Compulsory Licensing in Light of the Patent Misuse Doctrine: A Comparative Study between Iran and the United States
Subject Areas : Property lawMorteza Saeedghaderi 1 , Amin Mirzamani 2
1 - PhD Researcher in Private Law, Islamic Azad University, Varamin–Pishva Branch, Iran
2 - PhD Researcher in Private Law, Islamic Azad University, Varamin–Pishva Branch, Iran
Keywords: Patent misuse doctrine, compulsory licensing, competition law, patent rights, abuse of rights.,
Abstract :
In the complex landscape of modern innovation, excessive and unchecked patent monopolies can become serious barriers to healthy competition and equitable access to technology. Accordingly, this research—using a comparative analytical method and examining judicial precedents—explores the doctrine of patent misuse in U.S. law, the mechanism of compulsory licensing under the TRIPS Agreement, and their compatibility with Iran’s legal framework.The findings indicate that in the U.S. system, the possibility of temporarily suspending the enforcement of patent rights after establishing misuse serves as both an effective deterrent and a flexible remedy, enabling restoration of the patentee’s rights once the violation has been cured. Meanwhile, the international compulsory licensing mechanism, through requirements such as prior negotiation, payment of fair compensation, and limitations on duration and scope of use, provides an appropriate control mechanism against unjustified refusals to grant licenses. A review of Iranian regulations, however, reveals a limited and fragmented set of tools—such as compulsory licensing—lacking provisions for temporary suspension of rights or a coherent theoretical structure. As a result, the Iranian framework does not provide sufficient efficiency for preventing or remedying misuse. Therefore, it is recommended that an independent legal provision addressing patent misuse be introduced, along with recognition of temporary suspension of patent enforcement and formulation of relevant judicial guidelines. Such reforms would help align Iran’s legal system with international standards and strengthen the balance between monopoly and competition.
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Kovacic, W. E., & Shapiro, C. (2023). Antitrust Law and Economics. Harvard University Press. (pp. 210-225).
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Merges, R. P., & Duffy, J. F. (2023). Patent Law and Policy: Cases and Materials. 8th ed., Carolina Academic Press. (pp. 610-620).
Hovenkamp, Herbert, Innovation and competition policy, Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1937207(SSRN).
Articles
Cheung, W., & Pietsch, I. (2025). Considering the Status of the U.S. Doctrine of Patent Misuse. Covington & Burling LLP.
Golden, J. M. (2024). "Reconsidering Patent Misuse," Stanford Technology Law Review, vol. 27, pp. 330–358.
Kianzad, B. (2024). Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines. South Centre Research Paper No. 197.
Knowledge Ecology International. (2023). Moderna Claims Compulsory License from U.S. Government to Use Third Party Patents in its Covid-19 Vaccine. KEI.
McClanahan, John Baker, Copyright Misuse As A Defense In An Infringement Action: Copyright Misuse As A Defense In An Infringement Action,Available at: https://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=1857&context=wlulr
Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806 (1945).
Ouellette, L.L., & Sampat, B.N. (2024). Using Bayh-Dole Act March-In Rights to Lower US Drug Prices. JAMA Health Forum, 5(11): e243775.
John Baker McClanahan, ” Copyright Misuse As A Defense In An Infringement Action: Copyright Misuse As A Defense In An Infringement Action”, , Available at: https://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=1857&context=wlulr
Syam, N. (2024). SouthViews No. 258: Licensing and Government Use of Patents. South Centre.
Casse
Brulotte v. Thys Co., 379 U.S. 29 (1964), Case available at: https://supreme.justia.com/cases/federal/us/379/29.
Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011). (pp. 1280-1287), case available at: https://www.cafc.uscourts.gov/opinions-orders/09-1008.pdf.
THERASENSE V BECTON, No. 08-1511 (Fed. Cir. 2009), Available at: https://law.justia.com/cases/federal/appellate-courts/cafc/08-1511/08-1511o-2011-03-27.html
Precision Instrument Mfg. Co. v. Automotive Co., 324 U.S. 806 (1945), Avaiabale at: https://supreme.justia.com/cases/federal/us/324/806/.
Hovenkamp, Herbert, Innovation and competition policy, Available at: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1937207(SSRN)
Lasercomb America, Inc. V. ReynoldsLasercomb America, Inc. V. Reynold, case available at: https://casetext.com/case/lasercomb-america-inc-v-reynolds;
Motion Picture Patents Co. v. Universal Film Co., 243 U.S. 502 (1917); Case available at: https://supreme.justia.com/cases/federal/us/243/502/
Morton Salt Co. v. G. S. Suppiger Co., 314 U.S. 488 (1942); Available at: https://supreme.justia.com/cases/federal/us/314/488/
Kimble v. Marvel Entertainment, LLC, 576 U.S. 446 (2015); Available at: https://supreme.justia.com/cases/federal/us/576/446/
35 U.S. Code § 271 - Infringement of patent.( (a) Except as otherwise provided in this title, whoever without authority makes, uses, offers to sell, or sells any patented invention, within the United States or imports into the United States any patented invention during the term of the patent therefor, infringes the patent.)
