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Morgan Hartgrove, Contributing Member 2020-2021
Intellectual Property and Computer Law Journal
Introduction
Patent and patent rights incentivize creation and innovation. The Constitution empowers Congress “[t]o 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] However, these protections expire after a certain period of time.[2] In the pharmaceutical industry, in particular, patent rights play an essential role in incentivizing research, design, and innovation for new drugs.[3] Patents protect a drug manufacturer’s innovation by establishing a period of exclusivity, and sometimes, manufacturers extend this period of exclusivity by filing multiple or additional patents to cover one product.[4] Some argue patents create a way for manufacturers to maximize profits and prevent competition from generic drugs to enter the market. Others believe the option to extend patent protection is necessary to incentivize drug manufacturers to invest the billions of dollars it takes to create new drugs and bring them to market.[5]
The cost of prescription drug prices has been a concern for policymakers and consumers for several years. The price of drugs in the United States was nearly four times higher than average prices compared to similarly developed countries and providences, like the United Kingdom, Japan, and Ontario.[6] In fact, one in four Americans is unable to fill prescriptions due to the high prices.[7] The impact of high-priced drugs is wide-ranging and affects not only consumers but also insurance companies and hospitals. When manufacturers first introduce a new drug to the market, the drugs are the most expensive. The initial high cost of drugs is largely due to monopoly pricing. Before the original patent expires and generics are available, there cannot be a competitive market of other drugs in their class.[8] Prescription drug prices continue to rise and so does the out-of-pocket spending burden on consumers.[9]
This article will discuss the goals of the Second Look at Drug Patents Act of 2020, review drug patent legislative history, address current issues in the drug market, and finally, examine the opinions of supporters and opponents of the legislation.
The Second Look at Drug Patents Act of 2020: Overview
To combat the high prices of pharmaceutical drugs, Congress is taking legislative action. On July 21, 2020, Senators Patty Murray (D-WA) and John Cornyn (R-TX) reintroduced the Second Look at Drug Patents Act of 2020 (“the Act”), an act that Congress first introduced in 2019.[10] The Second Look Act aims to increase scrutiny in the process of obtaining a patent and prevent drug manufacturers from using patent protection to block competition from less expensive generic drugs. The Act also aims to improve the process for challenging drug patents and remove barriers for generic drugs to enter the market.[11]
The Second Look at Drug Patents Act would require that the U.S. Patent and Trademark Office (USPTO) reexamine a patent’s validity before the Food and Drug Administration (FDA) can list the drug in its Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the “Orange Book.”[12] The Orange Book is a monthly publication from the FDA that lists approved drugs.[13] For drug manufacturers, a listing in the Orange Book is valuable because it blocks a generic version of the drug from entering the market.[14]
Additionally, the Second Look Act attempts to improve transparency about which drugs have patents. To achieve a greater level of clarity around which drugs have patents, the Second Look Act requires name-brand drug manufacturers submit new patents to the USPTO within 30 days of approval.[15] After a manufacturer submits a new patent, the USPTO must post the new patent on the USPTO website and in the Official Gazette, the official weekly journal of the USPTO.[16] This change will increase transparency, solicit additional information about the strength of those patents, and invite patent challenges.[17] An accessible, up-to-date listing for patents will more easily allow generic manufacturers to know which patents are challengeable, which, in turn, increases the potential for generic competition to enter the market.[18]
Overall, the Second Look at Drug Patents Act would modify the patent process by easing the burden on generic drug manufacturers by allowing them to more easily identify the patents that are eligible for a legal challenge. The Act provides a new resource to help bring generic drugs to the market more efficiently, potentially giving consumers increased access to more affordable prescription drugs.[19]
