Faux-Populist Patent Fantasies from The New York Times

By Kevin E. Noonan --

On a spring Saturday in a year when three major holidays -- Easter, Passover, and Ramadan -- coincided or overlapped, The New York Times Editorial Board decided it was time to announce that the "United States Patent and Trademark Office is in dire need of reform" ("Save America's Patent System," The New York Times, April 16, 2022).  Were that the case, the Times' rhetoric would deserve serious consideration; as it is, the Times continues a history of wrongheaded, faux populist rhetoric that comes to the entirely wrong conclusion.

This is evinced immediately by the principle basis for the sentiment regarding the patent system -- "Drugs cost too much!" -- and the basis for this conclusion:  the Initiative for Medicines, Access and Knowledge (I-MAK), a policy advocacy group dedicated to lowering drug prices by attacking the patent system.  The Times' reliance on I-MAK is particularly inopportune in light of recent events.  First, Professor Adam Mossoff of George Mason University's Antonin Scalia School of Law published a report for the Hudson Institute, entitled "Unreliable Data Have Infected the Policy Debates Over Drug Patents," that raised serious issues over the data I-MAK relies upon in making its policy arguments regarding the relationship between drug pricing and patents.  Professor Mossoff's critique was sufficiently provocative that Senator Thom Tillis wrote to I-MAK asking them to explain themselves (see E. McDermott, Tillis Wants More Info on I-MAK and Other Data Driving Anti-Patent Narratives Around Drug Pricing).  I-MAK responded, not with the information the Senator requested but with a reiteration of their rhetoric (see E. McDermott, I-MAK Defends Integrity of Its Patent Data in Response to Tillis Letter), prompting the Senator to ask for further clarification.  Professor Mossoff's analysis suggests the Senator will have a long wait for a satisfactory answer.

The Times also wrongfoots its example of so-called "patent evergreening" -- insulin manufacturers providing devices for administering doses of the drug.  The Times might have had a point if drug companies had taken off the market traditional insulin in vials and administered by patient injection with syringes -- but a simple search shows that this is not the case.  What these devices supply are ways for a patient to readily inject the correct dose, therefore improving compliance and avoiding dosage mishaps, which improves clinical outcomes and so is desirable to physicians because it avoids complications, thus reducing costs to payors such as insurance companies.  And it is the very "simplicity" of the technology that prevents any one company from dominating the injection device market -- after all, many different drugs besides insulin are delivered using such devices -- and that both warrant and require patent protection, lest knockoffs flood the marketplace.  This protects both American industry -- from whence exactly does the Times Editorial Board suppose such cheap knockoffs would arise? -- as well as providing the return on investment that regulatory approval costs require to incentivize development of products having such benefits for patients, their doctors, the insurance industry, and (because the bulk of drug costs are borne by the U.S. government one way or the other) taxpayers.  And should the Times Editorial Board wish to understand rather than grandstand about this issue, there is academic scholarship, such as Professor Erika Lietzen's work in "The 'Evergreening' Metaphor in Intellectual Property Scholarship" and "Distorted Drug Patents" that would provide much better information for their readers.

The editorial resurrects for a new age an idea current at the turn of the century -- that applicants could "wear down" examiners who would then grant patents "out of kindness, I suppose" -- which created the ill-considered Claims and Continuation rules changes promulgated by the Patent Office encouraged by scholarship untethered to the realities of the Office or patent prosecution (see "The 'Word' on the New Continuation Rules (from the USPTO Webcast)" -- Part I and Part II); they were enjoined by the District Court of East Virginia (see "Tafas v. Dudas; SmithKline Beecham Corp. v. Dudas (E.D. Va. 2007)") and invalidated six months later.  These limitations on prosecuting patents were particularly deleterious for the type of complicated technology common in the biotechnology and pharmaceutical arts, where patent examiners, who are typically not lawyers and, while having degrees and perhaps experience in the relevant technologies are not "cutting edge," understandably require time to absorb and apply patent law to claims for such complex inventions.  Ironically, it is the very diligent gatekeeping function that the Times Editorial Board alleges the examiners are not doing that causes the delays that require applicants to pursue lengthy prosecution efforts (all while the twenty years from filing term clock is ticking and applicants are losing time during which commercial products embodying their inventions have exclusivity).

Paradoxically, the very means by which Congress has provided a mechanism for eliminating "bad patents" (which frequently just means someone else's patent that prevents you from selling something you'd like to; see "The IPO's Marc Adler on Patent 'Quality'"), the Patent Trial and Appeal Board and the various flavors of post-grant review afforded challengers under the Leahy-Smith America Invents Act, come in for criticism, based on rules permitting the Board to refuse to institute a proceeding based on avoiding duplicate adjudications before the Office and in the courts (see M. Buttman, "Turning Away a Patent Challenge: The NHK-Fintiv Rule Explained," Bloomberg Law, March 3, 2021).  In doing so, the Editorial Board comes perilously close to accusing the former Director of instituting the rules improperly, and in the process (again ironically) illustrating why Justice Thomas and others advocate overturning the protections from libel suits by public officials in N.Y. Times v. Sullivan.

Because no one can always be wrong -- including the Times Editorial Board -- there are a few, albeit precious few, reasonable ideas in the editorial.  One is giving examiners more time for examination, which could "solve" the excess prosecution "problem" the editors perceive exists.  Another is having increased public participation, although the means for achieving this goal smacks of the same motivation that has made virologists out of financial advisors during the pandemic -- the idea that people who actually understand the process and issues are somehow suspect.  And the idea asserted by the Times Editorial Board that the PTO does not coordinate with other agencies like the FDA and FTC is just wrong and illustrated by an example not representative of the realities of patent prosecution, such as the duty of candor and the penalty for violating it called inequitable conduct.

