A Legal Analysis of Big Pharma’s Evasion and Weaponization of Copyright Law

United States’  copyright laws were first established with a clear goal outlined in the United States Constitution: "...To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries.” [1] Copyright law was enshrined in the Constitution as a way to motivate intellectual creativity and progress through legal protections, however, large pharmaceutical companies operating in United States’ markets have manipulated this fundamental principle of intellectual property to bolster their profit margins. By exploiting United States’ copyright law, these pharmaceutical companies depart from the original intent of the law, prioritizing economic gain over the greater well-being of humanity. Specifically, pharmaceutical companies have found ways to weaponize United States’ patent law and FDA policies. This manipulation of copyright law undermines its foundational ideals and compromises its intended purpose.

Understanding how pharmaceutical companies undermine copyright law requires an examination of both its historical context and contemporary application. Copyright law finds its roots in the United States Constitution, with the Copyright Act of 1790 representing the nation’s inaugural copyright legislation. Initially limited in scope to protecting books, maps, and charts, copyright law swiftly evolved throughout the 19th century to encompass a broad spectrum of media, all to safeguard third parties from claiming rights to an inventor’s creation. This evolution underscores the significance of intellectual property rights within the American legal system. Enshrined in the Constitution itself, these rights were intended to safeguard entrepreneurial innovation and foster a competitive marketplace of ideas—values that are now undermined by the contemporary pharmaceutical industry. [2]

Today, copyright law continues to pursue its original objectives of advancing science and the arts within an increasingly diverse media landscape. Given the array of intellectual property requiring protection, the U.S. Copyright Office at the Library of Congress has established two additional forms of protection: patents and trademarks. Copyright law governs creative works such as songs, photographs, and literary works existing in tangible mediums. While trademarks safeguard distinctive elements such as words, phrases, or designs associated with specific goods or services. Patents, meanwhile, protect technical innovations like mechanical processes for complex machinery or, notably, pharmaceutical drugs. [3] This multifaceted approach to intellectual property protection reflects the evolving nature of creative expression and technological innovation in contemporary society and the law’s ability to change with it.

Patents grant inventors the exclusive right to “exclude others from making, using, offering for sale, or selling” an invention, or “importing” it into the United States. In order to uphold the original spirit of copyright law, patents limited rights to inventors for specified durations, maintaining these privileges for their inventors for a period of twenty years. However, for pharmaceutical companies, this threatens their ability to maximize profits. During the twenty-year protection period for a pharmaceutical compound, the owning company enjoys a monopoly over its production and distribution. [4] Consequently, these companies can impose unregulated prices for their medications. Recognizing this danger to public welfare, the District of Columbia City Council passed the Prescription Drug Excessive Pricing Act of 2005. The council justified this legislation by stating:

“The excessive prices of prescription drugs in the District of Columbia are threatening the health and welfare of the residents as well as the government's ability to ensure that all residents receive necessary healthcare. These excessive prices directly and indirectly cause economic harm to the District and endanger the health and safety of its residents.” [5]

On October 12, 2005, the Pharmaceutical Research and Manufacturers of America (PhRMA), a trade group representing U.S. pharmaceutical companies, filed a lawsuit against the District of Columbia, arguing that the act violated the Commerce Clause of the United States Constitution. This clause grants Congress, not individual states and territories, the authority to regulate interstate commerce. PhRMA argued that by instating laws affecting their pricing, the District of Columbia was violating the Commerce Clause, which stipulates that commerce between multiple states is regulated under federal law. Just fifteen days later, the Biotechnology Industry Organization (BIO), another trade group representing companies in the biotechnology sector internationally, filed a similar lawsuit. [6] These two cases were eventually consolidated and appealed to the United States Supreme Court, which concluded that the Prescription Drug Excessive Pricing Act of 2005 was preempted by federal patent law and constituted an obstacle to the objectives established by Congress.