Legislative History
The Second Look at Drug Patents Act of 2020 is not the first piece of legislation that Congress has introduced to improve affordable access to prescription drugs. In response to Roche Products, Inc. v. Bolar Pharmaceutical Co., Congress enacted the Drug Price Competition and Patent Term Restoration Act in 1984, commonly known as the Hatch-Waxman Act.[20] In Roche, Roche, a brand-name pharmaceutical company, owned a drug called flurazepam, and Bolar Pharmaceutical, a generic pharmaceutical company, was developing a copy of the same drug in hopes of gaining patent approval exactly when the patent on Roche’s drug expired. To time its patent approval with the expiration of Roche’s, Bolar Pharmaceutical began drug research and development while Roche’s patent was still active, which Roche believed infringed on the company’s active patent. Roche sued Bolar Pharmaceutical for infringement and won.[21]
The Roche case set a precedent that another manufacturer cannot research and develop a different version of a patented drug while the original patent is still in effect, which effectively extends the life of a patent. If a manufacturer cannot work on creating a new version of a drug until the original drug patent expires, the original patent essentially extends because the research and subsequent approval process for a new drug take years. Congress saw the potential harm this case had on inhibiting drug innovation and competition and reversed the decision in Roche when it passed the Hatch-Waxman Act.[22]
Hatch-Waxman Act’s Effect on Generic Drug Manufacturers
The Hatch-Waxman Act established a new drug application and approval process for generic drug products in which generic manufacturers can submit an abbreviated new drug application (ANDA) under section 505(j) of the Federal Food, Drug, and Cosmetic Act.[23] The new process allows generic drug manufacturers to show they created a “bioequivalent” of a brand-name drug.[24] This Act created the generic drug industry that the U.S. has today.
Hatch-Waxman requires the FDA publicly list approved drug products with monthly supplements, which was satisfied by the Orange Book.[25] Further, Hatch-Waxman includes provisions that allow the first generic approval that challenges a patent from the Orange Book up to 180 days of market exclusivity. This change encourages competition for drug companies to enter the market faster.[26]
Additionally, Hatch-Waxman allows the FDA to provide a research exemption to generic drug manufacturers before the expiration of the innovator patent for the name-brand drug the generic seeks to copy.[27] To get an exemption, the generic manufacturer needs to file a certification that the name-brand drug is in the Orange Book and is invalid, unenforceable, or will not be infringed by the generic product. This certification is called a “Paragraph IV certification.”[28]
Finally, Hatch-Waxman established a process for generic drug companies to challenge patents.[29] To challenge a patent, a generic drug manufacturer that submits a Paragraph IV certification must notify the name-brand product sponsor and any patent holder of the submission of the ANDA and patent challenge.[30] After the generic manufacturer makes this notification, the name-brand product patent holder can file an infringement suit within 45 days of the notification.[31]If the name brand patent holder files a suit, FDA approval to market the generic drug is postponed for 30 months unless the patent expires, is deemed invalid, or remains uninfringed before that time.[32] The 30-month time frame gives the patent holder time to assert patent rights before a generic version of the drug receives approval and can begin marketing.[33] Before Hatch-Waxman, there was not an avenue for generic manufacturers to challenge drug patents in order to enter the market.[34]
Hatch-Waxman Act’s Effect on Innovator Drug Manufacturers
Hatch-Waxman is not only favorable to generic drug manufacturers, but it also provides incentives to name-brand drug companies. One provision grants name-brand drug companies a five-year period of regulatory exclusivity.[35]Exclusivity means that the FDA will not approve a generic version of the drug for five-years after it goes to market. Additionally, the Hatch-Waxman Act gives name-brand innovators the possibility of a five-year extension to market exclusion to compensate for the marketing time lost in the FDA drug approval process.[36] This period of exclusivity could produce billions in revenue for the manufacturer, in addition to the added revenue from the extension. In addition to the five-year market exclusivity and possible five-year extension, the Act triggers an automatic 30-month stay of the FDA approval process for the generic drug if there is patent litigation.[37] This stay postpones the approval process to allow the patent holder to assert patent rights in court before a generic competitor gets approval and can enter the market.[38]
