Population of Patents at Risk from Proposed WTO Patent Waiver

By Kevin E. Noonan --

Dennis Crouch, our colleague at Patently-O, tweeted last week that there have been 148 U.S. patents granted having disclosure related to (COVID-19 or SARS-CoV-2); see Search of U.S Patent and Trademark Office Patent Full-Text and Image Database and

With regard to issues involving the proposed WTO IP waiver (see "If the Devil of the WTO IP Waiver Is in the Details, What Are the Details?"), it may be instructive to inspect the relatively few (4) of these patents directed to COVID-19 specific vaccines (another 4 were directed to therapeutic antibodies).  These are set forth in this table:

Of these, the only assignee associated with an actual, in-development SARS-CoV-2 vaccine is Novavax; however, the company has delayed its application for Emergency Use Authorization (EUA) from this month to sometime in the third quarter of this year (although maintaining that there is nothing troubling about the delay).

In addition to these granted patents, there are 420 published applications that are found on the USPTO website when queried with (COVID-19 or SARS-CoV-2); the same pattern persists here, with only a small fraction being directed to vaccines or immunization methods:

As with granted patents, the remainder of these pending applications are directed to detection methods, personal protective equipment, disease monitoring, and disinfectant preparations, as well as various pharmaceuticals and methods of treatment (not all of which are COVID-19 specific).

This raises the question of whether the uproar over the proposed WTO waiver is "much ado about nothing" in view of the small number of granted patents and pending applications directed to COVID-19 vaccines.  A proper understanding of what is at stake involves considerations much more broadly shaped than these small number of patent properties.  For example, there are many other patented technologies involved in making any of the vaccines now available:

U.S. Food and Drug Administration EUA Information

In addition, these vaccines are also produced using trade secrets that are undoubtedly not disclosed in these patents (see "Suspending IP Protection: A Bad Idea (That Won't Achieve Its Desired Goals").

Most importantly, the cure is worse than the disease; as has been enunciated heretofore, the proposed IP waiver will do little if anything to solve the accessibility problem (see "Latest COVID Conundrum: Accessibility of Vaccines (When They Are Available)") but will almost certainly damage the very innovation system whose existence permitted these vaccines and others now in development to be produced on an accelerated timescale (see "The Road to Hell Is Paved with What Everybody Knows").

The Biden administration has had the benefit of learned, reasoned calls (see "Pfizer CEO Pens Open Letter on COVID-19 Vaccine IP Waiver"; "BIO & IPO Issue Statements on Biden Administration's Support for Proposed WTO Waiver"; "Sen. Tillis Asks Biden Administration to Oppose WTO Waiver Proposal"; "IP Organizations Support Continued Opposition to Waiver Proposal") not to scramble willy-nilly down the rabbit hole enticingly proposed by those who may have good hearts but other with less than clear motives.  One of the nascent hallmarks of this administration (as compared with the last one) is an ability to recognize a blunder and correct it; after all, that is what political professionals who aspire to be statesmen are supposed to be able to do.  The negotiation period for any proposed WTO IP waiver gives this administration the opportunity to achieve the desired goal (global COVID-19 vaccination) without harming the global innovation system.  It is an opportunity the President and his administration should take.

Comments

[Atari Man]

"One of the nascent hallmarks of this administration (as compared with the last one) is an ability to recognize a blunder and correct it..."

Apparently you and I are looking at two different Biden administrations. Please, enlighten us with some examples.

[skeptical]

Atari Man,

That one phrase also seemed gratuitously unnecessary - even as it was alarmingly inaccurate.

Anyone who thinks this country is better off under Biden (regardless of how one may think of the utter crassness of Trump) loses believability.

[Kevin E Noonan]

Not going to get into a political debate, hence the qualifiers of "nascent" and "political professionals." One of the hallmarks of the rhetoric of the last administration was that it was not made up of politicians. And no one can think that a President with 40+ years in government is anything but a political professional. Whether you like it or not.

[skeptical]

It should be quite evident that the 'land grab' is not -- and has never been -- merely about the 'COVID Patents.'

The non-patent IP and the ANCILLARY aspects are the real game.

[Greg DeLassus]

A few thoughts in response:

1) U.S. IP covering anti-COVID technology is irrelevant to the proposed TRIPS waiver. The U.S. is not going to wave IP rights even if a TRIPS waiver is granted.

2) FWIW, the Pfizer vaccine is covered by US 9,295,717. The Moderna vaccine is covered by US 10,022,435. All three of Pfizer, Moderna, and J&J use the construct of US 10,960,070.

3) I think that you are likely on to something when you speculate that the negotiations over the precise language of a TRIPS waiver could take so long that events will overtake the waiver.

[skeptical]

Dr. Noonan - refraining from a political debate in the same sense that you advance, it must be recognized then that “political professional” is NOT a good thing, and evokes the very worst images when one hears the term, ‘politician.’

