Law Commons^™

Renewing Faith In Antitrust: Unveiling The Hidden Network Behind Pharmaceutical Product Hopping, Victoria Field

Fordham Journal of Corporate & Financial Law

Patents grant time-limited market exclusivity to drug manufacturers, meaning that other companies are prohibited from copying and selling the patented pharmaceutical. This allows manufacturers to lawfully charge monopoly prices. Generic competition starts at the expiration of the patent. To maintain coveted monopoly power, manufacturers often release an alternative formulation of the drug with a fresh patent that enjoys continued market exclusivity. Manufacturers who can convert their consumer base to the new formulation can continue charging peak prices. This process, called “product hopping,” has been the target of significant antitrust inquiry, with mixed results.

A product hop may be the result …

Patents And Price Fixing By Serial Colluders, Michael J. Meurer, William Kovacic, Robert Marshall

Faculty Scholarship

Antitrust law has long been mindful of the danger that firms may misuse their patents to facilitate price fixing. Courts and commentators addressing this danger have assumed that patent-facilitated price fixing occurs in a single market. In this Article, we extend conventional analysis to address firms’ patent misuse to facilitate price fixing across multiple products lines. By doing so, we expose gaps in existing agency enforcement and scholarly proposals for reform. Important legal tests that make sense in the single market setting do not carry over to the context we call serial collusion, where certain offenders engage in repeat collusion …

United States Supreme Court Ip Cases, 1810–2019: Measuring & Mapping The Citation Networks, Joseph Scott Miller

Catholic University Law Review

Intellectual property law in the United States, though shaped by key statutes, has long been a common-law field to a great degree. Many decades of decisional law flesh out the meaning of broad-textured, sparely worded statutes. Given the key roles of patent law and copyright law, both federal, the Supreme Court of the United States is i.p. law’s leading apex court. What are the major topical currents in the Supreme Court’s i.p. cases, both now and over the course of the Court’s work? This study uses network-analysis tools to measure and map the entirety of the Court’s i.p. jurisprudence. It …

Google V. Oracle Amicus Merits Stage Brief: Vindicating Ip’S Channeling Principle And Restoring Jurisdictional Balance To Software Copyright Protection, Peter Menell, David Nimmer, Shyamkrishna Balganesh

All Faculty Scholarship

The Federal Circuit’s decisions in Oracle v. Google conflict with this Court’s seminal decision in Baker v. Selden, 101 U.S. 99 (1879), misinterpret Congress’s codification of this Court’s fundamental channeling principle and related limiting doctrines, and upend nearly three decades of sound, well-settled, and critically important decisions of multiple regional circuits on the scope of copyright protection for computer software. Based on the fundamental channeling principle enunciated in Baker v. Selden, as reflected in § 102(b) of the Copyright Act, the functional requirements of APIs for computer systems and devices, like the internal workings of other machines, are …

The New Madison Approach To Antitrust Law And Intellectual Property Law, Anita Alanko

Catholic University Journal of Law and Technology

The New Madison Approach has recently been introduced by the Department of Justice Antitrust Division in an effort to address a weakening of patent rights in recent years. The approach has four premises: patent hold-up is not an antitrust problem, standard setting organizations should better protect against patent hold-out to ensure maximum incentives to innovate, patent holder injunction rights should be protected and not limited, and a unilateral and unconditional refusal to license a valid patent should be per se legal. After providing an introduction to the relevant law and terms of art, support and criticism of the New Madison …

Regulatory Malfunctions In The Drug Patent Ecosystem, Ana Santos Rutschman

All Faculty Scholarship

Patent protection for several of the world’s best-selling and most promising drugs — biologics — has begun waning. Over the next few years, many other drugs in this category will lose critical patent protection. In principle, this should open the United States market to competition, as more manufacturers are now able to produce relatively cheaper versions of these expensive drugs, known as biosimilars. That, however, has not been the case. This Article examines this problem in the context of the articulation between anticompetitive behaviors and regulatory interventions in the biopharmaceutical arena, and argues for a novel solution: a timelier response …

