Archives For innovation

Carrie Wade, Ph.D., MPH is the Director of Harm Reduction Policy and Senior Fellow at the R Street Institute.

Abstinence approaches work exceedingly well on an individual level but continue to fail when applied to populations. We can see this in several areas: teen pregnancy; continued drug use regardless of severe criminal penalties; and high smoking rates in vulnerable populations, despite targeted efforts to prevent youth and adult uptake.

The good news is that abstinence-oriented prevention strategies do seem to have a positive effect on smoking. Overall, teen use has steadily declined since 1996. This may be attributed to an increase in educational efforts to prevent uptake, stiff penalties for retailers who fail to verify legal age of purchase, the increased cost of cigarettes, and a myriad of other interventions.

Unfortunately many are left behind. Populations with lower levels of educational attainment, African Americans and, ironically, those with less disposable income have smoking rates two to three times that of the general population. In light of this, how can we help people for whom the abstinence-only message has failed? Harm reduction strategies can have a positive effect on the quality of life of smokers who cannot or do not wish to quit.

Why harm reduction?

Harm reduction approaches recognize that reduction in risky behavior is one possible means to address public health goals. They take a pragmatic approach to the consequences of risk behaviors – focusing on short-term attainable goals rather than long-term ideals—and provide options beyond abstinence to decrease harm relative to the riskier behavior.

In economic terms, traditional public health approaches to drug use target supply and demand, which is to say they attempt to decrease the supply of a drug while also reducing the demand for it. But this often leads to more risky behaviors and adverse outcomes. For example, when prescription opioids were restricted, those who were not deterred from such an inconvenience switched to heroin; when heroin became tricky to smuggle, traffickers switched to fentanyl. We might predict the same effects when it comes to cigarettes.

Given this, since we know that the riskiest of behaviors, such as tobacco, alcohol and other drug use will continue—and possibly flourish in many populations—we should instead focus on ways to decrease the supply of the most dangerous methods of use and increase the supply of and demand for safer, innovative tools. This is the crux of harm reduction.

Opioid Harm Reduction

Like most innovation, harm reduction strategies for opioid and/or injection drug users were born out of a need. In the 1980s, sterile syringes were certainly not an innovative technology. However, the idea that clean needle distribution could put a quick end to the transmission of the Hepatitis B virus in Amsterdam was, and the success of this intervention was noticed worldwide.

Although clean needle distribution was illegal at the time, activists who saw a need for this humanitarian intervention risked jail time and high fines to reduce the risk of infectious disease transmission among injection drug users in New Haven and Boston. Making such programs accessible was not an easy thing to do. Amid fears that dangerous drug use may increase and the idea that harm reduction programs would tacitly endorse illegal activity, there was resistance in governments and institutions adopting harm reduction strategies as a public health intervention.

However, following a noticeable decrease in the incidence of HIV in this population, syringe exchange access expanded across the United States and Europe. At first, clean syringe access programs (SAPs) operated with the consent of the communities they served but as the idea spread, these programs received financial and logistical support from several health departments. As of 2014, there are over 200 SAPs operating in 33 states and the District of Columbia.

Successes

Time has shown that these approaches are wildly successful in their primary objective and enormously cost effective. In 2008, Washington D.C. allocated $650,000 to increase harm reduction services including syringe access. As of 2011, it was estimated that this investment had averted 120 cases of HIV, saving $44 million.

Seven studies conducted by leading scientific and governmental agencies from 1991 through 2001 have also concluded that syringe access programs result in a decrease in HIV transmission without residual effects of increased injection drug use. In addition, SAPs are correlated with increased entry into treatment and detox programs and do not result in increases in crime in neighborhoods that support these programs.

Tobacco harm reduction

We know that some populations have a higher risk of smoking and of developing and dying from smoking-related diseases. With successful one-year quit rates hovering around 10 percent, harm reduction strategies can offer ways to transition smokers off of the most dangerous nicotine delivery device: the combustible cigarette.

In 2008, the World Health Organization developed the MPOWER policy package aimed to reduce the burden of cigarette smoking worldwide. In their vision statement, the authors explicitly state a goal where “no child or adult is exposed to tobacco smoke.”

Using an abstinence-only framework, MPOWER strategies are:

  1. To monitor tobacco use and obtain data on use in youth and adults;
  2. To protect society from second-hand smoke and decrease the availability of places that people are allowed to smoke by enacting and enforcing indoor smoking bans;
  3. To offer assistance in smoking cessation through strengthening health systems and legalization of nicotine replacement therapies (NRTs) and other pharmaceutical interventions where necessary;
  4. To warn the public of the dangers of smoking through public health campaigns, package warnings and counter advertising;
  5. To enact and enforce advertising bans; and
  6. To raise tobacco excise taxes.

These strategies have been shown to reduce the prevalence of tobacco use. People who quit smoking have a greater chance of remaining abstinent if they use NRTs. People exposed to pictorial health warnings are more likely to say they want to quit as a result. Countries with comprehensive advertising bans have a larger decrease in smoking rates compared to those without. Raising taxes has proven consistently to reduce consumption of tobacco products.

But, the effects of MPOWER programs are limited. Tobacco and smoking are often deeply ingrained in the culture and identity of communities. Studies repeatedly show that smoking is strongly tied to occupation and education, smokers’ self-identity and also the role that tobacco has in the economy and identity of the community.

As a practical matter, the abstinence approach is also limited by individual governmental laws. Article 13 of the Framework Convention on Tobacco Control recognizes that constitutional principles or laws may limit the capabilities of governments to implement these policy measures. In the United States, cigarettes are all but protected by the complexity of both the 1998 Master Settlement Agreement and the Family Smoking Protection and Tobacco Control Act of 2009. This guarantees availability to consumers – ironically increasing the need of more reduced-risk nicotine products, such as e-cigarettes, heat-not-burn devices or oral Snus, all of which offer an alternative to combustible use for people who either cannot or do not wish to quit smoking.

Several regulatory agencies, including the FDA in the United States and Public Health England in the United Kingdom, recognize that tobacco products exist on a continuum of risk, with combustible products (the most widely used) being the most dangerous and non-combustible products existing on the opposite end of the spectrum. In fact, Public Health England estimates that e-cigarettes are at least 95% safer than combustible products and many toxicological and epidemiological studies support this assertion.

