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Wed May 5, 2021, 03:39 PM

The Biden administration says it will support lifting patent protections

Source: New York Times

The Biden administration on Wednesday came out in support of waiving intellectual property protections for Covid-19 vaccines, a breakthrough for international efforts to suspend patent rules as the pandemic rages in India and South America. The United States had been a leading opponent of a proposal at the World Trade Organization to suspend intellectual property protections in an effort to ramp up vaccine production. But President Biden had come under increasing pressure to throw his support behind the proposal, including from many congressional Democrats.

Katherine Tai, the United States trade representative, announced the administration’s position in a statement on Wednesday afternoon. “This is a global health crisis, and the extraordinary circumstances of the Covid-19 pandemic call for extraordinary measures,” she said. “The administration believes strongly in intellectual property protections, but in service of ending this pandemic, supports the waiver of those protections for Covid-19 vaccines.”

Ms. Tai added that the United States would participate in negotiations at the World Trade Organization over the matter, adding, “Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.” Earlier Wednesday, members of the World Trade Organization held another round of discussions about waiving intellectual property protections. Further discussions are expected in the coming weeks, as India and South Africa, which proposed the waiver, are preparing a revised plan for nations to consider.

Ngozi Okonjo-Iweala, the director general of the World Trade Organization, urged members to proceed with negotiations over the text of the plan. “I am firmly convinced that once we can sit down with an actual text in front of us, we shall find a pragmatic way forward,” she said at a meeting of the organization’s General Council.

Read more: https://www.nytimes.com/2021/05/05/us/politics/covid-vaccine-patent-biden.html



Full headline: The Biden administration says it will support lifting patent protections to help produce more vaccines globally.

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Arrow 25 replies Author Time Post
Reply The Biden administration says it will support lifting patent protections (Original post)
BumRushDaShow May 5 OP
cloudythescribbler May 5 #1
Gaugamela May 5 #2
Shermann May 5 #5
Gaugamela May 5 #7
crickets May 5 #23
progree May 5 #3
BumRushDaShow May 5 #6
progree May 5 #9
BumRushDaShow May 5 #10
progree May 5 #12
BumRushDaShow May 5 #13
progree May 5 #14
BumRushDaShow May 5 #16
progree May 5 #17
BumRushDaShow May 5 #18
progree May 5 #19
BumRushDaShow May 5 #20
progree May 5 #21
BumRushDaShow May 5 #22
Lancero May 5 #11
progree May 5 #15
JohnSJ May 5 #4
ancianita May 5 #8
NurseJackie May 6 #24
muriel_volestrangler May 6 #25

Response to BumRushDaShow (Original post)

Wed May 5, 2021, 04:02 PM

1. Not a moment too soon!!!!!!

A key example of how pressure can indeed move the Biden Administration on major issues

Now we need similar pressure on Julian Assange case, & much else

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Response to cloudythescribbler (Reply #1)

Wed May 5, 2021, 04:08 PM

2. +1000

This should have been a no-brainer from the start.

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Response to Gaugamela (Reply #2)

Wed May 5, 2021, 05:06 PM

5. I agree with the "from the start" part

Anything like this should have been negotiated up front with the pharmaceutical companies.

You can't let them develop it and then go SURPRISE! at the end.

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Response to Shermann (Reply #5)

Wed May 5, 2021, 05:44 PM

7. The Pharma companies got billions in advance from the government, the basic research was

paid for by tax dollars, and the original patents are held by two Turkish scientists living in Germany. Moreover, the Pharma companies will be paid their royalties. What they don’t want to divulge are trade secrets on how to produce it. Of course the last administration wasn’t going to waive the patents, but Biden said he would do it during the campaign. I say screw their trade secrets. The public good outweighs private profits, especially when the profits have already been guaranteed. There was never any risk to them, and they’ve known from the start that this would likely happen.

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Response to Gaugamela (Reply #7)

Wed May 5, 2021, 10:52 PM

23. Agreed, and well said! nt

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Response to BumRushDaShow (Original post)

Wed May 5, 2021, 04:36 PM

3. Oh, ughh. How about coming up with something quick like very real soon?

“Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.” ... Further discussions are expected in the coming weeks...


Sounds like climate negotiations

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Response to progree (Reply #3)

Wed May 5, 2021, 05:14 PM

6. That's because of all the patent law

involved in drug and biologics products, as well as medical devices.

https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity#What_is_the_difference_between_patents_a

Orange Book Frequently Asked Questions

1. What is the difference between patents and exclusivity?
Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act. Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.

