Friday, 21 January 2022

What are the challenges in developing information around mixing-and-matching COVID-19 vaccines and therapies?

By Rachel Sachs, Jacob S. Sherkow, Lisa Larrimore Ouellette, and Nicholson Price

The FDA has now authorized three vaccines and several treatments (including both monoclonal antibodies and small-molecule drugs) for the prevention and treatment of COVID-19. But the initial evidence supporting these products’ introduction into the market did not include information about how they might work together. Nevertheless, information about mixing-and-matching COVID-19 vaccines and therapies would be highly valuable not only to physicians and their patients, who must already make decisions about what treatment options to pursue under conditions of uncertainty (if the treatments are available), but also for policymakers, who want to know what products to prioritize for investment. Why is it so difficult to obtain this information? How can policymakers encourage its development? 

What, if anything, is known about mixing-and-matching COVID-19 vaccines and therapies?

A growing body of evidence suggests that mixing and matching different COVID-19 vaccines is safe and generates an effective immune response, but evidence is more uncertain on whether switching vaccines mid-course leads to a more or less effective response, particularly when the initial dose was of an mRNA vaccine. This information seems especially important given that global vaccine distribution remains patchwork and viral variants continue to arise. What evidence is there for vaccines’ and boosters’ interchangeability? 

The CDC currently advises that vaccines are not interchangeable for the initial two doses of the Pfizer-BioNTech and Moderna mRNA vaccines, but that mix-and-match dosing (more formally known as “heterologous” dosing) is allowed for booster shots. People who received non-FDA-authorized vaccines can also receive a heterologous primary dose and booster. The agency cites preliminary results from a pre-Omicron study by the NIH-funded Mix and Match Team, which found that heterologous boosters resulted in similar or higher antibody responses in the first month after boosting. But short-term antibody responses may not indicate clinical outcomes, and the study authors caution that the study was not designed to compare different booster regimes (given the sample size and lack of controls for relevant variables). Last week, the Mix and Match Team posted very preliminary results that most booster combinations (heterologous or homologous) increase antibody response to the Omicron variant, but these results have similar limitations.

The European equivalents of the FDA and CDC—the European Medicines Agency (EMA) and the European Centre for Disease Prevention and Control (ECDC)—issued updated guidance on heterologous vaccination in December, concluding that the mix-and-match approach may be used not just for boosters, but also for initial courses. This guidance was supported by a literature review of studies available by December 3, including both immunogenicity studies like those from the Mix and Match Team and longer-term studies of vaccine effectiveness. Most of these studies involve the AstraZeneca vaccine that has not yet been authorized in the United States, and while a few describe the benefits of boosting J&J recipients with mRNA vaccines (like the COV-BOOST and SWITCH trials), the EMA emphasizes that there is “limited data on interchangeability of mRNA vaccines.”

The WHO’s recommendations, also published in December along with a literature review, state that although homologous dosing is “considered standard practice,” the WHO “supports a flexible approach to homologous and heterologous vaccination schedules” and says countries may consider administering mRNA vaccines or vectored vaccines (like J&J or AstraZeneca) after any other vaccines, but it doesn’t recommend switching to inactivated vaccines (like Sinovac-CoronoVac) after initial dosing with other vaccines. Recommendations for the global context may be more lenient toward mix-and-match dosing in part because of the inequitable global vaccine rollout. As the WHO notes, “[a] common reason for considering heterologous COVID-19 vaccine schedules is lack of availability of the same vaccine product in settings with limited or unpredictable supply.”

As incomplete as the evidence base is for heterologous vaccines, there is even less information like this about combining different COVID-19 therapies like monoclonal antibodies and the antivirals molnupiravir and Paxlovid. The information we want is in part comparative effectiveness (which therapy is best?) and in part combinatory (is it better to have two therapies rather than one?), which would be valuable for patients, providers, and healthcare payers. But as discussed in the following section, firms have limited incentives to develop this kind of information about their products. 

Why is it difficult to obtain information about the comparative benefits of different health care technologies?

Despite the benefits of comparative and combinatory information for health care technologies, data is hard to come by. Companies generally don’t have good incentives to generate such information. Two “lingering questions” concerning the antivirals molnupiravir and Paxlovid, for example, are whether they work better in combination and how they compare with monoclonal antibodies. In an assessment of these questions in STAT News, Dr. Céline Gounder at NYU’s Grossman School of Medicine bluntly noted that “neither Merck nor Pfizer is incentivized to run a combination therapy trial.”