As to Mr. DeLassus and the eternal quest for a place in the sand to rest one’s head, the view of “the US would never” is beyond PollyAnna — given the explicit circumstances of the global pandemic, and the fact that the Biden administration just DID what has never been done before (in voicing support for India’s ALL IP waiver move.

[Greg DeLassus]

"Please, enlighten us with some examples [of 'an ability to recognize a blunder and correct it']."

If, as Dr. Noonan says, he does not wish to get into a political debate, I will not try to drag him into one. Nevertheless, I agree with you, Atari Man, than I cannot really think of any examples that would justify the claim that "this [nascent] administration... [has] an ability to recognize a blunder and correct it... ."

The ability to admit error is regrettably rare among politicians of all parties in all nations. As failings go, this is pretty small beer. Still and all, I cannot see that the present administration is less a failure on *this* front than was the previous administration.

[Kevin E Noonan]

Greg: Should have been a little more accurate to say that there are no COVID-19/SARS-CoV-2 specific patents except the ones on the table.

Interestingly, of the patents you listed I have these thoughts:

USP 10,960,070 would likely not cover the mRNA vaccines, because the claims are directed to immunogens that are proteins, and the nucleic acid claims are conventional methods for making the protein recombinantly. It has an earliest priority claim to October 2016

USP 9,295,717 claims mRNA for use as vaccines modified in specific ways at the 5' cap. This may be a preferred way to make these molecules but unless it is the only way this may not be an impediment. Its earliest priority date is August 2009.

USP 10,022,435 is one on point, which makes sense seeing as Moderna has produced a vaccine that (I assume) falls within the scope of these claims. But this patent was filed in April 2016 and the exemplified viruses are H1N1, H10N8/N1 and H7N9 influenza (as well as bacteria and mycobacteria and many other viruses, specifically including MERS).

Thanks for the chance to clarify.

[Greg DeLassus]

"US[] 10,960,070 would likely not cover the mRNA vaccines, because the claims are directed to immunogens that are proteins..."

Sure, but the mRNA---once inside the vaccinee---gives rise to infringing protein. The vaccines have no substantial use that does not necessarily involve producing the infringing protein. Therefore one who manufactures the vaccine is still liable for contributory or induced infringement of US 10,960,070.

[Kevin E Noonan]

Yes, but that protein is made in cells in the vaccinated human, and neither the RNA nor the protein are isolated at that point. Although I admit this might be how the infringement argument would go.

[Kevin E Noonan]

One more thing. As most know, U.S. patent applications, and patent applications in most other countries, are not published until 18 months after they are filed. This suggests that there may be many applications that will be published over the next 6-12 months for which the proposed WTO waiver would be relevant and damaging to innovation.

[Greg DeLassus]

“Yes, but that protein is made in cells in the vaccinated human, and neither the RNA nor the protein are isolated at that point.”

The independent claim does not require that the protein be “isolated.” That point is simply irrelevant to the infringement analysis.

[Greg DeLassus]

“[T]he cure is worse than the disease… [T]he proposed IP waiver will do little… to solve the accessibility problem… but will almost certainly damage the very innovation system whose existence permitted these vaccines and others now in development to be produced on an accelerated timescale.”

A few thoughts:

1) I know that this is hard to believe for those of us who earn our honest crusts by obtaining IP protections, but pharmaceutical companies do not innovate in order to *obtain IP*. Rather, we (I am in-house pharma patent attorney, so I say “we”) innovate in order to *help our customers* and to *earn profits* (the precise order of those goals varies among companies, but all have those two goals). IP is a means toward profits, not an end in itself.

COVID-19 vaccines have been profit-gushers for every company that has gotten one approved. By this point, every company that has brought a vaccine to market is admirably satisfying both the “help patients” goal and the “earn profits” goal. Even if IP rights were *totally* abrogated at this point (not at all a likely outcome, but just go with the hypo for the moment), that would take nothing away from the success that each vaccine maker has achieved to date.

Why then should a waiver—arriving at this point in the story—lead a rational pharma exec to conclude that the next disease is not worth investing to cure? The facts on the ground from this experience should logically lead to exactly the opposite conclusion.

2) The concern above that a waiver “will… damage the… innovation system” is what economists call a “Tinkerbell” (URL below)—it becomes true only if people believe it to be true. *If* a waiver were to damage the innovation system going forward, it would be because pharma execs *believe* that the present waiver constitutes the first of many, rather than the highly unusual response to an exceptional circumstance. There is, however, no necessary reason *why* they should believe TRIPS waivers to be the “new normal.” I do not see why we in the innovation business should be working to convince anyone of this conclusion.

In talking up that conclusion, one gives Tinkerbell the power to fly. We would all do better to clip Tinkerbell’s wings by emphasizing the “one off” nature of the present circumstances and the possible (highly unusual) TRIPS waiver that might emerge from such exceptional circumstances.

https://en.m.wikipedia.org/wiki/Tinkerbell_effect

[skeptical]

The Link is interesting, as I find Mr. DeLassus' protests to be having a reverse-Tinkerbell effect.