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"The unique and mutually beneficial partnership that led to the approval of Kalydeco serves as a great model for what companies and patient groups can achieve if they collaborate on drug development." 1 In January 2012, the FDA approved a new breakthrough drug for cystic fibrosis: Kalydeco (ivacaftor), the first available drug that treats the cause and not just the symptoms of cystic fibrosis. 2 Cystic fibrosis is the most common fatal genetic disease among Caucasians, affecting approximately 30,000 people in the United States. 3 The average life expectancy for people with the disease is thirty-eight years. 4 [*287] While the gene that causes cystic fibrosis was discovered in 1989, 5 it has taken over two decades and a unique collaboration to find a cure. 6 The collaboration that gave rise to this drug discovery involved a partnership between a for-profit bioscience company, Vertex Pharmaceuticals, and a national nonprofit organization, the Cystic Fibrosis Foundation. 7 The impetus for this collaboration was simple: "the disease is prevalent enough to cause widespread pain, but too small for profit-minded bioscience companies to risk massive resources in pursuit of a cure." 8 Thus, the Foundation invested over $ 45 million into Vertex in 2000 for research and development of a drug for the disease. 9 This was "the largest grant of its kind by a nonprofit disease group." 10 By 2012, the Foundation had awarded Vertex over $ 75 million in funding 11 and has invested $ 260 million in drug development since the mid-1990s. 12 When the Cystic Fibrosis Foundation made its initial investment, such "venture philanthropy" was uncommon. 13 As the chief executive, Robert Beall, told one reporter, it was "the biggest gamble I ever made." 14 Today, however, such partnerships are becoming more common. 15 In 2008, U.S. disease foundations [*288] invested approximately $ 90 million into for-profit companies for drug development. 16 This was thirteen times more than was invested in 2000. 17

The core question for intellectual property law is identifying which branch of government, Congress or the Supreme Court, is more likely to effect intellectual property laws that achieve socially desirable objectives. The answer to this question turns somewhat on whether one takes an instrumentalist or deontological view of the goals of intellectual property law.

The Intellectual Property Clause of the Constitution grants Congress the power "to promote the Progress of Science and useful Arts" by enacting copyright and patent laws. 326 Consistent with this consequentialist preamble, the dominant view of intellectual property law and policy in the United States has often been that intellectual property law exists in order to incentivize creative and innovative activity. 327 The incentive theory of intellectual property law is based on the rationale that providing authors and inventors with the potential for intellectual property rights will induce them to engage in greater innovative activity than they would otherwise, from the creation to the production to the commercialization of intellectual works. 328

This compilation represents the first systematic attempt to present in complete and available form the vast quantity of judicial interpretation and construction of the meaning of words and phrases found in the reported decisions of the American appellate courts. It has been over ten years in preparation, and has involved enormous editorial labor and research. The effort has been made to secure all the words judicially defined and all the definitions of each word. In collecting the material recourse has been had in all cases to the opinions of the courts as the original sources, and the work is the result of a page-to-page examination of the reported American cases. A careful search for definitions for words and phrases has also been made in all the latest codes and revisions of statutes, state and federal.

If possible, every word and every provision is to be given effect (verba cum effectu sunt accipienda1). None should be ignored. None should needlessly be given an interpretation that causes it to duplicate another provision or to have no consequence.

“These words cannot be meaningless, else they would not have been used.”

The verb to include introduces examples, not an exhaustive list.

In normal English usage, if a group “consists of” or “comprises” 300 lawyers, it contains precisely that number. If it “includes” 300 lawyers, there may well be thousands of other members from all walks of life as well. That is, the word include does not ordinarily introduce an exhaustive list, while comprise—with an exception that we will discuss shortly—ordinarily does. That is the rule both in good English usage1 and in textualist decision-making.2 Some jurisdictions have even codified a rule about include.3

Virtually all the authorities who discuss the negative-implication canon emphasize that it must be applied with great caution, since its application depends so much on context.1 Indeed, one commentator suggests that it is not a proper canon at all but merely a description of the result gleaned from context.2 That goes too far. Context establishes the conditions for applying the canon, but where those conditions exist, the principle that specification of the one implies exclusion of the other validly describes how people express themselves and understand verbal expression.

