Facilitating Innovation to Fight Coronavirus Act

S. 3630. I wonder what percentage of patentees would take this trade-off.  Patents covering COVID-19 related inventions rights don’t begin until the National Emergency officially ends; 10 years is then added to the patent term.

Patents impacted:

  • Eligible Patent – a patent issued for a new or existing pharmaceutical, medical device, or other process, machine, manufacture, or composition of matter, or any new and useful improvement thereof used or intended for use in the treatment of the Coronavirus Disease 2019 (COVID–19).

Impact:

  • The term of any eligible patent shall not begin until the date on which the national emergency declared by the President under the National Emergencies Act (50 U.S.C. 1601 et seq.) with respect to that disease terminates.
  • The term of the patent shall extend for 10 years longer than it otherwise would under such title.

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10 thoughts on “Facilitating Innovation to Fight Coronavirus Act

  1. 3

    When will the National Emergency Act terminate? In the 1960s, President Johnson declared a War on Poverty; as far as I know are still fighting that war. I am not familiar with the National Emergencies Act (50 U.S.C. 1601 et seq.), is it completely open-ended or is there a well-defined end point?

    If an applicant can wait until the Notice of Allowability to decide whether to take advantage of the Facilitating Innovation to Fight Coronavirus Act, that would give the applicant substantial leverage. If it appears that the Emergency will end within the next few months, the trade-off (lose a few months now, gain ten years in future) could be worthwhile. But if it appears that the end of the Emergency is a year or more off, then the applicant would probably prefer to strike while the iron is hot, realizing that the value of the patent in the period from about 17 to about 27 years in the future is highly speculative.

    A patent to be “used or intended for use in the treatment of … COVID–19” would presumably include devices whose primary market is unrelated to COVID-19. So if the end of the Emergency is imminent, I could see patent practitioners including speculative language in their applications about how the invention could be used to fight COVID-19 … so give me those ten years!

  2. 2

    NOIP, scientific reports I have seen are that The Covis-19 virus is not rapidly mutating in a away that would make a vaccine only temporarily effective. It is not at all the same viral structure as the kind of mutating flu and its flu shots that rational people get every year. Your other dire concerns, even if all valid, are not relevant to the only subject here, which is just the effectiveness of this proposed patent law change. Especially, anyone refusing vaccinations or other medications.

  3. 1

    It raises a lot of questions that could affect the choice. First, in the extended 10 year time period, can the patent be challenged via an IPR or Hatch-Waxman litigation? Second, what kind of resources would be available to ensure that once the patent term begins, all other entities using the patent during the National Emergency would stop (or be forced to stop)? Third, what about international rights? How would if affect those rights? Fourth, what if the subject matter of the patent (e.g., a drug) turned out to be ineffective (or just slightly effective) in treating the virus? Would the extended term still apply?

    1. 1.1

      Dvan,

      I think that you ask some interesting questions, but the answers (as I understand the straight up proposal) are less interesting.

      1) the deal is for extended patent term only. There are no other caveats such as the protections or immunity that you indicate.

      2) No such resources — exactly like all other patents — would be provided. Again, the deal is only for extended patent term.

      3) What about international? Again, the deal is only extended patent term. Whatever applies (to any other patent) during normal patent term is what you get in the extended patent term.

      4) Again, same as any other patent during normal patent term. Efficacy (in the notion of ‘less than perfect’) has no bearing on normal patents during normal term, so, no, you would not see any effects during the extended patent term.

      1. 1.1.1

        Anon,

        I think your answers are reasonable, but they make me ask the next obvious question – would it be worth it to take advantage of this extension? In some instances, it might be but in others, it might not be. So much would depend on the specific subject matter of the patent. For a small molecule drug, it would most likely be worth it, but for other areas the answer is much less clear.

        There is also a fifth question that I should have included with the first four. Who decides if the subject matter of the patent is directed to treating the virus? Does something about the virus have to be included directly in the claims? or would support in the specification be enough? On a similar note, would this extension apply to all patents in the same family or only the ones that claim this subject matter. I can easily envision fraudulent assertions in order to get the extension. What penalties would attach for any kind of fraud associated with this?

        The answer I keep coming up with to the original question is the rather lawyerly answer of “it depends” – the kind of answer that keeps lawyers in business and drives clients crazy.

        1. 1.1.1.1

          Your last paragraph nails it.

          (and I was not trying to be flippant, you ask some good questions, but the answers are more mundane because the program is mundane)

    2. 1.2

      Could there be other issues with a presumably published patent with an unenforceable initial term? E.g., what if an effective one shot long term vaccination is developed and fully employed during this suppressed initial patent term [this delayed patent term start date]. Would that mean zero patent compensation for the vaccine developers?

      1. 1.2.1

        Covid-19 is never going to be eradicated. There will always be reservoirs of it especially since some people will not get vaccinated either because:

        1. They refuse to get vaccinated (the anti-vaxxers);

        2. They cannot afford it. You don’t think the vaccine is going to be cheap, do you?

        People who have had Covid-19 (and recovered) are getting it again. It might mean:

        1. The virus is rapidly mutating.

        2. The antibodies you produce to the virus don’t last very long. The antibodies you produce from a vaccine are the same antibodies you produce to the virus so you would need periodic vaccinations for the rest of your life.

        3. Not all of the viruses immediately hijack the cells they have infected. They could wait and become active later, just like the varicella-zoster virus that causes chicken pox. It can become active decades later to cause shingles.

        4. The scientists might have gotten it wrong. Covid-19 might be a retrovirus that incorporates itself into the cell’s DNA. It could take over the cell right away or it could wait. If it waits, then the section of Covid-19 is reproduced when the cell reproduces. Thus it becomes part of the human genome. Eight percent of the human genome consists of ancient viruses which have (supposedly) become permanently disabled due to mutations.

        Covid-19 can infect any of the cells of the human body. It can infect nerve cells in the brain causing the symptoms of dementia.

        It can cause diabetes in formerly healthy people. In people who already have diabetes it can make it worse and cause other metabolic diseases. That is why a high percentage of the deaths are with people who already have diabetes.

        Suppose it infects the germ cells?

        All of the literature I have seen are the effects on woman who were already pregnant when they got infected.

        I don’t see anything about women who have become pregnant after they have had the virus (and recovered).

        Are there any? Does Covid-19 make everyone sterile?

        If women can become pregnant after recovering from Covid-19 are the fetuses viable?

        Perhaps the women will have only girls.

        Or perhaps they will have only boys.

        That would mean an end to the human race after the current generation so that the extended patent term won’t do you that much good.

        1. 1.2.1.1

          >>I don’t see anything about women who have become pregnant after they have had the virus (and recovered). Are there any? Does Covid-19 make everyone sterile?

          You should take a deep breath and go for a walk.

        2. 1.2.1.2

          People who have had Covid-19 (and recovered) are getting it again. It might mean:

          Thanks NOiP – this is an area that I try to stay current on, and all I have is a bunch of click-bait with “maybe’s” buried therein.

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