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Comment of 25 Law Professors, Economists, and Former U.S. Government Officials in Response to EU Commission Call for Evidence on Standard-Essential Patents

Led by Prof. Adam Mossoff and C-IP2 Senior Fellow and Senior Scholar Prof. Jonathan M. Barnett, twenty-five law professors, economists, and former United States Government officials—including C-IP2 Advisory Board members the Honorable Andrei Iancu, the Honorable David J. Kappos, the Honorable Paul Michel, and the Honorable Randall R. Rader; Faculty Director Prof. Sean M. O’Connor; Senior Scholar Prof. Kristen Osenga; and Scholar Dr. Bowman Heiden—submitted a letter in response to a “call for evidence” on the licensing, litigation, and remedies of standard-essential patents (SEPs). The response discusses core functions of SEPs in the wireless ecosystem, the lack of evidence of Patent Holdup and Royalty Stacking, assumptions about SEPs and Market Power, the importance of the potential for injunctive relief even for FRAND, levels of licensing, and SEP licensing in SME markets. The letter is available here on SSRN.

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Biotech C-IP2 News International Law Patents

Panel Discussion: Vaccines, Intellectual Property, and Global Equity

scientist looking through a microscopeThe following post comes from Colin Kreutzer, a 2E at Scalia Law and a Research Assistant at C-IP2

The COVID-19 pandemic has shined a spotlight on the role of intellectual property in modern medicine and on the complex social questions surrounding a system that grants exclusive rights over life-or-death products. On the one hand, there is clearly a difference between public access to lifesaving medicines and other patented goods, such as consumer electronics. However, creating these drugs required billion-dollar investments and enormous risk, made feasible only by that promise of IP rights. Wouldn’t taking that promise away harm future development of new medicines? As the world considers a waiver of IP rights over COVID-19 vaccines and other technologies, experts are analyzing not only what’s right and what’s wrong, but also what works and what doesn’t.

On June 10, 2021, C-IP2 and the Smithsonian’s Lemelson Center for the Study of Invention and Innovation held a panel discussion on vaccines, intellectual property, and global equity. With opening remarks by Lemelson Director Arthur Daemmrich, and moderated by C-IP2 Faculty Director Professor Sean O’Connor, the panel featured Dan Laster, Director of the Washington State COVID-19 Vaccine Action Command and Coordination System (VACCS) Center; Professor Arti K. Rai, Elvin R. Latty Professor of Law and Co-Director of the Duke Law Center for Innovation Policy; and Eric Aaronson, Senior Vice President and Chief Counsel, Corporate Affairs, Intellectual Property and Intellectual Property Enforcement, Pfizer Inc.

Opening Remarks

Mr. Daemmrich began with a historical perspective of medical developments in this country, as well as the social, economic, and regulatory issues that would invariably be tangled up within them. His tale foretold many of the conflicts we see today—going from a time when most modern medicines didn’t exist, and high mortality was a fact of life, to a time when vaccines and other treatments existed, but access depended partly on wealth. In between those two periods, we saw rapid growth in IP protection that helped move society from one to the other. But whether in the form of religious opposition to smallpox inoculation, regulatory reforms after tragedies from bad medicine, or protests from a marginalized community during the AIDS crisis, legal and social issues have always played a prominent role in the story of medical science.

Building on this historical base, Mr. Daemmrich posed the problem now facing us: compared to other medicines, there are relatively few vaccines. On a grand scale, the entire field of vaccination is still in a stage of early development, and there exists great potential for growth in the future. The question is how to best stimulate that growth, or rather, how to ensure the greatest access to already-developed vaccines without stifling the creation of new ones?

Prof. O’Connor then led the panel with a series of questions. He began by asking about the difference between two classes of medicine. Vaccines are generally thought of as biologics—treatments that are derived from live cells­—whereas pharmaceuticals belong to the class of “small-molecule” drugs. They are primarily chemical compounds rather than a biological product.

Q: From an IP perspective, are vaccines different from small molecule pharmaceuticals? What role does IP play in making vaccines available?

 Prof. Rai responded that vaccines are indeed very different from small molecule drugs. From an IP perspective, the two classes derive their greatest protection from different sources.

Small molecule drugs can be produced without the need for company trade secrets. All the most critical information can be found within the text of the patent. So, the greatest protection comes from the patent itself, which grants its owner the right to exclude others from making or using the drug, and from data exclusivity, which prevents other companies from using the original developer’s clinical data to obtain regulatory approval of its own product.

Vaccines, on the other hand, cannot be quickly copied solely by reading the patent. There is a great deal of “know-how” involved in the manufacturing process. Because of this, trade secrets can be just as important to vaccine protection as the patent.

The role of IP in vaccine access, she said, is an interesting question. While public funding exists in the world of small molecule drugs, it has a “heavier footprint” in vaccine development, which then has some impact on the incentive model as it applies to vaccines.

Mr. Laster said the role of public funding was critical to his prior work at PATH, an organization devoted advancing global healthcare equity through public-private partnerships and other initiatives. Public funding has a “de-risking” effect in that the high costs and uncertainty of clinical trials are not borne entirely by the private sector. And because vaccine development typically requires cooperation among many parties, it is valuable to have different types of incentives in play (i.e., “pull”-type incentives, such as patent grants, as well as “push”-types, such as public funding). But from an IP perspective, exclusivity can pose a challenge to those cooperative efforts.

Additionally, he said that the detailed know-how involved with vaccines makes technology transfer incredibly difficult. If the intended receiver in a developing nation lacks the capacity to utilize the technology, how can effective tech transfer work in real-world practice? The question is less about whether we should be transferring vaccine technology to developing nations than it is about whether we can.

Mr. Aaronson said that a key piece of our IP system is that it does allow for greater cooperation by providing a means of transferring technology among partners while preventing that technology from being used for unauthorized purposes. He credits that cooperative system for enabling Pfizer to partner with BioNTech, producing a vaccine in record time. He added that this vaccine is currently supplied in 116 countries and counting, that they have committed to supplying at least 2.5 billion doses, and that they have just struck a purchase agreement with the United States for 500 million doses to supply lower-middle income nations. The required research, discovery, and development would not have been possible without a strong IP system that provides the right incentives and enables secure technology sharing among a large host of players.

Q: While we don’t know what final form the waiver might take, do you see it playing a necessary role in actually increasing vaccine supply and access in the coming year or two? Are there potential downsides to an IP waiver that should be considered?

Prof. Rai said that the biggest effect of a waiver would likely be its “symbolic” value, as other factors will have a much greater impact on vaccine access. But even if there were no substantive effect, it would be good for high-income nations to demonstrate an interest in global health issues. However, she considered the waiver issue “a little bit of a sideshow,” saying it likely would be “neither as bad as opponents fear nor as good as proponents hope.”

Prof. O’Connor noted that this is a particularly difficult question to answer when nobody knows what form any potential waiver would eventually take.

Mr. Laster based his perspective on his ten years of negotiating vaccine development and distribution efforts with PATH, saying he is “not sure [the waiver] aligns well” with what’s needed. Recognizing the importance of trade secrets and the complexity of the partnerships involved, he says a successful system must encourage willing cooperation. Simply waiving IP rights won’t necessarily do that. He also cautioned against taking a “static view” of the problem by taking for granted that the vaccine already exists rather than considering the IP system that helped create it, and failing to ensure that the same system is incentivizing new vaccines in the future. That said, the threat of a waiver might provide enough encouragement to bring about voluntary participation before an actual waiver becomes a reality. He credits this threat with already having a noticeable effect on pricing and other strategies.

Mr. Aaronson added that we are dealing with multiple vaccines based on very different technologies. Concentrating “a little more on the practical versus the theoretical,” he noted that the impacts of an IP waiver can vary greatly from one technology to another. The mRNA vaccine is the first drug of its type to ever receive approval. Much of the necessary tech transfer would not be limited to COVID-19, but could apply to the entire mRNA technology platform, drastically impacting its value. Waiving the rights to a groundbreaking technology could reduce the incentive to explore uncharted technological fields.

