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In addition to the practice of multiple petitioners challenging a single patent, well-funded large corporations, especially tech companies, also discovered the ability of leveraging IPRs to overwhelm and destroy the portfolios of smaller competitors who are in no way malicious patent assertion entities. In the name of defending their own patents, it appears that large companies have been sinisterly neutralizing competitors’ intellectual property. For example, in one case study, Apple once filed twelve IPR petitions against a North Carolina–based startup, Valencell, after a failed attempt to collaborate with the startup on an Apple Watch technology.95 Although Valencell is only one case in point, Apple’s treatment of its competitors reflects an industry wide mindset: tech companies with well resourced legal departments are willing to counterattack innovators so aggressively as to threaten the smaller innovative entities’ livelihood, forcing them to settle or give up their enforcement rights altogether in district courts.

The difference in evidentiary standards essentially creates a second bite at the apple for those challenging patent invalidity. If challengers fail to invalidate a patent in district court, they may file an IPR petition with the PTAB where the evidentiary standard is lower and, while arguing the same factual matter, prevail. 135 Additionally, if one party fails in district court, a separate third party can challenge patent validity using the IPR system.136

Problem: When validity of a patent is challenged in district court, "clear and convincing" evidence is needed to invalidate the patent. But at the PTAB, a petitioner need only show invalidity by a "preponderance of the evidence" standard. Further, until recently, the PTAB interpreted patent claims under a different standard than the district court. These differences often lead to inconsistent results between the two tribunals.

Solution: Harmonize PTAB claim interpretation and burden of proof with federal district court. The PREVAIL Act requires the PTAB to find a patent invalid by "clear and convincing" evidence and requires the PTAB to interpret claims using the same "plain and ordinary meaning" standard used in federal district court.

Concerns raised by opponents of the PTAB to date are largely unpersuasive. However, underlying their concerns may be a more legitimate problem - ex post patent invalidation undermines reliance interests of patent owners that never would have developed if the patent had been rejected as unpatentable during ex ante patent examination. This is a potential problem of ex post patent invalidation generally, not the PTAB specifically, but has become more apparent as the PTAB has made ex post invalidation more common. The extent, source, and consequences of such reliance costs are questionable and require much more exploration and evaluation. These issues, however, would be a better focus for debates over the optimality of the PTAB generally, and its design choices specifically, than existing arguments focused on constitutional power, supposed procedural bias, and the PTAB's absolute invalidity rate. They also may be relevant to ongoing debates about whether it would be rational to expend more resources on ex ante patent examination.

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However, it is the two great powers, China and Russia, that pose the greatest challenge to the relatively peaceful and prosperous international order created and sustained by the United States. If they were to accomplish their aims of establishing hegemony in their desired spheres of influence, the world would return to the condition it was in at the end of the 19th century, with competing great powers clashing over inevitably intersecting and overlapping spheres of interest. These were the unsettled, disordered conditions that produced the fertile ground for the two destructive world wars of the first half of the 20th century. The collapse of the British-dominated world order on the oceans, the disruption of the uneasy balance of power on the European continent due to the rise of a powerful unified Germany, combined with the rise of Japanese power in East Asia all contributed to a highly competitive international environment in which dissatisfied great powers took the opportunity to pursue their ambitions in the absence of any power or group of powers to unite in checking them. The result was an unprecedented global calamity. It has been the great accomplishment of the U.S.-led world order in the 70 years since the end of the Second World War that this kind of competition has been held in check and great power conflicts have been avoided.

The role of the United States, however, has been critical. Until recently, the dissatisfied great and medium-size powers have faced considerable and indeed almost insuperable obstacles to achieving their objectives. The chief obstacle has been the power and coherence of the order itself and of its principal promoter and defender. The American-led system of political and military alliances, especially in the two critical regions of Europe and East Asia, has presented China and Russia with what Dean Acheson once referred to as “situations of strength” in their regions that have required them to pursue their ambitions cautiously and in most respects to defer serious efforts to disrupt the international system. The system has served as a check on their ambitions in both positive and negative ways. They have been participants in and for the most part beneficiaries of the open international economic system the United States created and helped sustain and, so long as that system was functioning, have had more to gain by playing in it than by challenging and overturning it. The same cannot be said of the political and strategic aspects of the order, both of which have worked to their detriment. The growth and vibrancy of democratic government in the two decades following the collapse of Soviet communism have posed a continual threat to the ability of rulers in Beijing and Moscow to maintain control, and since the end of the Cold War they have regarded every advance of democratic institutions, including especially the geographical advance close to their borders, as an existential threat—and with reason. The continual threat to the basis of their rule posed by the U.S.-supported order has made them hostile both to the order and to the United States. However, it has also been a source of weakness and vulnerability. Chinese rulers in particular have had to worry about what an unsuccessful confrontation with the United States might do to their sources of legitimacy at home. And although Vladimir Putin has to some extent used a calculated foreign adventurism to maintain his hold on domestic power, he has taken a more cautious approach when met with determined U.S. and European opposition, as in the case of Ukraine, and pushed forward, as in Syria, only when invited to do so by U.S. and Western passivity. Autocratic rulers in a liberal democratic world have had to be careful.

