1、 INFORMATION TECHNOLOGY 2) spurring domestic innovation; 3) spurring increased domestic production; and 4) combatting foreign mercantilism. INFORMATION TECHNOLOGY however, they dipped from a high of 5,694 in 2005 to 4,688 in 2015, the latest year for which this data is available. (See figure 19.) Fi

2、gure 19: Number of triadic biotechnology and pharmaceuticals patent applications by priority date86 0 10,000 20,000 30,000 40,000 50,000 60,000 70,000 United StatesChinaIndiaGermanyUnited Kingdom 0 1,000 2,000 3,000 4,000 5,000 6,000 United StatesEuropean Union (28 countries)JapanRest of World INFOR

3、MATION TECHNOLOGY between 1975 and 1979, Europe led the United States, with 149 drugs to 66.88 When considering new drugs as a share of GDP, the United States also leads, but not by as much, followed by Japan and Europe (See table 6.) 0 50 100 150 200 250 300 350 400 450 United StatesEuropean Union

4、(28 countries)Japan INFORMATION TECHNOLOGY effective technology transfer and commercialization mechanisms; robust IP protections; a pricing system that allows innovators to earn sufficient revenues to reinvest in innovation; tax incentives to encourage investment; and an effective drug approval syst

5、em. A signature strength of Americas biopharmaceutical innovation system has been complementarity between public and private-sector investment in life-sciences R $23.6 billion contributed by “other” sources, including universities themselves and other nonprofit research institutions; and $4.8 billio

6、n contributed by industry.117 Bayh-Dole enables universities to retain the IP rights stemming from federally funded, university-conducted basic life-sciences research, which universities then often license to businesses (with 67 percent of these university licenses going to start-ups and small busin

7、esses) or research institutes, so that this novel IP can be commercialized into innovative drugs or therapeutics. Its largely through this process that the public-private partnerships the Bayh-Dole Act catalyzed have led to the development of over 300 novel drugs and vaccines.118 These medicines tre

8、at conditions ranging from Crohns disease to hepatitis B, HIV/AIDS, and HPV, melanoma, CML, and inherited blindness.119 The Bayh-Dole Act has also proven pivotal in facilitating the development of tests, treatments, and vaccines combatting the coronavirus. For instance, Moderna, the company that has

9、 come the furthest in developing a coronavirus vaccinewith Phase II clinical trials already underway in Seattlecredits the pivotal role of patents in the fields of messenger RNA and associated mRNA delivery technologies, which it licensed from Harvard and the University of Pennsylvania.120 Similarly

10、, Ridgeback Biotherapeutics, which is developing the only oral direct-acting antiviral vaccine treatment for the coronavirus, licensed key COVID-19 technology from Emory University. Gilead Sciences partnered with various universities, led by the University of Alabama, on its remdesivir research dati

11、ng back to 2014.121 Another company, Cepheid, which has developed a point-of-care COVID-19 diagnostic, leveraged Bayh-Dole to license technology developed at the INFORMATION TECHNOLOGY then proceed to three stages of human clinical trials, which culminate in a drugs approval (or rejection) by the FD

12、A; and finally culminate in pharmacovigilance (that is, post-approval safety monitoring). (See figure 24.) Biopharmaceutical companies conduct laboratory screening of 5,000 to 10,000 chemical compounds for each new drug approved for use in humans. On average, as many as 5,000 to 10,000 compounds may

13、 be screened to get to approximately 250 promising molecular compounds that can enter preclinical testing, with 5 entering actual clinical testing.123 And thats just getting to the clinical trial stage, as less than 12 percent of candidate medicines that even make it into Phase I clinical trials are

14、 ultimately approved by the FDA.124 Figure 24: The R and those in the first decile had discounted profits that were more than twice their discounted R in 2013, it introduced Sovaldi, the hepatitis C cure; and in 2020, it introduced remdesivir, the first FDA-sanctioned coronavirus therapeutic, derive

15、d from 2018 research it undertook in efforts to develop a treatment for the Ebola virus. Against this backdrop, Gileads gambit to tackle pancreatic cancer in 2014 (a gruesome disease for which there remains no treatment whatsoever) faltered when simtuzumab failed Phase I clinical trials; in 2016, Gi