He also said it’s not certain that waiving IP rights would yield a net increase in the number of doses produced. The existing developers are producing large amounts of the vaccine. Opening the supply chain up to new entrants who may not be able to effectively utilize those supplies could yield a net decrease in production.

Prof. O’Connor also took audience questions for the panel. Some are listed below, starting with a “great foundational question.”

Q: How would it be ethical to allow lifesaving medicines and vaccines to be patented?

Prof. O’Connor began by addressing the purely legal perspective—that such patents are allowed under U.S. law, although there have been exceptions in some other countries at certain times because of this complex ethical question.

Mr. Aaronson said it’s important to think about patents as a part of a broader incentive structure. Are we putting the incentives in place to get someone to get up every morning and put in the work, money, and risk to create a product? We need an incentive structure, or there won’t be anyone making those lifesaving medicines. A patent system is one way to achieve this.

Q: If patent disclosures cannot teach producers how to make a vaccine without also getting corresponding know-how, how can they satisfy the disclosure requirement for patentability?

Prof. Rai has written multiple articles about this question (see one here) and offered several reasons. Some of the know-how is not easily written down. The need for shared know-how could possibly be satisfied by depositing biological materials with the Patent Office, but this is unlikely to happen. Another reason is that the final product that emerges from a years-long regulatory approval process is not always identical to the product described in the patent. There is also a mistaken view that patents and trade secrets cannot protect the same product. It is true that a singular feature cannot be both patented and kept as a trade secret, but a single product may have different features that are protected under one regime or the other.

Mr. Aaronson also pointed out that a single drug may be protected by many patents. Some of the know-how simply involves knowing how to properly combine the patented technologies.

Q: If most of the medical innovations occur in wealthy nations, IP laws will lock developing nations out, at least initially. Is there a way to include developing nations earlier in the innovation process?

All panelists agreed on the importance of this issue, as well as on the fact that it’s much easier said than done. Prof. Rai said that every nation must begin to create its own manufacturing capacity to avoid reliance on others, but this requires large amounts of human capital and infrastructure. The problem really goes beyond medicine to the balance of rich and poor nations generally. Mr. Laster said this is the sort of thing he was working on with PATH, which has created some networks, but there is a long way to go. Building the required skillsets and infrastructure locally takes time, but public-private partnerships can help. Mr. Aaronson said that it’s essentially like asking a nation to stop being a low-income country. It’s a somewhat circular issue, in which money is required to build infrastructure, but infrastructure is required to make money. However, this is where IP is not the problem; it is the solution. A strong IP system can create the necessary investment incentives to begin building a better future in any nation.

Closing Remarks

In closing, Prof. Rai said that “regrettably, the public debate on the . . . waiver has been very simplistic.” She hoped that the panel had “shed some light” on the issue and thanked her fellow panelists for a respectful and productive dialogue. Mr. Last er agreed that “it is a complex topic” but said that “it’s not about the waiver;  I do think there are mechanisms that can lead more likely to the outcomes we want.” Mr. Aaronson finished by saying that “we all have the same goal, to figure out ways to bring medicines and vaccines to patients, no matter where they are in the world. We’re fortunate and thrilled that our vaccine has had that potential to change lives, and our goal is to continue . . . to ensure access” to both this and to future vaccines.

A recording of the panel is available here.

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WIPO

CPIP Celebrates World Intellectual Property Day 2021

lightbulbs drawn on a chalkboardToday marks the 21st annual World Intellectual Property Day. The event is held each year on the 26th of April to commemorate the day the WIPO Convention, which established the World Intellectual Property Organization (WIPO), entered into force in 1970. The theme of this year’s World IP Day is “IP & SMEs: Taking Your Ideas to Market,” and events are being held around the world to highlight the critical role of small- and medium-sized enterprises (SMEs) to bringing creative innovations to the marketplace. As President Biden noted in his World IP Day proclamation, small businesses “make up 90 percent of businesses in the United States, employ nearly half of America’s private sector workers, and create two-thirds of new jobs, and bring opportunity to every corner of our Nation.”

CPIP Executive Director Sean O’Connor spoke about the importance of IP for med tech SMEs at a World IP Day event organized by the U.S. Embassy in Tokyo, Japan. The event, entitled “Patents to Patients: The Role of Intellectual Property in Innovative Healthcare,” brought together leading experts to discuss how Japanese SMEs can take advantage of intellectual property rights. Traditionally, Japanese SMEs have often foregone IP protection because of the expense and uncertainty about its value. But as this sector increasingly relies on venture capital and commercialization based on licensing throughout the value chain, secure IP rights to define and convey the developing innovation are a necessity.

There are several events in the Washington, D.C., area this week that will underscore the success stories of SMEs and discuss the IP resources that are available to help them with their IP needs. The U.S. Patent and Trademark Office, along with several other organizations, is hosting an event today to discuss the role of IP in supporting the creativity and innovation of small businesses. The U.S. Copyright Office is likewise holding an event today to discuss the importance of SMEs in copyright, the economy, and our culture. Also today, the Licensing Executives Society (LES) has organized an event to celebrate the ingenuity and creativity embodied in SMEs, and the Intellectual Property Owners (IPO) Education Foundation is holding an event to discuss different approaches to bring ideas to the market. The Copyright Alliance is hosting two panel presentations later this week on how IP and advocacy can help creative small businesses to grow and succeed.

We are thrilled to see these and many other events celebrate the power of intellectual property to help small businesses succeed in the global economy.

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C-IP2 News Law and Economics

Scalia Law’s Innovation Law Clinic Partners with BizLaunch for Online Legal Clinic on Business Entities for Startups

The following post comes from Wade Cribbs, a 2L at Scalia Law and a Research Assistant at CPIP.

a hand hovering under lightbulbs drawn on a chalkboardBy Wade Cribbs

Last week, Arlington Economic Development’s BizLaunch network co-hosted an online legal clinic event entitled “Mason Law Clinic @BizLaunch: Which Entity is Right for Your Startup?” with Antonin Scalia Law School’s Innovation Law Clinic, which is led by CPIP Executive Director Sean O’Connor. The virtual clinic addressed entrepreneurship and which business entities might best fit a business’s needs and attract investment. The panelists were Kenneth Silverberg, Senior Counsel at Nixon Peabody, and third-year Scalia Law students Mitch Gibson and Rebecka Haynes.

Mr. Gibson opened the discussion by describing the kinds of non-corporate pass-through business entities: sole proprietorships, partnerships, and limited liability companies (LLC). Sole proprietorships are operated by only one person, while partnerships can have as many participants as desired. Neither form of business entity requires registration with the State Corporation Commission; nevertheless, registering a business’s name or obtaining an employer identification number may be necessary. Similarly, partnership agreements are borderline necessary before beginning a partnership so that all parties agree on profit splits, decision making, and how much say each partner has in the venture.

An entrepreneur must register an LLC with the State Corporation Commission. An LLC is made of members and managers. A member of an LLC is anyone who owns a stake in the company—analogous to a shareholder—while a manager can be either a member or an outside person who handles the business decisions. Either members or a manager can run an LLC. To create an LLC, form LLC-1011 must be filed with the State Corporation Commission. If the business is for professional occupations—such as for doctors, lawyers, or architects—form LLC-1103 is needed.

Pass-through taxation is where the business itself is not taxed for the gains and losses. Pass-through taxation occurs at the ownership level, and its most significant advantage is that there is only a single level of taxation. Gains are taxed as the owners’ income and are taxed only once—instead of being taxed when made as profit by the business and then again when distributed to shareholders. Similarly, another advantage is pass-through losses. If the business loses money, the losses can be used to diminish other tax burdens. Liquidity, however, is a disadvantage of pass-through taxation. Liquidity occurs when the business has made a profit that remains within the business. When this happens, the owners are still taxed on the profits without receiving any of them. Another disadvantage is that there is a limit of $10,000 that can be deducted from state or local taxes per member or partner.