To the contrary, such trials are prone to yield “negative information,” i.e., information that’s harmful to the market prospects of either drug. In a 2013 article in the Yale Law Journal, Professors Amy Kapczynski and Talha Syed presented the case study of Norvasc for cardiovascular disease and older, similar cardiovascular drugs. At the time of approval, Norvasc’s manufacturer (Pfizer) failed to conduct any study of its drug compared to the standard treatment at the time—a study which, when conducted thirteen years later by NIH, demonstrated Pfizer’s product was not clinically superior—and in some respects, was inferior. This, Professors Kapczynski and Syed argue, is an example of how the downside to developers in producing such comparative data far outweighs any potential upside. Professors Kapczynski and Syed further categorize this negative information into two groups: information that the studied drug is not as safe and efficacious as previously demonstrated (like Vioxx); and information that the studied drug is comparatively less safe or efficacious than its competitors. In either case, the only entity currently incentivized to produce such information seems to be an independent third-party—like NIH, the sponsor for the COVID vaccine Mix and Match trials.

Incentives aside, there are practical barriers to conducting comparative trials as well. Developers may have a hard time negotiating with a competitor to obtain enough of their drug to do a comparative analysis. If the competitor’s drug is already approved or authorized, it can typically be obtained from the market. But garnering enough—at reasonable prices—is often difficult for even the simplest analyses, and a point of antitrust scrutiny. Further, the mere asking for excess product for a clinical trial is likely a signal of the developer’s confidence in its product’s superiority—further discouraging sharing. And, for comparative trials at least, differing dosing regimens may complicate any analysis. For the COVID-19 mRNA vaccines, for example, how should researchers compare mixing and matching second shots when Pfizer’s original data spaced doses three weeks apart to Moderna’s four?

There are practical barriers to combinatory trials, too. Combinatory trials generally require more treatment arms, which require more participants to be robustly statistically powered—and thus more time, and more money. This is likely exacerbated by the need for participants who fulfill each arm’s criteria. Fielding enough participants to demonstrate the combinatory efficacy of mixing-and-matching two-dose COVID-19 vaccines, for example, requires a subset of participants who have received one dose but not the second. As the number of permutations of combinations increase, there may simply not be enough participants out there to enroll—and especially to include participants from traditionally underrepresented communities. And, for observational studies as opposed to controlled trials, combinatory information relies on both products being approved for heterologous use, available, and covered by patients’ insurance—none of which are a guarantee.

Lastly, the desire for comparative and combinatory data is ultimately about updating information against constraints of financial resources, patients, and time. The pandemic continues to evolve as new viral variants and new therapies come online; running comparative trials each time a new therapy is authorized or a new variant comes to the fore is impractical and, of course, costly. Even with good incentives for developers, there may simply not be enough money or patients to go around—or enough time to conduct a study before new variants continue their march down the Greek alphabet.

What tools can policymakers use to encourage the development of this information?

Despite these difficulties, policymakers have multiple tools to help develop this sort of combinatorial information, including incentivizing or mandating drug companies to come up with the information, directly generating the information, or facilitating its collection in some other way.

One possibility is using agency incentives to encourage drug companies to develop the information. Authorization or approval of a therapy or reimbursement for its use by federal payers like CMS could be contingent on evidence of not just effectiveness versus a placebo, but also effectiveness versus the current standard of care. If one product is developed later than another, the second product’s developer could be required to include a comparison arm or a mix-and-match arm in the clinical trial. In the Paxlovid trials, for instance, the treatment arm was compared to placebo, and no patients had received monoclonal antibody treatment. To develop comparative information, the FDA could have considered requiring Pfizer to include a comparator arm for mAb therapy or one where patients got both to see what the added benefit would have been (assuming medical feasibility). This approach is, of course, more complicated where both products are being developed simultaneously, as with the mRNA vaccines. In the simultaneous development context, requirements or guidelines for more standardized clinical trials could help make the data at least more directly comparative, though, as we have discussed, such standardization efforts bring their own complications.

