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The United States Patent and Trademark Office (USPTO) experienced significant backup and processing delays during the COVID-19 pandemic. While delays have eased, they still haven’t gone away, due in part to the doubling of applications between 2020 and 2022. Overall, the trademark registration process has become notably more challenging in recent years, but there are ways to ease the burden.

The United States Patent and Trademark Office (USPTO) issued a memorandum to the patent examining corps to assist patent examiners in addressing means-plus-function and step-plus-function claim limitations, and to create a clearer record for the applicant, the public, and the courts. The issued memorandum will help ensure consistent analysis by USPTO employees in addressing means-plus-function and step-plus-function limitations and will result in clearer communications to applicants from the USPTO as to the interpretation of means-plus-function and step-plus-function limitations and any related deficiencies. Clearer USPTO communications provide both the applicant and the public with notice as to the claim interpretation used by the patent examiner during prosecution, and if the applicant intends a different claim interpretation, the issue can be clarified early in prosecution.

On April 18, 2023, the United States Patent and Trademark Office (“USPTO”) updated the patent grant system to an electronic patent grant (“eGrant”) system. Previously, the USPTO issued patent grants to patent applicants via mail. In the mail system, applicants would typically receive their grant about two to four weeks after paying the issue fee for the patent. Soon, applicants will only have about a week from payment of the issue fee to file a continuing application.

Under the eGrant system, patents now issue electronically through the USPTO’s electronic patent application filing and management system (“Patent Center”). The eGrant system was put into place to reduce paper waste, permit issued patents to be viewable and printable by applicants and the public immediately upon issuance, and expediate the grant process.

The United States Patent and Trademark Office (USPTO) recently proposed a significant change to the rules governing terminal disclaimers. The USPTO says that the rule change would “promote innovation and competition,” but is more likely designed to reduce the backlog of cases at the USPTO regardless of the cost to innovators, who will end up with weaker patents if they result from continuation applications with terminal disclaimers.

Competitors of patentees will sometimes utilize the teaching of a patent but, to avoid infringement, design around the claims of the patent. Patentees often file patent applications based on an original patent (called “continuation practice”) to cover products designed in this manner. Continuation applications are sometimes rejected on the basis of “double patenting,” particularly if the patent office sees the continuation application as merely an attempt to extend the term of the original patent. Terminal disclaimers, which limit the patent term to the expiration date of the original patent, are frequently employed in response to such double patenting rejections.

One of the many challenges government agencies and their employees face is finding the information they need, when they need it, and having confidence the information is correct, up to date and they haven’t missed essential data.

While advances in search technology have provided government employees with more powerful search tools, the dramatic growth of multi-modal data in all its forms has made search, and the ability to find the right information in petabytes of datasets more challenging than ever.

The United States Patent and Trademark Office’s (USPTO) efforts to modernize its practices and increase the efficiency of examination have started to take shape. As of May 24, 2022, the USPTO is now only issuing electronic trademark registration certificates. This change marks a move in the direction of full electronic processing and registration for trademarks in the United States.

The change to electronic trademark registration certificates is intended to give trademark owners easier and quicker access to their trademark certificates upon registration. According to the USPTO, the electronic trademark registration certificates will allow trademarks to be issued 1-2 weeks sooner than the current paper printed registration certificates. The new electronic certificates will be issued by the USPTO with a digital seal to authenticate the registration, and then emailed to trademark owners and attorneys through all emails of record associated with the trademark.

Orange County, California – Amidst the escalating backlog at the U.S. Patent and Trademark Office (USPTO), Orange County trademark lawyer, Michael N. Cohen of Cohen IP Law Group underscores the necessity of timely and error-free trademark filings. The current backlog at the USPTO has resulted in a trademark examination time of 8.5 months, extending the overall registration period to 14.6 months.

In light of this, Michael N. Cohen, an experienced trademark lawyer and founder of Cohen IP Law Group, is advocating for early submission of trademark applications and warns against Do-It-Yourself (DIY) filings. One minor mistake could potentially derail the application process, or worse, cause outright rejection resulting in further delays.