Ms. Haynes continued the discussion of pass-through taxation with how it applies to corporations. A corporation utilizes pass-through taxation by electing to be taxed as an S-Corporation, which is a corporation that chooses to be taxed under Subchapter S of the tax code. An S-Corporation is formed by incorporating in the desired state and submitting form 2553, “Election by a Small Business Corporation,” signed by all shareholders. For a business to be an S-Corporation, it must be a domestic corporation, have no more than 100 shareholders, and have only one class of stock. Furthermore, the kind of shareholder is limited to individuals, certain trusts, and estates. Certain financial institutions, insurance companies, and international sales corporations are ineligible to be S-Corporations. An S-Corporation is different from other tax-through businesses in that it allows for tax-free reorganization, provides stock options, and can easily convert to a C-Corporation.

A C-Corporation, on the other hand, is a corporation that does not elect to be taxed under Subchapter S of the tax code and by default is taxed under Subchapter C of the tax code. C-Corporations are closely or publicly held. A closely held corporation has a limited number of shareholders, whereas a publicly held corporation has a large number of shareholders with shares on the market. Some states allow for closely held C-Corporations to dispense with some of the formalities of operating a corporation. C-Corporations are taxed separately from their owners at a flat 21% tax rate. Any further profits distributed to shareholders are then taxed again, resulting in an effective tax rate of 41% on the distributions. The exception to this is that qualified small business stock that has been held for more than five years after its issuance is eligible for 100% exclusion from gain on disposition, not to exceed $10 million for any one shareholder. For a stock to be a qualified small business stock, there are three requirements: it must be issued by a C-Corporation at original issuance; the corporation must be engaged in active business that is not a service business; and the business’s gross assets cannot exceed $50 million. A C-Corporation’s benefits are that it can issue more than one class of stock and have unlimited deduction of state and local taxes.

Prof. Silverberg addressed how the various tax and business structures apply to someone who wants to start, run, and sell a business. Prof. Silverberg did this by examining the sale of a hypothetical landscaping business. Through this hypothetical example, Prof. Silverberg looked at what motivates a purchaser to buy a business and how this affects the taxation of the transaction. The buyer and seller have to agree on the purchase price and how that price is allocated to different assets. Prof. Silverberg then discussed the amount pocketed by the entrepreneur after selling the business under pass-through taxation; he also discussed the sales structure under the different possible business structures and compared it to taxation under a C-Corporation. Looking at the numbers, Prof. Silverberg highlighted the tension between the seller’s desire to sell the business as stock under a C-Corporation and the buyer’s desire to buy assets under a sole proprietorship or the like.

The event page can be found on AED’s website and on the Eventbrite page. The video of the event is available below:

Categories
Patents Pharma

IP Scholars Question the Legality and Wisdom of Joint AG Proposal to Seize Remdesivir Patents

The following post comes from Colin Kreutzer, a 2E at Scalia Law and a Research Assistant at CPIP.

dictionary entry for the word "innovate"By Colin Kreutzer

While the vaccines are starting to roll out in the fight against COVID-19, the precise timelines for when they will be widely available continue to be uncertain. But we do have treatments currently available under Emergency Use Authorization authority that have been shown to blunt the impact of the coronavirus and reduce the length of hospital stays. The first one these was Gilead Sciences’ antiviral drug, remdesivir. In July, after an initial period in which Gilead donated its production supply, the company announced a price of $390 per vial, or $2,340 for an estimated 5-day course. While the price is lower than what many analysts were expecting, not everyone was happy about it.

In an August joint letter to HHS Secretary Alex Azar, thirty-four state Attorneys General urged him to do what they contend would resolve a problem of access to the drug: use the “march-in rights” provision of the Bayh-Dole Act to seize Gilead’s patent and license it to generic manufacturers. The response to this proposal from many IP experts can be roughly divided into three main points: (1) it is not legal; (2) it is not effective; and (3) it is dangerously unwise.

What Is Bayh-Dole?

The Bayh-Dole Act of 1980 was a watershed event in the growth of the American pharmaceutical industry. It allowed companies and universities to retain the IP rights to inventions that were developed using government-funded research. The goal was to improve the efficiency with which innovations were brought to market and to encourage investment and collaboration between government, university, and private researchers. Previously, many research developments never saw the light of day due to lack of commercialization, and likely many other inventions were never born in the first place. Bayh-Dole is widely regarded as a success story on both sides of the aisle.

What Are March-In Rights?

Since the aim of the law is to spur innovation and development, the march-in rights provision was included to counteract patent owners who “hold out” or fail to commercialize their inventions. Under very limited circumstances, it allows the government to “march in” and force the owners to license their patent on reasonable terms to a third party. Just how limited are those circumstances? So far, the 40-year-old provision has been used exactly zero times. It stands to reason that valuable products don’t need to be forced into the market, and many modern treatments–for cancer, diabetes and hepatitis­, among others–have been invented and commercialized under Bayh-Dole collaborations without any intervention.

It Is Not Legal

Notably absent from the list of Bayh-Dole creations is remdesivir. The law only applies to inventions that are “conceived or actually reduced to practice in the performance of work under a funding agreement,” i.e., things that were invented with government help. It does not apply to every case in which a drug maker has worked alongside a government agency at one stage or another. The AG letter cites $30 million in NIH-funded work on remdesivir. It claims that this funding exposes the drug to the march-in provision. The letter also makes a general appeal to our sense of fairness—the public paid for this, and so it rightly belongs to all of us.

As noted by Stephen Ezell of the Information Technology and Innovation Foundation (ITIF), the total government expenditure is actually closer to $70 million. That number includes additional work performed with USAMRIID, the U.S. Army Medical Research Institute of Infectious Diseases. Both projects took place in 2014. The Army study was investigating Gilead’s library of antiviral compounds for effective Ebola treatments. Remdesivir’s compound gave positive results, but other treatments proved better. The NIH project was a clinical trial to explore whether remdesivir could be used against coronaviruses as a general class. Again, it showed promise. But the relevant coronaviruses at the time (SARS and MERS) did not spread widely enough to make larger studies feasible. The NIH study might have enabled Gilead to home in so quickly on remdesivir as a COVID-19 treatment, and in that sense, it would have played a crucial role. But that is not the same thing as having a hand in the actual invention of the drug.

Critically, under both studies, the drug had already been invented by Gilead. Regarding the NIH work, a HHS spokeswoman told STAT that the department does not consider the march-in rights to apply. And as pointed out by Scalia Law Professor Adam Mossoff, Army lawyers have stated that their contributions did “not qualify USAMRIID as a joint inventor of the compound.” Even if they were joint inventors, the NIH has stated that “the extraordinary remedy of march-in is not an appropriate means of controlling prices.”

As CPIP Executive Director Sean O’Connor explains at The Hill, even if inventorship could be established, march-in rights would still not be legal in this case: “[m]arch-in rights under Bayh-Dole’s Section 203 only authorize the government to grant new licenses if the original funding recipient fails to take steps to bring the invention to the market (achieve ‘practical application’) or reasonably satisfy health or safety needs.”

And yet, while it pales in comparison to the over $1 billion that Gilead expects to spend this year on remdesivir, $70 million sounds like a lot of tax dollars. CPIP Senior Scholar Kristen Osenga argues that proponents of marching in “mislead the public, specifically regarding remdesivir and, more generally and dangerously, regarding government support of scientific research.” She urges people to understand that government collaborations are a great deal for the public, and among the most efficient ways that the government spends our money: “The Milken Institute estimates that the long-term boost to total economic output could be as high as $3.20 for every dollar the NIH invests in biopharmaceutical research. Even conservative estimates peg the value of the NIH at $1.70 of economic activity per dollar spent. If only all government spending were so productive.”

It Is Not Effective

The preceding section alone answers the question of whether Bayh-Dole is a legal means of seizing Gilead’s property rights. Clearly, though, it does not quiet the sentiment felt by many that something else needs to be done. In addition to the price tag, the AG letter speaks of a “dangerously low supply” of the drug. But the letter supports that claim with a dubious comparison of Gilead’s expected production output to every single confirmed case of COVID-19 in the country. It should be clear on its face that this is not a valid manner of determining how many patients would actually benefit from remdesivir. It would have been more appropriate to say that future demand is uncertain. Because of course, supply is only one half of the equation. Demand can vary greatly depending on whether we cooperate as a society to contain this virus.

