Is space pharma the next big thing? In 2017, Merck demonstrated the value of conducting pharmaceutical R&D in space by growing crystals for its blockbuster Keytruda antibody drug on the International Space Station (ISS).
The “space crystals” grown in such microgravity conditions turned out to be far superior to their Earth-grown counterparts1. In fact, Merck found that microgravity so suppressed the negative effects of sedimentation and convection that the space-grown Keytruda crystals were predominantly single-sized and exhibited lower viscosity (in crystalline suspension),2 such that Keytruda could theoretically be formulated as an injection rather than intravenous infusion3. Such a breakthrough might not only permit patients to skip the IV center4 and conveniently administer from home, but might also benefit Merck’s bottom line.
While intravenous formulations of Keytruda are reportedly set to go off-patent in 20285, injectable formulations of Keytruda could remain patented until 2036 and beyond6. Even taking into consideration the upfront-costs associated with launching experiments into orbit (which costs are still high, but going down all the time), the Keytruda success story suggests that space R&D could be more than worth the investment. Those astronomical projections, however, all take as their foundation the fundamental assumption that Merck (and others who would invest in space technology) will be able to own and commercialize their technology, regardless of whether such technology is developed and applied on Earth or in space. So, is intellectual property developed in space patentable?
In each of the 157 nations where patent protection is recognized7, an inventor may apply for (and be granted) a patent covering the use of a novel and inventive idea8, giving the inventor a temporary quasi-monopoly over the idea and the legal right to exclude others from using the invention in those nations where the patent issues.9 The modern patent regime stems from principles concerning possession and ownership articulated10 in a 19th century case about an English fox hunt,11 which established the significance of recovery and capture in the determination of legal ownership on Earth. But what about above the atmosphere? Can one who discovers and captures (i.e., by reducing to practice) elusive technologies up in space legally own and exclusively commercialize such technologies?
The Outer Space Treaty of 1967 states that: (i) the “exploration and use of outer space … shall be carried out for the benefit and in the interests of all countries … and shall be the province of all mankind”; (ii) “there shall be freedom of scientific investigation in outer space”; (iii) “outer space … is not subject to national appropriation by claim of sovereignty, by means of use or occupation, or by any other means”; and (iv) “States Parties to the Treaty conducting activities in outer space . . . agree to inform the Secretary-General of the United Nations as well as the public and the international scientific community, to the greatest extent feasible and practicable, of the nature, conduct, locations and results of such activities.”12
On the surface, then, it would seem that the exclusionary nature of patents might be at odds with the Outer Space Treaty, since a patent, by definition, allows the patentee exclusive benefits, in this case benefits derived from the supposedly non-exclusive, communal properties of space (microgravity, cosmic radiation, etc.). The exclusive legal protections conferred by patents are, arguably, neither for the benefit and in the interests of all countries, nor the province of all mankind, and the traditional legal regime would seem to curtail the freedom of scientific investigation in the interest of protecting a patentee’s exclusive patent rights (including the patent rights of the federal government). Fortunately, Article VIII of the Outer Space Treaty provides that a state retains jurisdiction and control over any objects launched into outer space under that state’s registry. As further developed by the 1976 Convention on Registration of Objects Launched into Outer Space, such “registry” is simply a state-maintained document for each “launching state.”13
A launching state is: (i) one that launches or procures the launching of a space object; or (ii) one from whose territory or facility a space object is launched.14 Thus, if a space object over which the U.S. originally has jurisdiction and control is launched into outer space on the U.S.’ registry, that space object would continue to fall under the jurisdiction and control of the U.S., and U.S. law (including patent law) would apply.