Of course for tobacco harm reduction to work, people must have an incentive to move away from combustible cigarettes.There are two equally important strategies to convince people to do so. First, public health officials need to acknowledge that e-cigarettes are less risky. Continued mixed messages from government officials and tobacco use prevention organizations confuse people regarding the actual risks from e-cigarettes. Over half of adults in the United States believe that nicotine is the culprit of smoking-related illnesses – and who can blame them when our current tobacco control strategies are focused on lowering nicotine concentrations and ridding our world of e-cigarettes?

The second is price. People who cannot or do not wish to quit smoking will never switch to safer alternatives if they are more, or as, expensive as cigarettes. Keeping the total cost of reduced risk products low will encourage people who might not otherwise consider switching to do so. The best available estimates show that e-cigarette demand is much more vulnerable to price increases than combustible cigarettes – meaning that smokers are unlikely to respond to price increases meant to dissuade them from smoking, and are less likely to vape as a means to quit or as a safer alternative.

Of course strategies to prevent smoking or encourage cessation should be a priority for all populations that smoke, but harm-reduction approaches—in particular with respect to smoking—play a vital role in decreasing death and disease in people who engage in such risky behavior. For this reason, they should always be promoted alongside abstinence approaches.

ICLE has released a white paper entitled Vapor products, harm reduction, and taxation: Principles, evidence and a research agenda, authored by ICLE Chief Economist, Eric Fruits.

More than 20 countries have introduced taxation on e-cigarettes and other vapor products. In the United States, several states and local jurisdictions have enacted e-cigarette taxes.

The concept of tobacco harm reduction began in 1976 when Michael Russell, a psychiatrist and lecturer at the Addiction Research Unit of Maudsley Hospital in London, wrote: “People smoke for nicotine but they die from the tar.”  Russell hypothesized that reducing the ratio of tar to nicotine could be the key to safer smoking.

Since then, much of the harm from smoking has been well-established as caused almost exclusively by toxicants released through the combustion of tobacco. Public Health England and the American Cancer Society have concluded non-combustible tobacco products as well as pure nicotine products are considerably less harmful than combustible products. Earlier this year, the American Cancer Society shifted its position on e-cigarettes, recommending that individuals who do not quit smoking, “… should be encouraged to switch to the least harmful form of tobacco product possible; switching to the exclusive use of e-cigarettes is preferable to continuing to smoke combustible products.”

In contrast, some public health advocates urge a precautionary approach in which the introduction and sale of e-cigarettes be limited or halted until the products are demonstrably safe.

Policymakers face a wide range of strategies regarding the taxation of vapor products. On the one hand, principles of harm reduction suggest vapor products should face no taxes or low taxes relative to conventional cigarettes, to guide consumers toward a safer alternative to smoking. the U.K. House of Commons Science and Technology Committee concludes:

The level of taxation on smoking-related products should directly correspond to the health risks that they present, to encourage less harmful consumption. Applying that logic, e-cigarettes should remain the least-taxed and conventional cigarettes the most, with heat-not-burn products falling between the two.

In contrast, the precautionary principle as well as principles of tax equity point toward the taxation of vapor products at rates similar to conventional cigarettes.

Analysis of tax policy issues is complicated by divergent—and sometimes obscured—intentions of such policies. Some policymakers claim that the objective of taxing nicotine products is to reduce nicotine consumption. Other policymakers indicate the objective is to raise revenues to support government spending. Often missed in the policy discussion is the effect of fiscal policies on innovation and the development and commercialization of harm-reducing products. Also, often missed are the consequences for current consumers of nicotine products, including smokers seeking to quit using harmful conventional cigarettes.

Policy decisions regarding taxation of vapor products should take into account both long-term fiscal effects, as well as broader economic and welfare effects. These effects might (or might not) suggest very different tax policies to those that have been enacted or are under consideration.

Apart from being a significant source of revenue, the cigarette taxes have been promoted as “sin” taxes to discourage consumption either because of externalities caused by smoking (increased costs for third-party health payers and health consequences) or paternalism. According to Centers for Disease Control and Prevention in U.S., smoking-related illness in the U.S. costs more than $300 billion each year, including; (1) nearly $170 billion for direct medical care for adults and (2) more than $156 billion in lost productivity, including $5.6 billion in lost productivity due to secondhand smoke exposure.

The CDC’s cost estimates raise important questions regarding who bears the burden of smoking related illness. Much of the cost is borne by private insurance, which charges steeper premiums for customers who smoke. In addition, the CDC estimates reflect costs imposed by people who have smoked for decades—many of whom have now quit. A proper accounting of the costs vis-à-vis tax policy would measure the incremental discounted costs imposed by today’s smokers.

According to Levy et al. (2017), a strategy of replacing cigarette smoking with e-cigarettes would yield substantial life year gains, even under pessimistic assumptions regarding cessation, initiation, and relative harm. Increased longevity does not simply extend the individual’s years of retirement and reliance on government transfers but has impact on greater work effort and productivity together with higher tax payments on consumption.

Vapor products that cause less direct harm or have lower externalities (e.g., the absence of “second hand smoke”) should be subject to a lower “sin” tax. A cost-benefit analysis of the desired excise tax rate on vapor products would include reduced health spending as an offset against excise tax revenue that was foregone by putting a lesser rate on those products.

State and local governments in the U.S. collect more than $18 billion a year in tobacco taxes. While some jurisdictions earmark a portion of tobacco taxes for prevention and cessation efforts, in practice most tobacco taxes are treated by policymakers as general revenues to be spent in whatever way the legislative body determines.

In the long-run, the goals of reducing or eliminating consumption of the taxed good and generating revenues are in conflict. If the tax is successful in reducing consumption, it falls short in generating revenue. Similarly, if the tax succeeds in generating revenues, it falls short in reducing or eliminating consumption.

Substitutability is another consideration. An increase in the tax on spirits will result in an increase in beer and wine purchases. A high toll on a road will divert traffic to untolled streets that may not be designed for increased traffic volumes. Evidence from the U.S. and Europe indicate high or rising tobacco taxes in one jurisdiction will result in increased sales in bordering jurisdictions as well as increase illegal cross-jurisdiction sales or smuggling.