2. How long is a patent term?
Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.

3. How long does an exclusivity period last?
It depends on what type of exclusivity is at issue.

  • Orphan Drug Exclusivity (ODE) – 7 years
  • New Chemical Entity Exclusivity (NCE) – 5 years
  • Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities
  • New Clinical Investigation Exclusivity – 3 years
  • Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
  • Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)
  • Competitive Generic Therapy (CGT) - 180 days (this exclusivity is for ANDAs only)


  • See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.

    (snip)

    6. Where can I find patent and exclusivity regulations in the Code of Federal Regulations (C.F.R.)?

    See 21 C.F.R. 314.50 Content and format of an NDA
    See 21 C.F.R. 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
    See 21 C.F.R. 314.53 Submission of patent information
    See 21 C.F.R. 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
    See 21 C.F.R. 314.60 Amendments to an unapproved NDA, supplement, or resubmission
    See 21 C.F.R. 314.70 Supplements and other changes to an approved NDA
    See 21 C.F.R. 314.94 Content and format of an ANDA
    See 21 C.F.R. 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
    See 21 C.F.R. 314.96 Amendments to an unapproved ANDA
    See 21 C.F.R. 314.97 Supplements and other changes to an ANDA
    See 21 C.F.R. 314.101 Filing an NDA and receiving an ANDA
    See 21 C.F.R. 314.107 Date of approval of a 505(b)(2) application or ANDA
    See 21 C.F.R. 314.108 New drug product exclusivity
    See 21 C.F.R. 316.31 Scope of orphan-drug exclusive approval
    See 21 C.F.R. 316.34 FDA recognition of exclusive approval

  • Code of Federal Regulations on the Government Publishing Office web site.




  • They'll probably have to work out NDAs (in this case "NDA" = "Non-Disclosure Agreements" ) and compensation stipulations, etc. I'm not sure (haven't researched it) when they filed the patent for the entity used in the vaccine but I expect it may have been awhile ago (multiple entities including the one they eventually selected to use for the actual vaccine).

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    Response to BumRushDaShow (Reply #6)

    Wed May 5, 2021, 08:06 PM

    9. None of this crap can be cut through by government edict? Like what if this was WWII and

    we needed GM to make tanks NOW? Or millions of GI's needed whatever vaccinations NOW?

    (We've already lost more lives in the U.S. than we did in that conflict. Internationally, not yet ... e.g. the Soviet Union alone lost 20 million lives or whatever the number was in WWII. Total Covid deaths worldwide according to NY Times is a mere 3.2 million)

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    Response to progree (Reply #9)

    Wed May 5, 2021, 08:26 PM

    10. Well remember there was an agreement put in place for Merck to work with J&J on the Janssen vaccine

    so they have some kind of baseline to use as a template. It also included this -

    The Department of Health and Human Services said later Tuesday that the U.S. will use Defense Production Act to provide an investment of $105 million for Merck to convert, upgrade and equip the company’s facilities to the standards necessary to safely manufacture the vaccine.

    https://www.cnbc.com/2021/03/02/covid-vaccine-biden-to-announce-merck-will-help-make-johnson-johnsons-shot.html


    There are piles of companies out there but they need to make sure that there is consistency in the finished products across "partners", so doing this goes beyond the patent issue. They also need to make sure that schlock places don't get a hold of it and butcher the process (see Emergent for an example of bad, bad and bad).

    Unfortunately, biologics like a vaccine aren't "widgets" and will require some pretty stringent controls for sterility, purity, potency, stability, and uniformity since they are going to be injected (or ingested) in a human being.

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    Response to BumRushDaShow (Reply #10)

    Wed May 5, 2021, 08:38 PM

    12. " they are going to be injected (or ingested) in a human being"

    Meanwhile, Covid19 is being breathed in by millions a day, causing a worldwide reported case rate of over 800,000 a day, reported deaths about 13,000/day. https://www.nytimes.com/interactive/2020/world/coronavirus-maps.html

    As I understand it, the issue is letting other countries to start producing it for their own populations. I'm not saying we should willy-nilly waive our standards of quality to ramp up production in the U.S. for U.S. use. That's not what the issue of patent protection is about.

    I would argue that a competitive military weapon like a tank, ship, or bomber is no more of a "widget" than a vaccine, or that the quality of vaccines was unimportant in WWII. I served on a nuclear submarine (not in WWII ).

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    Response to progree (Reply #12)

    Wed May 5, 2021, 08:55 PM

    13. When you're talking about mRNA or virus-based vectors

    vs metal and silicon (or whatever), then yeah, there is a big difference.

    Most of our APIs (active pharmaceutical ingredients) are made overseas and imported from places like China and India and I think in their cases, it's a matter of dealing with international agreements related to patents (particularly with China and their tendency to ignore such).

