CP - Medical PIC - CNDI 2024

Medical PIC
Notes
Most of the cards in this file are taken from the Public Interest DA, but this file tries to enhance the strategy by demonstrating the ways that the neg can “PIC out” of certain industries to gain a net-benefit while solving the case. This CP would argue that it still protects IP for patents related to tech competitiveness and military superiority (the first advantage) but maintains existing “public interest” and “balancing” standards for medical related patents (challenging the second advantage).
Neg
1nc
Text: The United States federal government should substantially increase its use of injunctions as the presumptive remedy for violations of valid non-medically related patents.
The CP solves broad innovation but protects public health.
Wyatt ‘13 (Lance, attorney Lance Wyatt at Fish & Richardson via law news provider JD Supra extensive experience practicing in U.S. District Courts around the country, Rebuttable Presumption of Public Interest in Protecting the Public Health --The Necessity for Denying Injunctive Relief in Medically-Related Patent Infringement Cases after Ebay v. Mercexchange, 13 Chi.-Kent J. Intell. Prop. 298 (2013). Available at: https://scholarship.kentlaw.iit.edu/ckjip/vol13/iss1/12)
IV. REBUTTABLE PRESUMPTION OF PUBLIC INTEREST IN MEDICAL PATENT INFRINGEMENT CASES
A. The Public Interest in Medicine The public has always had a large interest in medicine.207 This heightened interest in medicine exists due to its role in diagnosing and treating illnesses, extending the term of life, and improving the overall health of the general population.208 The United States patent system helps encourage innovation in medical technologies that improve the health of the population by granting exclusive rights to patent holders for limited terms.209 President Lincoln once commented on the patent system, expressing that “the patent system added the fuel of interest to the fire of genius.” 210 While the patent system plays an important role in protecting inventors and encouraging innovation, there have been multiple times that the public interest in health has superseded this system.211 After the demise of the Federal Circuit’s “general rule” to automatically grant permanent injunctions in most infringement cases, courts have been given more flexibility to protect the public interest in health by denying permanent injunctions when medically-related patents are involved.212
B. Reasons Why Permanent Injunctions Should Be Denied in Most Medically Related Patent Infringement Cases After eBay, courts were required to apply the traditional four-factor test when deciding to grant injunctive relief.213 The fourth factor, the public interest, has sparingly been used in medically-related cases to deny injunctive relief.214 Because the public has such a great interest in medicine, courts should apply a rebuttable presumption, finding that the public interest weighs in favor of denying injunctive relief in all cases that involve medically-related patents. If a plaintiff cannot produce convincing evidence to rebut this presumption, courts should deny injunctive relief, even when the other three factors weigh in favor of granting a permanent injunction. This rebuttable presumption would not contravene eBay because Justice Kennedy’s concurrence suggests that certain patents might not be suited for injunctive relief.215 Furthermore, if injunctive relief was denied in these cases, the plaintiff would not be left without remedy but would be able to obtain remedies at law via monetary awards, reasonable royalties, or compulsory licenses.216 Overall, this rebuttable presumption would protect and promote the substantial public interest in the public health. 217
The healthcare crisis kills 68,000 people a year. Our CP protects quality of life.
Julia Conley 5/17, Julia Conley is a staff writer for Common Dreams, DOA 6/24/23, “Medicare for All Reintroduced to Save $650 Billion and 68,000 Lives Per Year”, Common Dreams, May 17th 2023, https://www.commondreams.org/news/medicare-for-all-introduced ,// JL
More than half of the Democratic caucus in the House has signed on as co-sponsors of the Medicare for All Act of 2023, including 13 powerful ranking members of congressional committees. Sen. Bernie Sanders (I-Vt.) was joined by Reps. Pramila Jayapal (D-Wash.) and Debbie Dingell (D-Mich.) in leading more than 120 lawmakers in introducing the bill, with a number of supporters speaking about the worsening healthcare crisis at a press conference on Capitol Hill. "We live in a country where millions of people ration lifesaving medication or skip necessary trips to the doctor because of cost," said Jayapal. "Sadly, the number of people struggling to afford care continues to skyrocket as millions of people lose their current health insurance as pandemic-era programs end. Breaking a bone or getting sick shouldn't be a reason that people in the richest country in the world go broke." "There is a solution to this health crisis—a popular one that guarantees healthcare to every person as a human right and finally puts people over profits and care over corporations," the congresswoman added. "That solution is Medicare for All—everyone in, nobody out." About 15 million people in the U.S. are set to lose their health coverage this year as pandemic-era assistance ends, adding to the 85 million people who are currently either uninsured or underinsured—with coverage that includes high deductibles and other out-of-pocket costs, leaving them unable to afford the healthcare they need. Sanders, who has advocated for a government-run health program for decades, noted in a press statement than 68,000 people per year in the U.S. die due to a lack of health coverage. "The American people understand, as I do, that healthcare is a human right, not a privilege," said Sanders, who serves as chairman of the Senate Health, Education, Labor, and Pensions Committee. "As we speak, there are millions of people who would like to go to a doctor but cannot afford to do so. That is an outrage... We must act to end the international embarrassment of the United States being the only major country on earth to not guarantee healthcare to all."