Although the District of Columbia City Council failed to enact legal protections for its citizens, they highlighted the adverse effects of the pharmaceutical industry's exploitation of patent law. Specifically, in the case, the district court said that the role of Congress in the pharmaceutical industry is to regulate the economic and regulatory aspects to protect American consumers’ welfare, and to encourage and reward the innovation, research, and development of new drugs.” [7] Pharmaceutical Research and Manufacturers of America, Plaintiff-Appellee, v. District of Columbia,  importantly highlighted the plight of regulating the pharmaceutical industry and the role of copyright within it. The federal government is tasked with empowering the pharmaceutical industry through copyright protections while still regulating their economic and social repercussions. As the court case stated, the tensions between these powers can be seen in the pharmaceutical industry's economic effects. According to Forbes, the American pharmaceutical industry exemplifies monopolistic or unfair pricing rather than merely exorbitant pricing. This pricing model motivated the District of Columbia’s City Council in creating the Excessive Pricing Act in the initial case. While both types of pricing involve prices far exceeding production costs, monopolistic pricing in the pharmaceutical industry restricts consumer options to a "pay up or suffer" scenario, unlike industries such as automotive, which offer a range of luxury and affordable products. [8] Policy struggle between pharmaceutical corporations and government institutions once again evidences the effects of the interplay between simultaneous federal regulation and liberalization.

The current state of United States patent laws allows pharmaceutical companies to maintain monopolistic control over their drug compounds without necessarily introducing new and innovative products to the market, as originally intended by copyright law enacted 200 years ago. However, manipulating United States’ patent law and FDA policies to prevent competition in the pharmaceutical industry directly undercut that goal. While the original purpose of patent protection was to incentivize innovation by rewarding risk-taking inventors, today, the actual legal enactment of copyright law in the United States only boosts corporate profit margins without commensurate clinical advancements. For instance, in 2022, six out of just eight new cancer drugs were released with price tags exceeding $220,000 per year of treatment. However, these drugs typically offered an average increase in life expectancy of just 73 days, often spent enduring debilitating side effects.[6] High pricing amid little progress is facilitated by patent law in conjunction with the Food and Drug Administration's Accelerated Approval Program, which fast-tracks drugs meant to treat severe conditions for approval. [9] Additionally, the FDA's Accelerated Approval system does not mandate measurable clinical improvements for iterations of the same compound, only the potential for additional value. As a result, pharmaceutical companies exploit these systems by making minor, sometimes ineffective, molecular modifications to extend their patents beyond the standard twenty-year term. [10] The Accelerated Approval system was established to expedite the market entry of drugs addressing severe conditions and unmet medical needs. However, by leveraging the program's less stringent requirements to fast-track the process, companies aim to prolong their monopoly on their drug, thereby undermining the program's initial intent.
The case, Massachusetts Laborers' Health & Welfare Fund v. Boehringer Ingelheim Pharmaceuticals Inc, U.S. District Court for the District of Massachusetts, provides an another example of how pharmaceutical companies weaponize patent law to maintain monopolistic pricing. The case was filed on March 6, 2024, against the German pharmaceutical company Boehringer Ingelheim by the voluntary employees’ beneficiary association, the Massachusetts Laborers' Health & Welfare Fund. The association maintained that Boehringer Ingelheim had intentionally misused multiple patents for its respiratory inhaler, Respimat, to extend its monopoly by a decade (2020-2030). [11] On September 14, 2023 Senator Elizabeth Warren and Representative Pramila Jayapal submitted a letter to the chair of the Federal Trade Commision, Lina Khan, urging the FTC to address Big Pharma’s abuse of the patent system. In the letter, they addressed the type of abuse Boehringer Ingelheim was accused of. Specifically, they said that companies purposely submitted “improper ‘sham’' patents to prevent their competitors from introducing generic competitors to their name-brand drugs. They attributed this to an FDA policy stipulateing that they are “automatically barred from approving a generic drug for 30 months if a brand-name drug company sues a generic competitor for infringing on an Orange Book-listed patent.” As a result, companies list more of their patents in the Orange-Book, officially titled the Approved Drug Products with Therapeutic Equivalence Evaluations, regardless of whether or not they meet the requirements to extend their monopolies. [12]

The Orange Book is defined by the FDA as a publication that “identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act and related patent and exclusivity information” but has now taken on the secondary purpose of helping enable monopolies on brand-name drugs by preventing the entrance of generic alternatives onto the market.The lawmakers cited an FDA study revealing that generic drugs are detrimental to pharmaceutical companies’ ability to engage in monopolistic pricing as even a single generic competitor was found to decrease a drug’s price by 40% and two competitors by over 50%. [13]

Efforts have been made to address the pharmaceutical industry's pricing model without directly amending copyright law. On March 26, 2024, the U.S. Department of Health and Human Services announced The Inflation Reduction Act. This act mandates pharmaceutical companies to rebate funds to Medicare whenever their prices rise faster than the current inflation rate. The rebates collected would be deposited into the Federal Supplementary Medical Insurance Trust Fund to support the longevity of Medicare. [14] While The Inflation Reduction Act aims to assist American citizens amidst dire circumstances, it does little to alleviate the exorbitant prices they are compelled to pay.