Why should we care about patent pendency?: Reducing patent pendency has been a major goal of the Kappos directorship. However, it is probably useful to pause for a moment to consider whether we should care about pendency and backlog. Certainly we want to know and understand the delay in order to advise our clients on how to order their affairs. But, should we care whether the delay is relatively longer or shorter? In my view, the major harm of long delay is not felt by patent applicants, but rather by parties releasing new products who cannot rely upon parties who cannot rely on

Most of the backlog delay occurs between the time that the patent application is filed and the mailing of the first action on the merits (FAOM). From a patentee’s perspective, that delay can actually be good. It allows the patent applicant to delay payment of certain fees (such as issue fees) and costs (such as attorney fees for prosecution) and provides the applicant with additional time to consider whether or not to pursue rights based upon the additional expected costs of patenting. When taking market developments into account, the delay also provides the applicant with time to adjust claim scope to better capture the market value of the invention. One potential problem with delays in prosecution is a reduction in patent term. However, the Patent Act generously compensates patentees for any term lost due to PTO delays (by adding additional time to the end of the term). Sometimes applicants have good reasons to want quick patent issuance. For those instances, the USPTO allows the applicant to pay a fee in order to skip the backlog queue. The so-called “track one” fee is a hefty $4.8k, but it is an option and my pre-AIA survey found that charge not unreasonable. At least in a somewhat simplified world, this $4.8k limits the per-application loss to applicants caused by the delay. I.e., if an applicant was going to be harmed by more than $4.8k due to the lengthy backlog, then the applicant can simply pay the fee to avoid that harm. This is a simplified world because, inter alia, applicants might not know from the outset that there is any benefit to a more rapid patent issuance.

Climate change intersects with pre-existing national security risks to function as a threat multiplier and accelerant to instability, contributing to escalating cycles of humanitarian and socio-political crises, conflict and forced migration.

Climate-change impacts on food and water systems, declining crop yields and rising food prices driven by drought, wildfire and harvest failures have already become catalysts for social breakdown and conflict across the Middle East, the Maghreb and the Sahel, contributing to the European migration crisis.

That may sound familiar to you, and that's because improving patent quality has always been at the core of the PTO's mission. But, for too long, due to uncertain budgetary conditions and limited resources, the PTO has had to make do with less. Despite our best intentions, we've had to accept trade-offs between quality and application backlog and pendency, forcing us to cut programs and shift resources to maximize output without sacrificing quality.

