DISTORTED DRUG PATENTS

by Dennis Crouch

Prof. Erika Lietzan (Missouri) and Prof. Kristina Lybecker have released an important new article that they title Distorted Drug Patents. (Forthcoming in Washington Law Review).

The basics: New drug treatments require pre-approval based upon evidence of safety and effectiveness. That research takes time — with the treatment’s 20-year patent clock typically ticking away throughout the approval period. This is an old issue that was addressed in the 1984 Drug Price Competition and Patent Restoration Act.  However, as Lietzan and Lybecker point out – the Patent Term Extension (PTE) “doesn’t restore all of the lost time.”  In particular, PTE restors 1/2 of clinical testing time (after the patent issues) and caps recovery at five years of added time. In addition, PTE cannot extend the patent more than 14 years beyond regulatory approval and can only be applied to one patent for each drug treatment listing. Note – PTE is added to any PTA term.

The new data-driven article focuses on the question of whether the partial-restoration  steers research “away from drugs that take a long time to develop.”  

The article looks at every PTE grant (1984-2018) and ties that grant to product to the clinical research period and launch dates of the brand and generic (if launched). Some conclusions:

  1. Longer clinical period => shorter patent life post-approval;
  2. Being a “child” in a family of patents => shorter patent life post-approval;

This second point seems obvious to patent-law youngsters who have always seen patent term calculated from the parent-filing-date.  However, the article argues that the shorter child-life is “the opposite of what lawmakers intended in 1984.”

[Read it here]

 

20 thoughts on “DISTORTED DRUG PATENTS

  1. 5

    Re: “shorter child-life is “the opposite of what lawmakers intended in 1984.”
    Amazingly incorrect. Patent terms running 20 years from the earliest application filing date from which priority benefit is claimed [plus extensions for PTO delays], rather than 17 years from issue date, were specifically intended to prevent massive patent term extensions from serial continuations and divisionals and other prosecution delays made famous by Lemelson and others.

    1. 5.1

      I agree with Paul (as reflected in post 1.1.1 below).

    2. 5.2

      Also, valid continuations, divisionals or other “child” applications other than CIPs cannot add new matter, and CIPs do not have valid priority benefit for any claims to or 112 supported by the new matter.
      [P.S. What, no commentator attack here by our usual attacker of academic writing with his usual alleging of K street influence or funding? Is that only for selective subjects?]

      1. 5.2.1

        Who is this attacker that you are referencing? I am typically not a fan of academia, but your phrasing sounds like you are indicating someone else.

    1. 4.1

      Oddly enough, I do not disagree all that much here Malcolm.

      Of note to me: “In other words, the American middle class is already taxed like Europe’s. But instead of buying us universal health care and other forms of social protection, our paycheck deductions go toward sustaining redundant private-insurance bureaucracies, Big Pharma’s high profit margins, and American doctors’ extraordinary salaries.

      Now, the doctor’s salaries are NOT that exorbitant to me, given how most all professionals in the US are comparably higher (and this is not necessarily a bad thing).

      But the real problem to me is that LACK of clarity on all of the “Big Pharma” profit margins combined with a serious “kick-back” aspect of the medical insurance and other players.

      As I have noted previously, a solid first step would be merely making public the data — allowing the public to “follow the dollar.”

      One may then realize that “government control” may NOT be necessary, as the power of the public (especially a public that sees the 0bscene profit margins) will be a correcting force in and of itself.

      And ALL of this need not even impact patent law.

      1. 4.1.1

        whew – that must have been a heck of a typo in the email line to generate that mug.

      2. 4.1.2

        Re: “doctor’s salaries are NOT that exorbitant to me.”
        But there is a real problem in the inadequate number of medical school placements and the very low compensation for internists versus the very much higher compensation for surgeons for surgeries that are now routine and can be done several times a day.

        1. 4.1.2.1

          Interesting Paul.

          While separate (clearly) from the comparative dynamics of insurance and Pharma, your point may well be worth exploring as to why such a disparity seems to be arising.

          And while looking there, one may also compare/contrast another “self-regulated” service industry for similar disparities. Of course, this “another” is the legal field. As you may be aware, there is a rather sizable movement (across MANY states) to deconstruct the controls that the various Bar organizations employ as they “self-control” the level of competition within their ranks. Notably, many of these movements are employing the ‘moralistic’ Ends of “Access to Justice,” while the underlying pragmatic aim may be said to be the more plebian ‘cost’ of that access.

  2. 3

    The most important thing is to never talk about non-patent related methods of promoting research and development of new drugs.

