Waiving IP For Covid-19 Related Health Products And Technologies

Waiving IP For Covid-19 Related Health Products And Technologies Global Vaccine Timeline Stretches to 2023 • Countries by when they are expected to have vaccinated 60-70% of their adult population against COVID-19 The Problem The root of the problem is not the science, but business-as-usual - Intellectual property barriers - Limited manufacturing capacity Forecasted production for 2021 is twice total non-COVID vaccines Estimated vaccine production vs global demand (75% population) COVID Vaccine Production - Vaccine demand is calculated as 75% of the population being vaccinated - assuming vaccine efficacy is ~90%, then this results in 67% (2/3) of the population being immunized. Furthermore, it is assumed that 2 doses are required to fully vaccinate each person. - To successfully produce this vaccine at a large scale there needs to be effective technology transfer; therefore, lifting IP barriers is crucial to ensuring equitable, fair and timely access - Patents are routinely used to protect the underlying technology used to make the vaccines - Proprietary information for vaccine manufacturing is often protected through trade secrets. Type of Vaccine • MODERNA possesses extensive intellectual property, proprietary technology and expertise with respect to the research, development, manufacture and formulation of messenger RNA (mRNA) therapeutics and vaccines. • LONZA possesses world class manufacturing and process expertise in biologics manufacturing consistent with cGMP (as defined below). • MODERNA Manufacturing Know-How. Notwithstanding anything herein to the contrary, the Parties recognize that maintaining the confidentiality and trade secret nature of the MODERNA Manufacturing Know-How requires an even higher level of vigilance than other Confidential Information. - (...) (iii) use the MODERNA Manufacturing Know- How only for Manufacturing and supplying the applicable Product under the relevant Statement of Work and for no other purpose. The Solution at Hand The TRIPS Waiver Proposal 1. Removes IP barriers 2. Provides legal certainty & full freedom to operate 3. Allows more countries to locally manufacture diagnostics & treatments 4. Facilitates knowledge sharing and meaningful technology transfer Data Exclusivity: An IP Trojan horse in the making • Waiving IP for COVID-19 related health products and technologies: prospects and solutions TRIPs Agreement - Art. 39 & The Waiver Draft • Test data falls within the scope of IPR but is this an IPR of sort? • However, no application is required, as the protection stems from the regulation as a governmental or administrative obligation.... • Exists in connection with the marketing authorization also a national right "of sorts" in the EU wide effect or at the individual Member State level • The obligations of Members to implement or apply Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement or to enforce these Sections under Part III of the TRIPS Agreement, shall be waived in relation to health products and technologies including diagnostics, therapeutics, vaccines, medical devices, personal protective equipment, their materials or components, and their methods and means of manufacture for the prevention, treatment or containment of COVID-19. Marketing Authorizations in the EU COVID-19 vaccines obtain MA through the centralize procedure, and can be an abridged or informed consent applications • Article 3 → REGULATION (EC) No 726/2004 ∼ No medicinal product appearing in the Annex may be placed on the market within the Community unless a marketing authorization has been granted by the Community in accordance with the provisions of this Regulation. Regulation (EC) No 726/2004 Of The European Parliament And Of The Community Of 31 March 2024 Laying down Community procedures for the authorization and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency Medicinal Products To Be Authorized By The Community 1. Medicinal products developed by means of one of the following biotechnological processes: • Recombinant DNA technology, • Controlled expression of genes coding for biologically active proteins in prokaryotes and eukaryotes including transformed mammalian cells, • Hybridoma and monoclonal antibody methods 2. Medicinal products for human use containing a new active substance which, on the date of entry into force of this Regulation, was not authorized in the Community, for which the therapeutic indication is the treatment of any of the following diseases: • Acquired immune deficiency syndrome, • Cancer, • Neurodegenerative disorder, • Diabetes, • Auto-immune diseases and other immune dysfunctions, • Viral diseases. I.e. COVID-19 Vaccine 3. A medicinal product could be used as reference medicinal product if three cumulative conditions are met: • The reference medicinal product is (or has been) authorized in the EU (through a centralized or national procedure); • The reference medicinal product is or has been authorized in accordance with the pharmaceutical acquis, • The relevant data exclusivity period has expired. What if not?! Directive 2004/27/EC Of The European Parliament And Of The Council Of 31 March 2004 • Amending Directive 2001/83/EC on the Community code relating to medicinal products for human use • Article 10c o Following the granting of a marketing authorization, the authorization holder may allow use to be made of the pharmaceutical, pre-clinical and clinical documentation contained in the file on the medicinal product, with a view to examining subsequent applications relating to other medicinal products possessing the same qualitative and quantitative composition in terms of active substances and the same pharmaceutical form.'; • Voluntary licenses or agreements but..... COVID-19 vaccines • Currently under rolling review o CVnCoV o NVX-CoV2373 o Sputnik V (Gam- COVID-Vac) o COVID-19 Vaccine (Vero Cell) Inactivated • Marketing authorization application submitted o No marketing authorization applications currently under evaluation • Authorized for use in the European Union o Comirnaty o COVID-19 Vaccine Moderna o Vaxzevria (previously COVID-19 Vaccine AstraZeneca) o COVID-19 Vaccine Janssen • When medicines are under rolling review, EMA's human medicines committee (CHMP) evaluates clinical trial data as soon as these become available until it decides there is enough evidence for the developer to apply for marketing authorization. • EMA cannot provide exact timelines as these depend on when developers provide the necessary data for CHMP review. EMA updates the status of each medicine under rolling review when the developer applies for marketing authorization. European Medicines Agency “Transparency rules The Clinical Trial Regulation requires all information stored in the database to be publicly available, unless exempted under the Regulation to protect: 1. Personal data; 2. Commercially confidential information, in particular the marketing-authorization status of the medicine, unless there is an overriding public interest, → exception!!! 3. Confidential communication between member states in the preparation of their assessment; 4. Supervision of clinical trials by Member States.” Challenges In Relation To The WTO Waiver Data Exclusivity Regime In General 1. Data Exclusivity → Test data protection is not harmonized within TRIPS; 2. Is a sui-generis system attached to the pharmaceutical product but not regulated within the IP framework; 3. Art. 39 (3) provides for an exception that seems to require recognition through domestic law; 4. Bilateralism; 5. Even if TRIPs allows for the use of flexibilities -e.g. compulsory licenses- these are not reaching to data exclusivity; 6. The IP waiver as proposed, is not perfect just at the current system isnt either, but seems to be a tool in the right direction; 7. Data exclusivity can only be circumvented IF a voluntary agreement takes place -> Why couldn't TEVA reach an agreement with major manufacturers? WTO Agreement – Article IX(3) • In exceptional circumstances, the Ministerial Conference may decide to waive an obligation imposed on a Member by this Agreement or any of the Multilateral Trade Agreements, provided that any such decision shall be taken by three fourths of the Members unless otherwise provided for in this paragraph. • (a) A request for a waiver concerning this Agreement shall be submitted to the Ministerial Conference for consideration pursuant to the practice of decision- making by consensus. The Ministerial Conference shall establish a time-period, which shall not exceed 90 days, to consider the request. If consensus is not reached during the time-period, any decision to grant a waiver shall be taken by three fourths of the Members.