Gilead has, in fact, licensed the drug to third parties in order to increase supply. Currently, its own production will remain domestic. But Joseph Allen at IPWatchdog notes that in addition to ramping up its own capacity, Gilead has deals with drug makers in Egypt, India, and Pakistan to provide supplies internationally. Mr. Allen is also is a former congressional staffer who worked on the Act with its namesake, Senator Birch Bayh (D-Ind.). He adds that, because march-in seizure is a hostile measure, it would involve a drawn-out legal battle. This would render the process far too slow to be effective in a pandemic.

It Is Dangerously Unwise

Far from being proof in support of the AGs’ position, Gilead’s work with NIH is a clear example of how damaging it would be to abuse the march-in rights provision. We desperately want these types of collaborations to continue. And if companies believe that doing so would expose them to the seizure of their IP, they will act accordingly.

Our intellectual property system provides the necessary incentives for companies to invest massive amounts of money and bring new lifesaving drugs to the world. We even allow patents for new uses of existing drugs. As CPIP Senior Fellow for Life Sciences Chris Holman points out, the next great cure might be hiding in your medicine cabinet. But without incentivizing the R&D expenditures that bring us these wonderful inventions, we may never realize it.

It is hard to worry about the future when the present appears so bleak, but it is critically important to understand why it is dangerous to weaken the incentives that have given us so many lifesaving developments. Even if exercising march-in rights were legal, and even if it could somehow increase production, it is necessary to consider the long-term implications. Taking away a company’s rights and forcing it to sell at close to the cost of production may help with the current situation, but it will likely decimate future research. Who would want to spend billions of dollars on R&D without the knowledge that they can obtain IP rights that will have a predictable value? We should ensure that companies remain strongly incentivized to research new treatments that benefit us all.

Categories
CPIP Roundup

CPIP Roundup – December 2, 2020


Greetings from CPIP Executive Director Sean O’Connor

Sean O'Connor

I hope you had an enjoyable, restful Thanksgiving. At CPIP, we’re winding down 2020 while planning our spring and summer events—including biopharma and copyright roundtables, the 2021 WIPO-CPIP Summer School on Intellectual Property, and more.

As usual, our team has been up to many great things. Director of Copyright Research and Policy Sandra Aistars’ Arts & Entertainment Advocacy Clinic co-hosted a virtual clinic with Washington Area Lawyers for the Arts (WALA). The event was a huge success. You can read our write-up here, and a recording of the Rock Creek Kings’ featured performance is available here. Sandra also participated in a November 12 panel hosted by the Law of Intellectual Property (LIP) student organization at the University of Oregon School of Law (home to CPIP Senior Scholar Eric Priest).

I taught my annual workshop on “Public-Private Partnerships–Innovation and Technology Transfer” in the CEIPI-WIPO-INPI Advanced Training Course on Intellectual Property, Technology Transfer and Licensing. I also published an op-ed at The Hill on price controls, explaining why the government cannot seize or bypass pharmaceutical patents.

Our affiliates have also been doing great things as well. Scalia Law Alumna and Arts & Entertainment Advocacy Clinic Adjunct Professor Terrica Carrington and Lateef Mtima of Howard University School of Law and IIPSJ have great quotes in this Billboard article on choreography, copyright, and social justice. CPIP Senior Fellow for Innovation Policy Jonathan Barnett continues to blog at Truth on the Market; you can catch his latest piece here and read his take on how antitrust law can be abused to promote unproductive rent-seeking. Meanwhile Chris Holman, CPIP Senior Fellow for Life Sciences, continues writing for the Biotechnology Law Report, where he serves as Executive Director; his latest article is available here.

Below we highlight new papers from CPIP Edison Fellows Christa Laser (Equitable Defenses in Patent Law), Talha Syed (Owning Knowledge: A Unified Theory of Patent Eligibility), and Tabrez Ebrahim (Artificial Intelligence Inventions & Patent Disclosure).

While 2020’s end-of-year holiday season may well be challenging, I hope you and yours will find a way to share the spirit and renewal of this coming season while looking forward to a successful new year!


Spotlight on Scholarship

a pair of glasses, an apple, and a stack of books

The scholars from our Thomas Edison Innovation Fellowship program continue to publish high quality scholarship and cutting-edge research that promotes the value of intellectual property. Here are some recent publications:

Tabrez Y. Ebrahim, Artificial Intelligence Inventions & Patent Disclosure, 125 Penn. St. L. Rev. 147 (2020)

In his new paper at Penn State Law Review, Artificial Intelligence Inventions & Patent Disclosure, Professor Tabrez Ebrahim of California Western School of Law claims that AI fundamentally challenges disclosure in patent law, which has not kept up with rapid advancements in AI, and seeks to invigorate the goals that patent law’s disclosure function is thought to serve for society. In so doing, Prof. Ebrahim assesses the role that AI plays in the inventive process, how AI can produce AI-generated output (that can be claimed in a patent application), and why it should matter for patent policy and for society. He also introduces a taxonomy comprising AI-based tools and AI-generated output that he maps with social-policy-related considerations, theoretical justifications and normative reasoning concerning disclosure for the use of AI in the inventive process, and proposals for enhancing disclosure and the impact on patent protection and trade secrecy.

To read our blog post summarizing the paper, please click here.

Christa J. Laser, Equitable Defenses in Patent Law, 75 U. Miami L. Rev. 1 (2020)

In patent law, equitable defenses can play an essential role in multi-million-dollar patent infringement cases. Unclean hands, misuse, or estoppel can render a potential verdict unenforceable. Professor Christa Laser of Cleveland-Marshall College of Law dives into the unique and unsettled role of equity in her new paper, Equitable Defenses in Patent Law, which is forthcoming at the University of Miami Law Review. Prof. Laser compares two theories to determine how courts might interpret undefined language governing equitable defenses in patent statutes, and she analyzes whether Congress codified preexisting decisional law or expanded it with the 1952 Patent Act. Finally, Prof. Laser suggests that Congress could delegate its authority to an agency to handle the ever-changing patent landscape.

To read our blog post summarizing the paper, please click here.

Talha Syed, Owning Knowledge: A Unified Theory of Patent Eligibility (forthcoming)

In his new draft paper, Owning Knowledge: A Unified Theory of Patent Eligibility, Professor Talha Syed of Berkeley Law argues that the confusion surrounding patentable subject matter under Section 101 is two-fold. First, it results from our failure to develop a functionality doctrine that can clearly distinguish technological applications of knowledge from other forms of knowledge. Second, he offers a root cause of this failure. There is a distracting preoccupation in patent law with “physicalism,” that is, the notion that a patent is awarded for a thing (tangible or not) rather than for knowledge of that thing. In order to move forward, Prof. Syed states that we must first unwind the physicalist assumptions that are tangled up in our Section 101 analyses. Only then can we develop a functionality doctrine free of those encumbrances.

To read our blog post summarizing the paper, please click here.


Categories
CPIP Roundup

CPIP Roundup – October 30, 2020


Greetings from CPIP Executive Director Sean O’Connor

Sean O'Connor

With the end of the crazy year of 2020 coming into view, we here at CPIP are striving for a strong finish and already looking forward to meeting 2021 as prepared as anyone can be. Our thoughts are with all of CPIP’s friends, and I’m glad to pass along yet another Roundup full of positive news.

CPIP’s Eighth Annual Fall Conference, 5G at the Nexus of IP, Antitrust, and Technology Leadership, took place via Zoom on October 7-8. Thanks to everyone who made the event such a huge success! If you weren’t able to join us, you can find videos of the sessions here on CPIP’s website, and you can read our blog posts here and here.

In other event-related news, we have posts covering our recent conference, The Evolving Music Ecosystem, now available on both CPIP’s blog and IP Osgoode’s blog, hosted by our friends at York University’s Osgoode Hall Law School in Toronto. Bradfield Biggers, recent Boston College Law School graduate and music fintech entrepreneur at Timshel, and Meghan Carlin, Osgoode Hall law student and Co-President of the Osgoode Entertainment & Sports Law Association. You can check out the CPIP posts, here, here, here, and here, and the IP Osgoode posts here, here, here, and here.

