PTAB Harmonization Aff - Michigan 7 2024 CPSW

Thanks
Thanks to Andrew Yim, Asha Laskar, Faiz Fatehali, Justin Kim, Lucas Plotkin, Maanyata Srikantam, Matthew DaSilva, Miao Sun, Noah Eisenman, Norah Parampath, and Shruti Parthasarathy for their work on this file!
Notes
***General miscellaneous notes
The 1AC 3rd adv is optional – it’s just preempts
The 1AC has a lot of link enforcement, which can be taken out or re-highlighted to take out duplicate warrants to save time.
You can probably use ! cards from different files as addons in the 2ac or to make the 1ac more impact heavy
i.e. there is a “disease leads to ag collapse” warrant in the USC 23 card.
***How this file is organized:
This file appears to have a lot of the same warrants and cards like “[x thing] k2 solve”. Or whatever. The reason for this is because I split advantage specific evidence on the top shelf and put generic but broad evidence in the bottom shelf.
2AC section has 5 components – the 3 advantages, Inherency, and Solvency. The 2 shelfs for the advantages are the top shelfs with more specific evidence. (The 3rd advantage is just stuff pulled from the back shelf.) Therefore, they are quite a bit smaller. The 2 other sections comprise the back shelf, which has a lot of good cards that aren’t specific to either advantage BUT can be used to extend or answer stuff on both advantages (because the link work is similar).
Miao Sun
Case --- PTAB Aff --- W1
1AC
Plan
Plan: The United States Federal Government should require that the Patent Trial and Appeals Board use a clear and convincing evidence standard when determining patent validity.
Advantage 1 --- Pharma
Contention 1 is Pharma:
Pharma innovation is slow now due to increased R&D costs. More investment in pharma is key to solve.
Daniel I., 4-10-2024. Daniel I graduated from John Hopkins University and is a current healthcare stategist. "The Innovation Gap: Why Drug Development has Gotten Slower and More Expensive", Linkedin, https://www.linkedin.com/pulse/innovation-gap-why-drug-development-has-gotten-slower-daniel-qoqef/ || 苗
Over the past six decades, tremendous progress has been made in the scientific, technological, and managerial areas that drive pharmaceutical research and development (R&D). Paradoxically, the efficiency of drug development has significantly declined during this same period. The number of new drugs approved per billion dollars invested has decreased dramatically, a phenomenon termed "Eroom's Law." This trend stands in stark contrast to Moore's Law, which describes the exponential growth patterns seen in Computer technology.
Researchers and industry experts have worked diligently to understand and enhance the commercial R&D process. Studies have pinpointed reasons for project overruns, factors impacting financial returns, techniques for outsourcing, and regulatory considerations. Despite these efforts, R&D efficiency continues to dwindle. While improvements in our grasp of project management and financial models are valuable, they have failed to reverse the central trend: less innovation for more money spent.
The underlying cause of this decline is multifaceted. The sheer complexity of biological systems poses a fundamental challenge far greater than that found in the predictable realm of solid-state physics that underpins Moore's Law as well as the fact that understanding how drugs interact with intricate biological pathways is far less straightforward than refining circuit designs.
Ultimately, the pharmaceutical industry is grappling with a critical problem. Even as scientific knowledge expands and sophisticated management tools are adopted, rising R&D investments simply aren't producing the expected increase in new and effective drugs. Reversing this trend will require a deeper examination of the factors impeding innovation and perhaps a fundamental shift in how drug discovery and development are approached.
PTAB’s lower standards cause duplicative litigation, which significantly undermines the certainty of pharma patents. That decks pharma innovation and funding. The plan is key to invigorate R&D investment.