A world dominated by totalitarian states would be more incompetent, more war-prone, less cooperative, and more inhibitive of progress than one dominated by democratic states. Our current world is not particularly competent, peaceful, cooperative, or progressive—a totalitarian-dominated world would be worse. It would increase the risk of another collapse and extinction and could shape the future toward less desirable trajectories (Beckstead, 2013). Totalitarian states are incompetent. They are bad at forecasting and dealing with disasters (Caplan, 2008).16 This can be seen most clearly in the great famines of Communist China and the USSR, in which millions died (Applebaum, 2017; Becker, 1996; Dikotter, 2010; Snyder, 2010). In comparison, functioning multiparty democracies rarely, if ever, experience famines (Sen, 2010). “Established autocracies” (or “personal”/“sultanist”) are particularly bad, as there are few checks or restraints on arbitrary rule and the whims and ideology of the single individual, even from other elites (Svolik, 2012). From the inside, the “inner circle” around Mao, Stalin, and Hitler seems incredibly chaotic, with elites strongly incentivized to conceal information and encouraged by the autocrat to squabble and feud—so they are divided (Conquest, 1992; Kershaw, 2008; Zhang & Halliday, 2006). If totalitarian states are worse at addressing social, environmental, and technological problems, then a world dominated by them would likely be worse at responding to risks of collapse and extinction. A world dominated by totalitarian states is more likely to have major wars. States with near-universal adult suffrage rarely (if ever) go to war with one another (Barnhart et al., 2020), so a world dominated by democracies has fewer wars. Miscalculation might be a particular problem for totalitarian states due to personalization and disincentives for accurate information, leading to well-known strategic disasters such as Hitler and Stalin’s blunders in World War II (Bialer, 1970; Noakes & Pridham, 2001), or at a smaller level, Saddam Hussein’s rejection of diplomacy (Atkinson, 1993). War makes collapse and extinction more likely, by raising the chance of weapons of mass destruction being used. Linked to this, totalitarian states are less cooperative than democratic states. While cooperation is possible (Ginsburg, 2020), their internal norms are characterized by paranoia and treachery, and their lack of transparency limits their ability to credibly commit to agreements. This is bad for all risks that require cooperation such as pandemics or climate change (Tomasik, 2015). Finally, continued social and scientific progress is likely to reduce risks of collapse and extinction. Social progress could reduce global inequality and other risk factors. Scientific progress could help address natural risks and climate change (Sandberg, 2018), differentially increase defensive rather than offensive power (Garfinkel & Dafoe, 2019), and solve safety challenges in AI or biotechnology (Russell, 2019). However, as we will now discuss totalitarian states would likely inhibit social progress. A central question from a longtermist perspective is: Which values should shape the future? I would argue that we should prefer it to be shaped by liberal democratic values. This is not to say that the current democracy-dominated world is perfect—far from it. The fate of billions of factory-farmed animals or hundreds of millions of people in extreme poverty makes that abundantly clear. However, democracies have two advantages. First, democracies have space for cosmopolitan values such as human rights, plurality, freedom, and equality. These are better than those that characterize life under totalitarianism: Fear, terror, subjection, and secrecy. Second, they have within themselves the mechanism to allow progress. In the last 100 (or even 50) years, the lives of women, LGBT people, religious minorities, and non-white people have dramatically improved. Our “moral circle” has expanded, and could continue to expand (Singer, 1981). The arc of the moral universe is long, but given the right conditions, it might just bend toward justice (King, 1968). A global society dominated by these values, and with the possibility of improving more, has a better longterm potential. A totalitarian-dominated world, on the other hand, would reduce the space for resistance and progress—distorting the human trajectory. We should be particularly concerned about “bottlenecks” at which values are particularly important—where there is a risk of “locking-in” some particular set of (possibly far from optimal) values. While they are currently far-off, future technologies such as artificial general intelligence, space settlement, life extension (of autocrats), or much better surveillance could enable lock-in (Caplan, 2008).17 Conditional on them avoiding new catastrophes, world orders dominated by totalitarians could be quite long-lasting (Caplan, 2008). Democracies can undermine authoritarian and totalitarian regimes through the following ways: Control, including conquest; contagion through proximity; and consent, promoting receptivity toward democratization (Whitehead, 2001). Democracies can actively undermine these regimes through war, sanctions, hosting rebellious exiles, or sponsoring internal movements. Passively, through contagion, they offer a demonstration that a better, more prosperous life is possible. For example, in the final years of the USSR, ordinary Soviet citizens were able to see that the West had a higher standard of living—more innovation, more choice, and more consumer goods. The elites were able to read books from the outside, and travel—Gorbachev’s contacts and friendships with European politicians may have made him more favorable to social democracy (Brown, 1996). Democracies can undermine the will and capacity of the coercive apparatus (Bellin, 2004). However, in a world not dominated by democracies, all these pressures would be far less. A world in which, say, totalitarian regimes emerged as dominant after World War II (for example if the USA was defeated) could be self-reinforcing and long-lasting, like the self-reinforcing relationship of Oceania, Eurasia, and Eastasia (Orwell, 1949). Orwell’s fictional world is characterized by constant low-grade warfare to justify emergency powers and secure elites, and with shifting alliances of convenience as states bandwagon and balance, thereby preventing any resolution. A totalitarian-dominated world order could be rather robust, perhaps for decades or even centuries. A long-lasting totalitarian-dominated world would extend the period of time humanity would spend with a heightened risk of collapse or extinction, as well as increased potential for distortion of the human trajectory and the possibility that a “lock-in” event may occur. This example illustrates the possibility of a “negative recovery,” resulting in a trajectory with less or no scientific and social progress and a less favorable geopolitical situation, which would threaten the destruction of humanity’s longterm potential.