Medical technology advancements are coming now that enable disease prevention—but, continued innovation is necessary.
Sabeti & Botti-Lodovico 22—Dr. Pardis Sabeti, Professor at the Center for Systems Biology and Department of Organismic and Evolutionary Biology at Harvard University and the Department of Immunology and Infectious Disease at the Harvard School of Public Health; and Yolanda Botti-Lodovico, Policy Lead of the Sabeti Lab, Masters in Public Policy (“Breakthrough Technologies for Pandemic Preparedness.” Breakthrough: The Promise of Frontier Technologies for Sustainable Development, edited by Homi Kharas et al., Brookings Institution Press, 2022)//mgm
Biomedicine has undergone a recent revolution that transformed our ability to identify and characterize a virus—that is, detection—as well as our ability to treat and prevent it—that is, countermeasures. One of the key technologies that underlies this revolution is genome sequencing, which allows us to detect and characterize novel threats and informs the design of targeted diagnostics, treatments, and vaccines.
Detection Technologies
When a virus first enters a human population, containment hinges on rapid and accurate detection. Once it is detected and characterized, a distributed and reliable diagnosis is the foundation of pandemic preparedness and response. This is partly because many infectious diseases present with overlapping symptoms, so precise, an early diagnosis is necessary to prescribe appropriate clinical or public health measures. It is also because some infectious diseases spread through asymptomatic or presymptomatic carriers, like COVID-19, of which 20 percent of transmission comes from cases that are asymptomatic and 30–40 percent from those who are presymptomatic, meaning that those infected may spread the virus without knowing. Thus, widespread early detection efforts are critical to containment.9, 10 Moreover, early detection can reverse the course of a disease by signaling the need for lifesaving treatment, like in the case of Lassa fever, where early treatment has reduced case fatality from 55 percent to 5 percent.11
The first major breakthrough in our ability to detect viruses is genome sequencing, which allows us to identify and characterize the genome of viruses circulating in clinical and environmental samples and to gain continual insights into their genetic diversity, evolution, and transmission. For example, within a month of COVID-19 entering the human population, genome sequencing allowed Chinese scientists to identify and characterize SARS-CoV-2—the causative agent. Since then, there have been over 3.4 million genome submissions and counting, as of September 2021, to GISAID, the publicly accessible global database, which have helped uncover patterns of transmission (for example, super-spreader events, increases in virus transmissibility) and identify variants of concern.12
Traditionally, scientists have relied on two kinds of diagnostics—polymerase chain reaction (PCR) and antibody tests. A classic molecular diagnostic, PCR works by extracting genetic material (DNA, RNA) from a sample, which is then copied several times over to confirm or negate the presence of a virus. It is sensitive and specific, suitable for clinical testing, and readily adaptable to new infectious pathogens.13 Alternatively, antibody tests can detect either the virus or antibodies to a virus. This group includes antigen capture tests, often used as point-of-care tests, which use antibodies that bind to viral proteins and other elements to signal if they are present in a patient’s body.14 Another type of antibody test, classic serology tests, determine if a patient is currently mounting an immune response or previously had an infection that left memory antibodies. Both classes face barriers to implementation (see table 2-2). PCR requires sophisticated machinery, thereby limiting its deployability; and antibody tests—like the U.S. FDA- approved antigen test for COVID-19—require bespoke development, which often takes several months.15