As of March 2018, nine U.S. states have enacted taxes on e-cigarettes:

California 65.08% on wholesale price
Delaware 0.05 USD/ml
DC 70% on wholesale price
Kansas 0.05 USD/ml
Louisiana 0.05 USD/ml
Minnesota 95% of wholesale price
North Carolina 0.05 USD/ml
Pennsylvania 40% of wholesaler price
West Virginia 0.075 USD/ml

In addition, 22 countries outside of the U.S. have introduced taxation on e-cigarettes.

The effects of different types of taxation on usage and thus economic outcomes varies. Research to date finds a wide range of own price and cross price elasticities for e-cigarettes. While most researchers conclude that the demand for e-cigarettes is more elastic than the demand for combustible cigarettes, some studies find inelastic demand and some studies find highly elastic demand. Economic theory would point to e-cigarettes as a substitute for combustible cigarettes. Some empirical research supports this hypothesis, while others conclude the two products are complements.

In addition to e-cigarettes, little cigars and smokeless tobacco are also potential substitutes for cigarettes. The results from Zheng, et al. (2016) suggest increases in sales of little cigars and smokeless tobacco products would account for about 14 percent of the decline in cigarette sales associated with a hypothetical 10 percent increase in the price of cigarettes. On the other hand, another study using a seemingly identical data set (Zheng, et al., 2017), suggests that sales of little cigars and smokeless tobacco would decrease in the face of an increase in cigarette prices.

The wide range of estimated elasticities calls into question the reliability of published estimates. As a nascent area of research, the policy debate would benefit from additional research that involves larger samples with better statistical power, reflects the dynamic nature of this relatively new product category, and accounts for the wide variety of vapor products.

More importantly, demand and supply conditions for e-cigarettes, heated tobacco products and other electronic nicotine delivery products have been changing rapidly over the past few years—and are expected for rapidly change into the foreseeable future. Thus, estimates of demand parameters, such as elasticity and cross-price elasticity estimates, are almost certain to vary over time as users gain knowledge and experience and as products and suppliers enter the market.

Because the market for e-cigarettes and other vapor products is small and developing, the tax bearing capacity of these new product segments are untested and unknown. Moreover, current tax levels and prices could be also misleading based on the relatively sparse empirical data, in which case more data points and evaluation is needed. One can argue, given the slow growth rates of these segments in many markets, that current prices of e-cigarettes and heat-not-burn products are relatively high when compared to cigarettes and a tax or an increase on existing tax would slow down the segment growth or even lead to a decline.

Separately, the challenges in assessing a tax on electronic nicotine delivery products indicate the costs of collecting the tax, especially an excise tax, may be much higher than similar taxes levied on combustible cigarettes. In addition, as discussed above, heavy taxation of this relatively new industry would likely stifle innovation in a way that is contrary to the goal harm reduction.

Principles of harm reduction recognize that every proposal has uncertain outcomes as well as potential spillovers and unforeseen consequences. Nevertheless, the basic principle of harm reduction is a focus on safer rather than safe. Policymakers must make their decisions weighing the expected benefits and expected costs. With such high risks and costs associated with cigarette and other combustible use, taxes and regulations must be developed in an environment of uncertainty and with an eye toward a net reduction in harm, rather than an unattainable goal of zero harm.

Read the full report.

Senator Mark Warner has proposed 20 policy prescriptions for bringing “big tech” to heel. The proposals — which run the gamut from policing foreign advertising on social networks to regulating feared competitive harms — provide much interesting material for Congress to consider.

On the positive side, Senator Warner introduces the idea that online platforms may be able to function as least-cost avoiders with respect to certain tortious behavior of their users. He advocates for platforms to implement technology that would help control the spread of content that courts have found violated certain rights of third-parties.

Yet, on other accounts — specifically the imposition of an “interoperability” mandate on platforms — his proposals risk doing more harm than good.

The interoperability mandate was included by Senator Warner in order to “blunt [tech platforms’] ability to leverage their dominance over one market or feature into complementary or adjacent markets or products.” According to Senator Warner, such a measure would enable startups to offset the advantages that arise from network effects on large tech platforms by building their services more easily on the backs of successful incumbents.

Whatever you think of the moats created by network effects, the example of “successful” previous regulation on this issue that Senator Warner relies upon is perplexing:

A prominent template for [imposing interoperability requirements] was in the AOL/Time Warner merger, where the FCC identified instant messaging as the ‘killer app’ – the app so popular and dominant that it would drive consumers to continue to pay for AOL service despite the existence of more innovative and efficient email and internet connectivity services. To address this, the FCC required AOL to make its instant messaging service (AIM, which also included a social graph) interoperable with at least one rival immediately and with two other rivals within 6 months.

But the AOL/Time Warner merger and the FCC’s conditions provide an example that demonstrates the exact opposite of what Senator Warner suggests. The much-feared 2001 megamerger prompted, as the Senator notes, fears that the new company would be able to leverage its dominance in the nascent instant messaging market to extend its influence into adjacent product markets.

Except, by 2003, despite it being unclear that AOL had developed interoperable systems, two large competitors had arisen that did not run interoperable IM networks (Yahoo! and Microsoft). In that same period, AOL’s previously 100% IM market share had declined by about half. By 2009, after eight years of heavy losses, Time Warner shed AOL, and by last year AIM was completely dead.

Not only was it not clear that AOL was able to make AIM interoperable, AIM was never able to catch up once better, rival services launched. What the conditions did do, however, was prevent AOL from launching competitive video chat services as it flailed about in the wake of the deal, thus forcing it to miss out on a market opportunity available to unencumbered competitors like Microsoft and Yahoo!

And all of this of course ignores the practical impossibility entailed in interfering in highly integrated technology platforms.

The AOL/Time Warner merger conditions are no template for successful tech regulation. Congress would be ill-advised to rely upon such templates for crafting policy around tech and innovation.

Weekend Reads

Eric Fruits —  8 June 2018

Innovation dies in darkness. Well, actually, it thrives in the light, according to this new research:

We find that after a patent library opens, local patenting increases by 17% relative to control regions that have Federal Depository Libraries. … [T]]he library boost ceases to be present after the introduction of the Internet. We find that library opening is also associated with an increase in local business formation and job creation [especially for small business -ed.], which suggests that the impact of libraries is not limited to patenting outcomes.

Patent-Libraries

Don’t drink the Kool-Aid of bad data. Have a SPRITE. From the article published by self-described “data thugs“.