CPIP would like to congratulate Thomas Edison Innovation Fellow Christa Laser on her professorship at Cleveland-Marshall College of Law! We’re excited about this opportunity for Christa to move into the world of academia, and we eagerly look forward to seeing all she has to offer in this space.

Congratulations also to Terrica Carrington of the Copyright Alliance for testifying at the “Copyright and the Internet in 2020” hearing before the House Judiciary Committee on September 30! You can find the written testimony, as well as a video of the hearing, on the Committee’s website. Terrica blogged about the oral argument in Google v. Oracle as well, and she joined the Committee for Justice on October 9 for a virtual panel discussion about the oral argument.

In other notable new from CPIP affiliates, CPIP Senior Scholar Mark Schultz and other experts have participated in a video for the Geneva Network on how IP helps in the battle against COVID-19. CPIP Affiliate Scholar Hina Mehta is speaking on October 30 at a session titled “Intellectual Property and its Commercialization” during Industry Day, an event hosted by George Mason University’s Department of Mechanical Engineering. Also this month, I spoke at the Law & Economics Center’s virtual Symposium on the Economics and Law of Cannabis Markets on October 12, as well as on the “Machine Learning in the Lab and in the Marketplace” panel at the LES 2020 Annual Meeting on October 16.

I’m grateful to the indefatigable CPIP staff for another productive month—especially in these crazy times—and I hope the coming months will allow us to catch our collective breath to prepare for the new year. Please read on for more October news from CPIP, and I wish you an early, happy—and especially safe—Thanksgiving!


CPIP Hosts Eighth Annual Fall Conference on 5G and the Internet of Things

Eighth Annual Fall Conference flyer

On October 7-8, 2020, CPIP hosted its Eighth Annual Fall Conference, 5G at the Nexus of IP, Antitrust, and Technology Leadership, online from Scalia Law in Arlington, Virginia. The conference featured a keynote address by the Honorable Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, and it was co-hosted by Scalia Law’s National Security Institute (NSI).

This conference addressed fast-emerging intellectual property (IP), antitrust, and technology leadership issues in the 5G and “Internet of Things” innovation ecosystem. Coverage included standard-essential patents (SEPs) along with established and emerging markets on a regional and global basis. Speakers were drawn from the academic, industry, and policymaking communities, with an emphasis on using objective fact-based analysis to explore points of convergence among legal, economic, and geopolitical perspectives on the IP and regulatory infrastructures that underlie these critical industries.

Our blog posts summarizing the conference are available here and here, and you can watch the conference videos here.


CPIP Welcomes Ken Randall as Next Dean of Scalia Law School

the words "Mason" set up outside on campus with people walking behindGeorge Mason University has announced that Ken Randall will be the next Dean of Antonin Scalia Law School, beginning on December 1, 2020.

CPIP Executive Director Sean O’Connor welcomed the news: “We couldn’t be happier with the selection of Ken Randall as Dean-Elect. He cares deeply about the continued success of CPIP and is no stranger to innovation and commercialization. He and I have already developed a great working relationship, and CPIP endeavors to support his Deanship in any way we can. We also thank Dean Henry Butler for his outstanding leadership and look forward to working with him as a faculty colleague and Executive Director of the Law & Economics Center.”

The Center for the Protection of Intellectual Property congratulates Dean Randall on his appointment and welcomes him to the Scalia Law family. His rigorous academic mind, strong leadership skills, and expertise in online learning bring together the ideal skill set to take our law school to new heights. We very much look forward to working with him in the near future.

To read our announcement, please click here.


Spotlight on Scholarship

a pair of glasses, an apple, and a stack of books

Deepak Hegde, Joan Farre-Mensa, & Alexander Ljungqvist, What Is a Patent Worth? Evidence from the U.S. Patent “Lottery”, 75 J. Finance 639 (2020)

Deepak Hegde of New York University and co-authors Joan Farre-Mensa and Alexander Ljungqvist have published a new paper from our Edison Fellowship program entitled What Is a Patent Worth? Evidence from the U.S. Patent “Lottery” in the Journal of Finance. The paper provides empirical evidence that startups that obtain their first patent have, on average, 55% higher employment growth and 80% higher sales growth five years later. Utilizing a unique dataset drawn on unprecedented access to USPTO internal databases, the study also shows with causal evidence that these startups pursue more—and higher quality—follow-on innovation as the first patent boosts innovation by facilitating their access to funding.

Olena Ivus, Edwin L.-C. Lai, & Ted M. Sichelman, An Economic Model of Patent Exhaustion, 29 J. Econ. & Manag. Strategy 816 (2020)

CPIP Senior Scholar Ted Sichelman of the University of San Diego, along with Olena Ivus and Edwin Lai, have published a new paper in the Journal of Economics & Management Strategy entitled An Economic Model of Patent Exhaustion. The paper, which comes from our Edison Fellowship program, uses a sophisticated economic model to show that, contrary to the Supreme Court’s opinion in Impression Products v. Lexmark, mandatory patent exhaustion can be highly inefficient, particularly when transaction costs are low. The authors show that it is socially optimal for patent owners to be able to opt-out of exhaustion via contract when the social benefits from buyer-specific pricing outweigh the social costs from transaction cost frictions in individualized licensing.

Lauma Muizniece, University Autonomy and Commercialization of Publicly Funded Research: The Case of Latvia, ___ J. Knowl. Econ. ___ (2020)

In this paper from our Edison Fellowship program, Lauma Muizniece of the Investment and Development Agency of Latvia focuses on university autonomy as one of the key variables in commercializing publicly funded research in Latvia. The paper presents a case study using secondary data and interviews to demonstrate that, with greater funding flexibility and experimentation, universities could develop better ways to commercialize their research that are currently hindered by systemic bottlenecks. By taking a more nuanced approach at the research organization level that aligns incentives with opportunities, the paper argues that researchers and those who pursue commercialization of that research would be more successful in their endeavors.


Activities, News, & Events

a lit lightbulb hanging next to unlit bulbs

CPIP Director of Copyright Research and Policy Sandra Aistars and the students in her Arts & Entertainment Advocacy Clinic joined the Washington Area Lawyers for the Arts (WALA) and the Copyright Alliance to co-host a virtual event entitled Arts and the Pandemic to discuss how local venues and artists are affected by the pandemic and to offer legal assistance to individual artists and small businesses. Prof. Aistars has written two recent articles at Law360 about the Google v. Oracle case. The first, RBG’s Legacy Can Guide High Court In Oracle Copyright Case, traverses the late Justice Ginsburg’s love of the arts and copyright legacy and runs through the various legal issues to explain why Google’s position is wrong on the merits. The second, High Court Oracle-Google Copyright War May Benefit Artists, examines how a case that is ostensibly about computer code could have a significant impact on the livelihoods of all artists and authors. Finally, Prof. Aistars spoke at the 2020 National Volunteer Lawyers for the Arts (NVLA) conference, discussing how to protect the arts and the importance of reversing anti-IP biases in academia.

CPIP Senior Fellow for Innovation Policy Jonathan Barnett published an op-ed at The Hill entitled “Unfair Use,” Democracy and the Supreme Court about the imbalance created by the expansion of copyright law’s fair use doctrine in recent years. Prof. Barnett explains how and why the Court can rein in the fair use doctrine in Google v. Oracle, noting that the current fair use “groupthink” dogmatism fails to recognize that platform aggregators improperly rely on the exception to generate billions of dollars annually despite having borne neither the costs nor risks of developing the content. Prof. Barnett also published an essay at Truth on the Market entitled Antitrustifying Contract: Thoughts on Epic Games v. Apple and Apple v. Qualcomm. The essay explains how the Epic v. Apple and Apple v. Qualcomm cases demonstrate “the unproductive rent-seeking outcomes to which antitrust law will inevitably be led if, as is being widely advocated, it is decoupled from its well-established foundation in promoting consumer welfare—and not competitor welfare.”