New technologies are emerging that have enabled increased diagnostic development and operability in lower-resource settings worldwide. Thanks to genomic advancements and new discoveries around isothermal amplification, CRISPR, and synthetic biology, scientists have developed a range of new, ultrasensitive, low-cost, rapidly programmable, and widely deployable point-of-care diagnostics. Isothermal amplification technologies such as LAMP (Loop-Mediated Isothermal Amplification) operate similarly to PCR, but at a single lower temperature, so that they can be performed with minimal equipment. As a test, LAMP was found to be highly specific, scalable, and cost-effective, and can produce results within an hour (compared to the four to eight hours required by PCR methods).16, 17 CRISPR, which consists of a guide protein and nuclease originally discovered in nature as a bacteria’s immune system to viruses, has been paired with isothermal amplification to enable the development of even more sensitive, fast, and portable diagnostic tests, such as SHERLOCK, DETECTR, and HOLMES.18, 19 The synthetic biology-based INSPECTR—a molecular diagnostics platform—has also enabled accurate and specific viral detection on a portable and affordable lateral flow test strip.20 Meanwhile, efforts to accelerate the development of antibody tests have been underway to prepare for new and emerging threats, and could provide a viable option for household testing kits by 2030.21
Countermeasures
Prior to the genomic advancements described above, the development of medical countermeasures was slower, more experimental, and less precise. Traditionally, therapies were often discovered in nature and had to undergo a long evaluation process to understand effects on patients. Classic vaccines required a complex process of inactivation of the antigen or viral protein—that is, the part of the virus that induces production of antibodies—to trigger a natural immune response, and development generally took up to a decade before safe public deployment was possible.22 Today, with the unprecedented ability to target pathogens based on their genome, countermeasure development has been faster, more innovative, and more specific than ever before. Examples of treatment and vaccines made possible by genomic advancements include monoclonal antibodies, messenger RNA (mRNA) vaccines, and universal vaccines to target all types of flu and coronavirus.
2nc – Solvency
The CP’s strengthen of the public interest standard for medical cases solves.
1— Empirics: eBay’s public interest prong is key to life-saving medical tech development.
Fowler 24—JD from Villanova University School of Law with experience in Patent Law, MS Bioengineering and B.Sc. Chemical Engineering (Addison. “No Need to Reinvent the Wheel: The Positive Relationship Between Green Technology and Patent Enforcement.” Villanova Environmental Law Journal, vol. 35, no. 1, Feb. 2024, pp. 137–40, https://digitalcommons.law.villanova.edu/elj/vol35/iss1/4)//mgm
A. Post-eBay Injunctions by the Numbers
Empirical analyses of decisions post-eBay have confirmed that injunctions are now more difficult to obtain. One assessment found that courts are 44.1 percent less likely to grant permanent injunctions post-eBay. Analyses have demonstrated injunction success rates of seventy to eighty percent, whereas, prior to eBay, courts granted the overwhelming majority of injunctions upon finding patent infringement. In the two years prior to eBay, courts denied between zero and six percent of motions for injunction.
Another analysis sought to break down the different circumstances coinciding with injunction rejections. The study noted the public interest weighed against an injunction in fifty-two percent of the denied injunctions analyzed. The study further described an outsized rejection rate for medical device injunctions and theorized it may be the result of instances where public interest weighed in favor of device access.
B. The Public Interest and Select District Court Injunction
Decisions
District courts since eBay have demonstrated a willingness to consider a multitude of factors when adjudicating the public interest. In fact, the Eastern District of Virginia, in its eBay opinion on remand, listed a series of potential considerations: “the type of patent involved, the impact on the market, the impact on the patent system, and any other factor that may impact the public at large . . . .” The district court recognized that after eBay, the public’s interest in the integrity of the patent system could not create a presumption of public interest in favor of injunctions.
Courts, such as the District Court of Massachusetts in Smith & Nephew v. Interlace Medical, have placed significant emphasis on maintaining an uninterrupted supply of life-saving medical instruments. In Smith, the court found a “strong countervailing public interest” because the defense presented evidence that some doctors found the patent-infringing medical instrument more effective than what would otherwise be available if a permanent infringement were instituted. Similarly, in Waters Corp. v. Agilent Technologies Inc., the Delaware District Court denied a preliminary injunction partly because an unavailability of the chemical reagent product at issue would have hampered the drug development and approval pipeline.