    But more importantly, the last thing you want (particularly after what has now happened twice with J&J, and in a related circumstance, with AstraZeneca's vaccine) is uncertainty and doubt about the product itself. You can make all the doses in the world but if people refuse to take them (including due to misinformation and/or unforeseen issues with the products themselves), then you are no better off with or without a patent agreement

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    Response to BumRushDaShow (Reply #13)

    Wed May 5, 2021, 09:02 PM

    14. Quality in manufacturing and patent protection are two different issues. The patent protection

    thing is about releasing the formula to other companies and other countries. It has nothing to do with ensuring quality standards in manufacturing.

    When you're talking about mRNA or virus-based vectors vs metal and silicon (or whatever), then yeah, there is a big difference.


    Sorry. Just not buying that quality is more difficult or easier in one than the other. In a nuclear submarine (just metal and silicone I guess), is ever further pushing the limits of depth, speed, and noise reduction among innumerable other qualities that must be cutting edge.

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    Response to progree (Reply #14)

    Wed May 5, 2021, 09:12 PM

    16. They are related

    in terms of actually "following the process exactly" with whatever that gets synthesized actually being what it is supposed to be when synthesized. Any slight deviation (pH of buffers, medium temps, centrifuge speeds/timing, etc), might result in a near-identical but slightly different entity (that itself also might have been patented, but was not explicitly approved for manufacture in the agreement). And thus if further protocols were not followed for batch/lot testing of that, no one would be the wiser, and the efficacy might be altered.

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    Response to BumRushDaShow (Reply #16)

    Wed May 5, 2021, 09:20 PM

    17. You are talking about manufacturing quality and following the recipe exactly. That has nothing to do

    with whether we give the recipe to other companies and countries or not. Nobody is arguing that the U.S. should give an automatic stamp of approval and import and use whatever China or India produce. That's not what waiving intellectual property rights is about.

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    Response to progree (Reply #17)

    Wed May 5, 2021, 09:31 PM

    18. The issue is patents, which involve proprietary products/processes, and whether to waive the patents

    to allow others to make these products. The patents are generally 20 year things for these types of products and these pharmaceutical companies always argue that they take years to come up with this stuff and want exclusivity to market and sell it (at a premium). The "negotiations" are to deal with allowing that proprietary process to be shared with (I assume) some limit to liability of the originator if others using the process "gets it wrong", and I would assume, some agreement to appropriate compensation for giving up that exclusivity (which the DPA can provide).

    I think you were arguing "cut the red tape and just make it" and it's not that easy.

    **** ( ) ****

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    Response to BumRushDaShow (Reply #18)

    Wed May 5, 2021, 09:59 PM

    19. "I think you were arguing 'cut the red tape and just make it' and it's not that easy."

    Nope, didn't mean that at all. I'm talking about waiving the intellectual property rights and don't see why weeks and weeks have to be spent negotiating that with Pfizer etc.. I have no idea how long it will take other companies and countries to start and ramp up quality production, but we need to stop piddling around on intellectual property rights, and get to step 2 really very soon.

    pharmaceutical companies always argue that they take years to come up with this stuff and want exclusivity to market and sell it (at a premium).


    Of course. And we don't have to bow down to them in an international crisis. That's my point. In an international crisis (this isn't some "lifestyle drug" ) we don't have to spend weeks and weeks on negotiating with the drug companies something that they will be happy with.

    The "negotiations" are to deal with allowing that proprietary process to be shared with (I assume) some limit to liability of the originator if others using the process "gets it wrong", and I would assume, some agreement to appropriate compensation for giving up that exclusivity (which the DPA can provide).


    As for liability for when an Indian factory takes the e.g. Pfizer recipe and makes some generic and screws it up, I don't know why Pfizer would be responsible for that, it would be a really stretched case, and I'm sure there is boiler plate language out there used for many other generics that are manufactured by others.

    I do believe we (the U.S. government, aka taxpayers) should compensate our pharmaceutical companies (but not up to the level of scarcity-monopolistic pricing), but it's not that we have to spend forever coming up with terms that they will like. We didn't turn our selves into pretzels during WWII when we told companies what to do whether they liked it or not.



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    Response to progree (Reply #19)

    Wed May 5, 2021, 10:14 PM

    20. I really don't think it's going to take that long

    and I wouldn't be surprised if things are already getting set up behind the scenes, particularly given past agreements of the sort.

    Actually - according to the OP article, it's not so much the U.S. and red tape, but whatever happens with the WHO and the countries at the table who are doing the negotiations (from the OP) -

    Ms. Tai added that the United States would participate in negotiations at the World Trade Organization over the matter, adding, “Those negotiations will take time given the consensus-based nature of the institution and the complexity of the issues involved.” Earlier Wednesday, members of the World Trade Organization held another round of discussions about waiving intellectual property protections. Further discussions are expected in the coming weeks, as India and South Africa, which proposed the waiver, are preparing a revised plan for nations to consider.