The U.S. Patents in Space Act provides that “Any invention made, used or sold in outer space on a space object or component thereof under the jurisdiction or control of the United States shall be considered to be made, used or sold within the United States for the purposes of this title, except with respect to any space object or component thereof that is specifically identified and otherwise provided for by an international agreement to which the United States is a party, or with respect to any space object or component thereof that is carried on the registry of a foreign state in accordance with the Convention on Registration of Objects Launched into Outer Space.”15
The ISS is a unique conglomeration of modules under the registries of the various ISS partners (Canada, the member states of the European Space Agency,16 Japan, Russia, and the US),17 including several laboratory modules. Article 21.2 of the 1998 ISS Intergovernmental Agreement (IGA) provides: “for purposes of intellectual property law, an activity occurring in or on a Space Station flight element shall be deemed to have occurred only in the territory of the Partner State of that element’s registry.”
Thus, inventions made in the Destiny Laboratory Module (U.S.) would be subject to U.S. patent law; the Kibo Laboratory Module to Japanese law; and the Nauka Module to Russian law18. Because the ESA comprises a plurality of member states, inventions made in the ESA’s Columbus Laboratory Module are treated differently—any ESA member state may deem any activity (i.e., invention or infringement) occurring in an ESA-registered module as occurring within such member state’s territory19 (so inventions made, or infringing activity occurring in the Columbus module could be deemed to have occurred concurrently in France, Italy, and Germany, if each nation so chooses).
While the authors are unaware of any U.S. cases alleging patent infringement in or on the ISS, NASA was once sued (unsuccessfully) for infringing two U.S. patent20 in the manufacture and use of robotic hands incorporated into NASA’s Robonaut prototype,21 a production version of which was later brought aboard the ISS to conduct research in robotics technology.22
The UN/ISS constructive allocation of territory to space-made inventions has many practical consequences, including, for example, implications for foreign filing licenses. What is considered “foreign” turns on the underlying legal principles of jus soli23 or jus in personam.24 Under the jus soli regime (implemented by states such as the US,25 Russia,26 and China27), applications on inventions made or conceived in the jus soli state must be filed first in the jus soli state before they can be filed anywhere else, regardless of the citizenship or residency of the inventors.
Under the jus in personam regime (implemented by states such as India,28 France29, and the UK30), applications or inventions made by a resident or citizen of such in personam state must first be filed in the in personam state before such applications or inventions can be filed anywhere else, regardless of where such inventions were made (even if in the farthest reaches of outer space). These disparate foreign filing requirements can conflict under the ISS regime, where if, e.g., a French resident invents in the Destiny Laboratory Module (U.S.) a useful way to harness cosmic radiation to retard the otherwise accelerated proliferation of cancer cells in space,31 such French inventor technically must file first in both the U.S. and in France to comply with each country’s foreign filing requirements.
Perhaps in recognition of the impossibility of filing first in multiple states, the ISS IGA requires partner states not to apply their laws concerning “secrecy of inventions” (i.e., foreign filing laws) that would “prevent the filing of a patent application (for example, by imposing a delay or requiring prior authorization)” of inventions made aboard the ISS by a person who is not a national or resident of that partner state.32
NASA and most of its foreign partners expect the ISS to be deorbited by 2030,33 with private space stations primed to take the place of the ISS as the default destination for space R&D.34 It will be virtually impossible for private space station operators to negotiate the same type of generally applicable, multi-state waivers that made the ISS arrangement work, including but not limited to the waiver of foreign filing requirements.
Yet the repercussions of failing to obtain a foreign filing license could be commercially dire. To mitigate such negative legal consequences, it will be necessary to navigate the foreign filing requirements on a state-by-state and case-by-case basis. For example, in the U.S., foreign filing is prohibited “[e]xcept when authorized by a license obtained from the Commissioner of Patents.”35 Thus, to the extent that a foreign resident is able to obtain such a license from the USPTO, such foreign resident would be able to comply with the foreign filing requirements of both her home state (requiring such resident to file first in her home state) and those of the U.S. (requiring inventions made in the country to be first filed in the U.S.).