CPIP Senior Scholar Erika Lietzan has published a new article in the Cato Institute’s Regulation entitled The Evergreening Myth that discusses recent efforts by U.S. policymakers to reduce so-called pharmaceutical “evergreening” by changing the antitrust, intellectual property, and regulatory landscape. Prof. Lietzan explains that claims of evergreening, where drug companies supposedly block competition by improper means, are revealed to be myths upon closer inspection. Indeed, its proponents are making unstated normative claims that blind policymakers from making informed decisions based on rigorous evidence. As Prof. Lietzan concludes, the “term’s meaninglessness makes it impossible for audiences to distinguish among situations that may be different, as a legal, theoretical, or normative matter, and that may call for differing policy solutions,” and this “does a disservice to policymakers and the public.”

CPIP Senior Scholar Kristen Osenga has published a pair of op-eds on how policymakers and regulators are threatening innovation. In an op-ed entitled Price Controls Are Intellectual Property Theft by a Different Name at Townhall, Prof. Osenga discusses a recent executive order that would decrease Medicare payments for many prescription medications to match the lowest price paid in other developed countries. This policy, which she describes as “myopic at best and downright reckless at worst,” fails to consider the devastating impact it would have on medical innovation in the United States—and how it would ultimately hurt patients in the long run. At RealClearMarkets, Prof. Osenga published an op-ed entitled Today’s Federal Trade Commission Is Taking One Giant Leap Backwards that discusses the FTC’s misguided efforts to pit antitrust and patents against each other. As she explains, patent and antitrust law share the same goal of increasing innovation. Prof. Osenga concludes: “Rather than tilting at windmills already lost, it is time for the FTC to move forward and set their focus on real impediments to innovation and competition.”


Categories
C-IP2 News Patent Law

CPIP 2020 Fall Conference: Day Two Recap

The following post comes from Wade Cribbs, a 2L at Scalia Law and a Research Assistant at CPIP. This is the second of two posts (see day one recap) summarizing our two-day 5G at the Nexus of IP, Antitrust, and Technology Leadership conference that was held online from George Mason University Antonin Scalia Law School on October 7-8, 2020.

By Wade Cribbs

On October 7-8, 2020, CPIP hosted its Eighth Annual Fall Conference, 5G at the Nexus of IP, Antitrust, and Technology Leadership, online from George Mason University Antonin Scalia Law School in Arlington, Virginia. The conference featured a keynote address by the Honorable Andrei Iancu, and it was co-hosted by Scalia Law’s National Security Institute (NSI).

This conference addressed fast-emerging intellectual property (IP), antitrust, and technology leadership issues in the 5G and “Internet of Things” innovation ecosystem. Coverage included standard-essential patents (SEPs) along with established and emerging markets on a regional and global basis. Speakers were drawn from the academic, industry, and policymaking communities, with an emphasis on using objective fact-based analysis to explore points of convergence among legal, economic, and geopolitical perspectives on the IP and regulatory infrastructures that underlie these critical industries.

SESSION 3: MARKETS WORK: PRIVATE ORDERING MECHANISMS IN PATENT-INTENSIVE MARKETS

The first panel of the day consisted of academics and industry experts discussing the path moving forward for intellectual property licensing and how it relates to 5G technology. CPIP Executive Director Sean O’Conner moderated the panel, directing a conversation on the mechanisms for controlling intellectual property licensing and the conflict between antitrust policy and private-ordering initiatives. Panelists included Prof. Jonathan Barnett of the University of Southern California, Dr. Bowman Heiden of the University of California, Berkeley, David Kappos of Cravath, Swain & Moore, and Luke McLeroy of Avanci.

Prof. Barnett opened the panel with a discussion of the difference between the theoretical models of IP licensing and the actual standard-essential patent market. According to the models, the burden of many standard-essential patents involved in developing a smartphone should cripple the smartphone market. Smartphones should cost thousands of dollars due only to the cost of royalties necessary for production. However, as Prof. Barnett pointed out, smartphones are more available than ever and at every price point. The empirical evidence confirms the theoretical models’ fears are inaccurate as the aggregate royalty burden is in the single digits.

Prof. Barnett went on to illustrate how this empirical evidence is shaping the DOJ Antitrust Division’s view of IP licensing. The fear has shifted from patent holdup, large patent royalties preventing innovation and competition, to a fear of patent holdout. Prof. Barnett explained that patent holdout is becoming common place in the market where a company’s most efficient method of obtaining an IP license is through litigation as opposed to negotiating a competitive licensing fee. Prof. Barnett concluded by suggesting that patent holdout occurs where property rights are not strong and clear. Where injunctive relief is awarded readily and aggressively to license owners, in the United Kingdom and Europe, patent holdout is not a prevalent issue.

Dr. Bowman framed the issue as an interplay between the public and private spheres. For the private sphere to produce, protection of its investment in the form of patents is necessary. The conflict is the public’s access to the private sector’s production is easily frustrated by a large number of standard-essential patents in an industry. Because access to the product is in the interest of the private sphere, the private sphere has solved its own problem. Industries require an agreement from a patent owner to license its patents on terms that are fair, reasonable, and non-discriminatory (FRAND). Without a FRAND agreement, a patent cannot be a standard-essential patent.

Dr. Bowman then examined the implementation of FRANDs in the wireless communication ecosystem. He argued that the inherent vagueness of FRANDs are a necessary feature as it allows for varied and customized solutions. Additionally, the public sphere, or other members of the private sphere, can obtain an advantage through antitrust authorities. However, innovation on the private side is always preferable to antitrust regulations.

Mr. Kappos began by emphasizing the need for balance between innovators and implementers. Current innovation-based standards create enormous consumer surplus, totaling nearly four trillion dollars in the wireless communication industry. He went on to say that innovation-based standards are far superior to previous proprietary, winner-take-all standards that produced limited consumer surplus.

Mr. Kappos further developed Prof. Barnett’s point about the need for injunctive relief to protect innovators. He highlighted that preliminary injunctive relief is available in other IP hubs, such as China and Germany, but that the United States has all but given up on awarding injunctive relief to innovators. In many cases, even when injunctive remedies are available, more is needed to compensate innovators for the lost opportunity, income, and effort. He then added that there needs to be a new recognition in license negotiations. Those who delay or try to avoid paying for licenses should be forced to pay a premium once they finally comply.

Mr. McLeroy discussed the nature of his licensing company Avanci. The company streamlines licensing of cellular standard-essential patents for internet connectivity in commercial products such as cars. It simplifies licensing by compacting all standard-essential licenses, from multiple patent owners, necessary for a product and offering them to companies in the industry at a flat rate. Avanci lowers the transaction costs by removing the time needed to identify the patents necessary and evaluate what the proper fee should be. This reduction in transaction costs allows the innovator to spend money that would have been spent on searching and negotiation back into research and development.

In response to a question, Mr. McLeroy discussed the way that 5G licensing will be administered. One potential method is based on usage. He compared a water meter intermittently transmitting data with autonomous cars constantly interacting with other vehicles and intersection equipment. The licensing fee for the water meter would be much lower than for the autonomous car due to the significantly lower scale of data transfer necessary to operate it.

All panelists agreed that strong and clear property rights in innovation are necessary for a productive global licensing market. Injunctive relief is also a necessary tool that must be made available to those developing innovative standard-essential patents.

SESSION 4: TECHNOLOGY LEADERSHIP IN 5G/IOT MARKETS

The second panel of the day focused on what steps should be taken to protect American leadership in the innovative technology sectors such as 5G networks. Moderator Jamil Jaffer, Founder & Executive Director of the National Security Institute (NSI), led the discussion on how the federal government can best handle the global development of 5G standards and protect American innovation from the competitive threat of China. Panelists included Megan Brown of Wiley Rain, Dr. Jonathan Putnam of Competition Dynamics, the Hon. Randall Rader of the Federal Circuit, and Andy Keiser of Navigators Global.

Dr. Putnam opened the discussion by addressing China’s patent program. Dr. Putnam described a model he created using research and development, gross national product, population, and other national indicators of inventive behavior. He noted that China subsidizes patent applications, resulting in the largest number of patents worldwide. Dr. Putnam addressed whether China has become the world leader in innovative technology. The model shows that while Chinese patent application numbers are dramatically increasing, the quality of those patents are notably lower than the rest of the world.