Article 8: Principles:”…2. Appropriate measures, provided that they are consistent with the provisions of this Agreement, may be needed to prevent the abuse of intellectual property rights by right holders or the resort to practices which unreasonably restrain trade or adversely affect the international transfer of technology.”
Definition of March-in Rights (U.S. Law – Bayh–Dole Act, 35 U.S.C. § 203): March-in rights refer to the authority granted to the U.S. federal government to require the patent holder (typically a university or contractor who developed the invention with federal funding) to grant licenses to third parties, or for the government itself to grant such licenses, under certain conditions.
35 U.S. Code § 203 - March-in rights: “(a) With respect to any subject invention in which a small business firm or nonprofit organization has acquired title…, the Federal agency under whose funding agreement the subject invention was made shall have the right, in accordance with such procedures as are provided in regulations promulgated hereunder to require the contractor, an assignee or exclusive licensee of a subject invention to grant a nonexclusive, partially exclusive, or exclusive license in any field of use to a responsible applicant or applicants, …, and if the contractor, assignee, or exclusive licensee refuses such request, to grant such a license itself,….”
Text of Article 31(f) – TRIPS:”…(f) any such use shall be authorized predominantly for the supply of the domestic market of the Member authorizing such use..
References
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Dinwoodie, Graeme B., & Janis, Mark D. (2023). Trademarks and Unfair Competition Law and Policy. 5th Edition, Wolters Kluwer.
Kovacic, W. E., & Shapiro, C. (2023). Antitrust Law and Economics. Harvard University Press, pp. 210–225.
Leslie, Christopher R. (2011). Antitrust Law and Intellectual Property Rights: Cases and Materials. Oxford University Press.
Merges, R. P., & Duffy, J. F. (2023). Patent Law and Policy: Cases and Materials, 8th ed. Carolina Academic Press, pp. 610–620.
Hovenkamp, Herbert. Innovation and Competition Policy. Available at SSRN: https://papers.ssrn.com/sol3/papers.cfm?abstract_id=1937207
Cheung, W., & Pietsch, I. (2025). Considering the Status of the U.S. Doctrine of Patent Misuse. Covington & Burling LLP.
Golden, J. M. (2024). “Reconsidering Patent Misuse,” Stanford Technology Law Review, Vol. 27, pp. 330–358.
Kianzad, B. (2024). Compulsory Licensing as a Remedy Against Excessive Pricing of Life-Saving Medicines. South Centre Research Paper No. 197.
Knowledge Ecology International (KEI). (2023). Moderna Claims Compulsory License from U.S. Government to Use Third-Party Patents in Its Covid-19 Vaccine.
McClanahan, John Baker. Copyright Misuse as a Defense in an Infringement Action. Available at: https://scholarlycommons.law.wlu.edu/cgi/viewcontent.cgi?article=1857&context=wlulr
Precision Instrument Mfg. Co. v. Automotive Maintenance Machinery Co., 324 U.S. 806 (1945).
Ouellette, L. L., & Sampat, B. N. (2024). Using Bayh-Dole Act March-In Rights to Lower U.S. Drug Prices. JAMA Health Forum, 5(11): e243775.
Syam, N. (2024). SouthViews No. 258: Licensing and Government Use of Patents. South Centre.
Brulotte v. Thys Co., 379 U.S. 29 (1964). Case available at: https://supreme.justia.com/cases/federal/us/379/29.
Therasense, Inc. v. Becton, Dickinson and Co., 649 F.3d 1276 (Fed. Cir. 2011), pp. 1280–1287. Case available at: https://www.cafc.uscourts.gov/opinions-orders/09-1008.pdf
Therasense v. Becton, No. 08-1511 (Fed. Cir. 2009). Available at: https://law.justia.com/cases/federal/appellate-courts/cafc/08-1511/08-1511o-2011-03-27.html
Precision Instrument Mfg. Co. v. Automotive Co., 324 U.S. 806 (1945). Available at: https://supreme.justia.com/cases/federal/us/324/806/
Lasercomb America, Inc. v. Reynolds. Available at: https://casetext.com/case/lasercomb-america-inc-v-reynolds
Motion Picture Patents Co. v. Universal Film Co., 243 U.S. 502 (1917). Available at: https://supreme.justia.com/cases/federal/us/243/502/
Morton Salt Co. v. G. S. Suppiger Co., 314 U.S. 488 (1942). Available at: https://supreme.justia.com/cases/federal/us/314/488/
Kimble v. Marvel Entertainment, LLC, 576 U.S. 446 (2015). Available at: https://supreme.justia.com/cases/federal/us/576/446/
35 U.S. Code § 271 – Infringement of Patent. [in English]
TRIPS Agreement, Article 8(2): Preventing the abuse of intellectual property rights.
Definition of March-in Rights (Bayh–Dole Act, 35 U.S.C. § 203).
35 U.S. Code § 203 – March-in Rights.
TRIPS Agreement Article 31(f) – Use predominantly for the domestic market.