United States Copyright Law was founded on the principle of fostering a nation driven by innovation. However, today, pharmaceutical companies undermine this principle; By weaponizing intellectual property law, American pharmaceutical companies exploit the legal system to prioritize profits at the expense of the American consumers’ economic and health well-being With legal backing from both Massachusetts Laborers' Health & Welfare Fund v. Boehringer Ingelheim Pharmaceuticals Inc, U.S. District Court for the District of Massachusetts and Pharmaceutical Research and Manufacturers of America, Plaintiff-Appellee, v. District of Columbia, it becomes clear that many large pharmaceutical industries are weaponizing both the United States’ patent law and the FDA’s Accelerated Approval System and Orange Book to maintain legally-backed market monopolies. It is evident that amendments to intellectual property law in the pharmaceutical industry are necessary to adequately safeguard the welfare of American citizens.
Edited by Alicia Lopez-Guerra

[1]“U.S. Constitution - Article I | Resources | Constitution Annotated | Congress.gov | Library of Congress.” Constitution Annotated, https://constitution.congress.gov/constitution/article-1/. Accessed 8 April 2024.

[2]“Timeline 18th Century | U.S.” Copyright Office, https://www.copyright.gov/timeline/timeline_18th_century.html. Accessed 8 April 2024.

[3]“Trademark, patent, or copyright.” USPTO, 31 March 2021, https://www.uspto.gov/trademarks/basics/trademark-patent-copyright. Accessed 8 April 2024.

[4]“Patent essentials.” USPTO, 27 April 2023, https://www.uspto.gov/patents/basics/essentials. Accessed 8 April 2024.

[5] Pharmaceutical Research v. District of Columbia, 406 F. Supp. 2d 56 (D.D.C. 2005)

[6] Pharmaceutical Research v. District of Columbia, 406 F. Supp. 2d 56 (D.D.C. 2005)

[7] “Pharmaceutical Research and Manufacturers of America, Plaintiff-Appellee, v. DISTRICT OF COLUMBIA (2007).” FindLaw, https://caselaw.findlaw.com/court/us-federal-circuit/1396804.html. Accessed 8 April 2024.

[8]Pearl, Robert. “Pharma Companies: A Conglomerate Of Monopolies.” Forbes, 31 January 2023, https://www.forbes.com/sites/robertpearl/2023/01/31/pharma-companies-a-conglomerate-of-monopolies/?sh=35d203181ce1. Accessed 8 April 2024.

[9]“Accelerated Approval Program.” FDA, 22 February 2024, https://www.fda.gov/drugs/nda-and-bla-approvals/accelerated-approval-program. Accessed 8 April 2024.

[10] Pearl, Robert. “Pharma Companies: A Conglomerate Of Monopolies.” Forbes, 31 January 2023, https://www.forbes.com/sites/robertpearl/2023/01/31/pharma-companies-a-conglomerate-of-monopolies/?sh=35d203181ce1..

[11]Brittain, Blake, and Barnes Cellino. “Lawsuit claims Boehringer misused US patents to delay asthma-drug rivals.” Reuters, 6 March 2024, https://www.reuters.com/legal/litigation/lawsuit-claims-boehringer-misused-us-patents-delay-asthma-drug-rivals-2024-03-07/. Accessed 8 April 2024.

[12]Warren, Elizabeth. “Warren, Jayapal Urge FTC to Rein in Big Pharma Abuses of Patent System | U.S.” Senator Elizabeth Warren, 14 September 2023, https://www.warren.senate.gov/oversight/letters/warren-jayapal-urge-ftc-to-rein-in-big-pharma-abuses-of-patent-system. Accessed 8 April 2024.

[13]“Approved Drug Products with Therapeutic Equivalence Evaluations | Orange Book.” FDA, 8 March 2024, https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book. Accessed 8 April 2024.

[14] “HHS Announces Savings for 41 Prescription Drugs Thanks to Inflation Rebates from the Biden-Harris Administration's Lower Cost Prescription Drug Law.” HHS.gov, 26 March 2024, https://www.hhs.gov/about/news/2024/03/26/hhs-announces-savings-41-prescription-drugs-thanks-inflation-rebates-from-biden-harris-administrations-lower-cost-prescription-drug-law.html. Accessed 8 April 2024.