16、leads momelotinib, a treatment for the bone-marrow disorder myelofibrosis, delivered disappointing Phase II clinical trials and was scrapped; and, in 2019, Gilead suffered a high-profile Phase III clinical trial failure when it pulled the plug on selonsertib as a possible treatment for liver disease

17、. Critics skewered Gilead for charging what was thought to be too much for Sovaldi at the time, and they now want Gilead to price remdesivir at $1 a dose (roughly its marginal cost). But the reality is Gilead represents a perfect case study of a life-sciences innovator leveraging the profits from on

18、e generation of innovations to reinvest in the next, perpetuating a virtuous cycle; so an HIV prevention drug and a hepatitis C treatment contribute (in knowledge and capital) to a coronavirus treatment, whose success hopefully begets resources that Gilead can redeploy when it tries again to tackle

19、pancreatic cancer, or other similarly pernicious diseases.132 This pattern illustrates why there are extremely close linkages between the profits life-sciences companies earn and their ability to invest in future R clear standards for meeting standard patent-eligibility tests of non-obviousness, uti

20、lity, and capacity for industrial application; the ability to patent both pharmaceutical manufacturing product and process innovations; patent-linkage provisions (which clarify linkages between the patent status of an innovative drug and the granting of marketing approval for a generic medicine refe

21、rencing the originator product); patent-term extension provisions (to restore the portion of a patent term that may be lost while the patent holder awaits regulatory approval, or for delays in the granting process); trademark and trade-secret protections; and exclusive rights to the underlying clini

22、cal trial data that validates the safety and efficacy of novel drugs that continue past patent expiry. The United States also benefits from an effective USPTO to review patent applications and issue patents, as well as a judicial system capable of effectively adjudicating IP disputes. Ultimately, IP

23、 does not represent an impediment to access to medicines; rather, in the vast majority of cases, its the reason for the very existence of those medicines in the first place. Another strength of the U.S. IP system has been its data-exclusivity period for novel biologic drugs. Biologics refer to any p

24、harmaceutical drug product manufactured in, extracted from, or semi-synthesized from biological sources. For the first time in 2020, biologics now account for over 40 percent of the drugs in the global development pipeline.151 Unlike traditional pharmaceutical drugs, which involve smaller molecules

25、that operate largely on the basis of chemical reactions and that work by treating the consequences of a disease, biologics work by blocking diseases earlier in their development, in the immune system. And since they can be tailored to individuals taking the medicine, biologics constitute an importan

26、t step toward realizing the vision of personalized medicine.152 But as biologics are large, complex molecules that must be manufactured within living tissues, the resulting protein is unique to the cell lines and the specific process used to produce it, and even slight differences in the manufacturi

27、ng of a biologic can alter its nature.153 Accordingly, the IP components of a biologic include both the structure of the molecule itself and the process for how to reliably, safely, and consistently manufacture the molecule at scale in living tissues. While patents constitute one important form of I

28、P protection for biologics, they are not sufficient to support the environment needed to promote large-scale investment in biologic R the production process is relatively mature and product innovation (the development of new drugs) is not dependent on close linkages to the production process. This i

29、s why a significant share of API production has moved offshore. In contrast, theyve argued that biotechnology production (the production of large-molecule, living compounds) is not a mature production process and there are closer links between drug development and drug production. This is why a much

30、 larger share of biotechnology production is still in the United States. There are at least five main policy implications from this. The first is that to the extent that policy can spur more drug innovation, especially in large-molecule, biotech drugs, the more likely it is that production will loca

31、te in the United States. The converse is also true: The more there is a push to replace novel drugs with generics, the more likely that supply will be filled through offshore production. As Shih and Pisano wrote, in sectors developing breakthrough products at the INFORMATION TECHNOLOGY short-term fi

32、nancial gain building a long-term common good.”198 INFORMATION TECHNOLOGY however, the office does require an appropriation from Congress to spend the money it collects.208 Ensuring continued smooth operation of USPTO is critical to the functioning of the U.S. patent system. As it has acknowledged,