Scientific publications have not traditionally been accompanied by data, either during the peer review process or when published. Concern has arisen that the literature in many fields may contain inaccuracies or errors that cannot be detected without inspecting the original data. Here, we introduce SPRITE (Sample Parameter Reconstruction via Interative TEchniques), a heuristic method for reconstructing plausible samples from descriptive statistics of granular data, allowing reviewers, editors, readers, and future researchers to gain insights into the possible distributions of item values in the original data set.

Gig economy, it’s a good thing: 6.9% of all workers are independent contractors; 79% of them prefer their arrangement over a traditional job.

Gig economy, it’s a bad thing. Maybe.

[C]ensus divisions with relatively weak wage inflation also tend to have more “low-wage” informal FTE—that is, more hours of informal work performed at a wage that is less than formal pay.

Broetry. It’s a LinkedIn thing. I don’t get it.

 

 

Last week, several major drug makers marked the new year by announcing annual increases on list prices.  In addition to drug maker Allergan—which pledged last year to confine price increases below 10 percent and, true to its word, reported 2018 price increases of 9.5 percent—several other companies also stuck to single-digit increases.   Although list or “sticker” prices generally increased by around 9 percent for most drugs, after discounts negotiated with various health plans, the net prices that consumers and insurers actually pay will see much lower increases. For example, Allergan expects that payors will only see net price increases of 2 to 3 percent in 2018.

However, price increases won’t generate the same returns for brand drug companies that they once did.  As insurers and pharmacy benefit managers consolidate and increase their market share, they have been able to capture an increasing share of the money spent on drugs for themselves. Indeed, a 2017 report found that, of the money spent on prescription drugs by patients and health plans at the point of sale, brand drug makers only realized 39 percent.  Meanwhile, supply-chain participants, such as pharmacy benefit managers, realized 42 percent of these expenditures.  What’s more, year-after-year, brand drug makers have seen their share of these point-of-sale expenditures decrease while supply-chain entities have kept a growing share of expenditures for themselves.

Brand drug makers have also experienced a dramatic decline in the return on their R&D investment.  A recent Deloitte study reports that, for the large drug makers they’ve followed since 2010, R&D returns have dropped from over 10 percent to under 4 percent for the last two years.  The ability of supply-chain entities to capture an increasing share of drug expenditures is responsible for at least part of drug makers’ decreasing R&D returns; the study reports that average peak sales for drugs have slowly dropped over time, mirroring drug maker’s decreasing share of expenditures.  In addition, the decline in R&D returns can be traced to the increasing cost of bringing drugs to market; for the companies Deloitte studied, the cost to bring a drug to market has increased from just over $1.1 billion in 2010 to almost $2 billion in 2017.

Brand drug makers’ decreasing share of drug expenditures and declining R&D returns reduce incentives to innovate.  As the payoff from innovation declines, fewer companies will devote the substantial resources necessary to develop innovative new drugs.  In addition, innovation is threatened as brand companies increasingly face uncertainty about the patent rights of the drugs they do bring to market.  As I’ve discussed in a previous post,  the unbalanced inter partes review (IPR) process created under the Leahy-Smith America Invents Act in 2012 has led to significantly higher patent invalidation rates.  Compared to traditional district-court litigation, several pro-challenger provisions under IPR—including a lower standard of proof, a broader claim construction standard, and the ability of patent challengers to force patent owners into duplicative litigation—have resulted in twice as many patents deemed invalid in IPR proceedings.  Moreover, the lack of a standing requirement in IPR proceedings has given rise to “reverse patent trolling,” in which entities that are not litigation targets, or even participants in the same industry, threaten to file an IPR petition challenging the validity of a patent unless the patent holder agrees to specific settlement demands.  Even supporters of IPR proceedings recognize the flaws with the system; as Senator Orrin Hatch stated in a 2017 speech: “Such manipulation is contrary to the intent of IPR and the very purpose of intellectual property law. . . I think Congress needs to take a look at it.” Although the constitutionality of the IPR process is currently under review by the U.S. Supreme Court, if the unbalanced process remains unchanged, the significant uncertainty it creates for drug makers’ patent rights will lead to less innovation in the pharmaceutical industry.  Drug makers will have little incentive to spend billions of dollars to bring a new drug to market when they cannot be certain if the patents for that drug can withstand IPR proceedings that are clearly stacked against them.

We are likely to see a renewed push for drug pricing reforms in 2018 as access to affordable drugs remains a top policy priority.  Although Congress has yet to come together in support of any specific proposal, several states are experimenting with reforms that aim to lower drug prices by requiring more pricing transparency and notice of price increases.  As lawmakers consider these and other reforms, they should consider the current challenges that drug makers already face as their share of drug expenditures and R&D returns decline and patent rights remain uncertain.  Reforms that further threaten drug makers’ financial incentives to innovate could reduce our access to life-saving and life-improving new drugs.

It’s been six weeks since drug maker Allergan announced that it had assigned to the Saint Regis Mohawk Tribe the patents on Restasis, an Allergan drug challenged both in IPR proceedings and in Hatch-Waxman proceedings in federal district court.  The unorthodox agreement was intended to shield the patents from IPR proceedings (and thus restrict the challenge to district court) as the Mohawks would seek to dismiss the IPR proceedings based on the tribe’s sovereign immunity.  Although Allergan  suffered a setback last week when the federal court invalidated the Restasis patents and, in dicta, expressed concern about the Allergan/Mohawk arrangement, several other entities are following Allergan’s lead and assigning patents to sovereigns in hopes of avoiding IPR proceedings.

As an example, in August, SRC Labs assigned about 40 computer technology patents to the Saint Regis Mohawk Tribe.  Last week, the tribe, with SRC as co-plaintiff, filed lawsuits against Microsoft and Amazon for infringement of its data processing patents; the assignment of the SRC patents to the tribe could prevent a counter-challenge from Microsoft and Amazon in IPR proceedings.  Similarly, Prowire LLC, who has sued Apple for infringement, has assigned the patent in question to MEC Resources, a company affiliated with three tribes in North Dakota.  And state universities (whom the PTAB considers to be arms of the sovereign states, and thus immune to IPR challenges) are in discussions with lawyers about offering their sovereign immunity to patent owners as a way to shield patents in IPR proceedings.

