Aff and Neg Updates Interlabs - Michigan 2024 CPSW

Neg- ASPEC
ASPEC IP Cards
The actor is the most important question in IPR policy and implicates all of solvency.
Mandel 2017. [Gregory N, Dean & Peter J. Liacouras Professor of Law, Temple University; “Institutional Fracture in Intellectual Property Law: The Supreme Court Versus Congress,” 102 Minn. L. Rev. 803, https://scholarship.law.umn.edu/mlr/95, Available on ProQuest //cpsw-ay]
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
[*869] Other scholars and experts rely on John Locke's labor theory of property rights and similar concepts to argue that intellectual property law exists to protect authors' and inventors' natural rights in their creative works. 329 This deontological perspective views individuals as automatically entitled to the fruits of their efforts. 330 Natural rights theory supports intellectual property protection on the basis that a creator is morally entitled to control the copying and distribution of inventions or artistic creations produced as a result of the creator's own labor and effort. 331
Under the traditional, romantic view of the branches of government enshrined in the Constitution, those who believe in a deontological basis might tend to favor Congress as the intellectual property law decision-maker and be wary of Supreme Court interference. Natural rights in intellectual property law are an ill-defined concept, and majoritarian preferences could be an appropriate way to define such rights. 332 In fact, experts who support natural rights concepts in intellectual property law often [*870] point to popular opinion and perceptions as evidence corroborating their views about what intellectual property rights should be. 333
The Supreme Court, on the other hand, may appear more attractive to consequentialist proponents. Rather than deciding intellectual property rights based on popular vote, achieving optimal incentives requires balancing the incentive benefits that intellectual property protection provides against the exclusionary costs that it creates. 334 The Supreme Court, not Congress, may be better able to engage in this calculated weighing. In support of this perspective, the Supreme Court has affirmed the incentive objectives of intellectual property law in numerous opinions, recognizing the need to balance the incentives of protection against intellectual property rights "not inhibiting further discovery." 335
The agent of the plan determines solvency --- otherwise “doctrine creep” causes inconsistent.
Sherry Knowles 8-27-2019, Sherry M. Knowles is an intellectual property attorney with 30 years of experience in global corporate and private practice, and is a member of the inaugural class of the IPWatchdog Masters™ Hall of Fame. Currently the Principal of Knowles Intellectual Property Strategies, Ms. Knowles was the Senior Vice President and Chief Patent Counsel at GlaxoSmithKline from 2006-2010, where she served as the worldwide head of patents for all litigation and transactional matters, and managed a global department of over 200 people in 12 offices. Ms. Knowles was Chair of the IP Subcommittee of PhRMA in 2008, and Chair Emeritus of the PhRMA IP Subcommittees in 2009 and 2010. “Damage to Our Patent System by Failure to Honor the U.S. Legal Framework: Double Patenting” [IP Watchdog] https://ipwatchdog.com/2019/08/27/damage-patent-system-failure-honor-u-s-legal-framework-double-patenting/id=112629/ /MDC
Harm to Inventors, Damage to the System
Where the U.S. Constitution grants sole authority to Congress to create law in an area, the U.S. Supreme Court is limited to statutory construction. “Judicially-created” obviousness-type double patenting by definition cannot be a reasonable interpretation of a statute because there is no statute on which it is based—hence the name “non-statutory”.
The application of the “judicially created doctrine” on “non-statutory” obviousness-type double patenting harms innovators because to overcome the rejection, innovators must submit a Terminal Disclaimer that substantively affects patent ownership and any agreement to the Terminal Disclaimer runs with the patent and is binding on the grantee, its successors and assigns.
This post does not take any position on what the correct law of double patenting should be. This post is meant to highlight the damage caused to the system itself when the strict rules for the responsibility to create and enforce our laws as set out in the Constitution are not honored.
One of the biggest problems caused by the failure to honor the basic structure of our government is that we can’t put the toothpaste back in the tube. It has historically been the case that when courts change the law, it applies retroactively (often because the courts use the ruse that they are interpreting what the law always was, even when we know that isn’t the case and the new law causes a draconian change in how business is carried out). On the contrary, Congress cannot pass a statute (for example, a double-patenting statute) that retroactively enacts or ratifies a law or retroactively delegates past authority to the USPTO that didn’t previously exist. So, how can the lack of Constitutional and Congressional authority to create the double-patenting laws be fixed if the fix cannot apply retroactively to ratify years of application of unauthorized law? What a mess.