A more direct and thus far substantially more important pathway is direct government funding. The government can either run the relevant trials directly or provide grant funding for others (for instance, academics) to run the trials themselves. This results in higher on-book government expenses, of course, but can enable the government to design a relatively neutral trial rather than one designed to  favor one product over another. It also allows the enrollment of multiple manufacturers, and the possibility to conduct adaptive trials that examine the relevant questions in a more efficient way, as the RECOVERY trial has done in the UK.

Policymakers can also act to facilitate the development of such information from both private-sector and public-sector clinical trials. As noted above, those wishing to run comparative or mix-and-match trials may face problems acquiring enough of the relevant products to run their trials; policy mandates could require as a condition of authorization or approval that drug companies make sufficient amounts of their products available for later trials (the CREATES Act, enacted in December 2019, goes some way along this path). Policymakers could consider other facilitating actions, such as immunizing drugmakers for liability arising from side effects in clinical trials run by anyone other than the drugmaker. (In the COVID-19 context, for example, liability for injuries related to vaccines has been a persistent sticking point, generally).

Finally, policymakers can facilitate the development of knowledge about comparative effectiveness and mix-and-match treatments outside the context of clinical trials. Health care providers are already treating patients under conditions of uncertainty, sometimes mixing-and-matching vaccines, combining treatments, and otherwise acting outside the scope of clinical trials (including treating pregnant people even though they are often excluded from trials). Policymakers should encourage the collection of high-quality data about these ongoing practices so that this real-world evidence can be used to increase knowledge of what works, how, and when. This might mean the provision of infrastructure for better data collection, pathways for this data to be considered by regulators (already an area of significant and contestable interest), or incentives for private actors to share information. Clinical trials will remain the gold standard, but knowing something is far better than knowing nothing. Policymakers can move forward on all fronts to augment information about mixing and matching the COVID-19 vaccines and therapies we already have.

This post is part of a series on COVID-19 innovation law and policy. Author order is rotated with each post.

Wednesday, 12 January 2022

Jessica Litman: Who Cares What Edward Rogers Thought About Trademark Law?

Professor Jessica Litman has a fascinating forthcoming book chapter on the history of the Lanham Act and the influence of Edward S. Rogers, "Edward S. Rogers, the Lanham Act, and the Common Law. " Litman tells the history of the drafting of the Lanham Act of 1946 through the lens of Edward S. Rogers, detailing how his advocacy and drafting work influenced the final statutory text. 

Readers may be surprised to learn that Litman started research on the topic as a law student in the 1980s, while writing a student note on trade dress infringement. She went into the stacks of the Columbia Law Library and started reading bound copies of legislative history. She noticed it seemed like Rogers was everywhere, from 1932 all that way up to 1946, and that the chairs of the committees were deferring to him.  That was really interesting, she thought.  But after the note was done, she kind of forgot about it.

Now, forty years later, Litman is a professor at the very institution Rogers attended, the University of Michigan. She was surprised to find no one seemed to remember Rogers had been at Michigan, even though he "earned three law degrees and was a member of the adjunct faculty for 18 years" (3). In this book chapter, Litman is making up for that, returning to the topic of Rogers and his legacy. She's found her notes from 1981. She's read everything he wrote, and all his cases, starting in 1895 all the way until his death in 1949.

The result is a remarkably personal history of Rogers' involvement in the development of trademark law, full of contemporary details and selected quotes from Rogers' own writings. Litman's chapter, which engages extensively with the secondary literature as well as the primary sources, adds a tremendous amount to this history and to the many excellent recent articles touching on this subject, including The Lost Unfair Competition Law by Christine Haight Farley, The Erie/Sears/Compco Squeeze: Erie's Effects Upon Unfair Competition and Trade Secret Law by Sharon Sandeen, In the Shadow of the Trade-Mark Cases: The 1881 Trademark Act and the Supreme Court by Zvi Rosen, Mark McKenna's book chapter, Trademark Law's Faux Federalism, and many others.

My interview with Litman is transcribed in this post. The interview significantly deepened my knowledge of the subject and I am excited to share it with readers.

CAH: So who cares what Edward Rogers thought about trademark law? Why is this history of his views so important?