These arrangements that attempt to avoid the IPR process and force patent challenges into federal courts are no surprise given the current unbalance in the IPR system.  Critical differences exist between IPR proceedings and Hatch-Waxman litigation that have created a significant deviation in patent invalidation rates under the two pathways; compared to district court challenges, patents are twice as likely to be found invalid in IPR challenges.

The PTAB applies a lower standard of proof for invalidity in IPR proceedings than do federal courts in Hatch-Waxman proceedings. In federal court, patents are presumed valid and challengers must prove each patent claim invalid by “clear and convincing evidence.” In IPR proceedings, no such presumption of validity applies and challengers must only prove patent claims invalid by the “preponderance of the evidence.” In addition to the lower burden, it is also easier for challengers to meet the standard of proof in IPR proceedings.  In federal court, patent claims are construed according to their “ordinary and customary meaning” to a person of ordinary skill in the art.  In contrast, the PTAB uses the more lenient “broadest reasonable interpretation” standard; this more lenient standard can result in the PTAB interpreting patent claims as “claiming too much” (using their broader standard), resulting in the invalidation of more patents.

Moreover, whereas patent challengers in district court must establish sufficient Article III standing, IPR proceedings do not have a standing requirement.  This has given rise to “reverse patent trolling,” in which entities that are not litigation targets, or even participants in the same industry, threaten to file an IPR petition challenging the validity of a patent unless the patent holder agrees to specific pre-filing settlement demands.  The lack of a standing requirement has also led to the  exploitation of the IPR process by entities that would never be granted standing in traditional patent litigation—hedge funds betting against a company by filing an IPR challenge in hopes of crashing the stock and profiting from the bet.

Finally, patent owners are often forced into duplicative litigation in both IPR proceedings and federal court litigation, leading to persistent uncertainty about the validity of their patents.  Many patent challengers that are unsuccessful in invalidating a patent in district court may pursue subsequent IPR proceedings challenging the same patent, essentially giving patent challengers “two bites at the apple.”  And if the challenger prevails in the IPR proceedings (which is easier to do given the lower standard of proof and broader claim construction standard), the PTAB’s decision to invalidate a patent can often “undo” a prior district court decision.  Further, although both district court judgments and PTAB decisions are appealable to the Federal Circuit, the court applies a more deferential standard of review to PTAB decisions, increasing the likelihood that they will be upheld compared to the district court decision.

Courts are increasingly recognizing that certain PTAB practices are biased against patent owners, and, in some cases, violations of underlying law.  The U.S. Supreme Court in Cuozzo Speed Technologies v. Lee concluded that the broadest reasonable interpretation claim construction standard in IPR “increases the possibility that the examiner will find the claim too broad (and deny it)” and that the different claim construction standards in PTAB trials and federal court “may produce inconsistent results and cause added confusion.”  However, the Court concluded that only Congress could mandate a different standard.  Earlier this month, in Aqua Products, Inc. v. Matal, the Federal Circuit held that “[d]espite repeated recognition of the importance of the patent owner’s right to amend [patent claims] during IPR proceedings— by Congress, courts, and the PTO alike—patent owners largely have been prevented from amending claims in the context of IPRs.”   And the Supreme Court has agreed to hear Oil States Energy Services v. Greene’s Energy Group, which questions whether IPR proceedings are even constitutional because they extinguish private property rights through a non-Article III forum without a jury. 

As Courts and lawmakers continue to question the legality and wisdom of IPR to review pharmaceutical patents, they should remember that the relationship between drug companies and patients resembles a social contract. Under this social contract, patients have the right to reasonably-priced, innovative drugs and sufficient access to alternative drug choices, while drug companies have the right to earn profits that compensate for the risk inherent in developing new products and to a stable environment that gives the companies the incentive and ability to innovate.  This social contract requires a balancing of prices (not too high to gouge consumers but not too low to insufficiently compensate drug companies), competition law (not so lenient that it ignores anticompetitive behavior that restricts patients’ access to alternative drugs, but not so strict that it prevents companies from intensely competing for profits), and most importantly in the context of IPR, patent law (not so weak that it fails to incentivize innovation and drug development, but not so strong that it enables drug companies to monopolize the market for an unreasonable amount of time).  The unbalanced IPR process threatens this balance by creating significant uncertainty in pharmaceutical intellectual property rights.  Uncertain patent rights will lead to less innovation in the pharmaceutical industry because drug companies will not spend the billions of dollars it typically costs to bring a new drug to market when they cannot be certain if the patents for that drug can withstand IPR proceedings that are clearly stacked against them.  Indeed, last week former Federal Circuit Chief Judge Paul Redmond Michel acknowledged that IPR has contributed to “hobbling” our nation’s patent system, “discourag[ing] investment, R&D and commercialization.” And if IPR causes drug innovation to decline, a significant body of research predicts that consumers’ health outcomes will suffer as a result.

Today the International Center for Law & Economics (ICLE) Antitrust and Consumer Protection Research Program released a new white paper by Geoffrey A. Manne and Allen Gibby entitled:

A Brief Assessment of the Procompetitive Effects of Organizational Restructuring in the Ag-Biotech Industry

Over the past two decades, rapid technological innovation has transformed the industrial organization of the ag-biotech industry. These developments have contributed to an impressive increase in crop yields, a dramatic reduction in chemical pesticide use, and a substantial increase in farm profitability.

One of the most striking characteristics of this organizational shift has been a steady increase in consolidation. The recent announcements of mergers between Dow and DuPont, ChemChina and Syngenta, and Bayer and Monsanto suggest that these trends are continuing in response to new market conditions and a marked uptick in scientific and technological advances.

Regulators and industry watchers are often concerned that increased consolidation will lead to reduced innovation, and a greater incentive and ability for the largest firms to foreclose competition and raise prices. But ICLE’s examination of the underlying competitive dynamics in the ag-biotech industry suggests that such concerns are likely unfounded.

In fact, R&D spending within the seeds and traits industry increased nearly 773% between 1995 and 2015 (from roughly $507 million to $4.4 billion), while the combined market share of the six largest companies in the segment increased by more than 550% (from about 10% to over 65%) during the same period.

Firms today are consolidating in order to innovate and remain competitive in an industry replete with new entrants and rapidly evolving technological and scientific developments.