Modern Issues for Both Generic and Name-Brand Drug Manufacturers
The Hatch-Waxman Act caused an increase in ANDA applications, thus resulting in more than 70% of prescriptions having generic counterparts. Before the Act, only 15% of prescriptions had generics.[39] However, name-brand drug companies still find ways to work around the Hatch-Waxman Act and discourage generic competition by finding loopholes and anti-competitive strategies.[40] These workarounds have encouraged Congress to enact more legislation furthering the Hatch-Waxman Act. Recently, Congress attempted to address subsequent drug patent issues that prevented generics from entering the market by proposing legislation that reduced the number of patents that cover the same drug and decreased the ability of patent holders to enforce those patents. Many of the attempts to pass legislation promoting generic entry into the market have been unsuccessful, but the Second Look at Drug Patents Act of 2020 hopes to address some of the more modern issues.[41]
Whether the manufacturer is a name-brand or generic drug company, both drug manufacturers face barriers when it comes to innovating. For name-brand manufacturers, the average cost to bring a new drug to market is over one billion dollars.[42] To achieve FDA approval, drugs must go through stages of clinical trials which are expensive and time consuming.[43] With a steep price tag to obtain approval, name-brand drug companies are investing in hopes that the drug they are developing will produce a return on investment.[44] To ensure a return, drug companies often price new drugs higher when they first enter the market.[45] Additionally, name-brand drug manufacturers will fight for their patent in order to secure market exclusivity, further ensuring they will see a high return on investment.[46]
Unlike name-brand manufacturers, generic manufacturers do not need to conduct clinical trials and usually do not pay for advertising and marketing.[47] Because generic manufacturers do not have to incur these extra costs, generic drugs are typically less expensive than name-brand drugs.[48] This extra cost poses a problem for name-brand drug companies because it further increases the cost gap before the name-brand company sees a return on its investment.
Generic drug companies face different challenges when it comes to innovating new drugs. Patents are generic drug companies’ largest barrier to entering the market. Oftentimes, name-brand pharmaceutical manufacturers obtain patents not only for the active ingredients in the medication but also for features like a medication’s coating or mode of delivery, like a tablet compared to a capsule.[49] This leads name-brand manufacturers to have multiple patents on the same drug. For example, Humira, a rheumatoid arthritis drug, is protected by over 100 patents.[50] Having multiple patents on one drug creates difficulties for generic manufacturers to work around the patents to create a generic version of the drug.
Another issue arises with multiple patents when the patents are added on after FDA approval, also known as “evergreening.”[51] If a drug has one patent and another patent is added on years later, the addition effectively extends the life of the patented drug.[52] For example, if a drug is originally patented for its chemical compound, but a few years later the coating on the pill is patented, the entire patent life of the drug extends. Another barrier to entry generic manufacturers have to work around is name-brand manufacturers obtaining new patents on existing drugs by making minor changes to the same drug, like changing a liquid medication into a pill.[53] Obtaining patents for small changes to name-brand drugs postpones the time before a generic version can enter the market.
Although name-brand and generic manufacturers face their own unique challenges, both manufacturers make large investments when developing drugs and therefore, need to see a return on investment. To ensure a return, manufacturers, both name-brand and generic, go to great lengths to protect their investments through patent development and enforcement. Protecting a patent is expensive, and consumers end up paying the cost.