JL: One thing I got out of the project is I now know what all of the sections of the Lanham Act as originally enacted were intended to mean. Some stuff that was just incomprehensible to me, like Section 33(b)(6), I now know why that was there, and I now know why other things are not there, like the fact that there is no definition in the statute of likelihood of confusion; or how one comes to own a mark; or secondary meaning... That always seemed very peculiar to me.  But knowing why that is not there helps me to understand what Congress thought the Act was doing, and indeed what Rogers thought it was doing, given that he wrote most of the language in the 1946 Act.   

There were also many fun stories, trademark trivia stories, along the way. ... 

CAH:   So, in the decades leading up to the Lanham Act, trademark law was substantively common law. But there was a federal act, the 1905 Act.  Why did Rogers think this was not good enough? What was the biggest problem with the 1905 Act?

JL: It wasn't Rogers, it was the Supreme Court. The Court had said "no substantive trademark law," that exceeded Congress' limited Commerce Clause powers.  The 1905 Act was thus designed to just be an optional registry. But there were too many hoops to go through, and at the end you got nothing more than before you did it. And as our economy was getting more national, more international, and more complicated, it was really important to figure out if anyone was using the mark you were using.  But there was no way to do that.  Well, in fact, there was Henry Thompson... But besides him there was no central directory.  And that was Rogers' problem. Rogers was happy with the common law. He just wanted there to be a reliable registry.

CAH: So sellers wanted to have a better idea of whether a mark they wanted to use was owned by someone else, but the 1905 Act's route to registering was needlessly complicated, not mandatory, and it didn't add any real incentive to entice trademark owners to register.  So a lot of trademarks were not registered even though the option was available.

Would making registration mandatory have solved the problem for Rogers?

JL: His early drafts required registration, and if they didn't require it, they required it as a condition of using the mark in commerce, which is similar. But he could not get buy-in from the other trademark lawyers and the ABA. Henry Thompson in particular, who was just a lovely, crazy, flamboyant nut job, sent out these postcards and whipped up fear, and basically said "look people will come in and register marks they don't own and keep you from using the marks you've ben using forever." So Rogers had to drop mandatory registration. And he came up with incontestability as a "bribe" to get people to register.

CAH: I like how you bring to light that Thompson, who had this private business based on providing a catalogue of trademarks, started this movement against a federal registry; but it was really just self-interested because that would make his business obsolete. So then Rogers comes up with incontestability. And that's kind of a weird thing. It's an odd way to entice people to register...

JL: Well, we borrowed incontestability from England, where it works. But the difference is in England trademarks are mainly registration-based rights, so it basically acts just like a statute of limitations. If your mark is on the register for five years, it can't be taken off the registry for any of these grounds.  But what is weird about America, is we say you get your rights ultimately through using the mark in commerce, not from registration, but once it's registered, you can get this certificate of incontestability. (Rogers must have done that to give me exam questions to ask every year, because incontestability just asks to be the basis for an exam question.)

CAH: So incontestability works better in a pure registration system.

JL: If it's basically a "quiet title," you might think that is a bad idea, but it at least make sense. In a use based system, incontestability doesn't work well as an incentive to register.  It's incoherent.  Your rights can't be cancelled, you get a "quite title," except that's subject to all the potential defects in your title.  

CAH: Because your rights are still ultimately defined through use and the rights you've actually established through your use, so a quiet title for your registration is somewhat meaningless.

JL: Well, it's really good if your mark is not distinctive. It works for descriptive marks. Like for Park'N' Flybut not for inherently distinctive marks.  For those you don't need it. And I think if you have an un-distinctive mark without secondary meaning you shouldn't get it.

CAH: Do you think the Henry Thompson contingent was a big reason registration was not made mandatory? 

JL: I don't think so. His main contingent was in Boston, so his basic influence was in Boston, he controlled the Boston Patent Law Association. And that was enough friction to slow the bill down, but in fact it passed the House and Senate quite a few times while he was opposing it. So I think it was less that than that the trademark bar really liked the common law, and was very nervous of anything that was going to undermine it. 

CAH: And what exactly did they like so much about the common law?  Just that it was stronger?

JL: As Edward Rogers became the sort of "trademark lawyer to big pharma," he became less and less concerned about the rights of small trademark owners who Coca Cola or Quaker Oats was going to roll over, and more interested in making trademark rights as robust as possible. 