Update On Antitrust And Pay-For-Delay: Evaluating “No Authorized Generic” And “Exclusive License” Provisions In Hatch-Waxman Settlements, Saami Zain

San Diego Law Review

In Federal Trade Commission v. Actavis, the United States Supreme Court held that a patent litigation settlement where a branded drug company pays a generic drug company to end the litigation and delay launching its generic may violate the antitrust laws. Although the decision ended years of controversy over whether such settlements were subject to antitrust scrutiny, many issues remain unresolved concerning the lawfulness of these settlements. In particular, courts have struggled in assessing the legality of patent settlements between branded and generic drug manufacturers involving non-cash compensation or benefits. This article discusses one type of non-cash compensation that is …

The Mystery Of Section 253(B), Matthew Gagnier

Marquette Intellectual Property Law Review

In 2014, Elon Musk, the renowned and socially-minded CEO of Tesla Motors, Inc., posted a blog on Tesla’s website that stated the company would be freeing up many of its patents involved in the creation of the company’s electric cars to any interested party. Yet again, Musk astounded the public by choosing the betterment of society over corporate profits—stirring up a more positive image than any other corporate personality. But there are numerous questions that Musk’s positive PR have drowned out: Where can you access the patents?; How did freeing up the patents get past the other executive officers and …

Brief Amici Curiae Of Intellectual Property Professors In Support Of Petitioner, No. 18-600, Texas Advanced Optoelectronic Solutions, Inc. V. Renesas Electronics America, Inc., Timothy R. Holbrook, Ann Bartow, Andrew Chin, David C. Hricik, Yvette Joy Liebesman, Lucas Osborn

All Faculty Scholarship

To comply with the obligations of the Uruguay Round Agreements, particularly the Agreement on the Trade Related Aspects of Intellectual Property (TRIPS), Congress amended 35 U.S.C. § 271(a) to make it an act of infringement to “offer to sell” a patented invention within the United States. See Uruguay Round Agreements Act, Pub. L. No. 103-465, §§ 531-533, 108 Stat. 4809 (1994).

The Federal Circuit has interpreted this provision in a manner contrary to the presumption against the extraterritorial reach of United States laws. The Federal Circuit has held that location of the ultimate sale contemplated in the offer controls the …

The Antitrusting Of Patentability, Saurabh Vishnubhakat

Faculty Scholarship

Deciding a patent’s validity is costly, and so is deciding it incorrectly. Judges and juries must expend significant resources in order to reach a patent validity determination that is properly informed by the relevant facts. At the same time, patent validity determinations reached quickly and cheaply may conserve resources today while creating future costs. Wrongly preserving an invalid patent can distort the competitive market and enable abuses, such as nuisance litigation. Meanwhile, wrongly striking down a valid patent can undermine incentives for continued investment and commercialization in knowledge assets. Courts facing patent validity issues have begun to strike this balance …

The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition.This paper is an effort to assist courts and …

Activating Actavis, Aaron Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

In Federal Trade Commission v. Actavis, Inc., the Supreme Court provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. The Court came down strongly in favor of an antitrust solution to the problem, concluding that “an antitrust action is likely to prove more feasible administratively than the Eleventh Circuit believed.” At the same time, Justice Breyer’s majority opinion acknowledged that the Court did not answer every relevant question. The opinion closed by “leav[ing] to the lower courts the structuring of the present rule-of-reason antitrust litigation.”This article is an effort to help courts and counsel …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

Aaron Edlin

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to confirm …

The Rise Of Ethical License, Christi Guerrini, Margaret Curnette, Jacob S. Sherkow, Christopher Scott

Other Publications

The Broad Institute's recent licensing of its gene editing patent portfolio demonstrates how licenses can be used to restrict controversial applications of emerging technologies while society deliberates their implications.