Dr. Putnam proposed three methods for the United States government to protect domestic interests without following the Chinese model of subsidizing innovators. First, the U.S. should unify its fractured view of antitrust on the global market. Presenting a common understanding of antitrust principles would remove a substantive fracture in U.S. foreign policy that works to China’s advantage. Second, the U.S. should take a more aggressive stance in enforcing fair trade on the world stage. There is systemic theft of foreign patent technology that must be curtailed. Third, in the pharmaceutical industry, private companies can take advantage of basic research conducted by the National Institute for Health. Applying this model to other technological sectors would be beneficial for American innovation as basic research is the foundation for most innovation.

Judge Rader agreed with Dr. Putnam that a large quantity of inferior patents is produced by China. However, Judge Rader distinguished the average patent seeker from the Chinese mega-corporations such as Huawei that produce innovation technology. Chinese mega-corporations are like American innovation leaders such as Qualcomm. Judge Rader explained that China built its platform out of subsidies in the past, but currently individual companies like Huawei devote large percentages of their gross budget to research and development that makes China a competitive innovator. China cannot be dismissed as a competitor built on unfair advantage. Instead, he urged, China must be confronted as an innovative equal that is willing to spend and supply the technology of the future.

Mr. Keiser identified China’s unique control over its market through tariffs, credit, and market manipulation. Unlike any other economy of similar size, its unique control positions China perfectly to advance its interests in innovation. Given that China is the United States’ biggest geopolitical competitor, China poses a serious threat to national security. Mr. Keiser pushed back against Judge Rader’s equal competitor view of China. He cited cases from both the United States and Poland where Huawei was found to have committed espionage and theft of competitors’ patents. Regardless of how China arrived at its current state, he said that Chinese 5G networks are not trustworthy due to consistent exploitation of foreign patents.

Ms. Brown voiced her concerns regarding the impulse to respond to China’s action by nationalizing 5G. She suggested optimizing regulation by removing the fragmented regime currently impeding innovation. The hands-off approach of Congress has facilitated longstanding U.S. leadership in innovation, and unprecedented congressional involvement would only harm American innovators. Ms. Brown framed Mr. Keiser’s point about the trustworthiness of Chinese 5G equipment and networks as a question of government intervention. Assuming these networks cannot be trusted, she asked how much the government should intervene to address the problem. In response to Dr. Putnam’s proposal of government-subsidized basic research, Ms. Brown argued that the focus should be real-world research and development with telecommunication carriers.

Ms. Brown warned that, specifically relating to 5G standard setting, the government must be careful to expend influence in its natural spheres. The 3rd Generation Partnership Project (3GPP) is a private sector, global body that leads the development of standards in 5G technology. As a global private sector organization, the federal government, in the form of the Department of Defense, has no business influencing 3GPP policy. If any government activity is warranted, she continued, it should incentivize more private American businesses to participate in and influence private organizations like 3GPP.

All the panelists agreed that the focus should be on American policy promoting domestic innovation as opposed to overreacting to the imposing threat of China. Foremost on policy makers minds must be preserving and promoting innovation from garage inventors to Qualcomm. However, Mr. Keiser stated that the scale of theft of intellectual property by China is too large to be ignored. Congressional protection in the form of laws such as the CHIPS Act, a bill to incentivize and subsidize research into semiconductors, is necessary.

CLOSING REMARKS

CPIP Executive Director Sean O’Connor and CPIP Deputy Director Joshua Kresh closed out the two-day conference by thanking all of the moderators, panelists, and attendees for making the conference such a huge success. They also thanked CPIP staff members, including Kristina Pietro, Devlin Hartline, and Mary Clare Durel, for working behind the scenes and the generous sponsors of the conference whose financial support made it possible.

Categories
Conferences Patent Law

CPIP 2020 Fall Conference: Day One Recap

The following post comes from Terence Yen, a 4E at Scalia Law and a Research Assistant at CPIP. This is the first of two posts (see day two recap) summarizing our two-day 5G at the Nexus of IP, Antitrust, and Technology Leadership conference that was held online from George Mason University Antonin Scalia Law School on October 7-8, 2020.

CPIP 2020 Fall Conference flyerBy Terence Yen

On October 7-8, 2020, CPIP hosted its Eighth Annual Fall Conference, 5G at the Nexus of IP, Antitrust, and Technology Leadership, online from George Mason University Antonin Scalia Law School in Arlington, Virginia. The conference featured a keynote address by the Honorable Andrei Iancu, and it was co-hosted by Scalia Law’s National Security Institute (NSI).

This conference addressed fast-emerging intellectual property (IP), antitrust, and technology leadership issues in the 5G and “Internet of Things” innovation ecosystem. Coverage included standard-essential patents (SEPs) along with established and emerging markets on a regional and global basis. Speakers were drawn from the academic, industry, and policymaking communities, with an emphasis on using objective fact-based analysis to explore points of convergence among legal, economic, and geopolitical perspectives on the IP and regulatory infrastructures that underlie these critical industries.

OPENING REMARKS & INTRODUCTIONS

CPIP Executive Director Sean O’Connor opened the conference by welcoming everyone to this year’s event and explaining that the conference was limited to a few hours each day to avoid “Zoom burnout.” Prof. O’Connor discussed the developing technologies of 5G and Internet of Things (IOT), which represents the systems that connect everyday objects and allow them to communicate with each other in real time. This technology increases the capability of a wide variety of industries, including automotives, home appliances, healthcare systems, and more.

CPIP Deputy Director Joshua Kresh then highlighted the various topics that would be covered during the four panel sessions and the keynote address and fireside chat by USPTO Director Andrei Iancu. Mr. Kresh also thanked the CPIP team, including Kristina Pietro, Devlin Hartline, and Mary Clare Durel, and the conference sponsors for making the conference possible.

SESSION 1: USING DATA TO INFORM POLICY: EMPIRICAL EVIDENCE ON SEPS, SSOS AND FRAND ROYALTIES

The first panel focused on the use of data to inform policy, compared with the use of theoretical models for standard-essential patents (SEPs), standard setting organizations (SSOs), and fair reasonable and non-discriminatory (FRAND) commitments. The panelists included Dr. Anne Layne-Farrar of Charles River Associates, Prof. Stephen Haber of Stanford University, and Prof. Daniel Spulber of Northwestern University, and the panel was moderated by Ted Essex of Hogan Lovells.

The panelists discussed how one of the biggest issues in this field is the setting up of royalty rates for industries such as the automotive sector, which utilize 5G and IOT. In the past, economists have warned the public about the looming problem of royalty stacking. Royalty stacking is a theory about industry collapse, wherein market power is exercised excessively and repeatedly. The theory is based on the concept that one monopoly is bad, two monopolies is worse, three monopolies is even worse, and so on. The fundamental concept is that each monopolist sets its price without taking into consideration the prices charged by other monopolists, leading to a situation where, as the number of patent owners increases, the aggregate royalty grows unsustainably and output collapses.

Despite the fears generated by royalty stacking models, however, this issue has not seemed to materialize in the real world. For example, the actual cumulative royalty yield on a smartphone is less than one-twentieth of that predicted by royalty stacking models. The reason we don’t observe this in the real world is that the theory is built on the notion of “one-time” play, meaning the people setting royalties do so independently of each other. As the data shows, this is an inaccurate portrayal of how royalty rates are set up.

The panel then went on to explain that it is important to check theories against data and real results. At the beginning of FRAND litigation, courts worried that implementers were being anticompetitively harmed by high royalty prices. As such, decisions were issued with the policy goal of protecting implementers. Over time, however, we have begun to see more balance from the courts and a higher demand for data prior to the acceptance of theoretical models.

Courts have now recognized that there is a very real problem of people using products without licenses, and that strategic or opportunistic behaviors can happen on either side of the bargaining table. As such, they are now more willing to act as gatekeepers to enforce good faith on both sides, often falling back to comparable licenses as a basic standard.