But lots of other members of the bar were invested in the common law in part because it was quite balanced in many ways.  It was different from the doctrine we know. I mean if you sit down, as I did forty years ago, with the Trademark Reporter, and you start with Issue 1, and you read all the cases in chronological order, one of the things you discover is courts gave really robust remedies to unfair competition that wasn't trademark infringement, that if you copied a functional feature, you could nonetheless get equitable relief because courts thought of their equity power as incorporating the right and the obligation to punish people who were bad actors.  So lots of stuff was protected that we would absolutely not not protect today.

CAH: So I guess that still doesn't fully explain why you can't have mandatory federal registry. You say, great, we love the common law, all we're asking is mandatory federal registration? You can keep all those common law rights, but we just make registration mandatory.

JL: Ok, so you make everybody register a mark. Along comes Fred. He's been using a mark in commerce for thirty years, and he hasn't registered his mark. Saying to Fred, "you don't have any rights anymore, they're gone," is a problem.  The second problem is constitutional. You can't make Fred register his mark until he steps out of the state of Ohio. So long as he is only within the borders of a single state, he's earning common law trademark rights, but he's not in interstate commerce. And Congress doesn't have jurisdiction to make something mandatory if it is strictly intrastate.  So taking Fred's rights away because he didn't register, because we can't make him register, just struck people as really troubling. 

And, you know, maybe Rogers would have pushed for it harder if he hadn't left in 1941 to run the Sterling Drug Company. But once he took over as chairman of the board of Sterling he just, to all accounts, didn't really communicate with Congress or participate at all in the bill until after it was passed.  

CAH: So it links to that larger point about use. There's obviously this constitutional problem, but there's also this sort of obsession in the U.S. with use creates rights.

JL: Right.

CAH: So the other guy to talk about I guess is Frank Schechter. My students really just learn about him in the context of dilution and and his writings about the need for a dilution cause of action. But is it fair to say Schechter was the foil to Rogers' limited view of Congress' power?  Did they have an interchange? Did they disagree?  Because Schechter would have wanted those strong substantive federal rights...

JL: He would indeed. While I think Schechter's relationship with Rogers was certainly cordial, they served together in local trademark associations, and they cited each other's work infrequently but respectfully, I think we don't appreciate just how big the gulf was in the 1930s between Jewish lawyers and Gentile lawyers. Rogers did not have a Jewish lawyer in either of his law firms until the late 1930s; and so far as I can tell there was only the one. The Jewish lawyer, Jerome Issacs, practiced with the firm from the late-1930s to the mid-1940s.  He joined the firm after Lenore Stoughton, who had once been Edward Rogers’s legal secretary, was promoted to lawyer by Rogers’s partner, James Hoge. So there were women before there were Jews. And Rogers was not really a heavy proponent of the rights of women lawyers either. 

I think just socially, it was a very big gulf. The ABA, in particular, was committed to a system that was sort of bent on keeping Jews and immigrants from practicing law. I don't see evidence that Rogers was personally antisemitic, except in the sense that there weren't any Jews in his vicinity. But I think that he and Schechter didn't really interact because they were in completely different social circles. You know, Rogers was yachting, golf, Sons of the American Revolution, so he was "Protestant gentry" in some ways. 

CAH: That's all really interesting, obviously. Ok, so they didn't have the closest relationship, but they were not rude to each other.

JL: No. They didn't dislike each other. Schechter had a lot of respect for Rogers.

CAH: So a question I had reading your paper is, if Schechter had lived (he died in 1937), would there have been a different  Lanham Act? Would it look more robust at the federal level? Would we have gotten a dilution cause of action earlier...?  

JL: Only maybe, because of the other stuff that happened. Before Schechter died, Congress had really dropped everything in 1932 to enact economic legislation, and so there simply wasn't any trademark bill or trademark committee for five years.  And so I don't know whether when the trademark subcommittee got back going, and Fritz Lanham picked it up, whether he personally would have turned to Schechter, or turned to Rogers. Lanham had actually been in all the hearings from 1924 on through to when they stopped in 1932, so presumably he had some views on who was right.  This also was influenced by the Commissioner of Patents. So I just don't know what happens in the counter factual.

CAH: I didn't really get a sense of whether Schechter would have said "no more common law, it's all federal," right, he wouldn't necessarily have said that?