According to ICLE’s analysis, critics have unduly focused on the potential harms from increased integration, without properly accounting for the potential procompetitive effects. Our brief white paper highlights these benefits and suggests that a more nuanced and restrained approach to enforcement is warranted.

Our analysis suggests that, as in past periods of consolidation, the industry is well positioned to see an increase in innovation as these new firms unite complementary expertise to pursue more efficient and effective research and development. They should also be better able to help finance, integrate, and coordinate development of the latest scientific and technological developments — particularly in rapidly growing, data-driven “digital farming” —  throughout the industry.

Download the paper here.

And for more on the topic, revisit TOTM’s recent blog symposium, “Agricultural and Biotech Mergers: Implications for Antitrust Law and Economics in Innovative Industries,” here.

The Scalia Law School’s Global Antitrust Institute (GAI) has once again penned a trenchant law and economics-based critique of a foreign jurisdiction’s competition policy pronouncement.  On April 28, the GAI posted a comment (GAI Comment) in response to a “Communication from the [European] Commission (EC) on Standard Essential Patents (SEPs) for a European Digitalised Economy” (EC Communication).  The EC Communication centers on the regulation of SEPs, patents which cover standards that enable mobile wireless technologies (in particular, smartphones), in the context of the development and implementation of the 5th generation or “5G” broadband wireless standard.

The GAI Comment expresses two major concerns with the EC’s Communication.

  1. The Communication’s Ill-Considered Opposition to Competition in Standards Development

First, the Comment notes that the EC Communication appears to view variation in intellectual property rights (IPR) policies among standard-development organizations (SDOs) as a potential problem that may benefit from best practice recommendations.  The GAI Comment strongly urges the EC to reconsider this approach.  It argues that the EC instead should embrace the procompetitive benefits of variation among SDO policies, and avoid one-size fits all best practice recommendations that may interfere with or unduly influence choices regarding specific rules that best fit the needs of individual SDOs and their members.

  1. The Communication’s Failure to Address the Question of Market Imperfections

Second, the Comment points out that the EC Communication refers to the need for “better regulation,” without providing evidence of an identifiable market imperfection, which is a necessary but not sufficient basis for economic regulation.  The Comment stresses that the smartphone market, which is both standard and patent intensive, has experienced exponential output growth, falling market concentration, and a decrease in wireless service prices relative to the overall consumer price index.  These indicators, although not proof of causation, do suggest caution prior to potentially disrupting the carefully balanced fair, reasonable, and non-discriminatory (FRAND) ecosystem that has emerged organically.

With respect to the three specific areas identified in the Communication (i.e., best practice recommendations on (1) “increased transparency on SEP exposure,” including “more precision and rigour into the essentiality declaration system in particular for critical standards”; (2) boundaries of FRAND and core valuation principles; and (3) enforcement in areas such as mutual obligations in licensing negotiations before recourse to injunctive relief, portfolio licensing, and the role of alternative dispute resolution mechanisms), the Comment recommends that the EC broaden the scope of its consultation to elicit specific evidence of identifiable market imperfections.

The GAI Comment also points out that, in some cases, specific concerns mentioned in the Consultation seem to be contradicted by the EC’s own published research.  For example, with respect to the asserted problems arising from over-declaration of essential patents, the EC recently published research noting the lack of “any reliable evidence that licensing costs increase significantly if SEP owners over-declare,” and concluding “that, per se the negative impact of over-declaration is likely to be minimal.”  Even assuming there is an identifiable market imperfection in this area, it is important to consider that determining essentiality is a resource and time-intensive exercise and there are likely significant transaction-cost savings from the use of blanket declarations, which also serve to avoid liability for patent-ambush (i.e., deceptive failure to disclose essential patents during the standard-setting process).

  1. Concluding Thoughts

The GAI Comment implicitly highlights a flaw inherent in the EC’s efforts to promote high tech innovation in Europe through its “Digital Agenda,” characterized as a pillar of the Europe “2020 Strategy” that sets objectives for the growth of the European Union by 2020.  The EC’s strategy emphasizes government-centric “growth through regulatory oversight,” rather than reliance on untrammeled competition.  This emphasis is at odds with the fact that detailed regulatory oversight has been associated with sluggish economic growth within the European Union.  It also ignores the fact that some of the most dynamic, innovative industries in recent decades have been those enabled by the Internet, which until recently has largely avoided significant regulation.  The EC may want to rethink its approach, if it truly wants to generate the innovation and economic gains long-promised to its consumers and producers.

On Thursday, March 30, Friday March 31, and Monday April 3, Truth on the Market and the International Center for Law and Economics presented a blog symposium — Agricultural and Biotech Mergers: Implications for Antitrust Law and Economics in Innovative Industries — discussing three proposed agricultural/biotech industry mergers awaiting judgment by antitrust authorities around the globe. These proposed mergers — Bayer/Monsanto, Dow/DuPont and ChemChina/Syngenta — present a host of fascinating issues, many of which go to the core of merger enforcement in innovative industries — and antitrust law and economics more broadly.

The big issue for the symposium participants was innovation (as it was for the European Commission, which cleared the Dow/DuPont merger last week, subject to conditions, one of which related to the firms’ R&D activities).

Critics of the mergers, as currently proposed, asserted that the increased concentration arising from the “Big 6” Ag-biotech firms consolidating into the Big 4 could reduce innovation competition by (1) eliminating parallel paths of research and development (Moss); (2) creating highly integrated technology/traits/seeds/chemicals platforms that erect barriers to new entry platforms (Moss); (3) exploiting eventual network effects that may result from the shift towards data-driven agriculture to block new entry in input markets (Lianos); or (4) increasing incentives to refuse to license, impose discriminatory restrictions in technology licensing agreements, or tacitly “agree” not to compete (Moss).

Rather than fixating on horizontal market share, proponents of the mergers argued that innovative industries are often marked by disruptions and that investment in innovation is an important signal of competition (Manne). An evaluation of the overall level of innovation should include not only the additional economies of scale and scope of the merged firms, but also advancements made by more nimble, less risk-averse biotech companies and smaller firms, whose innovations the larger firms can incentivize through licensing or M&A (Shepherd). In fact, increased efficiency created by economies of scale and scope can make funds available to source innovation outside of the large firms (Shepherd).

In addition, innovation analysis must also account for the intricately interwoven nature of agricultural technology across seeds and traits, crop protection, and, now, digital farming (Sykuta). Combined product portfolios generate more data to analyze, resulting in increased data-driven value for farmers and more efficiently targeted R&D resources (Sykuta).