Aggregated Royalties For Top-Down Frand Determinations: Revisiting "Joint Negotiation", Jorge L. Contreras

Utah Law Faculty Scholarship

In an environment in which widely-adopted technical standards may each be covered by large numbers of patents, there have been increasing calls for courts to determine “fair, reasonable and non-discriminatory” (FRAND) royalties payable to holders of standardsessential patents (SEPs) using “top-down” methodologies. Top-down royalty approaches begin with the aggregate royalty that should be payable with respect to all SEPs covering a particular standard, and then allocate a portion of the total to individual SEPs. Top-down approaches avoid many drawbacks associated with bottom-up approaches in which royalties for individual SEPs are assessed, often in an inconsistent and piecemeal manner, without regard …

First Steps In Building An Intellectual Property Program And Portfolio, Jeffrey D. Sullivan

Journal of Intellectual Property Law

No abstract provided.

Network Effects In Technology Markets: Applying The Lessons Of Intel And Microsoft To Future Clashes Between Antitrust And Intellectual Property, John T. Soma, Kevin B. Davis

Journal of Intellectual Property Law

No abstract provided.

Intersection Between The Patent System And Antitrust Laws: Patents Speeding, Antitrust Yielding, Innovation Bleeding!, Stijepko Tokic

Akron Intellectual Property Journal

In this article, I explain the interaction between the two laws and describe the ways in which these two extremely important areas of government regulation are and are not in tension. I argue that the conflict between the two laws is overstated, but the proper balance is far from being found. The reason for that is a notion that the current state of the patent system is more of a hindrance than a spur to innovation and competition due to overprotection and broadening of patent rights, lowering of standards to grant patents, chronic inefficiency of the Patent and Trademark Office …

Permissible Product Hopping: Why A Per Se Legal Rule Barring Antitrust Liability Is Necessary To Protect Future Innovation In The Pharmaceutical Industry, Michelle L. Ethier

Akron Intellectual Property Journal

Pharmaceutical product hopping is a relatively new phenomenon in which a brand-name pharmaceutical company tactically reformulates a drug and patents the reformulation in an attempt to avoid competition by a generic competitor. When viewed in the context of the HatchWaxman framework, product hopping can effectively eliminate generic competitors from the market, thereby implicating § 2 of the Sherman Act. In addressing antitrust liability, this Note advocates a per se legal approach to product hopping so long as the hop is supported by a valid patent. Although some have argued that deference to the United States Patent and Trademark Office and …

Who Owns Gene Editing? Patents In The Time Of Crispr, Jacob S. Sherkow

Other Publications

New gene-editing technologies, like CRISPR, promise revolutionary advances in biology and medicine. However, several patent disputes in the USA and UK may have complicated who can use CRISPR. What does this mean for the future of gene editing?

The Actavis Inference: Theory And Practice, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

All Faculty Scholarship

In FTC v. Actavis, Inc., the Supreme Court considered "reverse payment" settlements of patent infringement litigation. In such a settlement, a patentee pays the alleged infringer to settle, and the alleged infringer agrees not to enter the market for a period of time. The Court held that a reverse payment settlement violates antitrust law if the patentee is paying to avoid competition. The core insight of Actavis is the Actavis Inference: a large and otherwise unexplained payment, combined with delayed entry, supports a reasonable inference of harm to consumers from lessened competition.

This paper is an effort to assist courts …

Licensing Of Intellectual Property Rights, Mark Joelson

Georgia Journal of International & Comparative Law

No abstract provided.

Buying Teams, Andres Sawicki

Seattle University Law Review

The Sixth Annual Berle Symposium reflects on Margaret Blair and Lynn Stout’s classic article: A Team Production Theory of Corporate Law. Blair and Stout recast the modern law of public corporations through the lens of the team production theory of the firm. Here, I apply Blair and Stout’s insights—emphasizing the value of team production, independent monitors, and intellectual property rights—to a novel corporate transaction structure: the acqui-hire. In an acqui-hire, a publicly owned technology firm wants to add a start-up’s engineers. Instead of simply hiring them, though, it buys the start-up, discards most of its assets, and retains the start-up’s …

Administrating Patent Litigation, Jacob S. Sherkow

Articles & Chapters

Recent patent litigation reform efforts have focused on every branch of govemment-Congress, the President, and the federal courts-save the fourth: administrative agencies. Agencies, however, possess a variety of functions in patent litigation: they serve as "gatekeepers" to litigation in federal court; they provide scientific and technical expertise to patent disputes; they review patent litigation to fulfill their own mandates; and they serve, in several instances, as entirely alternative fora to federal litigation.

