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Now, it is important to recognize that counseling Courts against considering caseload volume in this kind of decision making does not mean that there is no recourse when it comes to docket concerns. Our system provides several ways to relieve caseload pressure short of the courts not recognizing causes of action or deciding not to hear particular sets of cases. Specifically, our constitutional system gives Congress the authority to adjust laws so as to stem that flow.305 And Congress has indeed exercised that power. As noted earlier, Congress passed the Supreme Court Case Selections Act306 to alleviate the Court’s then “unmanageable workload” by eliminating most of the Court’s mandatory jurisdiction.307 With respect to the rest of the federal court docket, Congress has repeatedly enacted targeted legislation to reduce frivolous filings. For example, Congress passed the PLRA precisely as a way of “addressing a flood of prisoner litigation in the federal courts.”308 Similarly, part of the purpose of the Private Securities Litigation Reform Act of 1995309 was to limit frivolous securities claims.310 This is not to suggest that Congress could not do more in this vein; rather the point is simply that there is still a branch of government that has the clear authority to take the courts’ caseload into account in substantive decision making and has done so repeatedly in the past.

This does not leave the courts defenseless against the rising tide, however; they have many tools besides substantive law with which to keep themselves afloat. Perhaps most prominently, both the district courts and the courts of appeals can avail themselves of various procedural rules to help cope with, and indeed limit, their dockets. Most plainly, the Federal Rules of Civil Procedure employ what have been called three basic pretrial “discouragement mechanisms.”311 The first mechanism is the pleading stage itself, with the possibility for a motion to dismiss. Although pleadings obviously have several purposes, scholars have come to identify a significant one as “allowing a court to screen cases for merit.”312 At this juncture, courts can siphon off some of the frivolous cases that come before them. The second mechanism is summary judgment. The main goal of Rule 56 has been said to be “filtering out cases not worthy of trial,”313 and that rule is now regarded as a “powerful tool for judges to control dockets.”314 A third mechanism is the possibility of Rule 11 sanctions, which were developed to “punish lawyers for advancing meritless contentions that wasted the courts’ attention”315 and to deter such litigation from coming into court in the first place.316 In short, the district courts have at their disposal several critical procedural rules that have been fashioned, at least in part, so that district courts can more quickly dispose of frivolous filings and streamline the litigation process more generally.

Many of the mechanisms that exist at the district court level have analogues at the courts of appeals. Through the Federal Rules of Appellate Procedure, the circuit courts have several key ways to manage their dockets and reduce the time taken by frivolous filings. Rule 34 permits appeals courts to decide cases without oral argument317—a powerful time-saving mechanism.318 Additionally, courts of appeals can rely on staff attorneys to help draft summary dispositions.319 Finally, per Rule 38, if a court of appeals determines that a particular filing was frivolous, the court can award damages and costs to the appellee.320

A simple search engine query for “civil courts backlog” will yield hundreds and thousands of links that all say the same thing, that it’s not going away any time soon and things are unlikely to ever return to pre-Covid functionality.

Every US court jurisdiction, from the Federal Court right the way down to the District Courts is literally drowning in the backlog of cases that have piled up since the Pandemic struck. Not that it was a bastion of efficiency before the pandemic…

When the coronavirus struck American shores in early 2020, the red-brick courthouse that has stood sentry on Main Street in Newport, Vt., since the late 19th century abruptly shut down.

So did courthouses nationwide. But unlike most, the one in Newport — a small, lakeside community nestled a short drive from the Canadian border — has never fully reopened.

As judges around the country gingerly reopen their courtrooms and invite lawyers, litigants and jurors back for business—sometimes as usual, but often still far from the normal routines of years past—they’re being confronted by an array of pitfalls, real and potential.

Will a surge of COVID-19 cases among the unvaccinated and forceful advance of the delta variant force renewed shutdowns? Will jurors and staffers be willing to risk a return? Are mask mandates and vaccine passports in the offing?