It is no longer hard to see that the rising power and the mounting pugnaciousness of the People’s Republic of China (PRC) have become a comprehensive challenge for the United States. China’s Machiavellian policies and actions at home and abroad have turned an otherwise naturally complementary Sino-American economic relationship into a near zero-sum, if not already a zero-sum, competition for market, jobs, technology, and financial primacy. Beijing now openly flexes its new muscles in its neighborhood and beyond to resist, reduce, and replace American leadership and presence everywhere possible, seeking to undermine the U.S.-led international economic order and American-anchored collective security arrangements. The PRC has been burning billions, for example, hoping to replace the U.S. dollar with the over-printed Chinese Renminbi (RMB). Extraordinarily heavy extraction of its own economy, the world’s second largest, and its enormous foreign currency reserve resulting from the gross imbalance in U.S.-China trade have enabled the PRC to massively expand its military. That military is already the world’s second largest; its navy, for example, is projected to soon surpass the U.S. Navy in fleet tonnage. At the same time, massive but opaque spending sprees has allowed the PRC to actively procure power and proxies even inside the United States, positioning Beijing to reshape international opinions and norms more easily than ever.

What is less known, perhaps, is that the rising PRC state also seeks an overhaul of the very world order that has enabled the greatest advances of human civilization over the past few centuries – the Westphalian system of nation-states. This world order was codified in the 17th century, expanded to a global scale in the 20th century, and now is in its post-World War II and post-Cold War iteration — the so-called America-led Liberal International Order (LIO). The rise of Chinese power, under the autocracy of the Chinese Communist Party (CCP), is not just contesting U.S. national security and American global leadership but also the existing world order. Never since the heyday of the Cold War has the world seen such a full challenge to the United States and to the Westphalian system.

Now more than ever, the international community needs what emerging biotechnologies promise to do—for health, climate, energy security, agriculture, supply chain resilience, and more. And to meet the moment, the United States must reassert its biotech leadership, not only for its own economic and national security, but to ensure that democratic principles underpin the global biorevolution.

Biotech Matters

The Bayh-Dole Act and U.S. International Life-Sciences Competitiveness

As this report noted in addressing the history and impact of the Bayh-Dole Act, it’s important to reemphasize that the Bayh-Dole Act was introduced, in part, as a response to deteriorating U.S. economic competitiveness in the late 1970s and early 1980s in the face of heightened foreign competition. And while this report has placed the Bayh-Dole Act as one of a suite of policies that have turned the United States into the world’s leader in life-sciences innovation, it’s important to recognize that foreign competition remains intense and that U.S. leadership is not assured, especially if it were to start implementing policies that could undermine America’s leadership position (such as applying Bayh-Dole march-in rights for the purposes of controlling drug prices).

The United States leads the world in novel biomedical innovation, thanks in large part to its strong research universities, talented researchers, efficient drug approval processes, and a pricing system that enables companies to earn sufficient revenues to reinvest in future generations of innovation. Yet two other factors are indispensable: First, world-leading public and private investment in life-sciences research and development (R&D) activity, with these public and private investments playing unique yet complementary roles in America’s life-sciences innovation system. Second, effective technology transfer and commercialization policies that enable federally funded basic life-sciences research, often taking place at U.S. universities, to lead to research discoveries and inventions that can be patented and licensed to private-sector entities, which then undertake the risky, complex, and expensive process of bringing innovative new medicines and therapies to market. Underpinning this successful ecosystem is bipartisan legislation that gives universities rights to intellectual property (IP) generated from federal funding: the Bayh-Dole Act. Since its introduction in 1980, the act has played a catalytic role in stimulating innovation across many sectors, and especially in the life-sciences. However, calls made by some to use Bayh-Dole “march-in right” provisions to control drug prices threaten to undermine this successful ecosystem and reduce the pace of American biopharmaceutical innovation.