Not all foreign filing regimes, however, are as permissive. For example, French law appears to absolutely prohibit any foreign filing by a French resident, sans exception.36 If the USPTO makes it difficult for foreign residents to obtain a foreign filing license, and if foreign governments are inflexible in permitting their residents to file first outside of their home states, then private space station
Even apart from threshold issues of jurisdiction and territoriality, there are serious questions concerning enforcement. Under the ISS regime, even if a patentee successfully obtains a U.S. patent on an invention (which would only be enforceable against any persons practicing the patented invention both in earth-bound U.S. jurisdictions and applicable U.S. ISS modules), such invention would not be protected in other jurisdictions and modules (such as the Nauka Module (Russia) or the Kibo Laboratory Module (Japan)) except to the extent patents on such invention are also issued in such states.37
Enforcement on the ESA modules of the ISS is even trickier. Before any infringement claim can be assessed in an ESA partner state, such ESA partner state must first “deem the activity to have occurred within its territory.”38 The ISS IGA does not contemplate, and it is not clear whether such infringement claim could be maintained, if such ESA member state simply refused to make such determination (which refusal it could plausibly justify on the basis of judicial avoidance, especially if the alleged infringer is a private person).
Beyond the ISS, if infringement were to take place on a private space station launched on the registry of a state which has ratified or acceded to the Outer Space Treaty, such infringement would likely be treated as having occurred in the state on whose registry such station was launched.39 So a patentee bringing an infringement claim would need to own or control patents issued in such state to bring suit. For example, enforcing patents on Starlab (which will most likely be launched on the U.S.’ registry) and the Tiangong space station (which was launched on China’s registry)40 would be no different than enforcing patents on U.S. and Chinese soil, respectively.
Armed with this knowledge, it may make commercial sense for a private space station operators seeking to attract customers with large patent portfolios to launch such space stations on the registries of the major spacefaring nations offering the most sophisticated and robust intellectual property enforcement regimes. Regimes under which significant compensatory damages, punitive damages, and injunctions are routinely awarded.
Robust regulation is, however, a two-edged sword, and there may be some parties interested in operating in environments still ascendant in both gravity and regulation, which could in turn spur space-investment in nations where serious space programs,41 such as robust intellectual protections, have traditionally not been a focus.
Perhaps future commercial space treaties should be flexibly drafted with careful exceptions permitting private parties to contract around issues such as patent extraterritoriality, jurisdiction, liability waivers, allocation of risk, and order of precedence (in cases where international and national laws conflict). Such treaties could also elevate the normative hierarchy of such private contracts to at least the same level as existing U.N. space treaties, giving private space contracts the same normative effect as international law (albeit solely as between the contracting parties).
The certainty and flexibility engendered by such innovative treaties may incentivize greater private participation in the Low Earth Orbit (LEO) economy.42 With more than 500 ISS experiments on protein crystal growth and counting,43 it is clear that the appetite for bold space pharmaceutical developments will outlast ISS, as will the appetite for robust yet creative patent protections.
Curt Blake
Curt Blake, Senior Columnist to SatNews Publishers, is Senior Of Counsel for Wilson Sonsini Goodrich & Rosati. He is an attorney and senior executive with more than 25 years of experience leading organizations in high-growth industries — and more than 10 years as the CEO of Spaceflight, Inc.— at the forefront of the New Space revolution. Curt has extensive expertise in strategic planning, financial analysis, legal strategy, M&A, and space commercialization, with deep knowledge about the unique challenges of New Space growth and the roadmap to success in the that ecosystem.
The views expressed in this article reflect those of the authors themselves and do not necessarilyreflect the views of his employer or the firm’s clients.