While critics voiced concerns over such platforms erecting barriers to entry, markets are contestable to the extent that incumbents are incentivized to compete (Russell). It is worth noting that certain industries with high barriers to entry or exit, significant sunk costs, and significant costs disadvantages for new entrants (including automobiles, wireless service, and cable networks) have seen their prices decrease substantially relative to inflation over the last 20 years — even as concentration has increased (Russell). Not coincidentally, product innovation in these industries, as in ag-biotech, has been high.

Ultimately, assessing the likely effects of each merger using static measures of market structure is arguably unreliable or irrelevant in dynamic markets with high levels of innovation (Manne).

Regarding patents, critics were skeptical that combining the patent portfolios of the merging companies would offer benefits beyond those arising from cross-licensing, and would serve to raise rivals’ costs (Ghosh). While this may be true in some cases, IP rights are probabilistic, especially in dynamic markets, as Nicolas Petit noted:

There is no certainty that R&D investments will lead to commercially successful applications; (ii) no guarantee that IP rights will resist to invalidity proceedings in court; (iii) little safety to competition by other product applications which do not practice the IP but provide substitute functionality; and (iv) no inevitability that the environmental, toxicological and regulatory authorization rights that (often) accompany IP rights will not be cancelled when legal requirements change.

In spite of these uncertainties, deals such as the pending ag-biotech mergers provide managers the opportunity to evaluate and reorganize assets to maximize innovation and return on investment in such a way that would not be possible absent a merger (Sykuta). Neither party would fully place its IP and innovation pipeline on the table otherwise.

For a complete rundown of the arguments both for and against, the full archive of symposium posts from our outstanding and diverse group of scholars, practitioners and other experts is available at this link, and individual posts can be easily accessed by clicking on the authors’ names below.

We’d like to thank all of the participants for their excellent contributions!

John E. Lopatka is A. Robert Noll Distinguished Professor of Law at Penn State Law School

People need to eat. All else equal, the more food that can be produced from an acre of land, the better off they’ll be. Of course, people want to pay as little as possible for their food to boot. At heart, the antitrust analysis of the pending agribusiness mergers requires a simple assessment of their effects on food production and price. But making that assessment raises difficult questions about institutional competence.

Each of the three mergers – Dow/DuPont, ChemChina/Syngenta, and Bayer/Monsanto – involves agricultural products, such as different kinds of seeds, pesticides, and fertilizers. All of these products are inputs in the production of food – the better and cheaper are these products, the more food is produced. The array of products these firms produce invites potentially controversial market definition determinations, but these determinations are standard fare in antitrust law and economics, and conventional analysis handles them tolerably well. Each merger appears to pose overlaps in some product markets, though they seem to be relatively small parts of the firms’ businesses. Traditional merger analysis would examine these markets in properly defined geographic markets, some of which are likely international. The concern in these markets seems to be coordinated interaction, and the analysis of potential anticompetitive coordination would thus focus on concentration and entry barriers. Much could be said about the assumption that product markets perform less competitively as concentration increases, but that is an issue for others or at least another day.

More importantly for my purposes here, to the extent that any of these mergers creates concentration in a market that is competitively problematic and not likely to be cured by new entry, a fix is fairly easy. These are mergers in which asset divestiture is feasible, in which the parties seem willing to divest assets, and in which interested and qualified asset buyers are emerging. To be sure, firms may be willing to divest assets at substantial cost to appease regulators even when competitive problems are illusory, and the cost of a cure in search of an illness is a real social cost. But my concern lies elsewhere.

The parties in each of these mergers have touted innovation as a beneficial byproduct of the deal if not its raison d’être. Innovation effects have made their way into merger analysis, but not smoothly. Innovation can be a kind of efficiency, distinguished from most other efficiencies by its dynamic nature. The benefits of using a plant to its capacity are immediate: costs and prices decrease now. Any benefits of innovation will necessarily be experienced in the future, and the passage of time makes benefits both less certain and less valuable, as people prefer consumption now rather than later. The parties to these mergers in their public statements, to the extent they intend to address antitrust concerns, are implicitly asserting innovation as a defense, a kind of efficiency defense. They do not concede, of course, that their deals will be anticompetitive in any product market. But for antitrust purposes, an accelerated pace of innovation is irrelevant unless the merger appears to threaten competition.

Recognizing increased innovation as a merger defense raises all of the issues that any efficiencies defense raises, and then some. First, can efficiencies be identified?  For instance, patent portfolios can be combined, and the integration of patent rights can lower transaction costs relative to a contractual allocation of rights just as any integration can. In theory, avenues of productive research may not even be recognized until the firms’ intellectual property is combined. A merger may eliminate redundant research efforts, but identifying that which is truly duplicative is often not easy. In all, identifying efficiencies related to research and development is likely to be more difficult than identifying many other kinds of efficiencies. Second, are the efficiencies merger-specific?  The less clearly research and development efficiencies can be identified, the weaker is the claim that they cannot be achieved absent the merger. But in this respect, innovation efficiencies can be more important than most other kinds of efficiencies, because intellectual property sometimes cannot be duplicated as easily as physical property can. Third, can innovation efficiencies be quantified?  If innovation is expected to take the form of an entirely new product, such as a new pesticide, estimating its value is inherently speculative. Fourth, when will efficiencies save a merger that would otherwise be condemned?  An efficiencies defense implies a comparison between the expected harm a merger will cause and the expected benefits it will produce. Arguably those benefits have to be realized by consumers to count at all, but, in any event, a comparison between expected immediate losses of customers in an input market and expected future gains from innovation may be nearly impossible to make. The Merger Guidelines acknowledge that innovation efficiencies can be considered and note many of the concerns just listed. The takeaway is a healthy skepticism of an innovation defense. The defense should generally fail unless the model of anticompetitive harm in product (or service) markets is dubious or the efficiency claim is unusually specific and the likely benefits substantial.