How does China envision its longed-for post-Western world order?

Dams: ‘Beijing is aiming for a multipolar world order in which countries refrain from interfering in the internal politics of other countries. In which the notion of ‘universal values’ is viewed with scepticism, and where the United States is just one of the players.’

Artificial intelligence may transform many aspects of the human condition, nowhere more than in the military sphere. Although many Americans may only now be focusing on AI’s potential promise and peril, the U.S. Defense Department has worked for over a decade to ensure its responsible use. The challenge now is to convince other nations, including the People’s Republic of China, to join the United States in committing to norms of responsible AI behavior.

The Pentagon first issued a responsible use policy for autonomous systems and AI in 2012. Since that time, we’ve maintained our commitment even as technology has evolved. In recent years, we’ve adopted ethical principles for using AI, and issued a responsible AI strategy and implementation pathway. This January, we also updated our original 2012 directive on autonomy in weapon systems, to help ensure we remain the global leader of not just development and deployment, but also safety.

For better or worse, this standoffish relationship between the DoD and Silicon Valley is now changing.

Between 2022 and 2023, the military nearly tripled the amount of money it spent on AI, and in 2023, it announced Replicator, an initiative designed not only to get AI systems out of the lab and into the field en masse, but also establish the processes needed to ensure future tech innovations don’t succumb to the innovation valley of death.

Petitioners in district courts are barred by a set of criteria that needs to be satisfied in order for the claim to be considered

Current propositions to improve PTAB are insufficient in solving a litany of issues with the system

So you know more than half the time patent owners are winning if they fight. So now that we're a decade in, I think it's a good time to do exactly what you're doing here on this committee, which is let's take a look and see what's working and what's not working. You know, to be consistent with the AIA's purposes of having a faster, more efficient system, there are a few areas where I think you can make some tweaks and get a lot of value.

And so I'll bring up a couple here in my comments today. So one issue that I think everyone will agree on is the duplicative litigation. So when there is litigation in district court, there is usually an IPR or a PGR running in parallel. So what you effectively have are the same parties litigating the same issues at the same time in two different courts and that's wonderful for the lawyers, but it's not really wonderful for everybody else.

The Promoting and Respecting Economically Vital American Innovation Leadership Act

While the Supreme Court was establishing the Alice/Mayo framework, Congress implemented a second major reform to the patent system: the America Invents Act of 2011, which created the Patent Trial and Appeal Board (PTAB). The PTAB was established as a faster and cheaper alternative to district court for deciding patent validity. However, according to detractors, lawmakers unintentionally included several design flaws that are being exploited today to harass start-ups, small businesses, and individual inventors, making the system more complicated and expensive. Critics of the PTAB refer to it as a “death squad” killing property rights, as it invalidates over 80 percent of patents it agrees to review.

The US is quickly falling behind China in development of artificial intelligence, according to a report released today by data analytics firm Govini, making it nearly impossible for the US to win a war against the PLA if a conflict were to break out between the two global superpowers.

Govini releases annual reports measuring the performance of the federal government, looking at 15 top critical national security technologies through the lens of acquisition, procurement, supply chain, foreign influence and adversarial capital and science and technology.

Ambitious efforts to prevent diseases like AIDS or malaria and pandemics like influenza or Ebola have substantially improved the lives of people around the world. These initiatives by public health officials, government-sponsored programs, and nongovernmental organizations (NGOs) have done more than simply advance global citizens’ health and well-being, however.

Discover how global disease prevention efforts improve health while strengthening national security, increasing economic stability, and promoting human rights. This article will highlight:

The recent SARS-CoV-2 pandemic, which is causing COVID-19 disease, has taught us unexpected lessons about the dangers of human suffering through highly contagious and lethal diseases. As the COVID-19 pandemic is now being partially controlled by various isolation measures, therapeutics, and vaccines, it became clear that our current lifestyle and societal functions may not be sustainable in the long term. We now have to start thinking and planning on how to face the next dangerous pandemic, not just overcoming the one that is upon us now. Is there any evidence that even worse pandemics could strike us in the near future and threaten the existence of the human race? The answer is unequivocally yes. It is not necessary to get infected by viruses found in bats, pangolins, and other exotic animals that live in remote forests to be in danger. Creditable scientific evidence indicates that the human gut microbiota harbor billions of viruses that are capable of affecting the function of vital human organs such as the immune system, lung, brain, liver, kidney, or heart. It is remotely possible that the development of pathogenic variants in the gut can lead to contagious viruses, which can cause pandemics, leading to the destruction of vital organs, causing death or various debilitating diseases such as blindness, respiratory, liver, heart, and kidney failures. These diseases could result in the complete shutdown of our civilization and probably the gradual extinction of the human race. This essay will comment on a few independent pieces of scientific facts, and then combine this information to come up with some (but certainly not all) hypothetical scenarios that could cause human race misery, even extinction, in the hope that these hypothetical scenarios will trigger preventative measures that could reverse or delay the projected adverse outcomes.