The doctrine properly applies only when the unius (or technically, unum, the thing specified) can reasonably be thought to be an expression of all that shares in the grant or prohibition involved. Common sense often suggests when this is or is not so. The sign outside a restaurant “No dogs allowed” cannot be thought to mean that no other creatures are excluded—as if pet monkeys, potbellied pigs, and baby elephants might be quite welcome. Dogs are specifically addressed because they are the animals that customers are most likely to bring in; nothing is implied about other animals. On the other hand, the sign outside a veterinary clinic saying “Open for treatment of dogs, cats, horses, and all other farm and domestic animals” does suggest (by its detail) that the circus lion with a health problem is out of luck. (Notice how ejusdem generis [§ 32] also comes into play with this example.) The more specific the enumeration, the greater the force of the canon:

The expression of one thing implies the exclusion of others (expressio unius est exclusio alterius).

Expressio unius, also known as inclusio unius, is a Latin name for the communicative device known as negative implication. In English, it is known as the negative-implication canon. We encounter the device—and recognize it—frequently in our daily lives. When a car dealer promises a low financing rate to “purchasers with good credit,” it is entirely clear that the rate is not available to purchasers with spotty credit.

General terms are to be given their general meaning (generalia verba sunt generaliter intelligenda).

Without some indication to the contrary, general words (like all words, general or not) are to be accorded their full and fair scope. They are not to be arbitrarily limited. This is the general-terms canon, which is based on the reality that it is possible and useful to formulate categories (e.g., “dangerous weapons”) without knowing all the items that may fit—or may later, once invented, come to fit—within those categories.

Words are to be understood in their ordinary, everyday meanings—unless the context indicates that they bear a technical sense.

“The enlightened patriots who framed our constitution, and the people who adopted it, must be understood to have employed words in their natural sense, and to have intended what they have said.”

Schechter and Thomas ‘3 [Roger E. and John Thomas; 2003; professor of law at George Washington University; professor of law at Georgetown University; Intellectual Property: The Law of Copyrights, Patents and Trademarks, “Introduction to Intellectual Property,” West Group]

Trademark law protects a word, phrase, symbol or design that is used by an entity to identify its product or service. Examples are Dunkin Donuts orange and pink sausage style lettering, Apple’s apple logo, and Adidas’ three stripes. Trademark owners can prevent others from using their marks, or marks which are confusingly similar so that consumers would not be able to identify the source. Federal and state laws govern trademarks but the Lanham Act is the primary source of trademark protection. These laws protect against infringement and dilution. Rights in trademarks are gained by being the first to use a trademark in commerce or being the first to register the mark with the United States Patent and Trademark Office.

Trademarks consist of any word or symbol used by a merchant to identify its goods or services, and to distinguish them from those of others.21 To be subject to protection under the trademark laws, a mark must successfully distinguish the origins of its associated goods, and not be confusingly similar to marks used by others or merely describe the characteristics of those goods.22 Trademark rights arise under state law as soon as the mark is used on goods in commerce.23 However, trademarks may be registered with the PTO, a step that affords significant substantive and procedural advantages.24 Trademark law also protects the appearance of product packaging and, in some cases, the actual physical configuration of the goods, if these serve as brand identifiers. A trademark owner may prevent others from using any mark that creates a likelihood of confusion as to the source or sponsorship of the associated goods or services.25 Trademark rights persist so long as the mark continues to be used and retains its distinctiveness.26

Patricia E. Campbell, 2023 - Law School Professor and Director of the Intellectual Property Law Program at the University of Maryland Carey School of Law “Debugging the Trademark Laws: The Lanham Act and Counterfeit Microelectronics,” 31 TEX. INTELL. PROP. L.J. 211 (2023). Hein Online. Accessed via University of Michigan //DH

When the trademark owner prevails and the defendant is found to have engaged in use of a counterfeit mark, enhanced damages and other remedies are available. Under § 35(b) of the Act, willful use of a counterfeit mark subjects the user of the infringing mark to treble damages. 155 The trademark owner also has the option to elect an award of statutory damages instead of actual damages and profits.156 The purpose of § 35 is "to take all the economic incentive out of trademark infringement."157 However, under the Lanham Act, not all trademark infringement rises to the level of counterfeiting. Counterfeiting is "the act of producing or selling a product with a sham trademark that is an intentional and calculated reproduction of the genuine trademark.", 158 It is "'hard core' or 'first degree' trademark infringement and is the most blatant and egregious form of 'passing off."'159 It has been characterized as an aggravated form of trademark infringement "that seeks to trick the consumer into believing that he or she is getting the genuine article."160