Current Process for a Drug to Enter the Market and Receive a Patent
At present, the FDA is required to approve new drugs before they enter the market.[54] The FDA approves new drugs through the new drug application process (NDA). Generic drugs are approved through the abbreviated new drug application (ANDA), a streamlined process that Hatch-Waxman established.[55]
Patent rights are independent and distinct from the regulatory exclusivities that the FDA provides.[56] Patent rights, which the USPTO grants, focus on the novelty of the innovation, while the regulatory approval the FDA grants focuses on passing the FDA regulatory process by meeting set safety criteria.[57] A patent alone does not give a drug manufacturer the right to release a drug to the market. Even if a drug manufacturer has a patent for a specific drug, the manufacture cannot begin to market the drug until that same product has FDA approval.[58]
For the USPTO to grant a manufacturer a patent, the drug must be new, useful, and nonobvious, and the patent application must sufficiently describe the drug.[59] Additionally, if a manufacturer creates an improvement to an existing patented drug, the improvement is also eligible for patent protection.[60]
Potential Impact of Second Look at Drug Patents Act of 2020
If the Second Look Act goes into effect, it would amend the Food, Drug, and Cosmetic Act to require name-brand drug manufacturers to notify the USPTO after submitting patent information to the FDA within 30 days of FDA approval.[61]
The Second Look at Drug Patents Act requires the USPTO to reexamine a patent’s validity before the Orange Book can list the patented drug.[62] Reexamination would be a quicker, more efficient way to challenge name-brand patents without litigation. This type of review is called inter partes review (IPR).[63] Congress established IPR in 2011 as part of the Leahy-Smith America Invents Act, an act that allows the USPTO to reevaluate its initial decision to grant a patent.[64] This reexamination adds a step before the FDA can list a patent in the Orange Book.
Additionally, the Act would require the USPTO to list new patents on a website and in the Official Gazette.[65]These notices would make it easier for generic drug manufacturers to file a petition for IPR.[66] IPR creates another avenue to challenge the validity of drug patents in court. It has several advantages compared to litigation because it is less expensive and more efficient than filing a lawsuit.[67] IPR is less expensive than a traditional lawsuit or patent examination because it is a proceeding adjudicated before the Patent Trial and Appeal Board (PTAB).[68] However, unlike courts, the PTAB does not decide questions of infringement.[69] Further, IPR concludes in 12-18 months, which is typically faster than a traditional court proceeding.[70] In IPR, there is no presumption of validity, but limited discovery is allowed.[71]
In Support of Legislation
Those in support of the Second Look at Drug Patents Act believe setting new limits on patents would allow lower-priced generic competition to enter the market faster.[72] The Second Look at Drug Patents Act has support from the Campaign for Sustainable Rx Pricing (CSRxP) which stated, “[b]ringing more competition to the prescription drug market will give consumers more choices and more control – resulting in lower prices and improved access.”[73]Additionally, supporters are in favor of the Act because it adds a new tool to keep the public informed on what medicines are patented.[74] The tool adds a level of accessibility and transparency by creating a more accurate and accessible database of patents covering approved drugs. More clarity regarding which drugs have active patents will invite patent challengers and allow generic manufacturers to challenge the listed patents more easily, which could allow generic competition to enter the market more efficiently.[75]
In Opposition of Legislation
Those in opposition of the Second Look at Drug Patents Act, mainly the name-brand drug industry, believe the Act would hinder the development of new pharmaceuticals by making the challenging process easier.[76] If a patent holder of a drug loses a challenge, a generic version of the drug could enter the market. Added competition would make it more difficult for name-brand manufacturers to recoup their investments. With uncertainty about whether or not the investment is recoupable, opponents of the Second Look Act say drug manufacturers will be less willing to innovate new drugs if the ability to recoup their investment is uncertain or not as profitable as before the Second Look Act is passed.[77]
Opponents of the Second Look Act also believe it will likely increase settlements because the legislation may increase patent challengers.[78] In 2006, half of all patent settlements included compensation to the generic patent challenger and an agreement requiring the generic drug manufacturer refrain from launching its drug for a certain length of time.[79] These exclusionary payment settlements are highly profitable for both name-brand and generic manufacturers.[80] Opponents of the Act believe that if settlements increase, the time and barriers for generic drugs to enter the market will increase, which would be counterproductive to the Second Look Act.[81]
Looking Beyond the Act
While the Second Look Act would make some changes to the process of patenting a drug, the Act does not alter the inter partes review process for challenging a patent.[82] Additionally, the information that the Act would require drug manufacturers and the USPTO to provide is already available to the public.[83] The Second Look Act would help get generics on the market more efficiently, but more can be done.