The nation’s courts are facing overwhelming case backlogs because of the Covid-19 pandemic and it could take years for the legal system to dig out.

Tens of thousands of legal cases ranging from minor thefts to civil disputes to murder are stuck in limbo in state courts around the country, a situation that has left some defendants waiting in jail and strained prosecutors’ and defense attorneys’ ability to do their jobs.

The backlog of criminal cases in Washington County is so bad that it could take 15 years to resolve it, according to one lawyer’s calculations. Other counties, especially Penobscot, Piscataquis and Waldo, have also seen large increases in the backlog of criminal cases awaiting resolution in court in recent years.

There are a number of reasons for the growing backlog. Courts were closed for months and their operations were restricted because of the COVID pandemic. Maine has a chronic shortage of court-appointed defense attorneys for low-income defendants. There is a shortage of judicial marshals, who are needed to provide security in courtrooms.

The Shift: Judges Are Trying to Squeeze in More Trial Dates to Clear Court Backlogs

Trial dates have always been a bit fungible in some jurisdictions, but after the pandemic, certain judges are putting more pressure on litigators to be ready for trial at a moment’s notice.

Bioscience, which is broader than bioinformatics, however, faces various layers of uncertainties, such as the uncertainties in research, in finding an application of the research to human health, and in patent applications. Patents incentivize scientists and firms to engage in bioscience R&D despite these uncertainties.268 Even though innovation in bioscience may harm or benefit mankind, the Supreme Court has noted that it does not mean to deter or disincentivize innovation in bioscience, especially genetic research, by requiring a narrow scope of patentable subject matter in bioscience.269 The utility bar excludes some bioscience research from patentability if the application of the research is uncertain, regardless of the efforts made to obtain those research findings.270

When the utility requirement cannot be satisfied due to uncertainties in the research results, inventors may attempt to bring more specificity or clarity by engaging in further R&D. However, when the Alice decision induced more § 101 rejections, the previous utility rejections under § 101 were expanded to include rejections for ineligible subject matter, also under § 101, further compounding the uncertainty in prosecution outcomes and increasing the overall cost of patent prosecution. As David Taylor’s survey regarding investors shows, not receiving patent protection directly results in lesser investment in biotechnology by venture capitalists and private equity investors.271 There is a continuing concern that the Alice decision obfuscates the distinction between eligibility under § 101 and non-obviousness under § 103 by focusing on what is generally known in the art. This concern is also addressed in the text of the proposed eligibility legislation introduced in the House.272 Nevertheless, we find that the association between § 101 rejections and §§ 102, 103, or 112(b) rejections decreased after Alice among patent applications in narrowly defined bioinformatics (e.g., art units 1631 and 1639). By contrast, the association between § 101 rejections and § 112(a) rejections for patent applications in narrowly defined bioinformatics increased after Alice. That strengthened association may suggest that overcoming the problems of written description and enablement may help with overcoming § 101 eligibility rejections in bioinformatics.

This empirical study finds two indicators that suggest an increase in the difficulty of overcoming initial § 101 rejections in bioinformatics, both narrowly and broadly defined. First, applicants filed fewer patent applications in bioinformatics, narrowly and broadly defined, after the Alice decision. Second, an increasing number of these patent applications were finally rejected under § 101 after the Alice decision. Within those applications directed at the narrowly defined bioinformatics sector that were finally rejected under § 101, a larger proportion of the applications had also received initial § 101 rejections.

