PatentsRegulationCOVID-19: How to Implement the Ex Officio License – Elisabeth Berthet ⋅ Matthieu Dhenne ⋅ Lionel Vial

21 May 2020

Current research for COVID-19 treatments is based on known pharmaceutical active ingredients covered by industrial property titles (patents or supplementary protection certificates). These titles confer to their owner an exclusive right of exploitation on the claimed substances. Consequently, the manufacture by third parties of anti-COVID-19 medicinal products which composition would include protected molecules will require authorizations of exploitation, in principle granted at the discretion of the rights holders. The mechanism of ex officio licensing in the interest of public health enables third parties to dispense with the granting of such authorizations by compelling the owners to grant rights to use the patented inventions.


In adopting its emergency law to deal with the COVID-19 epidemic, the French legislator authorized its Government to “take any measure to make appropriate medicines for the eradication of the health disaster available to patients“. In application of this broad authorization, it is to be feared that the Government may order expropriation measures in contravention of the TRIPS Treaty (i.e. the Trade-Related Aspects of Intellectual Property Rights) which France has nevertheless signed within the framework of the WTO. Such a position would seem all the more surprising given that the supply of medicines to the population could be ensured without having to leave the balanced system of ex officio licensing — which is already laid down in that Treaty and in French law — provided that the mechanism is made more flexible in order to ensure the effectiveness of its implementation.


As law stands, difficulties in the application of the ex officio licensing system in the interest of public health concern the two phases of issuing this non contractual-licence, i.e. the procedure initiated by the Minister of Public Health with the Minister responsible for Industrial Property with a view to submitting industrial property titles to an ex officio licence (Phase I) and the application procedure for third parties to apply for the licence (Phase II). Texts in force should be amended accordingly.


Phase I. — Strictly following the letter of the law, the ex officio license in the interest of public health only covers “patents” (i.e., titles granted) thereby omitting patent applications. Furthermore, the application of the mechanism requires that the patented invention be “made available to the public in insufficient quantity or quality or at abnormally high prices“. But these conditions of implementation should be extended, upstream, to the foreseeable shortcoming of the patentee : for the ex officio license to be useful, the Government must be able to compensate for the future inability of the patentee to supply the population with medicines. Consequently, Article L. 613-16 of the Intellectual Property Code (IPC) should be amended as follows:

IPC, Art. L. 613-16 : “Where the interests of public health so require and in the absence of an amicable agreement with the owner of the patent, the Minister responsible for Industrial Property may, at the request of the Minister responsible for Public Health, submit by order, to the ex officio license system, under the conditions laid down in Article L. 613-17, any patent application or any granted patent for having as its subject matter:
(a) a medicinal product, a medical device, an in vitro diagnostic medical device, an ancillary therapeutic product;
(b) a process for obtaining them, a product necessary for obtaining them or a process for the manufacture of such a product;
(c) An ex vivo diagnostic method.
Patent applications or patents for such products, processes or diagnostic methods may be subject to the ex officio licensing system in the interest of public health only where such products, or products resulting from such processes or diagnostic methods of which they are the subject are, or when non exploited yet and on the basis of objective factors, will be made available to the public in insufficient quantity or quality or at abnormally high prices, or where the patent is exploited under conditions contrary to the interest of public health or constituting practices declared to be anti-competitive following an administrative or judicial decision which has become final. […]”


Phase II. — In the event that the ex officio license covers both the manufacturing and the marketing of medicinal products for COVID-19 treatments, the licensee candidate will have to obtain a marketing authorization, either from the development of its own products (i) or through the patentee (ii).


(i) — The licensee candidate could develop a generic alternative of the protected drug and file a national marketing authorization (MA) application for it. However, before the data protection of the MA and the market exclusivity of the originator drug have expired, the application will be refused. It would therefore be convenient to introduce an exception in the Public Health Code (PHC) worded as follows:

PHC, Art. L. 5121-28-1 [new]: “The periods of protection set out in Article 14(11) of Regulation (EC) n° 726/2004 and in Articles R. 5121-28 and L. 5121-10-1 shall not apply in cases where it is necessary to allow access to and the use of pharmaceutical test data to register a generic of a reference medicinal product, which is or has been authorised under Article L. 5121-8 or Article 3 of the abovementioned Regulation, for reasons of public interest, in case of ex officio licensing in the interest of public health of patents, and in situations of national emergency or extreme urgency.”


The applicant for the ex officio licence could apply for a Temporary Use Authorization (TUA), which would allow early access to new COVID-19 treatments since there is a real public health need. However, the TUA can only be granted in the absence of appropriate treatments. In order for the ex officio licensing to be usefully applied, access to this type of authorization should be extended to cases where medicines available to the public are available only in insufficient quantity or quality or at abnormally high prices:

PHC, Art. L. 5121-12 : “I. — Articles L. 5121-8 and L. 5121-9-1 do not preclude the use, on an exceptional basis, of certain medicines intended to treat serious or rare diseases, in the absence of appropriate treatments or if the existing treatments are the subject of patents or patent applications subject to ex officio licensing in the interest of public health pursuant to Articles L. 613-16 to L. 613-18 of the Intellectual Property Code and are made available to the public in insufficient quantity or quality or at abnormally high prices, where the implementation of the treatment cannot be deferred and one of the following conditions is met : […]”


(ii) — Another option to enable the applicant for the licence to manufacture and market anti-COVID-19 medicinal products would be to obtain from the patentee the corresponding know-how and all the necessary documents and data in order to file and obtain a marketing authorization. This should be expressly provided for in law:

IPC, Art. L. 613-17: “From the day of publication of the decree making the patent subject to the ex officio license, any qualified person may apply to the Minister responsible for Industrial Property for the grant of an operating license that also includes communication of the corresponding know-how and the provision by the owner of the patent of all the elements at his disposal that are necessary for the commercialization of the invention. Such license shall be granted by order of the said Minister on specified conditions, in particular as to its duration and scope, but excluding the royalties to which it gives rise. […]”



Elisabeth BERTHET
PhD in Law, PhD in Pharmacy, Attorney-at-law

Matthieu DHENNE
PhD in Law, Attorney-at-law

Lionel VIAL
Patent Attorney, European Patent Attorney