33、the U.S. Treasury currently holds some fees collected but that have not been apportioned to USPTO. (That does represent progress, as previously appropriators in Congress had not acknowledged the funds were “real.”) The U.S. Treasury should apportion these funds to USPTO with alacrity. This is especi

34、ally important because the funds represent money collected by users of USPTO and, moreover, when the practice of fee diversion ended, these funds should have been already appropriated. Doing this presently would be very beneficial to USPTO, which has experienced a significant decline in revenue and

35、fees collected due to the coronavirus crisis. Expand and Adopt New Policies to Spur Greater Levels of Domestic Innovation While America should maintain the policies that have worked, absent new and expanded initiatives, the risk of the United States losing its lead will grow. As such, there are seve

36、ral steps Congress should take. Boost NIH Funding As noted, public and private investment in life-sciences research is strongly complementary. The federal government is underinvesting in life-sciences R today, only about one-fifth of enterprise R clear rules for private-foundation program-related me

37、gafund investments; federal credit support; and tax incentives for funds investing in drugs (e.g., through the establishment of schedules and values of basis-point step-ups and penalties). To promote the creation of R better success at weeding out those types of drugs earlier in the R effective poli

38、cies can help ensure that Americas biopharmaceutical innovation and production engine continues to flourish into the future. INFORMATION TECHNOLOGY according to international drug standards, develop and promote 1020 chemical and high-end drugs, 35 new traditional Chinese medicines, 35 new biotech dr

39、ugs; complete drug registration in Europe, the United States, and other developed nations; speed up the development of internationalization of domestically produced drugs; before 2020, when international patents for blockbuster drugs expire, achieve over 90 percent generics production; achieve break

40、throughs for 1015 important core and critical technologies; and begin to establish national drug innovation system and innovation team. INFORMATION TECHNOLOGY develop chemical drugs, traditional Chinese medicine, biotech drugs focused on 10 major diseases, achieve industrialization of 2030 innovativ

41、e new drugs; 510 drugs with indigenous property rights receive U.S. Food and Drug Administration or EU authentication, and enter the international market; construct, improve, and support the national drug innovation system for external services, form of high-level innovation team with an internation

42、al perspective, promote Chinas drug internationalization development strategy.264 China appears to be “skating to where the puck will be” in the sense that the government is focusing more on biotechnology and biology, rather than on more traditional pharmaceuticals and chemistry. In addition to the

43、national Made in China 2025 plan, at least 19 of Chinas 23 provinces have their own plan. As Chinas State Council wrote in 2016: All regions and relevant departments must fully understand the importance of promoting the healthy development of the pharmaceutical industry, strengthen organizational le

44、adership, improve the working mechanism, and form a joint effort. All regions should formulate specific implementation plans based on actual conditions, carefully organize and implement them to ensure that all tasks are implemented. All relevant departments should promptly formulate supporting polic

45、ies in accordance with the division of responsibilities and create a good environment.265 China also appears to be “skating to where the puck will be” in the sense that the government is focusing more on biotechnology and biology, rather than on more traditional pharmaceuticals and chemistry. Its 13

46、th Five-Year Plan focuses on “genomics and other biotechnologies, networked application demonstration, and the scaling up of a new generation of biotechnology products and services, including personalized treatment and innovative pharmaceuticals.”266 Some genomics- based drugs may need to be tailore

47、d by ethnicity, which would give the Chinese an advantage in developing drugs for Chinese use. China is focusing more on complex biotechnology drugs in part because that is where much of the industry is going globally. As one article noted, “Chinas leading biotech companies are already aware of the

48、need to step up their game. The novel chemical drug space may be close to saturation, but theres still a lot to explore in the biopharmaceutical field, and that is where China has the potential to catch up with the world leaders.”267 In summary, Chinas biopharma strategy appears to be focused on gro

49、wing and improving its generics industry, in part by having a relatively weak IP system, and then on the basis of that growth, encouraging the generics industry to innovate more, coupled with state support of biotech start-ups.268 China also expects to have robust access to international markets to sell its biotechnology exports, with 86 percent of Chinese biopharma manufacturers expecting to produce for export to the United States and the European Union in the future, compared with 25 percent that do so today.269 INFORMATION TECHNOLOGY China origina