Innovation can enter merger analysis in an even more troublesome way, however: as a club rather than a shield. The Merger Guidelines contemplate that a merger may have unilateral anticompetitive effects if it results in a “reduced incentive to continue with an existing product-development effort or reduced incentive to initiate development of new products.”  The stark case is one in which a merger poses no competitive problem in a product market but would allegedly reduce innovation competition. The best evidence that the elimination of innovation competition might be a reason to oppose one or more of the agribusiness mergers is the recent decision of the European Commission approving the Dow/DuPont merger, subject to various asset divestitures. The Commission, echoing the Guidelines, concluded that the merger would significantly reduce “innovation competition for pesticides” by “[r]emoving the parties’ incentives to continue to pursue ongoing parallel innovation efforts” and by “[r]emoving the parties’ incentives to develop and bring to market new pesticides.”  The agreed upon fix requires DuPont to divest most of its research and development organization.

Enforcement claims that a merger will restrict innovation competition should be met with every bit the skepticism due defense claims that innovation efficiencies save a merger. There is nothing inconsistent in this symmetry. The benefits of innovation, though potentially immense – large enough to dwarf the immediate allocative harm from a lessening of competition in product markets – is speculative. In discounted utility terms, the expected harm will usually exceed the expected benefits, given our limited ability to predict the future. But the potential gains from innovation are immense, and unless we are confident that a merger will reduce innovation, antitrust law should not intervene. We rarely are, at least we rarely should be.

As Geoffrey Manne points out, we still do not know a great deal about the optimal market structure for innovation. Evidence suggests that moderate concentration is most conducive to innovation, but it is not overwhelming, and more importantly no one is suggesting a merger policy that single-mindedly pursues a particular market structure. An examination of incentives to continue existing product development projects or to initiate projects to develop new products is superficially appealing, but its practical utility is elusive. Any firm has an incentive to develop products that increase demand. The Merger Guidelines suggest that a merger will reduce incentives to innovate if the introduction of a new product by one merging firm will capture substantial revenues from the other. The E.C. likely had this effect in mind in concluding that the merged entity would have “lower incentives . . . to innovate than Dow and DuPont separately.”  The Commission also observed that the merged firm would have “a lower ability to innovate” than the two firms separately, but just how a combination of research assets could reduce capability is utterly obscure.

In any event, whether a merger reduces incentives depends not only on the welfare of the merging parties but also on the development activities of actual and would-be competitors. A merged firm cannot afford to have its revenue captured by a new product introduced by a competitor. Of course, innovation by competitors will not spur a firm to develop new products if those competitors do not have the resources needed to innovate. One can imagine circumstances in which resources necessary to innovate in a product market are highly specialized; more realistically, the lack of specialized resources will decrease the pace of innovation. But the concept of specialized resources cannot mean resources a firm has developed that are conducive to innovate and that could be, but have not yet been, developed by other firms. It cannot simply mean a head start, unless it is very long indeed. If the first two firms in an industry build a plant, the fact that a new entrant would have to build a plant is not a sufficient reason to prevent the first two from merging. In any event, what resources are essential to innovation in an area can be difficult to determine.

Assuming essential resources can be identified, how many firms need to have them to create a competitive environment? The Guidelines place the number at “very small” plus one. Elsewhere, the federal antitrust agencies suggest that four firms other than the merged firm are sufficient to maintain innovation competition. We have models, whatever their limitations, that predict price effects in oligopolies. The Guidelines are based on them. But determining the number of firms necessary for competitive innovation is another matter. Maybe two is enough. We know for sure that innovation competition is non-existent if only one firm has the capacity to innovate, but not much else. We know that duplicative research efforts can be wasteful. If two firms would each spend $1 million to arrive at the same place, a merged firm might be able to invest $2 million and go twice as far or reach the first place at half the total cost. This is only to say that a merger can increase innovation efficiency, a possibility that is not likely to justify an otherwise anticompetitive merger but should usually protect from condemnation a merger that is not otherwise anticompetitive.

In the Dow/DuPont merger, the Commission found “specific evidence that the merged entity would have cut back on the amount they spent on developing innovative products.”  Executives of the two firms stated that they expected to reduce research and development spending by around $300 million. But a reduction in spending does not tell us whether innovation will suffer. The issue is innovation efficiency. If the two firms spent, say, $1 billion each on research, $300 million of which was duplicative of the other firm’s research, the merged firm could invest $1.7 billion without reducing productive effort. The Commission complained that the merger would reduce from five to four the number of firms that are “globally active throughout the entire R&D process.”  As noted above, maybe four firms competing are enough. We don’t know. But the Commission also discounts firms with “more limited R&D capabilities,” and the importance to successful innovation of multi-level integration in this industry is not clear.

When a merger is challenged because of an adverse effect on innovation competition, a fix can be difficult. Forced licensing might work, but that assumes that the relevant resource necessary to carry on research and development is intellectual property. More may be required. If tangible assets related to research and development are required, a divestiture might cripple the merged firm. The Commission remedy was to require the merged firm to divest “DuPont’s global R&D organization” that is related to the product operations that must be divested. The firm is permitted to retain “a few limited [R&D] assets that support the part of DuPont’s pesticide business” that is not being divested. In this case, such a divestiture may or may not hobble the merged firm, depending on whether the divested assets would have contributed to the research and development efforts that it will continue to pursue. That the merged firm was willing to accept the research and development divestiture to secure Commission approval does not mean that the divestiture will do no harm to the firm’s continuing research and development activities. Moreover, some product markets at issue in this merger are geographically limited, whereas the likely benefits of innovation are largely international. The implication is that increased concentration in product markets can be avoided by divesting assets to other large agribusinesses that do not operate in the relevant geographic market. But if the Commission insists on preserving five integrated firms active in global research and development activities, DuPont’s research and development activities cannot be divested to one of the other major players, which the Commission identifies as BASF, Bayer, and Syngenta, or firms with which any of them are attempting to merge, namely Monsanto and ChemChina. These are the five firms, of course, that are particularly likely to be interested buyers.

Innovation is important. No one disagrees. But the role of competition in stimulating innovation is not well understood. Except in unusual cases, antitrust institutions are ill-equipped either to recognize innovation efficiencies that save a merger threatening competition in product markets or to condemn mergers that threaten only innovation competition. Indeed, despite maintaining their prerogative to challenge mergers solely on the ground of a reduction in innovation competition, the federal agencies have in fact complained about an adverse effect on innovation in cases that also raise competitive issues in product markets. Innovation is at the heart of the pending agribusiness mergers. How regulators and courts analyze innovation in these cases will say something about whether they perceive their limitations.