1 / 10

AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS IN DEVELOPING AND LEAST-DEVELOPED COUNTRIES

REVISING TRIPS FOR PUBLIC HEALTH AN IDEAS CONTEST FROM MSF. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS IN DEVELOPING AND LEAST-DEVELOPED COUNTRIES. ALIFAR is a non-profit, private international association, absolutely independent from any state or interstate organization.

mindy
Télécharger la présentation

AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS IN DEVELOPING AND LEAST-DEVELOPED COUNTRIES

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. REVISING TRIPS FOR PUBLIC HEALTH AN IDEAS CONTEST FROM MSF AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS IN DEVELOPING AND LEAST-DEVELOPED COUNTRIES

  2. ALIFAR is a non-profit, private international association, absolutely independent from any state or interstate organization. • ALIFAR was established in 1980 • ALIFAR is composed of locally-owned boards, associations and companies belonging to the Latin-American pharmaceutical sector. • ALIFAR assembles over 400 companies belonging to 14 Latin-American countries. • Reasons to participate in the MSF’s Ideas Contest.

  3. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • OVERVIEW • The Doha Declaration on TRIPs Agreement and Public Health has led the way in implementing TRIPs according to the needs of developing and least-developed countries. • WTO Members have not generally used TRIPs Agreement flexibilities. • TRIPs Agreement should be reformed to introduce specific exceptions to patent rights.

  4. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • OVERVIEW • ALIFAR supports an ALS for prescription medicines in DC and LDC. • ALS main axes • LC and LDC help to finance R&D costs required to invent and approve new drugs. • More access to prescription medicines.

  5. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • MAIN CHARACTERISTICS • DC and LDC shall be authorized to establish an ALS for patents related to prescription medicines. • Patentees and licensees shall negotiate and mutually agree on the royalty. • If they do not reach an agreement, licensees shall be entitled to exploit the patent according to the ALS.

  6. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • MAIN CHARACTERISTICS • The royalty rate shall be calculated using the following formula: • R = [(CR+D . MSC) / PT] . MSL PT represents the remaining patent protection term in such specific country. MSL represents the licensee market share for the patented invention. Rrepresents the royalty rate. CR&Drepresents the cost of the research and development (R&D) investment for the patented invention. MSCrepresents the specific country world market share for the prescription medicine.

  7. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • ROYALTY RATE EXAMPLE • R&D costs = USD 1 billion • Specific DC world market share for a prescription medicine = 0.5% • Remaining patent protection = 8 years • Proposed licensee market share in such DC country = 15% • USD 93,750 = [ (USD 1 billion . 0,5% MSC ) / 8 years PT ] . 15% MSL • The annual royalty rate should be USD 93,750.

  8. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • MAIN CHARACTERISTICS • DC and LDC shall be entitled to determine the administrative or judicial authority which shall establish the royalty. • The royalty rate may be duplicated if the prescription medicine represents a major therapeutic improvement. • The licensee must pay the royalty until the patent expiration.

  9. AUTOMATIC LICENSE SYSTEM FOR PHARMACEUTICAL PATENTS • ALS LEGAL COHERENCE • ALS is coherent with Article 8 of TRIPs Agreement. • ALS fulfills TRIPs Agreement’s Article 30 requirements: • It is a limited exception. It is not an illegitimate discrimination. • It does not unreasonably conflict with the normal exploitation of the patent and does not unreasonably prejudice the legitimate interests of the patentee. • It takes into account the legitimate interest of third parties. • ALS could be implemented adding a new Article to TRIPs Agreement – Article 31 ter.

  10. REVISING TRIPS FOR PUBLIC HEALTH AN IDEAS CONTEST FROM MSF Thank you.

More Related