    It just ruins all the fun. I mean … imagine students at a college doing something more useful than studying the great Ayn Rand or the fantastic speeches of Mussolini and Ronald Reagan (before he became a liberal).

    I knew you couldn’t do it! It’s time to really get serious. America needs to return to the Great Guild System. The Seventh Kondrakian Wave is about to break upon our spangled mantle at last.

  3. 2

    In the article, my specific point on the Pharma fallacy (not possessing the very thing being claimed AT the time of filing) is repeated as if such possession is totally optional (and filing on nothing but research plans is somehow “OK”):

    Distortion of the patent term stems from the fact that medicine inventors usually file their first patent applications before they start testing in humans. This generally means that the patents issue before the trials are done and before approval of the medicine.

    Here is an easy solution (that ALL other art units follow): don’t file until you have the utility that you want to claim.

    You want to claim a lower level of utility (and one not likely to make that $ from the HUMAN level claims) because THAT is what you possess at the earlier date? No problem.

    You want a magic waiver to play speculator and then want more? AND you want to pretend that this is normal and not in accord with the foundational patent laws? The least you could do is to be honest about it. But playing “the victim” while you are not following what ALL other art units have to follow should raise ire.

    1. 2.1

      Curious about how this very serious thinking might be applied to claims that cover non-obvious software functioning in every operating system under the sun, where precisely zero bug-free examples of actual working software are presented in the spec because no such software has been written by anyone involved with the patent application.

  4. 1

    “Prof. Erika Lietzan (Missouri) and Prof. Kristina Lybecker have released an important new article that they title Distorted Drug Patents. (Forthcoming in Washington Law Review).”

    “Law review” and “imporant article” are mutually exclusive. You’ve been drinking the Kool-Aid for too long, DC. The points made in the abstract are ones that have been well-understood by practitioners in this area for many years.

    Bob Armitage suggested long before this article that the system as presently constituted doesn’t give sufficient incentives to develop drugs for treating chronic illnesses. Drug for chronic illnesses require longer clinical trials and therefore the recoup-and-make-profit period under the current system is generally too short to justify investment in many such drugs. Armitage has suggested a flat 12-years-from-FDA-approval exclusivity regime, having nothing to do with patents.

    I don’t expect reality to stop law professors from congratulating themselves for publishing articles about things that are well-known to people who actually work in the field, in journals that aren’t peer-reviewed but rather edited by students. I suppose that’s a corollary of the adage “those that can’t do, teach”.

    1. 1.1

      AM,

      I would be interested in your view of the concern of “evergreening,” especially in view of “children” applications that may derive their claimed invention from a first application (phrases this way to distinguish from CIP’s).

      I don’t have an issue with “Continuation practice” (as that term means as a term of art), but I WOULD have an issue with any “new” child items having a different term treatment just because “Pharma.”

      1. 1.1.1

        Interestingly, the article is only circular in its citations as to a purported “not intending to cover” the child applications of Pharma when the wholesale changes in patent term was passed by Congress.

        I see zero support for the notion that child patent term for Pharma should be treated any differently at all from child patent term in any other art field.

        I think that trying to separate that sea-change in patent term with a carve-out for Pharma would be a disservice to patenting in general (much like the attempted carve out for patents after the AIA was passed for post grant reviews).

    2. 1.2

      in journals that aren’t peer-reviewed but rather edited by students.

      The situation is even worse than you phrase it here, given the way that the US Academia has become (became — it’s been decades this way) a bastion of non-meritocracy and “how best do you parrot a desired philosophy.”

      Those student editors are typically the ones closest “in track” with the desired group think.

    3. 1.3

      Great tr 0lls, Dennis. The finest, really.

      LOL

      1. 1.3.1

        Let’s all just pretend that this thread was not started with YOUR tr011ing (that was expunged in a lightening fast manner).

    4. 1.4

      Atari, that’s the key point confused by this article. If patent terms for drugs need to be even more different than they already are it should be by “a flat X-years-from-FDA-approval” – a mimimum term guarantee from when the drug can be marketed. That has no logical connection to extended terms for “child” patents.

      1. 1.4.1

        If I grasp where you are going, could not We (the Royal We — as in Congress) set up a NON-patent related period of exclusivity for any “distinguished” item that need run through the FDA gauntlet (not including copy cats)…?

        In other words, not only is the “parent/child” aspect strained (especially in light of the overarching reasons for the term limit switch), but there really not be a “patent” aspect at all.

        I am not as well versed with the Administrative Law considerations of the originating or supplementary charter for the administrative agency of the FDA, so there might (or might not) be limitations to such a consideration.

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