With this new emphasis on fair play from the courts, most royalty decisions are now being settled through out-of-court negotiations. Evidence shows that practically all SEP licenses are now subject to negotiation. While patent pools are often cited as the main exception, even they generally still have the option of negotiation. Evidence also suggests that SSOs develop standards through consensus decisions that are procompetitive, and most SEP licenses are mostly negotiated and enforced with contract law, making litigation rare. FRAND commitments have generally been found to be clear and effective, and it is believed that excessive regulation and antitrust intervention would impede standardization. Data shows that FRAND commitments encourage the adoption of standards, do not generate market power, and are consistent with invention and innovation.

The increase in negotiation eliminates many predicted outcomes for theories, which makes data even more important. Accurate real-life data informs public policy, and research in this field is shifting towards new techniques for gathering and analyzing big data, as well as increased use of AI and big data.

This trend helps to avoid policy decisions based on guesswork and provides evidence-based analysis helpful to courts and agencies.

KEYNOTE ADDRESS & FIRESIDE CHAT

“IP controls the destiny of virtually every industry.” Andrei Iancu, Under Secretary of Commerce for Intellectual Property and Director of the USPTO, started his keynote address with this bold statement. Advanced digital technologies are transforming virtually every product, manufacturing process, and logistical system, and protecting the IP rights to those technologies is not only a right mentioned in the Constitution, but is the foundation of wealth creation for our nation.

As Director Iancu explained, the advancement of 5G and IOT technology will form the backbone of a new system of autonomous vehicles, smart cities, intelligent appliances, telerobotic surgeries, precision agriculture, and much more. However, our nation faces the reality that the United States is falling behind in the intellectual property arms race.

Twenty years ago, the number of patent applications being filed by Chinese citizens was practically zero. By 2018, however, that number reached almost 1.5 million per year, approximately three times the number of American applications. Chinese applications have increased at an average rate of 26% each year, as opposed to a 2-3% annual increase for the U.S. While some may call into question the quality of these Chinese patent applications, Director Iancu noted that the sheer magnitude indicates that China is at minimum attending diligently to its intellectual property portfolios in areas critical to the next technological revolution. This remarkable trend can in part be attributed to China’s extensive system of government incentives for IP, which include tax incentives, subsidies for patents, and other monetary and nonmonetary rewards. As foreign nations like China continue to outperform the U.S. in amassing a rich depth of technological patents, U.S. companies may end up paying billions in royalties as those patents become increasingly vital to the upcoming technological revolution.

Director Iancu went on the explain that the U.S. must take steps to ensure that American technology is able to keep up with foreign technological development. To do so, we must have a robust system of predictable patent rights to maintain the incentives to innovate. If we are forced to use only technologies that are in the public domain, standards will inevitably be stunted.

Recognizing that private sector inventions are the primary source of SEPs, Director Iancu explained the need for a market-driven licensing system and the role of the government in the transition to 5G. He emphasized that it is the Patent Office’s goal to maintain balance between licensors and licensees, and he ended his presentation with the promise that the “USPTO will be steadfast in ensuring that we have a fair and balanced licensing system driven by the needs of the industry.”

Director Iancu then went on to have a fireside chat with CPIP Executive Director Sean O’Connor, taking questions from the audience at the end.

SESSION 2: IP MEETS ANTITRUST AROUND THE GLOBE: POLICY DEVELOPMENTS IN THE LEGAL TREATMENT OF SEPS AND FRAND

The final session of the day included panelists Maureen Ohlhausen of Baker Botts, Dr. Urška Petrovčič of the Hudson Institute, Prof. Daniel Sokol of the University of Florida, and Prof. John Yun of Scalia Law. The panel was moderated by Prof. Henry Butler, Dean of Scalia Law and Executive Director of the law school’s Law & Economics Center.

The panelists discussed how innovation is crucial to the U.S. economy and how IP has been one of the primary drivers of the economy for the last 60 years. Throughout that time, IP and antitrust law have consistently been found to be complementary fields, as both are aimed at encouraging innovation, industry, and competition.

FRAND issues arise in the context of standards setting, as SDOs commonly adopt patent policies to promote access after a standard is adopted. In tech areas especially, hundreds of patents are often necessary to create a working product. This requires standards for fair and reasonable licensing policies, though there is some dispute as to whether the breach of FRAND commitments is an antitrust concern. Blanket licensing policies can offer higher efficiencies related to reduced transaction costs and patent peace, but the concern is that it may be a form of tying arrangement. However, it should be noted that U.S. antitrust agencies have long acknowledged that blanket licensing does not always raise antitrust concerns.

One issue of contention is the topic of injunctions. The confusions raised on the subject have drawn the attentions of the DOJ and FTC, most recently with their post-Madison approach. The DOJ holds that patent holdup is not an antitrust problem and that SSOs should better protect against holdout to ensure maximum incentives to innovate. It believes that patent owner injunction rights should be protected, not persecuted, and that a unilateral and unconditional refusal to license a valid patent should be per se legal. The FTC agrees with some of that approach, with the opinion that breach of FRAND alone is not an antitrust problem, but both hold-out and hold-up can raise serious concerns.

As a general trend, U.S. courts have begun to move away from the idea that IP owners are very constrained by antitrust and must license. However, the advent of 5G is sure to raise a whole new slew of issues, and the 5G battle will be a very different conflict from what we have seen before. Up until now, many of the most politically connected companies around the world have not played a significant role in this debate. With 5G being the future of IOT, however, many more elements of the supply chain will be involved on this issue, and many previously uninvolved players will want to shake up the case law in their favor.

Thus far, European courts have also moved towards the trend of acknowledging that FRAND compliance may make injunctions more difficult, but there are no rules specifically barring injunctions, so the option remains on the table. European courts have generally put forth the opinion that they want to protect the interests of both implementers and SEP owners, and they are currently less willing to adopt conclusions based on categorical rules or abstract theories, preferring evidence-based analysis instead.

At the center of this multisided issue is SSOs. SSOs balance the interests of two competing groups with different incentives: the innovators and the implementers. By design, SSOs are avoiding cracking down on the issue with bold decisions so as not to disrupt the balance between two sides.

The panelists agreed that, as of right now, nothing is set in stone. Antitrust, especially in combination with IP and contract law, remains in a state of flux. This has led to a lot of uncertainty in investments, which may impact our ability to innovate. Amongst its concluding thoughts on the issue, the panel noted that there are titanic conflicts yet to come, and as far as this field is concerned, “winter is coming.”

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Scalia Law

CPIP Welcomes Ken Randall as Next Dean of Scalia Law School

the word "Mason" set up outdoors on campus with people walking behindGeorge Mason University has announced that Ken Randall will be the next Dean of Antonin Scalia Law School, beginning on December 1, 2020.

CPIP Executive Director Sean O’Connor welcomed the news: “We couldn’t be happier with the selection of Ken Randall as Dean-Elect. He cares deeply about the continued success of CPIP and is no stranger to innovation and commercialization. He and I have already developed a great working relationship, and CPIP endeavors to support his Deanship in any way we can. We also thank Dean Henry Butler for his outstanding leadership and look forward to working with him as a faculty colleague and Executive Director of the Law & Economics Center.”

Dean Randall has a proven track record as an effective administrator and innovator. He served as the Dean of the University of Alabama School of Law for twenty years, taking the school from 96th to 21st place in the U.S. News & World Report law school rankings. The school likewise rose to 7th place as the best public law school under his watch. Dean Randall is also the President and Founder of iLaw, a market leader in legal distance learning that has partnered with 30 graduate programs and worked alongside 25% of the accredited law schools.

Dean Randall is an accomplished scholar. He holds four law degrees: a J.S.D. and LL.M. from Columbia Law School, an LL.M. from Yale Law School, and a J.D. from Hofstra Law School, where he served as editor-in-chief of the Hofstra Law Review. He has authored a book on international law that was published by the Duke University Press, and his law review articles have appeared in many top journals.

The Center for the Protection of Intellectual Property congratulates Dean Randall on his appointment and welcomes him to the Scalia Law family. His rigorous academic mind, strong leadership skills, and expertise in online learning bring together the ideal skill set to take our law school to new heights. We very much look forward to working with him in the near future.