’s infinite wisdom, does not.

  9. MaxDrei August 26, 2020 4:54 am

    Well perhaps, Benny, but I would prefer to stay clear of the party politics. For me, the biggest issues threatening the future of humankind (climate change, viral and bacterial mutations) are best addressed by a judicious co-operation of vigorously competitive private industry, separation of powers, worship of The Rule of Law, vigorous rule-setting by a big strong State, and an actively engaged, educated voting populace. I like to think that is what we still have here in Germany (recently found to be the most innovative society in the world) and what seems to me to be leaching away in Great Britain, the island of my birth (whose response to COVID-19 has been lamentable).

    But yes, the lottery, of whether you get COVID-19 and how much long term damage it will do to you seems to me barbaric in any country that makes affordable health insurance available only to the comfortably-off members of society. The idea that the devil should take the hindmost is incompatible with civilised society. And anyway, when the threat is climate change or a virus, it’s self-defeating. How can the rich continue to enjoy their lives without all their servants?

  10. MaxDrei August 26, 2020 8:01 am

    In case any reader wants a citation for my “Germany most innovative” assertion within # 9, here it is:

    https://www.bloomberg.com/news/articles/2020-01-18/germany-breaks-korea-s-six-year-streak-as-most-innovative-nation

  11. Pro Say August 26, 2020 1:27 pm

    Benny (and Max). My point in this regard is that without the ability to obtain U.S. patent protection for diagnostics, some companies won’t spend (or be able to obtain) the money in order to develop new diagnostic innovations.

    Indeed, such lack of who-knows-what breakthrough/s will deny not just those in the U.S., but all people everywhere / in all countries.

    Regardless of the type / form of medical benefits / coverage / insurance any country provides its people.

    You see, even you and Max can’t benefit from diagnostics . . . which never exist/ed.

    Hope this helps.

  12. MaxDrei August 26, 2020 3:45 pm

    Ah, now I understand. Your hypothesis is that whether there is any investment in finding new methods of diagnosis depends decisively upon whether any such method is patentable in the USA.

    All I can say is that, from where I’m standing, it doesn’t look at all like that to me.

    Where I do agree with you is that it would indeed further stimulate progress towards diagnosis and treatment of new diseases if the courts of the USA could recognise patentability in all fields of technology, as obligated by its membership of GATT-TRIPS.

  13. Pro Say August 26, 2020 7:40 pm

    Max — just to be completely clear, I know that multiple, exciting, new Covid-17 diagnostics have and will continue to be developed as time goes on; in multiple countries and regardless of the ability to patent such innovations in America.

    My concern is that we may never know of other, potentially even better diagnostics which would have been developed could they have been (also) patent-protected in the U.S.

    As far as the USA abiding by our GATT-TRIPS obligations; sadly, the CAFC, SCOTUS — and Congress — just don’t seem to give a darn.

    While our politicians scream like banshees when other countries don’t abide by such international agreements and treaties, we too often hypocritically don’t hold ourselves to these very same agreements and treaties.

  14. MaxDrei August 27, 2020 4:53 am

    Yeah, Pro Say, this “international treaty” issue is interesting. Here in Germany, it is (still) routine to admonish adults who cross the street in the presence of little children at any time other than when the light for pedestrian traffic is showing green. Why that then? It is some deeply-embedded folk notion about the big old ones being expected to set a good example to the little young ones in society, otherwise that shared society will get ever more chaotic, unpleasant and dangerous. A lot more social responsibility and awareness of the importance of the general welfare is expected of the adults than of the children.

    Crazy notion, no?

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