Joanna Shepherd 3-8-2019. Joanna Shepherd is the Thomas Simmons Professor of Law at Emory University School of Law. She served as Vice Dean from 2020 - 2023 and again beginning in the summer of 2024. “Reducing Duplicative Patent Challenges in the Drug Industry,” Truth on the Market, https://truthonthemarket.com/2019/03/08/reducing-duplicative-patent-challenges-in-the-drug-industry/ || 苗
If the Federal Circuit agrees with the USPTO, patent challengers could be strongly deterred from bringing IPR proceedings because it would mean they couldn't reuse any arguments in district court. This deterrent effect would be especially strong for generic drug makers, who must prevail in district court in order to get approval for their Abbreviated New Drug Application from the FDA. Critics of the USPTO's position assert[3] that it will frustrate the AIA's purpose of facilitating generic competition. However, if the Federal Circuit adopts the position, it would also reduce the amount of duplicative litigation that plagues the pharmaceutical industry and threatens new drug innovation. According to a 2017 analysis[4] of over 6,500 IPR challenges filed between 2012 and 2017, approximately 80% of IPR challenges were filed during an ongoing district court case challenging the patent. This duplicative litigation can increase costs for both challengers and patent holders; the median cost[5] for an IPR proceeding that results in a final decision is $500,000 and the median cost for just filing an IPR petition is $100,000. Moreover, because of duplicative litigation, pharmaceutical patent holders face persistent uncertainty about the validity of their patents. Uncertain patent rights will lead to less innovation because drug companies will not spend the billions of dollars it typically costs to bring a new drug to market when they cannot be certain if the patents for that drug can withstand IPR proceedings that are clearly stacked against them. And if IPR causes drug innovation to decline, a significant body of research predicts that patients' health outcomes will suffer as a result.In addition, deterring IPR challenges would help to reestablish balance between drug patent owners and patent challengers. As I've previously discussed here[6] and here[7], the pro-challenger bias in IPR proceedings has led to significant deviation in patent invalidation rates under the two pathways; compared to district court challenges, patents are twice as likely to be found invalid in IPR challenges. The challenger is more likely to prevail in IPR proceedings because the Patent Trial and Appeal Board (PTAB) applies alower standard of proof[8]for invalidity in IPR proceedings than do federal courts. Furthermore, if the challenger prevails in the IPR proceedings, the PTAB's decision to invalidate a patent can often 'undo' a prior district court decision in favor of the patent holder. Further, although both district court judgments and PTAB decisions are appealable to the Federal Circuit, the court applies a more deferential standard of review to PTAB decisions, increasing the likelihood that they will be upheld compared to the district court decision. However, the USPTO acknowledges that its position is counterintuitive because it means that a court could not consider invalidity arguments that the PTAB found persuasive. It is unclear whether the Federal Circuit will refuse to adopt this counterintuitive position or whether Congress will amend the AIA to limit estoppel to failed invalidity claims. As a result, a better and more permanent way to eliminate duplicative litigation would be for Congress to enact the Hatch-Waxman Integrity Act of 2019[9] (HWIA). The HWIA was introduced by Senator Thom Tillis in the Senate and Congressman Bill Flores In the House, and proposed in the last Congress by Senator Orrin Hatch. The HWIA eliminates the ability of drug patent challengers to file duplicative claims in both federal court and IPR proceedings. Instead, they must choose between either district court litigation (which saves considerable costs by allowing generics to rely on the brand company's safety and efficacy studies for FDA approval) and IPR proceedings (which are faster and provide certain pro-challenger provisions). Thus, the HWIA would reduce duplicative litigation that increases costs and uncertainty for drug patent owners. This will ensure that patent owners achieve clarity on the validity of their patents, which will spur new drug innovation and ensure that consumers continue to have access to life-improving drugs.
Current PTAB standards also allow for reverse patent trolling, which creates significant uncertainty in pharma patents.