Patent applicants in bioinformatics, narrowly and broadly defined, became pessimistic about filing more patent applications after Alice. The average number of patent applications filed in bioinformatics, narrowly defined, decreased by 74.21% per month during the nineteen months after the Alice decision (June 2014 to December 2015) compared to the same length of time before the Alice decision (January 2013 to May 2014).266 The median number of patent application filings per month was 144 before the Alice decision. This number decreased to thirty-one after the Alice decision.267 The sharpest decrease occurred in June 2014, when the Alice decision was delivered by the Supreme Court. Applications filed in June 2014 were 48.56% lower than the average patent applications in bioinformatics, narrowly defined, filed in the nineteen months before the Alice decision and continued to decrease over time. In January 2015, the first month after the PTO implemented the Alice decision, this number further decreased by 63.07% as compared to before the Alice decision. The applicants in narrowly defined bioinformatics made cautious adjustments by modifying the disclosures and claims after the Alice decision, and applicants in broadly defined bioinformatics did the same. The patent applicants in broadly defined bioinformatics also filed fewer patent applications after Alice. The number of applications filed per month on average decreased by 51.06% after the Alice decision. The median for the number of patent applications was 638 before the Alice decision, and this number decreased to 307 after Alice.

BIO is concerned that more than nine years after the Supreme Court decided Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012), there continues to be unabated uncertainty about the patent-eligibility of many biotechnological inventions, with diagnostic and prognostic methods being particularly affected. The unstable state of patent-eligibility jurisprudence affects modern biotechnologies ranging from biomarker-assisted methods of drug treatment to companion diagnostic tests, fermentation products, industrial enzyme technology, and marker-assisted methods of plant breeding. As inventors, developers, and investors in such technologies, BIO’s members have a strong interest in clear and predictable rules of patent-eligibility.

In this submission, BIO focuses on the impact of patent-eligibility jurisprudence on the biotech industry including its ability to attract the capital investment necessary to develop products the help heal, feed, and fuel the world. Accordingly, BIO will limit its submission to the USPTO’s questions that are relevant to these issues.

Never, in the history of the American-patent system, has there been a time of less clarity regarding patentable subject matter.155 The lack of clarity and predictability is directly attributed to the judiciary. The Supreme Court reached far beyond the statutory language of Section 101, blurring the lines, and adding new ones. In its opinions, the Court has been incoherent and provided no guidance for untangling the lines of precedent justifying its decisions.156 These decisions have led to a rise in subjectivity.157 Some have said the only determining factor in subject matter eligibility rests on selection of the panel.158

In response to this lack of clarity, the Patent and Trademark Office (PTO) and courts rejected and invalidated countless patents covering innovation in various fields, namely, biotechnology, pharmaceuticals, and life sciences following Alice. 159 In an attempt to track the rate of these invalidations, a researcher conducted periodic reviews of the average invalidation rate among the three court levels at one-, two-, and five-years post-Alice. 160 The data showed that a year after Alice the average rate of invalidation was 82.9%. 161 The rate declined in both the two-year and five-year points, holding at 78.2% and 56.2%, respectively.162 Though declining, an invalidation rate of over 50% does not breathe confidence into investors or inventors.

Lastly, as an additional criticism of the Supreme Court’s two-part test, many members of the public raised questions regarding the relationship between the Supreme Court test and international norms.305 Some pointed to U.S. obligations under Article 27 of the TRIPS Agreement, which requires that patents be “available for any inventions, whether products or processes, in all fields of technology.”306

Several commenters were also concerned with having a patent eligibility standard in the United States they see as inconsistent with that of other countries. 307 They observed that the scope of eligible subject matter in the United States is narrower than that of foreign jurisdictions, such as Europe and China, which especially impacts software and biological innovations. 308 In fact, several commentators noted that many biopharmaceutical inventions that are patent eligible in other industrialized countries are not eligible for protection in the United States.309 According to a trade association, having inconsistent standards internationally could place the United States at an economic disadvantage if the patent system failed to adequately stimulate future research and development.310 One commentator warned that foreign companies may have an economic advantage in the global marketplace because they will enjoy a “free ride” in the United States.311

Finally, the fact that U.S. eligibility jurisprudence produces systematically different patentability outcomes as compared to other industrialized countries is likely to have implications for U.S. international competitiveness. As a simplified proposition, when U.S. companies seek to enter e.g. the Chinese or EU markets, they will have to contend with relevant patents that may exist in those jurisdictions. Conversely, when Chinese or European companies seek to enter the U.S. market they will encounter a form of free-for-all. In this way, by denying patents on valuable inventions that are patentable in other countries, U.S. eligibility jurisprudence invites imitators and copyists into the United States while coaxing U.S.-based innovators to focus more on jurisdictions where patents can be obtained and enforced.