Copyright law grants the authors of original creative works a set of exclusive rights in their creations, including the right to prevent others from copying or selling the work without the copyright holder’s permission. The U.S. Constitution empowers Congress to create a copyright system to promote the progress of science and learning. The main goal of copyright law is to spur the growth and spread of knowledge by encouraging authors to create new works.

Copyright protections are critical to many areas of the U.S. economy, particularly in industries such as entertainment and technology. A study by the U.S. Patent and Trademark Office found that copyright-intensive industries—such as computer software, motion pictures, music, and news reporting—contributed $1.29 trillion to U.S. gross domestic product and directly employed 6.6 million people in 2019.

The Lanham Act provides civil liability for trademark infringement, trademark dilution, cybersquatting, and false advertising. The act gives U.S. district courts nonexclusive jurisdiction over these lawsuits, meaning that plaintiffs may choose to file such lawsuits either in federal or state court.

Trademark Infringement

Trademarks are a form of intellectual property that serve to identify the sources of goods. Trademarks have attracted renewed attention since the U.S. Supreme Court decided two cases regarding the main federal trademark law, the Lanham Act, 15 U.S.C. §§ 1051 et seq., in June 2023 and agreed to hear a third such case in its 2023–2024 term. This In Focus provides an overview of U.S. trademark law.

What Are Trademarks?

Just as the Supreme Court has seemingly taken an increased interest in patent law in recent years, as indicated by the rise in the number of patent law cases for which it has granted certiorari,261 Congress has also recently enacted several major patent reforms. Congress enacted the AIA in 2011, which introduced a number of new administrative procedures for challenging patents and restructured the substantive patent laws.262 Congress also enacted specialized procedures governing patent disputes involving drugs (the Hatch-Waxman Act)263 and biologics (BPCIA).264 To the extent that Congress wishes to further reform the law governing patents, it could do so under the powers granted to it in the Constitution.265 Indeed, various reforms have been proposed over the past several years.

For example, Congress could modify the patentable subject matter requirement under Section

Patents provide exclusive rights to inventors of new, useful and nonobvious inventions.12 The patent law concerns hard technologies, including chemical, electrical and mechanical products and processes, as well as other pragmatic innovations in fields ranging from biotechnology to business methods.13 An inventor may obtain a patent by filing a patent application with the United States Patent and Trademark Office (“PTO”). Such an application must completely describe and precisely claim the invention.14 Issued patents confer the right to exclude others from making, using, selling, offering to sell or importing into the United States the patented invention.15 The term of a patent is 20 years from the date the application was filed.16

A patent is a document, issued by the federal government, that grants to its owner a legally enforceable right to exclude others from practicing the invention described and claimed in the document. Congress allows this right, for a term ending twenty years from the date of filing of an application for patent, to encourage the public disclosure of technical advances and as an incentive for investing in their commercialization.

The application of copyright to artificial intelligence (AI) is another emerging issue. The Copyright Office has taken the position that only a human being—and not an AI—may be an “author” under the Copyright Act. Others dispute that view, or argue that at least some human-assisted outputs of generative AI should be copyrightable. Related issues (and ongoing litigation) include whether AI outputs or the use of material on the internet to “train” AI infringes the copyrights in existing works. (For more on these issues, see CRS Legal Sidebar LSB10922, Generative Artificial Intelligence and Copyright Law, by Christopher T. Zirpoli.)

Copyright is a form of protection provided by the laws of the United States to the authors of “original works of authorship” that are fixed in a tangible form of expression. An original work of authorship is a work that is independently created by a human author and possesses at least some minimal degree of creativity. A work is “fixed” when it is captured (either by or under the authority of an author) in a sufficiently permanent medium such that the work can be perceived, reproduced, or communicated for more than a short time. Copyright protection in the United States exists automatically from the moment the original work of authorship is fixed.1