Perhaps the editors will be motivated to look into some of the deficiencies of their reasoning and understanding of the real issues facing innovation that the patent system grapples with, like "efficient infringement" by large companies with the financial wherewithal to expropriate smaller companies' inventions (see "The Proper Role of the Federal Circuit" and "The ACLU, Working for the Man").  But this is unlikely because reality does not fit the editors preconceived notion of what "everybody knows" (see "The Road to Hell Is Paved with What Everybody Knows").  The editorial pages of the Times have a long history with this type of prejudice (see "Science Fiction in The New York Times"; "The Anti-Patent Beat Goes on at The New York Times"; "Anti-Patent ("Sullivan?") Malice by The New York Times"; "The Continuing Assault on Innovation at The New York Times"; "War is Peace, Freedom is Slavery, Ignorance is Strength"; "New York Times to Innovation: Drop Dead"; and "More Patent Nonsense from The New York Times") and frankly there is no reason to think it will change.  There is nothing in this latest editorial to the contrary.

Comments

[Chester]

Thank you for writing this; very well said. Even though labeled as opinion, the New York Times piece was so inaccurate and misleading that it should not have been published.

[Greg DeLassus]

The hard fact that the NYT ed board neglects to consider is that the patent laws of the U.S. are scarcely different than those of Canada, Europe, Japan, etc, and yet all of those countries have lower drug costs than we have. Should that not suggest that *patents* are not really the decisive factor driving our high drug costs here? The Sunday editorial rather missed the forest for the trees.

[skeptical]

In a day and age of growing concern with DIS and MIS information, the New York Times simply

does

not

care.

[Greg DeLassus]

"The Times might have had a point if drug companies had taken off the market traditional insulin in vials and administered by patient injection with syringes---but a simple search shows that this is not the case."

Whole vistas of perfectly serviceable insulin varieties have been taken off the market, precisely in order to achieve the sort of evergreening that you are denying here. The URL below constitutes a complete list of commercially available insulin varieties in the U.S. Notice how there is not a single entry in there for ordinary old porcine insulin, of the sort that used to be standard of care. Indeed, not a single sort of insulin that was in use in the 1970s is still available on the U.S. market. That is because the innovator manufacturers withdraw their NDAs when the patents expire.

This is not, of course, a problem of patent law. It is a problem of FDA law. If the FDA were permitted to approve generics/biosimilars based on a *prior* NDA (instead of a *current* NDA), then we could have real generic competition in the U.S. to drive down insulin prices. There are, in other words, necessary reforms to be made---in FDA law. Fiddling around with patent law to solve this problem, however, is rather like the proverbial drunk looking for his keys under the streetlamp because that is where the light is better.

https://www.ncbi.nlm.nih.gov/books/NBK278938/table/insulin-pharmacology.T.insulins_commerci/

[Kevin E Noonan]

Greg: I think the reason for taking these insulins off the market is that non-human insulin has serious drawbacks longterm. When diabetics died young this wasn't an issue. But once diabetes began living longer, and human insulin came on the market, there was a change in the standard of care to avoid the immunogenicity and other issues that were accepted for porcine and other animal insulins when there was no alternative.

Also, in the 1970's "long-acting" insulins were developed by complexing them with zinc, but for the past 20 years genetically engineered versions have longer in vivo half-lives that work better. These insulins (which are provided using injectors) can also be purchased in vials and administered with syringes. That is what I was referring to; sorry if I was unclear.

Thanks for the comment.

[Greg DeLassus]

"I think the reason for taking these insulins off the market is that non-human insulin has serious drawbacks longterm."

So does not taking your insulin for days at a time because you cannot afford it, or taking only a quarter of the necessary dose because of budget constraints. This is a bootlegger-&-baptist story. There is a noble reason for withdrawing prior art insulins from the market, and a self-interested reason. The different explanations are not mutually exclusive, and do not cancel each other out.

Mind you, I am not trying to demonize drug companies. I do not see that there is much to be gained from making policy decisions based on the halos or horns that we choose to draw behind the heads of the relevant actors.

Rather, we should simply focus on the lived reality of how FDA policy decisions affect patients. Would diabetic patients be better off with greater market competition in this space? To my mind, the answer to that question seems like a no-brainer. Even if 1970s era technology is worse than 2020 era tech, it is a darn site better than just doing without insulin altogether. We should set FDA law accordingly to achieve the better policy outcome.

[skeptical]

Is the FDA actively BLOCKING anyone from doing the necessary steps to put in place those older technologies?

Would they for safety reasons?

As far as I can tell, the withdrawal by a first provider does not mean that a second provider is necessarily foreclosed. "IF" per Mr. DeLassus (I may not be reading his position correctly) the capability for another IS THERE "but for" the FDA itself, and that capability is ethically medically permissible, then that option should ALREADY be available, correct? If that option is NOT ethically medically permissible, then Mr. DeLassus may be asking for something that should NOT be granted.

[Dan Feigelson]

You were expecting truth from the NYT? This is the same outfit that told us that Trump was collaborating with Russia, that buried the Hunter Biden laptop story, and whose editorial staff in the summer of 2020 threw a collective tantrum because their boss said some things they didn't like. And that's before considering the NYT's long and inglorious track record of attacking patents and innovation, which you've discussed on many occasions, as mentioned in your last paragraph. (I also wrote about this last year, here: https://www.iliplaw.com/americaisrael_patent_law/2021/09/new-york-times-gets-it-wrong-but-whats-new.html).

I'm surprised anyone still subscribes to NYT, let alone uses it for anything other than wrapping dishes before moving house, or cleaning a certain bodily orifice.