America’s wresting of global life-sciences leadership has been no accident, but rather the result of a series of intentional policy decisions designed to make America the world’s preeminent location for life-sciences research, innovation, and product commercialization. For instance, the United States’ introduction of the world’s first R&D tax credit in 1981 played a catalytic role in spurring greater levels of private-sector R&D. In the life-sciences sector, this was complemented by the 1986 introduction of the orphan drug tax credit, which allows drug manufacturers to claim a tax credit on research costs for orphan drugs (i.e., drugs for rare diseases affecting 200,000 or fewer U.S. patients). The 1992 introduction of the bipartisan Prescription Drug User Fee Act (PDUFA), which authorized the FDA to collect user fees associated with applications from the biopharmaceutical industry for regulatory approval of new human-drug submissions, has played a pivotal role in reducing the time it takes the FDA to make safety and efficacy determinations for new drugs—from the over 30 months it took on average in the mid-1980s to less than 10 months today.11 The United States has also benefitted greatly from having a drug-pricing system that permits companies to earn sufficient revenues from one generation of biomedical innovation to reinvest in the next.12 That matters greatly because, as the Organization for Economic Cooperation and Development (OECD) has clearly stated, “There exists a high degree of correlation between pharmaceutical sales revenues and R&D expenditures.”13

Increases in federal funding for health research also played a key role. National Institutes of Health (NIH) funding increased from around 0.12 percent of GDP in 1979 to around 0.21 percent in 2009—much of which went to research universities. The combination of increased funding for health research coupled with better policies to help transfer those discoveries to the marketplace played an important role in spurring the growth of the United States’ U.S. biopharmaceutical competitive advantage. In particular, the Bayh-Dole Act, which affords universities rights to the intellectual property generated from federal funding, has played a key enabling role. The act, passed in 1980, permitted contractors, such as universities, small businesses, and nonprofit research institutions, to secure intellectual property rights, often in the form of patents for molecular compounds or biotechnological processes, which in turn may be licensed to private-sector entities, including start-ups and existing biopharmaceutical companies, which then invest the hundreds of millions—often billions—of dollars required to bring safe and effective drugs to market.

The United States leads the world in life-sciences innovation. In the 2000s, more new chemical entities were developed in the United States than in the next five nations—Switzerland, Japan, the United Kingdom, Germany, and France—combined.1 Broadening the lens to the years 1997 to 2016, U.S.-headquartered enterprises accounted for 42 percent of new chemical and biological entities introduced across the world, far outpacing contributions from European Union member countries, Japan, China, and other nations.2

Again, the impact was immediate. The Bayh-Dole Act has been widely praised as a significant factor contributing to the United States’ “competitive revival” in the 1990s.184 In 2002, The Economist called Bayh-Dole:

Possibly the most inspired piece of legislation to be enacted in America over the past half-century. Together with amendments in 1984 and augmentation in 1986, this unlocked all the inventions and discoveries that had been made in laboratories throughout the United States with the help of taxpayers’ money. More than anything, this single policy measure helped to reverse America's precipitous slide into industrial irrelevance.185

Weakening the certainty of access to IP rights provided under Bayh-Dole by employing march-in to address drug pricing issues—especially if it meant a government entity could walk in and retroactively commandeer innovations private-sector enterprises invested hundreds of millions, if not billions, to create—would significantly diminish private businesses’ incentives to commercialize products supported by federally funded research.245 As David Bloch notes, “The reluctance of such [biopharmaceutical] companies to do business with the government is almost invariably tied up in concerns over the government’s right to appropriate private sector intellectual property.”246 As he continues, “Each march-in petition potentially puts at risk the staggeringly massive investment that branded pharmaceutical companies make in developing new drug therapies.”247 Put simply, using march-in rights to control drug prices could seriously compromise medical discovery and innovation.

Obtaining the full benefits from federally funded research relies on the effective transfer of knowledge from universities (and national and other federally funded laboratories) to the private sector so that it can be developed into marketable innovations.167 Here, the 1980 Bayh-Dole Act, which gave universities rights to the intellectual property generated from federal funding, spurred vastly more universities to work more closely with industry, and so created a powerful vehicle for leveraging U.S. investment in basic research into a far stronger engine for commercialization and job creation.168

The Bayh-Dole Act spurred many more universities to work more closely with industry, and so created a powerful vehicle for leveraging U.S. investment in basic research into a far stronger engine for commercialization.