Faux-Populist Patent Fantasies from The New York Times

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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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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