In the body of our letter in response to this Notice, we reference prior responses of our Section as well as the Mossoff Statement with respect to this question. As noted by Professor Mossoff on pages 2-3 of his testimony and in the citations in footnote 9, other jurisdictions began taking advantage of the uncertainty and unpredictability in U.S. patent eligibility jurisprudence several years ago. As noted in footnote 9 of the Mossoff Statement, China, for example, relaxed rules on software patentability beginning in 2017, and in the biotech field of technology research and development dollars have been reported as shifting to China. Thus, the uncertainty and unpredictability in patent eligibility appears to be weakening U.S. leadership, and importantly signals to other countries that subject matter that was globally accepted as patent eligible subject matter now can be denied protection in the U.S. without violating Trade-Related Aspects of Intellectual Property Rights (TRIPS).18 If Pandora’s box on subject matter eligibility has been thrown open, the diminution of global rights in intellectual property may be inevitable.

As a specific example of a significant difference in the treatment of substantially identical patent claims in corresponding patent applications in the U.S. and Europe, the second real world example laid out in the body of our letter is directly on point. In contrast to the fate of Sequenom’s U.S. patent which was found to be subject matter ineligible, Sequenom’s counterpart European Patent EP 994 963 (whose claims 1 and 18 are substantially identical to claims 1 and 21 of U.S. Patent No. 6,258,540) twice survived third-party challenges and were upheld as patentable by the European Patent Office. The German Federal Supreme Court expressly ruled that it would not follow the U.S. approach to subject matter eligibility: “unlike the U.S. Supreme Court (in 566 U.S. (2012) – Mayo v Prometheus), … a teaching that involved performing a technical act which used a discovery to achieve a specific outcome was patentable, regardless of whether the teaching also contained ‘inventive added value’ above and beyond the use of the naturally occurring correlation discovered.”

Effect on firm outcomes across borders. Immigrants may play an even larger role for firm outcomes across borders. There is a well-documented strong positive relationship in the research literature going back several decades between immigrant diasporas and the trade, capital, and investment linkages with the countries of origin of these immigrant diasporas. For some recent examples (and of course, interested readers will want to check earlier studies cited in these works), Burchardi, Chaney, and Hassan (2019) find that the presence of historical diasporas in US counties leads to more foreign direct investment to and from those counties and the countries of origin of the diasporas, and Balachandran and Hernandez (2021) find that US venture capital firms become more likely to invest in India as their ties expand to Indian entrepreneurs in the United States. Hernandez (2014) further links the presence of immigrant diasporas to the success of foreign subsidiaries.

These immigrant diasporas increase cross-border investment success through three main channels. First, immigrants can reduce information frictions; in particular, because immigrants understand features of their home country such as market structure, consumer preferences, and business norms, they can identify business opportunities and alleviate many of the challenges inherent in cross-border trade and investment. Second, diasporas increase demand for “nostalgia” goods from the country of origin and in that way influence consumer preferences and tastes. Third, diasporas can provide social capital; for example, when courts do not work well, the social connections of immigrants and their knowledge of the local regime can decrease the costs of enforcing contracts.

Criticism of the Alice/Mayo two-step framework was especially strong among representatives of the life sciences community. Indeed, nearly all participants from the life science industry expressed concern with the recent holdings of the Supreme Court, which reportedly have seriously harmed thousands of companies through patent invalidations or the prospect thereof.317 Several commentators asserted that the new eligibility test is disproportionately impacting the biopharmaceutical sector, given the industry’s reliance on patent rights to cover the enormous investment costs associated with developing new medicines and bringing them to the market.318 According to a trade association, “developing a new medicine takes between 10 and 15 years of work and costs an average of $2.6 billion of investment in [research and development].”319 Thus, a national law association argued that without patent protection, “emerging businesses and universities would be at risk with respect to their ability to attract needed investment, and established businesses would risk losing an important mechanism for protecting their investment in new products.”320