Courts’ assessments of these countervailing interests have also extended beyond human health. In Centripetal Networks, Inc. v. Cisco Systems, Inc., for example, the District Court for the Eastern District of Virginia declined to issue a permanent injunction against Cisco, even though it found Cisco had infringed with an array of its products. The court explained an injunction would create significant disruptions to both civilian and military networks because Cisco’s products were interwoven within the global internet infrastructure. The court further reasoned monetary damages were justified in lieu of an injunction because Centripetal had previously demonstrated a willingness to accept such damages against other direct competitors.
2—Market transparency competition: public interest prong is key—empirics.
Yixin H. Tang 21, Litigation, patent law · Experience: Upadhye Tang LLP · Education: Harvard Law School · Location: Greater Chicago AreaHarvard Journal of Law & Technology Volume 20, Number 1 Fall 2006 “THE FUTURE OF PATENT ENFORCEMENT AFTER EBAY V. MERCEXCHANGE” Yixin H. Tang, https://jolt.law.harvard.edu/articles/pdf/v20/20HarvJLTech235.pdf
The Supreme Court admonished the practice of categorically defining the limits of patentability.175 In the absence of a categorical approach, permanent injunctions in patent cases must be based on a case-by-case assessment.176 Two recent cases, however, demonstrate a possible shift in courts’ remedial approach to medical device and medical process infringement cases; in addition, these decisions are inconsistent with the findings discussed above regarding courts’ predictability in interpreting and applying the eBay test.177 Accordingly, it seems that the ruling in eBay impacts the biotechnology and medical device industries more significantly than other high tech industries. A. Conceptus v. Hologic In Conceptus, Inc. v. Hologic, Inc.,178 a recent decision from the Northern District of California, the court denied a permanent injunction in a dispute between two medical device companies producing transcervical hysteroscopic sterilization devices.179 The court found that Hologic’s contraceptive device did not infringe the Conceptus’ patented device.180 Conceptus, however, had also secured patent protection on the method by which treating physicians implanted the sterilization device in the patient’s body.181 The court found that 175 “[T]raditional equitable principles do not permit such broad classifications . . . . Just as the District court erred in its categorical of equitable relief, the Court of Appeals erred in its categorical grant of such relief.” eBay, 547 U.S. at 393-94; see Janutis, supra note 149, at 604-05. 176 eBay, 547 U.S. at 393-94. 177 See generally Conceptus, Inc. v. Hologic, Inc., No. C 09-02280 WHA, 2012 WL 44064 (N.D. Cal. Jan. 9, 2012); Bard Peripheral Vascular v. W.L. Gore & Assoc., Inc., No. CV-03-0597-PHX-MHM, 2009 WL 920300 (D. Ariz., Mar. 31, 2009); see also supra note 175 and accompanying text. 178 Conceptus, 2012 WL 44064, at *2. 179 Id; see also Conceptus, Inc. v. Hologic, Inc., 771 F. Supp. 2d 1164 (N.D. Cal. 2010) (“The Adiana system [Hologic], like the Essure System [Conceptus], supposedly involves the minimally invasive transcervical placement of a contraceptive device into woman’s fallopian tubes. . . . [Both systems are] intended to produce intrafallopian occlusion . . . .”). 180 Conceptus, 2012 WL 44064, at *2 (“The insert itself was accused as well but it was found to infringe in pretrial rulings.”); Conceptus, 771 F. Supp. 2d at 1177 (holding that even applying the rule provided in Graver, the two devices were not similar enough to merit a finding of infringement); see also Graver Tank & Mfg. Co. v. Linde Air Prods. Co., 339 U.S. 605, 608 (1950) (“[I]f two devices do the same work in substantially the same way, and accomplish substantially the same result, they are the same, even though they differ in name, form, or shape.”). 181 Conceptus, 771 F. Supp. 2d at 1170-71 (“Claims 37 and 38 (as well as independent claim 36, which 296 B.U. J. SCI. & TECH. L. Vol. 20:2 Conceptus held valid patents on method claims associated with the insertion of the contraceptive device.182 Subsequently, the jury found that, by selling its device, Hologic induced doctors’ direct infringement of the patented method, and there

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