Who’d have guessed that a year later pharma would be getting credit for saving the world? From cruise lines to meatpackers, business will have plenty to answer for in its handling of the pandemic, but this part of it worked. The Covid-19 vaccines developed by the drug industry, in partnership with governments, will almost certainly prevent hundreds of thousands of American deaths and millions more around the world. They will revive trillions of dollars in economic activity, let grandparents see grandchildren, and finally bring an end to a year that has—sing it together one last time as the ball drops over an empty Times Square—really sucked. In a time where almost everything else went wrong, the vaccine effort was something that went (mostly) right.

The quest started in early January, before most people in the U.S. and Europe were even thinking about a pandemic. The biotechnology company Moderna Inc. had downloaded the genetic code for the novel coronavirus from researchers in China. Within a few days, scientists there had developed a vaccine with the U.S. National Institute of Allergy and Infectious Diseases, the research agency led by Anthony Fauci. By mid-March, they’d started a clinical trial.

Since the 2000s, many pundits and scholars have attributed two rising powers’ instances of aggression to their domestic problems. Russia’s invasion of Ukraine and annexation of Crimea and its deployment of troops to Syria, along with China’s assertive actions in the South China Sea, have been seen as aggressions arising out of domestic weakness (Kaplan, 2016). Some have attributed China’s recent provocative actions against India, Japan, and Taiwan to its struggling economy in the wake of the pandemic (Myers, 2020). In the post-Cold War period, these two great powers, often regarded as revisionist powers, have regained their national capabilities to some extent and have sought higher status in international politics (Larson & Shevchenko, 2010). What made them more aggressive in the 2010s? One promising explanation is their decreasing economic growth rates. Due to their abundance of natural and human resources, the two former communist countries had maintained their increased status relative to their neighboring states since the 2000s or even earlier. However, falling energy prices and the reform-incapable structures of their economies retarded their further growth and increased the burden on their authoritarian leaders, who also had to manage domestic calls for political freedom and maintain the legitimacy of their rule. According to this article’s causal explanation, Russia and China became more revisionist actors in the 2010s at least partly because their economies went downhill, and their aggressions were directed at smaller and more vulnerable economies. A slowing economy and economic dependence have both individual and interactive effects on military conflict in international politics. Slow growth rates contribute positively to conflict initiation, especially when an autocracy suffering from a slowing economy targets a democracy whose economy is dependent on the autocracy. Whereas economic interdependence has been regarded by many liberal scholars as a reason for international cooperation, this study shows why and how asymmetric interdependence contributes to interstate conflict by articulating its interaction with an economic slowdown in a dyadic relationship. Both political unrest and economic problems have destabilizing effects on international politics, but their effects differ when economically dependent democracies are the target. Future research should compare different types of domestic unrest and their effects on international relations with sophisticated logic and strong evidence. This analysis shows that economic growth has two distinct effects. Slower growth makes one state weaker than others and its leaders more vulnerable to domestic challenges. A state’s economic slowdown not only causes a change in the balance of economic power so as to favor its competitor but also increases the troubled state’s foreign aggression, which can harm its adversary. Therefore, it is uncertain whether one state’s economic slowdown benefits its rival’s security. An autocracy’s slowing economy can be a warning, rather than good news, to its democratic opponents if the latter maintain economic relationships with the former. In this regard, economic sanctions may provoke the target leader’s diversionary tactic of blaming its poor economy on the sanctioner. We can see this pattern in Tokyo’s surprise attack on Pearl Harbor at a time of US sanctions against Japan, which had continued since the late 1930s. The current global economic outlook is uncertain in the wake of COVID-19. Although we do not yet know the pandemic’s long-term economic consequences, all states will likely struggle with slower growth and the erosion of democracy and will engage in more protectionist policies to reboot their economies and save major industries. In this context, we should be especially concerned about the risk that troubled economies pose to international security. As this study’s findings suggest, slower growth causes domestic problems, which often lead to the diversionary use of force against foreign states. If we cannot prevent struggling leaders from using diversionary tactics, worsening economies in authoritarian states will likely drive such states into a more confrontational or aggressive stance toward their economic partners, if not toward political and ideological partners. We can all hope world leaders will realize that this is a time to beat a global pandemic and an economic recession, not to beat up on a foreign state.

“Creating Cures, Saving Lives” analyzes the sector ’ s contributions to the broader economy and its commitment to R&D that drives the development of lifesaving treatments, such as advancements in therapeutics that fight cancer. The study further examines the ways that federal price controls on the sector, such as those contained in the Inflation Reduction Act, could jeopardize these treatments. The study comes at a critical time, as the Centers for Medicare & Medicaid Services recently announced the first tranche of treatments that will be subject to price controls.

“Pharmaceutical manufacturers are a major contributor to the U.S economy, employ millions of Americans and drive innovation. The industry ’ s investments in R&D have led to lifesaving treatments and therapies that have improved the quality of life for all Americans,” said NAM Chief Economist Chad Moutray. “This study explores the negative implications of price control policies on pharmaceutical leadership, putting American jobs and innovation in the health care system at risk. ”

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.

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.

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.