Understanding administrative agencies' functions in managing or directing, i.e., "administrating," patent litigation sheds both descriptive and normative insight on several aspects of patent reform. These include several problems …

Actavis And Error Costs: A Reply To Critics, Aaron S. Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

All Faculty Scholarship

The Supreme Court’s opinion in Federal Trade Commission v. Actavis, Inc. provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. In our previous article, Activating Actavis, we identified and operationalized the essential features of the Court’s analysis. Our analysis has been challenged by four economists, who argue that our approach might condemn procompetitive settlements.

As we explain in this reply, such settlements are feasible, however, only under special circumstances. Moreover, even where feasible, the parties would not actually choose such a settlement in equilibrium. These considerations, and others discussed in the reply, serve to …

Non-Price Competition In “Substitute" Drugs: The Ftc's Blind Spot, Gregory Dolin

All Faculty Scholarship

As the recent case of United States v. Lundbeck illustrates, the Federal Trade Commission’s lack of knowledge in medical and pharmacological sciences affects its evaluation of transactions between medical and pharmaceutical companies that involve transfers of rights to manufacture or sell drugs, causing the agency to object to such transactions without solid basis for doing so. This article argues that in order to properly define a pharmaceutical market, one must not just consider the condition that competing drugs are meant to treat, but also take into account whether there are “off-label” drugs that are used to treat a relevant condition, …

Inevitable Imbalance: Why Ftc V. Actavis Was Inadequate To Solve The Reverse Payment Settlement Problem And Proposing A New Amendment To The Hatch-Waxman Act, Rachel A. Lewis

Seattle University Law Review

The law regarding reverse payment settlements is anything but settled. Reverse payment settlements are settlements that occur during a patent infringement litigation in which a pharmaceutical patent holder pays a generic drug producer to not infringe on the pharmaceutical patent. Despite the recent decision by the United States Supreme Court in FTC v. Actavis, Inc., there are still unanswered questions about how the “full rule of reason” analysis will be applied to reverse payment. This Comment argues that despite the outcome in Actavis, the complex regulatory framework of the Hatch–Waxman Act will create repeated conflicts between antitrust law and patent …

Intellectual Property Experimentalism By Way Of Competition Law, Tim Wu

Faculty Scholarship

Competition law and Intellectual Property have divergent intellectual cultures – the former more pragmatic and experimentalist; the latter influenced by natural law and vested rights. The US Supreme Court decision in Federal Trade Commission v. Actavis is an intellectual victory for the former approach, one that suggests that antitrust law can and should be used to introduce greater scrutiny of the specific consequences of intellectual property grants.

Activating Actavis, Aaron Edlin, C. Scott Hemphill, Herbert J. Hovenkamp, Carl Shapiro

All Faculty Scholarship

In Federal Trade Commission v. Actavis, Inc., the Supreme Court provided fundamental guidance about how courts should handle antitrust challenges to reverse payment patent settlements. The Court came down strongly in favor of an antitrust solution to the problem, concluding that “an antitrust action is likely to prove more feasible administratively than the Eleventh Circuit believed.” At the same time, Justice Breyer’s majority opinion acknowledged that the Court did not answer every relevant question. The opinion closed by “leav[ing] to the lower courts the structuring of the present rule-of-reason antitrust litigation.”

This article is an effort to help courts and …

Fixing Frand: A Pseudo-Pool Approach To Standards-Based Patent Licensing, Jorge Contreras

Jorge L Contreras

Technical interoperability standards are critical elements of mobile telephones, laptop computers, digital files, and thousands of other products in the modern networked economy. Most such standards are developed in so-called voluntary standards-development organizations (SDOs) that require participants to license patents essential to the standard on terms that are “fair, reasonable and non-discriminatory” (FRAND). FRAND commitments are thought to avoid the problem of patent hold-up: the imposition of excessive royalty demands after a standard has been widely adopted in the market. While, at first blush, FRAND commitments seem to assure product vendors that patents will not obstruct the manufacture and sale …