Joanna Shepherd 10-23-2017. Joanna Shepherd is the Thomas Simmons Professor of Law at Emory University School of Law. She served as Vice Dean from 2020 - 2023 and again beginning in the summer of 2024, “Inter Partes Review Jeopardizes the Social Contract between Drug Makers and Patients”, Truth on the Market, https://truthonthemarket.com/2017/10/22/inter-partes-review-jeopardizes-the-social-contract-between-drug-makers-and-patients/ || 苗
Last week, the tribe, with SRC as co-plaintiff, filed lawsuits[3] against Microsoft and Amazon for infringement of its data processing patents; the assignment of the SRC patents to the tribe could prevent a counter-challenge from Microsoft and Amazon in IPR proceedings. Similarly, Prowire LLC, who has sued Apple for infringement, has assigned the patent[4] in question to MEC Resources, a company affiliated with three tribes in North Dakota. And state universities (whom the PTAB considers[5] to be arms of the sovereign states, and thus immune to IPR challenges) are in discussions[6] with lawyers about offering their sovereign immunity to patent owners as a way to shield patents in IPR proceedings. These arrangements that attempt to avoid the IPR process and force patent challenges into federal courts are no surprise given the current unbalance in the IPR system[7]. Critical differences exist between IPR proceedings and Hatch-Waxman litigation that have created a significant deviation in patent invalidation rates under the two pathways; compared to district court challenges, patents are twice as likely to be found invalid in IPR challenges. The PTAB applies a lower standard of proof[8] for invalidity in IPR proceedings than do federal courts in Hatch-Waxman proceedings. In federal court, patents are presumed valid and challengers must prove each patent claim invalid by 'clear and convincing evidence.' In IPR proceedings, no such presumption of validity applies and challengers must only prove patent claims invalid by the 'preponderance of the evidence.' In addition to the lower burden, it is also easier for challengers to meet the standard of proof in IPR proceedings. In federal court, patent claims are construed[9] according to their 'ordinary and customary meaning' to a person of ordinary skill in the art. In contrast, the PTAB uses the more lenient 'broadest reasonable interpretation' standard; this more lenient standard can result in the PTAB interpreting patent claims as 'claiming too much' (using their broader standard), resulting in the invalidation of more patents. Moreover, whereas patent challengers in district court must establish sufficient Article III standing, IPR proceedings do not have a standing requirement. This has given rise to 'reverse patent trolling,'[10] in which entities that are not litigation targets, or even participants in the same industry, threaten to file an IPR petition challenging the validity of a patent unless the patent holder agrees to specific pre-filing settlement demands. The lack of a standing requirement has also led to the exploitation[11] of the IPR process by entities that would never be granted standing in traditional patent litigation—hedge funds betting against a company by filing an IPR challenge in hopes of crashing the stock and profiting from the bet. Finally, patent owners are often forced into duplicative litigation in both IPR proceedings and federal court litigation, leading to persistent uncertainty about the validity of their patents. Many patent challengers that are unsuccessful in invalidating a patent in district court may pursue subsequent IPR proceedings challenging the same patent, essentially giving patent challengers 'two bites at the apple[12].' And if the challenger prevails in the IPR proceedings (which is easier to do given the lower standard of proof and broader claim construction standard), the PTAB's decision to invalidate a patent can often 'undo' a prior district court decision. Further, although both district court judgments and PTAB decisions are appealable to the Federal Circuit, the court applies a more deferential standard of review to PTAB decisions, increasing the likelihood that they will be upheld compared to the district court decision. Courts are increasingly recognizing that certain PTAB practices are biased against patent owners, and, in some cases, violations of underlying law. The U.S. Supreme Court in Cuozzo Speed Technologies v. Lee[13] concluded that the broadest reasonable interpretation claim construction standard in IPR 'increases the possibility that the examiner will find the claim too broad (and deny it)' and that the different claim construction standards in PTAB trials and federal court 'may produce inconsistent results and cause added confusion.' However, the Court concluded that only Congress could mandate a different standard. Earlier this month, in Aqua Products, Inc. v. Matal[14], the Federal Circuit held that '[d]espite repeated recognition of the importance of the patent owner's right to amend [patent claims] during IPR proceedings— by Congress, courts, and the PTO alike—patent owners largely have been prevented from amending claims in the context of IPRs.' And the Supreme Court has agreed to hear Oil States Energy Services v. Greene's Energy Group[15], which questions whether IPR proceedings are even constitutional because they extinguish private property rights through a non-Article III forum without a jury. As Courts and lawmakers continue to question the legality and wisdom of IPR to review pharmaceutical patents, they should remember that the relationship between drug companies and patients resembles a social contract[16]. Under this social contract, patients have the right to reasonably-priced, innovative drugs and sufficient access to alternative drug choices, while drug companies have the right to earn profits that compensate for the risk inherent in developing new products and to a stable environment that gives the companies the incentive and ability to innovate. This social contract requires a balancing of prices (not too high to gouge consumers but not too low to insufficiently compensate drug companies), competition law (not so lenient that it ignores anticompetitive behavior that restricts patients' access to alternative drugs, but not so strict that it prevents companies from intensely competing for profits), and most importantly in the context of IPR, patent law (not so weak that it fails to incentivize innovation and drug development, but not so strong that it enables drug companies to monopolize the market for an unreasonable amount of time). The unbalanced IPR process threatens this balance by creating significant uncertainty in pharmaceutical intellectual property rights. Uncertain patent rights will lead to less innovation in the pharmaceutical industry because drug companies will not spend the billions of dollars it typically costs to bring a new drug to market when they cannot be certain if the patents for that drug can withstand IPR proceedings that are clearly stacked against them. Indeed, last week former Federal Circuit Chief Judge Paul Redmond Michel acknowledged[17] that IPR has contributed to 'hobbling' our nation's patent system, 'discourag[ing] investment, R...nd commercialization.' And if IPR causes drug innovation to decline, a significant body of research predicts that consumers' health outcomes will suffer as a result.