Representatives from the life sciences industry noted that natural products and their derivatives form the basis for many biopharmaceutical innovations.321 Therefore, some members of the public argued that, contrary to the Court’s decision in Myriad, the act of isolating a natural product should be sufficient for patent subject matter eligibility, at least when isolation permits the product to be used or applied in a new or different way. 322 Regarding the scope of eligible subject matter after Myriad, one representative from the biotechnology industry offered the following anecdote from one of his member companies: “I couldn’t get a claim to a laundry detergent enzyme but I could get a claim to a method of washing laundry in a washing machine using a washing liqueur that contains the enzyme.” 323 He explained that, “at the end of the day, everyone understands that claim scope is vastly different under these circumstances and has very different commercial applications.”324 Citing a recent study by the National Institutes of Health, one commentator estimated that about 75 percent of antibacterial drugs and 80 percent of anti-cancer drugs approved by the FDA between 1981 and 2010 would be unpatentable under a strict application of the Myriad test.325

More generally, it is also important to bear in mind that the impact of the current state of patent eligibility is disparate not only by technology, but also by categories of patentees. Thus, while manufacturing businesses and academic institutions, for example, are all to some degree affected, it has been shown that the “bite” of Section 101 jurisprudence is felt most acutely by independent inventors and small inventor-started businesses.11 In an economy that values individual entrepreneurship and startup company formation, the long-term effects of this phenomenon, if allowed to continue, need to be better-understood.

The 2022 guidance doesn’t alter those limits on employment-based green cards but clarifies the visa process for foreign-born scientists pending any significant changes to the 1990 law. The O-1A work visa, which can be renewed indefinitely, was designed to accelerate the path to a green card for foreign-born high-tech entrepreneurs. For example, Sanjay, who had been working in the U.S. for a decade, was awarded an O-1A visa in the first week of 2022, shortly before the revised USCIS guidance was issued.

Although there is no cap on the number of O-1A visas awarded, foreign-born scientists have largely ignored this option because it wasn’t clear what metrics USCIS would use to assess their application. The 2022 guidance on O-1As removed that uncertainty by listing eight criteria—including awards, peer-reviewed publications, and reviewing the work of other scientists—and stipulating that applicants need to satisfy at least three of them.

What accounts for the gap between theory and practice in the process of international economic exchange? In large measure, cross-border exchange is stymied by both formal and informal barriers. Scholars have devoted considerable energy toward documenting that trade and investment are facilitated by the reduction in barriers (e.g., Pandya 2014b), the adoption of bilateral investment treaties and preferential trade agreements (Buthe & Milner 2008, Neumayer & Spess 2005), and membership in international organizations such as the WTO (Milner 1999). Less attention has been paid to the importance of informal barriers—the role of inadequate information about trade and investment opportunities and the problems associated with weak contract enforcement. Migration, we argue, mitigates these latter barriers.

The idea that migrants or coethnic networks play an important role in international economic exchange is not novel. Greif (1989, 1993) illustrates the role of the Maghrebi traders of the eleventh century in providing informal institutional guarantees that facilitated trade. Cohen (1997, p. 170) identifies not only the Phoenicians but also the “Spanish Jews [who] were indispensable for international commerce in the Middle Ages. The Armenians controlled the overland route between the Orient and Europe as late as the nineteenth century. Lebanese Christians developed trade between the various parts of the Ottoman Empire.” Rauch & Trindade (2002) provide robust empirical evidence linking the Chinese diaspora to patterns of imports and exports with their home country. In fact, numerous studies show a robust effect of migrant flows on trade flows (Dunlevy 2006, Dunlevy & Hutchinson 1999, Felbermayr & Toubal 2012, Gould 1994, Hatzigeorgiou 2010, Head & Ries 1998, Herander & Saavedra 2005).