The failure to honor the basic structure of our government in the area of patent law results in doctrine creep. In the 101 area, innovators are victims of doctrine creep whereby the Supreme Court has instructed federal courts to read into Section 101 judicially created exceptions and an inventive concept requirement, which, as Judge O’Malley points out, is a baffling standard that Congress removed when it amended the Patent Act in 1952. In the double patenting area, we find doctrine creep as the requirement slides from application only to directly overlapping claims, to application to claims that are held obvious over those in related patents, to claims rejected over claims in a related patent in combination with a third-party reference, and on it goes.
We Must Get Back to the Blueprint
When building a house, the construction team constantly refers to the blueprints. When deciding how to spend money at a company, the Board repeatedly refers back to the approved business plan to see if the spend is consistent. When manufacturing products, companies repeatedly check the specifications and design. So why is it verboten to strictly refer to the nation’s blueprint, the U.S. Constitution, to check to make sure the government is conducting itself according to the established balance of powers between the branches of government when carrying out the country’s business? And why, for example, are the courts so comfortable applying tax code as written by Congress but not the patent code?
There are a range of views on the Constitution, from “originalist” to “living”. However, these range of views pertain to subtleties such as interpretation of wording when ratified versus today. Regardless of your proclivities on how to interpret words of the Constitution, these differences cannot rise to the very structure of government itself, or else we would have no framework. If the Constitutional structure of the government unambiguously grants power to only one branch of government to create law, that is neither subtle nor interpretable in different ways.
Neg---PTAB
Cant solve pharma
More patents don’t solve – Disease treatment is too risky for private companies to invest in
Readel 13, Anne Readel is a Patent Litigation Associate, Perkins Coie LLP; J.D., University of Wisconsin Law School 2012; Ph.D., University of Illinois, 2009; Knauss Marine Policy Fellow, 2007; B.S., University of Illinois, 2003, “FINDING A CURE: INCENTIVIZING PARTNERSHIPS BETWEEN DISEASE ADVOCACY GROUPS AND ACADEMIC AND COMMERCIAL RESEARCHERS,” x/x/2013, https://engagedscholarship.csuohio.edu/cgi/viewcontent.cgi?article=1342&context=jlh
"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
Big Pharma – they don’t innovate – more big pharma patents means LESS medical innovation, turns case
Jung et al 19, Emily H. Jung is a medical student at Emory School of Medicine and a former research assistant at the PORTAL in the Division of Pharmacoepidemiology and Pharmacoeconomics at Brigham and Women’s Hospital. Alfred Engelberg, J.D., is a retired pharmaceutical intellectual property attorney and philanthropist. Aaron S. Kesselheim, M.D., is a professor of medicine at Harvard Medical School and director of PORTAL, “Do large pharma companies provide drug development innovation? Our analysis says no,” 12/10/2019, https://www.statnews.com/2019/12/10/large-pharma-companies-provide-little-new-drug-development-innovation/
Large pharmaceutical companies oppose legislation being considered by Congress to lower the prices of prescription drugs. Reducing their revenues, they contend, will reduce their investment in drug development and the discovery of new medicines, and thus lead to a decline in drug innovation. If that argument is credible, there should be evidence to show that the large pharmaceutical companies are responsible for discovering innovative new drugs. To test that claim, we examined the provenance of the highest-selling prescription medicines of Pfizer and Johnson & Johnson, the two largest pharmaceutical and biotechnology companies in 2018. We found that these large pharmaceutical companies did not actually invent most of the drugs they sell. Indeed, it appears they have already reduced their investment in the discovery of new medicines to the point where the threat of additional reductions rings hollow and is no longer a persuasive reason for opposing legislation to lower drug prices. Pfizer’s and J&J’s annual reports identify the medications that account for most of each company’s sales of prescription drugs. We gathered information on the discovery and early development of these products from peer-reviewed publications, media reports, and company press releases. We scoured the companies’ 2017 annual reports. A total of 62 products — 44 from Pfizer and 18 from J&J — were listed in them. The discovery and early development work were conducted in house for just 10 of Pfizer’s 44 products (23%), as listed in Table 1. Only two of J&J’s 18 leading products (11%) were discovered in house, as shown in Table 2. For example, sildenafil, the phosphodiesterase inhibitor that is the active compound in the erectile dysfunction drug Viagra and the pulmonary hypertension drug Revatio, was synthesized at Pfizer in the 1980s, originally as a cardiovascular medicine. Research leading to the development of risperidone (Risperdal), one of several newer-generation atypical antipsychotic drugs, began at J&J in the 1980s. The majority (81%) of other products were discovered and initially developed by third parties. Some of them came to Pfizer and J&J from the acquisition of other pharmaceutical companies. For example, Pfizer’s highest-selling product, Prevnar 13, a vaccine for pneumococcal disease, was developed at Wyeth, which Pfizer acquired in 2009. Pfizer’s palbociclib (Ibrance), used to treat breast cancer, had its origins at Warner-Lambert and Onyx Pharmaceuticals. J&J’s rivaroxaban (Xarelto), an anticoagulant, originated at Bayer. Research leading to the discovery and development of other Pfizer and J&J drugs originated in universities and academic centers. J&J’s highest-selling product, infliximab (Remicade), is a monoclonal antibody that was synthesized by researchers at New York University in 1989 in collaboration with the biotechnology company Centocor. The original work showing its efficacy in rheumatoid arthritis was led by Marc Feldmann and Ravinder Maini at Imperial College London.