At present, patent law states that “a patent shall be presumed valid,” which places the burden on the litigant to prove a patent’s invalidity.[84] Rep. Hakeem Jeffries (D-NY) and Rep. Doug Collins (R-GA) have proposed additional legislation that would shift the burden of proof to the name-brand manufacturer.[85]
Eliminating additional patents on the same drug is another step that would promote generic competition. This would establish that the original formula of the drug is the core concept of the patent, and minor changes do not infringe on a patent and therefore would not be protectable.[86]
Similarly, eliminating later-filed patents on the same drug would prevent a manufacturer from making minor changes to the drug and still obtaining a new patent, effectively extending the life of the original patent.
Additionally, other legislation is in the works to lower the price of prescription drugs. The legislation includes the Biologic Patent Transparency Act, Affordable Prescriptions for Patients Through Improvements to Patent Litigation Act of 2019, Preserving Access to Cost Effective Drugs Act, Preserve Access to Affordable Generics and Biosimilars Act, and FAIR Generics Act.[87] The outcome of these pieces of legislation, among others, may affect how the Second Look at Drug Patents Act unfolds.
Beyond the Second Look at Drug Patents Act, patents are used in creative ways to improve access to medication while still retaining the incentive to innovate.[88] Voluntary licensing agreements are used as a way to improve access.[89] Some name-brand manufacturers grant licensing agreements with generic drug manufacturers in specific regions, like developing countries, like South Africa, to improve access to medicines.[90] Voluntary licensing agreements have the potential to make medications more accessible while preserving the drive to innovate.[91]
Conclusion
Prescription drug prices have been a topic of concern for several years, and there is legislative interest to address such concerns. The Second Look at Drug Patents Act has both strengths and weaknesses and aims to be one step in solving the problem of the excessive cost of drugs. It is clear that to tackle the problem, more legislative action is necessary and there needs to be a balance between fostering and protecting innovation while still creating space for generic manufacturers to enter the market. To tackle this issue, more research and action are necessary as well as input from both law and health experts.
[1] U.S. Const. art. I, § 8, cl. 8.
[2] Drug Pricing and Pharmaceutical Patenting Practices, Congressional Research Service (Feb. 11, 2020), https://fas.org/sgp/crs/misc/R46221.pdf.
[3] Id.
[4] Id.
[5] Id.
[6] A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices, Committee on Ways and Means (September 2019), https://waysandmeans.house.gov/sites/democrats.waysandmeans.house.gov/files/documents/U.S.%20vs.%20International%20Prescription%20Drug%20Prices_0.pdf.
[7] Id.
[8] Brandy Henry, Drug Pricing and Challenges to Hepatitis C Treatment Access, J. of Health & Biomedical L., Sept. 14, 2018, at 265-83.
[9]A Painful Pill to Swallow: U.S. vs. International Prescription Drug Prices, supra note 6.
[10] Murray, Cornyn Re-Introduce Legislation to Crack Down on Sham Drug Patents, U.S. Senate Committee on Health, Education, Labor & Pensions (July 22, 2020), https://www.help.senate.gov/ranking/newsroom/press/murray-cornyn-re-introduce-legislation-to-crack-down-on-sham-drug-patents-.
[11] Id.
[12] Id.
[13] Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book), U.S. Food & Drug Admin. (Sept. 11, 2020), https://www.fda.gov/drugs/drug-approvals-and-databases/approved-drug-products-therapeutic-equivalence-evaluations-orange-book.
[14] Murray, Cornyn Re-Introduce Legislation to Crack Down on Sham Drug Patents, supra note 10.
[15] Id.
[16] U.S. Patent and Trademark Office, Official Gazette (Jan. 6, 2020), https://www.uspto.gov/learning-and-resources/official-gazette.
[17] Id.
[18] Id.
[19] Id.
[20] Martha M. Rumore, The Hatch-Waxman Act—25 Years Later: Keeping the Pharmaceutical Scales Balanced, Pharmacy Times (Aug. 15, 2009), https://www.pharmacytimes.com/publications/supplement/2009/GenericSupplement0809/Generic-HatchWaxman-0809.