References
1 https://www.issnationallab.org/reshaping-drug-delivery-millions-of-crystals-at-a-time/
2 https://www.issnationallab.org/merck-lab-publishes-pembrolizumab-results/
3 Id
4 https://www.keytruda.com/taking-keytruda/
5Merck & Co., Inc., Annual Report (Form 10-K) (Feb. 28, 2017)
6 https://www.warren.senate.gov/download/02/21/2023/20230222-letter-to-uspto-re-keytruda-patent
7 https://www.wipo.int/pct/en/pct_contracting_states.html
8 Patent Cooperation Treaty, art. 3
9 See, e.g., 35 U.S.C. § 154(a)(1)
10 Requiritur autem corporalis quædam possessio ad dominium adipiscendum; atque ideo, vulnerasse non sufficit
11 See Pierson v. Post, 3 Cai. 175, 179 (N.Y. Sup. Ct. 1805)
12 Outer Space Treaty, arts. I, II, and XI
13 See 35 U.S.C. § 101 (providing that “whoever invents … may obtain a patent therefor”); see also 35 U.S.C. § 202(c)(2) (providing that with respect to federally funded inventions, the “Federal Government may receive title to any subject invention in which the contractor does not elect to retain rights or fails to elect rights within such times”)
14 1976 Convention on Registration of Objects Launched into Outer Space, art. I
15 35 U.S.C. § 105
16 Belgium, Denmark, France, Germany, Italy, the Netherlands, Norway, Spain, Sweden, Switzerland, and the United Kingdom. See ISS IGA, at 1
17 See ISS IGA, at art. 5 and Annex
18 Outer Space Treaty, art. VIII, and ISS IGA, arts. 5 & 21
19 See ISS IGA, art. 21, stating “Subject to the provisions of this Article, for purposes of intellectual property law, an activity occurring in or on a Space Station flight element shall be deemed to have occurred only in the territory of the Partner State of that element’s registry, except that for ESA-registered elements any European Partner State may deem the activity to have occurred within its territory.”
20 US Patent Nos. 5,967,580 and 6,658,962
21 See Ross-Hime Designs, Inc. v. United States, 139 Fed. Cl. 444 (2018)
22 https://www.nasa.gov/robonaut2/what-is-a-robonaut/#:~:text=The%20Robonaut%20 project%20has%20been,capable%20processors%2C%20and%20new%20sensors
23 See United States v. Wong Kim Ark, 169 U.S. 649, 667 (1898) (describing jus soli as the “rule of country of birth”)
24 See R. Lawrence Dessem, Personal Jurisdiction After Asahi: The Other (International) Shoe Drops, 55 Tenn. L. Rev. 41, 84 (1987) (describing that “the courts of other major industrial nations exercise jurisdiction over foreign country defendants that have caused injury within the nation; French courts will entertain a suit brought by a French citizen against any defendant, anywhere in the world, regardless of contacts with France”)
25 35 U.S.C. § 184(a)
26 Grazhdanskiĭ Kodeks Rossiĭskoĭ Federatsii [GK RF] [Civil Code] art. 1395 (Russ.)
27 Patent Law of the People’s Republic of China, art. 19
28 The Patent Act, 1970, § 39 (India)
29 Code de la Propriété Intellectuelle [Intellectual Property Code] arts. L614-2, L614- 18 (Fr.)
30 Patents Act 1977, s. 23 (UK)
31 See https://fortune.com/well/2024/02/04/axiom3-astronauts-california-researchers-battle- cancer-space-kill-switch-rebecsinib/
32 ISS IGA, art. 21.3
33 https://www.nasa.gov/faqs-the-international-space-station-transition-plan/
34 https://spacenews.com/nasa-revises-contract-strategy-for-iss-deorbit-vehicle/
35 35 U.S.C. § 184
36 See Code de la Propriété Intellectuelle [Intellectual Property Code] art. L614-2 (Fr.)
37 While ISS IGA, art. 16 sets forth a cross-waiver of liability pursuant to which each partner state waives certain claims against the other partner states, intellectual property claims are specifically excluded under Article 16.3(c)(3)
38 See ISS IGA, art. 21.2
39 See Outer Space Treaty, art. VIII
40 U.N. Doc ST/SG/SER.E/1033 (Apr. 20, 2022)
41 See, e.g., https://www.cia.gov/the-world-factbook/field/space-program-overview/
42 https://www.nasa.gov/humans-in-space/commercial-space/what-is-the-commercial-low- earth-orbit-economy/
43 https://cen.acs.org/pharmaceuticals/drug-development/Pharma-goes-space-drug-development/100/i40