    The "change" was that the U.S. decided to go ahead and join whatever WHO was working on with other interested nation parties and not stand in the way.

    (of course WHO has its own issues but that's another subject for another day )

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    Response to BumRushDaShow (Reply #20)

    Wed May 5, 2021, 10:22 PM

    21. I saw the WTO and WHO stuff in the OP - that's what my question originally was about

    I quoted part of that paragraph in my post #3

    If we're essentially giving something away (in the form of waiving intellectual property rights), then I don't understand why there have to follow weeks of negotiations with other countries about it.

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    Response to progree (Reply #21)

    Wed May 5, 2021, 10:27 PM

    22. Well that might not be anything that we can control

    It's those other countries (some of whom may have to deal with their Parliaments and whatnot - particularly if it comes to funding such an endeavor). I.e., the world's "red tape" not ours (although obviously we are "at the table" to monitor).

    (E.g., there has been a chronic problem with reagents and other raw materials and these countries may be trying to get agreements with manufacturers from various other countries to help fulfill that, etc)

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    Response to progree (Reply #9)

    Wed May 5, 2021, 08:31 PM

    11. Profit above all else. That ends up in some companies having more interesting in taking lives...

    Than they do in saving them.

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    Response to Lancero (Reply #11)

    Wed May 5, 2021, 09:09 PM

    15. Precisely /nt

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    Response to BumRushDaShow (Original post)

    Wed May 5, 2021, 04:45 PM

    4. It will be interesting to see if this ends up in court

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    Response to BumRushDaShow (Original post)

    Wed May 5, 2021, 05:52 PM

    8. Immediate thoughts: Which patents? All of them? If Biden can persuade pharmaceuticals who used the

    vaccines as delivery mechanisms to deliver the CRISPR therapies into the outside cytoplasm of human cells, then Biden's covid team could be dealing with pharma, who already paid patent royalties to the scientists who produced the covid virus genetic material mapping and editing. These companies manufacture the vaccine delivery mechanism for the RNAmolecule.

    Other countries use mostly AstraZeneca (not an RNA vaccine) and just can't produce enough vaccines, and long term effective enough vaccines, and so they need to borrow intellectual property on U.S.'s RNA vaccines.

    I'd be surprised if this was about lifting protections for the patents on the science that enable the vaccines. Mostly because other countries don't yet have the lab capabilities to do the CRISPR work to map and edit virus genetic material.

    Those are held by both the institutions (Berkeley National Laboratory and Harvard's Broad Institute) and the scientists (the Doudna & Zhang teams) who developed the science tools (gene-edited coronavirus) to delivered by the vaccines.

    Just for the record, Eldora Ellison, with degrees in biology and law, explained the nuances of both of those to the U.S. Patent Office and the U.S. Court of Appeals (she'd be good for SCOTUS, which could use at least one justice who understands biology and technology) that the editing tool, CRISPR-Cas9 was patent worthy because of Doudna's and Charpentier's bench research and data that proved it could be used in all organisms from bacteria to humans. They were granted 15 patents in the U.S.

    By 2020, Doudna and Charpentier had been awarded major patents for their gene editing tool in Britain, China, Japan, Australia, New Zealand and Mexico.

    So if it's the scientific patents Biden might lift protections on, it's okay with these scientists, who've never really done what they did for the money, anyway. Even if their institutions might want the money, at least it's clear that Doudna (UCal Berkeley) and Charpentier (U. of Vienna) don't. Besides, they can still get royalties from other countries with their own vaccine production strengths.

    Sounds like a no-brainer for Biden because spreading manufacturing and science capacity worldwide is a good thing. It can raise US international leadership capital, too. And it also sounds like the kind of big deal help that's been expected of America.

    Just putting out what I've read about, and what Biden's commitment means.

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    Response to BumRushDaShow (Original post)

    Thu May 6, 2021, 07:34 AM

    24. They should tread carefully. Also, any generic Covid vaccines would be a year away...

    ... if that.

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    Response to BumRushDaShow (Original post)

    Thu May 6, 2021, 03:53 PM

    25. Covid: Germany rejects US-backed proposal to waive vaccine patents

    Germany has voiced opposition to a US-backed proposal to waive patents on Covid-19 vaccines, saying they were not hindering production of the jabs.

    Its government said "the protection of intellectual property is a source of innovation and must remain so".
    ...
    Meanwhile, officials in other member states such as France and Italy gave the proposal their full backing.
    ...
    Outside of the EU, Russian President Vladimir Putin said he supported the idea of a waiver.

    The UK government said it was "working with WTO members to resolve this issue" and was "in discussions with the US and WTO members to facilitate increased production and supply of Covid-19 vaccines".

    https://www.bbc.co.uk/news/world-europe-57013096

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