[21] Roche Prods. v. Bolar Pharm. Co., 733 F.2d 858, 860 (Fed. Cir. 1984).
[22] Andrew Berks, The Hatch-Waxman Act (Simply Explained), Berks IP Law (June 10, 2019), https://berksiplaw.com/2019/06/the-hatch-waxman-act-simply-explained/.
[23] Hatch-Waxman Letters, U.S. Food & Drug Admin. (July 19, 2018), https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/hatch-waxman-letters.
[24] Rumore, supra note 20.
[25] Orange Book Preface, U.S. Food & Drug Admin. (Feb. 13, 2020), https://www.fda.gov/drugs/development-approval-process-drugs/orange-book-preface.
[26] Hatch-Waxman Letters, supra note 23.
[27] Patent Certifications and Suitability Petitions, U.S. Food & Drug Admin. (Sept. 10, 2020), https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/patent-certifications-and-suitability-petitions.
[28] Id.
[29] Prepared Statement of the Federal Trade Commission, Protecting Consumer Access to Generic Drugs: The Benefits of a Legislative Solution to Anticompetitive Patent Settlements in the Pharmaceutical Industry (May 2, 2007), https://www.ftc.gov/sites/default/files/documents/public_statements/prepared-statement-federal-trade-commission-protecting-consumer-access-generic-drugs-benefits/p85991020protecting_consume_20access_testimony.pdf.
[30] Patent Certifications and Suitability Petitions, supra note 28.
[31] Id.
[32] Frequently Asked Questions on Patents and Exclusivity, U.S. Food & Drug Admin. (Feb. 5, 2020), https://www.fda.gov/drugs/development-approval-process-drugs/frequently-asked-questions-patents-and-exclusivity.
[33] Patent Certifications and Suitability Petitions, supra note 28.
[34] Prepared Statement of the Federal Trade Commission, supra note 30.
[35] S. 1538, 98th Cong. (1984).
[36] D. Christopher Ohly, The Hatch-Waxman Act: Prescriptions for Innovative and Inexpensive Medicines, Schiff Hardin LLP (Spring 2010), https://www.schiffhardin.com/Templates/Media/files/publications/PDF/ohly-Hatch_Waxman_Prescriptions-42010.pdf.
[37] S. 1538.
[38] Patent Certifications and Suitability Petitions, supra note 28.
[39] Rumore, supra note 20.
[40] Id.
[41] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[42] Kenneth I. Kaitin, The Landscape for Pharmaceutical Innovation: Drivers of Cost-Effective Clinical Research, Pharm Outsourcing, (2010), https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3150117/.
[43] Cost of Clinical Trials for New Drug FDA Approval Are Fraction of Total Tab, Johns Hopkins Bloomberg Sch. of Pub. Health, (Sept. 24, 2018), https://www.jhsph.edu/news/news-releases/2018/cost-of-clinical-trials-for-new-drug-FDA-approval-are-fraction-of-total-tab.html.
[44] Ezekiel Emanuel, Big Pharma’s Go-To Defense of Soaring Drug Prices Doesn’t Add Up, The Atlantic, (Mar. 23, 2019), https://www.theatlantic.com/health/archive/2019/03/drug-prices-high-cost-research-and-development/585253/.
[45] Id.
[46] Himanshu Gupta et al., Patent Protection Strategies, J. of Pharmacy & Bioallied Sci. (2010),
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3146086/.
[47] Generic Drugs Undergo Rigorous FDA Scrutiny, U.S. Food & Drug Admin. (Oct. 8, 2014), https://www.fda.gov/consumers/consumer-updates/generic-drugs-undergo-rigorous-fda-scrutiny.
[48] Id.
[49] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[50] Cynthia Koons, This Shield of Patents Protects the World’s Best-Selling Drug, Bloomberg Businessweek (Sept. 7, 2017), https://www.bloomberg.com/news/articles/2017-09-07/this-shield-of-patents-protects-the-world-s-best-selling-drug.