JL: Schechter wouldn't have necessarily said that. Everybody liked the common law. But unlike Rogers — who thought the common law was plenty robust in everything but false representation law and re-sale price maintenance, which were the two holes Rogers saw in the doctrine, and he couldn't get anyone to come aboard on re-sale price maintenance— I think Schechter thought that trademark rights should be more muscular and should be enforced with criminal as well as civil penalties. He was the lawyer for BVD Underwear. I have no idea what problems BVD Underwear was having with trademark infringement. There aren't cases. But Schechter felt pretty strongly, probably as a theoretical matter, that trademarks should be treated as very valuable property.  

CAH: So my understanding is that Rogers, Schechter, and all the guys you're talking about were mostly plaintiff-side trademark lawyers, and they're working for big corporations like Coca-Cola.  

JL: They are by the mid-1930s. Rogers was also defense-side in the early twentieth century. 

CAH: So they're really pro trademark rights from the perspective of big companies.  I guess when you keep saying they liked the common law so much, I keep thinking of what I'm reading, from the trade secrets perspective, about the origins of unfair competition law. It was so expansive. The number of acts that were actionable...

JL: It's not quite that bad. You certainly get cases and you see courts enjoining stuff that we in the twenty-first century would say "how could that possibly be actionable?" But the hook is courts are really only doing this if they decide that defendants are bad actors. So in a sense, once they find the defendant is a bad actor, they are really expansive in what kind of injunctive relief they are going to give. That's a predicate. If it just seem like normal competition, they won't intervene. So in that sense, this really is very much like federal equity jurisprudence everywhere else in the first third of the twentieth century.  Courts sitting in equity absolutely believed that part of their job was to find and punish the wrong doer, even if there may not be a body of statutory or even previously discerned common law that makes this illegal, it was just their sense of what courts could do.

CAH: It's really different from, and again coming from the trade secrets perspective, the strong "property-rights" view, where the focus is all on the definition of whether there is a right in the first place. But there is a worry about the sort-of roving judge operating under the common law, based on her discretionary power to look for the bad actor. That's I think the main point Mark Lemley made in his article arguing for treating trade secrets as intellectual property. It can be very problematic in the trade secrets space.

 JL: I think it's problematic everywhere. It's awful in copyright. And I think it's bad in trademark, and it's very manipulable. Good lawyers can do all sorts of stuff with that. Of course, good lawyers like that system better. Because it's much easier to paint defendant as a bad actor than to look at the statute and say, you know, this is what the language says and that applies here...

CAH: Yeah, I'm thinking of defendants like Anthony Levandowski in the trade secret space, and even now Elizabeth Holmes in a different context. When the lawyers paint the defendant in a certain way, that almost wins the case.

So now I have to ask about Erie's role. The Supreme Court's 1938 Erie decision held common law now had to be state law. So this, ostensibly, eliminated the notion that there could be one uniform "federal common law" of trademarks—

JL: But it doesn't. I mean, it should. But it didn't. First, courts say, well Erie does not apply to equity. There is a completely respectable argument that this is so, to the extent the Supreme Court in Erie was interpreting the Rules of Decision Act, and the RDA was limited in its terms to actions at common law, then people for six or eight years after Erie took the position, quite defensibly, that Erie did not apply to federal courts' power in equity, it only applies to common law and obviously statutory law.  Second, you get the innovation, which was I think spearheaded by a 1942 Columbia Law Review article, that says, well, okay, if the trademark is unregistered, the law is state law per Erie, but if it's a registered trademark, the law is still federal. And so for the first time we separate out the two sources of law. 

But I think what we learn then is that, suddenly, state law gets amazingly robust, protecting all kinds of things that don't resemble traditional trademarks. Eventually the Supreme Court kills that off in Sears/CompcoAnd then of course, lawyers find Section 43(a)

There seems to be a strong sense of entitlement that unfair competition needs to be actionable, and we will find a plausible source for it so that we can keep bringing suits.  So I've been as critical as anyone at the crazy expansiveness of court decisions under 43(a). And I thought that Two Pesos v. Taco Cabana was just a decision the Supreme Court should have been embarrassed to issue. But I think the impulse is that if we really think that trademarks are created by use and these use-based rights should be actionable, we're going to find a way to get there.