Empirics prove. Noven Pharmaceuticals won the case in district courts, but lost because of inter partes review under PTAB with a lower burden. The choice of the Circuit Court to uphold the PTAB’s decision proves that patent strength is unreliable for big pharma.
McDermott Will & Emery 5-30-2017. McDermott Will & Emery partners with leaders around the world to fuel missions, knock down barriers and shape markets. “Previous District Court Ruling on Obviousness Does Not Bind PTAB,” The National Law Review, https://natlawreview.com/article/previous-district-court-ruling-obviousness-does-not-bind-ptab || 苗
v. Noven Pharmaceuticals Inc., Case Nos. 16-1678; -1679 (Fed. Cir., Apr. 4, 2017) (Wallach J). Novartis AG owns two patents for a transdermal drug patch containing rivastigmine. The patents were challenged in inter partes review (IPR), where the PTAB found the challenged claims unpatentable as obvious under § 103. By contrast, in a concurrent litigation, a district court analyzed the same arguments and prior art, and found the patents to be valid. Novartis appealed to the Federal Circuit, arguing that under Federal Circuit precedent, prior judicial decisions control the PTAB's findings, and that the PTAB failed to show any motivation to combine the prior art. Regarding Novartis's argument that the PTAB should have been bound by the prior district court decision, the Federal Circuit disagreed on both factual and legal grounds. Factually, while the previous case may have been 'substantively the same,' the presence of an additional piece of prior art and new declaratory evidence undercut Novartis' argument that the facts were entirely the same. As the Court explained, different records may lead to different findings and conclusions. Legally, even had the records been exactly the same, the PTAB reviews patentability issues using a preponderance of evidence standard, while district courts require clear and convincing evidence to invalidate a patent. While the same evidence and argument will ideally result in the same findings, under the lower standard there is no mandate that the PTAB reach the same conclusion as a district court. Novartis also argued that the PTAB erred by concluding that adding antioxidants to an acrylic polymer drug patch to prevent the degradation of the drug rivastigmine would have been obvious. Novartis argued that without any evidence of rivastigmine's oxidative degradation, a person having ordinary skill in the art (PHOSITA) would not have been motivated to include an antioxidant to stabilize the rivastigmine in a transdermal patch. While the prior art taught that antioxidants can forestall the breakdown that occurs when drugs are exposed to acrylic polymers, such as those in a patch, there was no express teaching that rivastigmine breaks down. But the Court pointed out that prior art does not have to explicitly disclose a motivation to combine. Furthermore, the PTAB had reasonably concluded a PHOSITA's level of skill would include organic chemistry training for analyzing and recognizing compound characteristics. That training would have allowed a PHOSITA to understand that rivastigmine had the potential to oxidatively degrade because of its chemical structure. That knowledge would motivate the PHOSITA to add antioxidants. Although Novartis argued that its expert's testimony countered this argument, the Court would not give the expert evidence more weight than the PTAB already had.
Pharma innovation key to U.S economy – it’s rapidly growing, supports other industry, employs high amounts of educated workers, and produces huge output per worker.
NAM 11-02-2023. The National Association of Manufacturers (NAM) is an advocacy group headquartered in Washington, D.C., with additional offices across the United States. It is the nation

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