[51] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[52] Id.
[53] Id.
[54] Wallace F. Janssen, The Story of the Laws Behind the Labels, FDA Consumer Magazine (June 1981), https://www.fda.gov/downloads/aboutfda/history/forgshistory/evolvingpowers/ucm593437.pdf.
[55] 21 C.F.R. §§ 314.92, 314.94 (2019).
[56] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[57] Erin H. Ward, Drug Pricing and the Law: Regulatory Exclusivities, Congressional Research Service (May 17, 2019), https://fas.org/sgp/crs/misc/IF11217.pdf.
[58] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[59] 35 U.S.C. §§ 101-03, 112 (2006).
[60] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[61] Murray, Cornyn Re-Introduce Legislation to Crack Down on Sham Drug Patents, supra note 10.
[62] Id.
[63] Liam Bendicksen et al., Challenging Patents to Promote Timely Generic Drug Entry: The Second Look Act and Other Options, Health Affairs (Aug. 31, 2020), https://www.healthaffairs.org/do/10.1377/hblog20200827.532806/full/.
[64] Id.
[65] Murray, Cornyn Re-Introduce Legislation to Crack Down on Sham Drug Patents, supra note 10.
[66] Bendicksen, supra note 64.
[67] Howard W. Levine et al., Inter Partes Review in Generic Drug Litigation—Why the USPTO Should Exercise Its Discretion to Deny IPR Petitions in Appropriate Hatch-Waxman Act Disputes, Finnegan, (Mar. 7, 2014),
[68] Nora Xu, AIA Proceedings: A Prescription for Accelerating the Availability of Generic Drugs, 66 Emory L. J. 1007 (2017).
[69] Id.
[70] Levine, supra note 68.
[71] Id.
[72] Patent Legislation to Watch in 2020, Kirkland & Ellis (Jan. 1, 2020), https://www.kirkland.com/news/in-the-news/2020/01/patent-legislation-to-watch-in-2020.
[73] Drug Pricing Overview 116th Congress, The Campaign for Sustainable Rx Pricing, https://www.csrxp.org/wp-content/uploads/2019/04/CSRxP-New-Congress-Materials-2019-Final-V5.pdf (last visited Sept. 29, 2020).
[74] Murray, Cornyn Re-Introduce Legislation to Crack Down on Sham Drug Patents, supra note 10.
[75] Id.
[76] Patent Legislation to Watch in 2020, supra note 73.
[77] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[78] Ohly, supra note 37.
[79] Prepared Statement of the Federal Trade Commission, supra note 30.
[80] Id.
[81] Gregory Jones et al., Strategies that Delay or Prevent the Timely Availability of Affordable Generic Drugs in the United States, Blood (Mar. 17, 2016) https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4915805/.
[82] Drug Pricing and Pharmaceutical Patenting Practices, supra note 2.
[83] Bendicksen, supra note 64.
[84] 35 U.S.C. § 282 (2006).
[85] Bendicksen, supra note 64.
[86] Robin Feldman, ‘One-and-done’ for New Drugs Could Cut Patent Thickets and Boost Generic Competition, STAT (Feb. 11, 2019) https://www.statnews.com/2019/02/11/drug-patent-protection-one-done/.
[87] Second Look at Drug Patents Act of 2020, S. 4253, 116th Cong. (2019-2020).
[88] Prescription Drug Prices: Problems, Solutions, and What States Can Do, United States of Care, https://unitedstatesofcare.org/wp-content/uploads/2018/10/USoC_PDSA_Briefing.pdf (last visited Sept. 29, 2020).
[89] Id.
[90] Amir Attaran, How Do Patents and Economic Policies Affect Access to Essential Medicines in Developing Countries?, Health Affairs (May/June 2004), https://www.healthaffairs.org/doi/full/10.1377/hlthaff.23.3.155.
[91] Id.
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