Most drug funding comes from the government
Sampat 21, Bhaven N. Sampat, Ph.D., M.Phil., M.A., is an Associate Professor at Columbia University and Research Associate, National Bureau of Economic Research, “The Government and Pharmaceutical Innovation: Looking Back and Looking Ahead,” Spring 2021, DOI: 10.1017/jme.2021.3
. One strand of research examines who funds what. The most comprehensive research on funding suggests that the U.S. government, primarily through the National Institutes of Health (NIH), provides about one-third of total U.S. biomedical research funding, pharmaceutical and biotechnology companies about 50 percent, with the medical device industry, state and local governments, and foundations accounting for the rest. 18 However, there is a rough division of labor, with the vast majority of pharmaceutical R&D focused on clinical research, and the majority of NIH funding focused on "basic" research. . Cross-industry firm surveys consistently suggest stronger linkages between public sector and private sector research activities in pharmaceuticals than in other sectors. 19 In the largest such survey, Cohen and colleagues suggest that in the drug industry 41 percent of R&D projects used research findings from the public sector, 35 percent instruments and techniques from public science, and 12 percent were based on prototypes from public sector research. 20 Overall, the surveys suggest a larger enabling role for the public sector in drugs than other industries, though only 10-15 percent of projects are based directly on public sector research, or build on public sector prototypes. . Another approach uses detailed case studies of important drugs to assess, through histories and/ or interviews, the role of the public sector. 21 Each of these studies suggests the public sector has a role in the vast majority of important drugs. However, very rarely is the public or private sector solely responsible. . Analyses of drugs' key patents suggest that the public sector did enough work to obtain a patent associated with the final product (listed on the FDA's Orange Book, see below) for about 20 percent of "important" drugs. 22 This "direct" role of the public sector in principle can be traced through government interest statements which must list any government grants or contracts directly supporting the research on the invention. 23 . Bibliometric analyses tracing publication inputs for FDA approved drugs 24 and publications cited in the patents on FDA approved drugs 25 suggest that nearly all important drugs have publication links to NIH or other government funded research. . Econometric analyses relating variation in NIH funding to drug development suggest a statistically significant increase in drugs in trials 26 and approved drugs 27 following increases in NIH funding in the relevant area.
Neg---Green Patents
Innovation can’t solve
Innovation is too slow and unreliable to solve climate change
Foley 24, Jonathan Foley is a renowned environmental scientist, sustainability expert and the director of Project Drawdown, the world’s leading resource for climate solutions, “New tech won’t save us from climate change. Here’s what will,” 3/30/2024, https://www.sciencefocus.com/nature/climate-change-tech-solution
The fundamental reason high-tech solutions won’t save us from climate change is simple: time. Time is by far the most important variable – and the one thing technology can’t give us more of. Climate change is a cumulative problem. The warming we see now is caused by the year-by-year, decade-by-decade build-up of greenhouse gas pollution in Earth’s atmosphere. The severe climate disruptions of 2023 – the record temperatures, storms, fires and other disasters – weren’t caused by 2023’s emissions alone. Nor were they caused by those of 2022. They were caused by our long-term, cumulative emissions, building up over many, many years. Over the past several decades we’ve been emitting a lot of greenhouse gases – tens of billions of tonnes each year, adding up to a staggering amount of pollution dumped into the atmosphere. The cumulative impact of that pollution has fundamentally changed our atmosphere and climate system. The longer we keep emitting greenhouse gases, the more this pollution builds up in the atmosphere, and the more climate heating it causes. It’s a process that effectively locks in warmer temperatures on our planet for thousands of years to come. The only solution is to stop polluting as quickly (and as safely and equitably) as possible. To avoid the worst outcomes of climate change, we need to start lowering our emissions immediately. By cutting emissions now, and continuing to cut them in each consecutive year, we can reduce the future impacts of climate change. Every tonne of greenhouse gases we don’t emit, starting today, will help reduce the amount of warming we’ll see. Every tonne matters. Every year matters. Solutions today for saving tomorrow That’s why we need to focus on the solutions we already have. Despite what some think, climate solutions are already here. In fact, today’s climate solutions are abundant, whether they’re achieving huge gains in efficiency, reducing food was

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