And what was weird for me doing this article was discovering, yeah, and that's what they expected to happen back in 1946. They expected the common law to continue to provide the substantive rules of infringement actions, and that's why they didn't put them in the statute. Because I, like everyone else, had assumed the Lanham Act was supposed to replace and codify trademark law, not supplement it.  

CAH: So I know some have suggested Erie was really on peoples' minds in thinking about the need for a federal statute. Is that so?  

JL: Oh sure, both Erie and the fact that state governments had started enacting state trademark statutes— and under Erie it seemed clear they could— but the state trademark statutes, which gave rights within the state based on registration in the state, just had the trademark bar going nuts.

CAH: So Erie and these state laws were on peoples' minds in thinking about the need for a federal law, and eventually we get that Sears/Compco preemption on the state side. I really like your point that even after Erie, in a post-Erie world, we really do in effect still have a federal common law of trademarks. It's statutory, sure, but it's just courts doing federal common law. The've got their circuit splits, but it looks a lot like a federal common law might have—

JL: It does, but interestingly, back before 1938, there weren't circuit splits. It was a remarkably uniform body of law. And folks said it was stable. So it's very unlike the world today.

CAH: And why was that? Was it because it was pre-Erie, and so there was this opportunity to seek a more uniform law?

JL: Because courts believed the common law derived from "natural law." So they looked up in the sky, and they used as evidence what other courts—any courts— had done. So you had a lot of citations to decisions from jurisdictions that we would think of today as "foreign," but back then, because it was all natural law, it was all "persuasive authority." 

CAH: So it was in a sense more uniform. Sharon Sandeen, along with her Sears/Compco article, makes a lot of these points with respect to the broader law of unfair competition; she calls it the "myth of uniformity", she essentially says the idea that federalization after Erie is going to make things more uniform is a farce.

JL: Well it certainly hasn't.

CAH:  To me, one of the big themes of your paper is that Rogers didn't really get what he wanted. Rogers thought trademark law should remain common law, but that there should be a really useful, comprehensive registry of marks. But this did not happen. Instead, we get this mix. We don't eliminate common law, we have a federal cause of action for common law, we also have optional registration and some substantive federal rights that go with that, but it's not mandatory... 

So what would Rogers think of the modern state of trademark law, if Rogers saw what we have today?

JL: He would be more happy today than he was in 1949, right before his death, when people were insisting that, no, the common law and unfair competition had not survived passage of the Lanham Act, and he was starting to suggest looking to 44(h) and (i) —

CAH: I really enjoyed Christine Farley's article on that attempt—

JL:  I think he'd be pleased at the extent to which, today, the common doctrine has crept back in to all of the cases, and at the use of 43(a) as a vehicle to bring in the common law.  And I think with incontestability, I guess he'd say, okay, that was an idea, maybe it doesn't work, but "gee it would be good if there were a registry of all trademarks..."   

CAH: And now we have many thousands of Mr. Thompson's supplying us with paid trademark searches...

JL:  Now we have Google. And I don't know when you graduated law school, but the major, dominant Thompson & Thompson trademark search service back in the 1980s was in fact the descendant of Henry Thompson's bureau. He left it to his sons, they eventually built it up and sold it. That was a fairly long-lived enterprise. It lasted a long time until we got digital networks and no longer need someone filing little index cards in a catalogue in a Boston office.

CAH: Today he'd have to develop a really great software. ... So is there anything else you want to mention about what you found here?

JL: Yes, I think it poses a philosophical question for those of us who are philosophically inclined.  If I am right, and the drafters envisioned that robust common law protection for trademarks and non-trademarks would survive, and if many of us are right that that is where the problem is, then it's no longer tenable, if you believe me, to argue that this is not what Congress had in mind, that Congress did not intend this.  We need to really come up with a next level of arguments for why this is a really bad thing.

CAH: Because it is what Congress had in mind.

JL: Yeah, it seems to have been. They weren't imagining the 21st century obviously. But yeah.

CAH: Okay, well, there are twenty thousand more questions I could ask you, on this and many other topics. But I truly appreciate your time.

*** 

Litman's book chapter, "Edward S. Rogers, the Lanham Act, and the Common Law," is available on SSRN. It will be published in the forthcoming volume, ROBERT G. BONE & LIONEL BENTLEY, RESEARCH HANDBOOK ON THE HISTORY OF TRADEMARK LAW.

Labels: ,