Regional Seminar on the multilateral legal framework and practice of patent protection in the pharmaceutical field

Overview of Patent Related Flexibilities in the Pharmaceutical field.

Marco M. ALEMAN

Acting Director, Patent Law Division, WIPOIssyk Kul, May 27 and 28, 2014

PATENT RELATED FLEXIBILITIES. LEGISLATIVE IMPLEMENTATION

I. The Multilateral legal framework of patentsII. The implementation of Multilateral Treaties III. Some examples of flexibilities and a definitionIV. WIPO work and discussions at the CDIP and SCP

I. The Multilateral Legal Framework

Total freedom of countries

1883: Paris Convention (asymmetries)

1994: TRIPS Agreement. The period of minimum standards

II. Implementation of Multilateral Treaties on Patents

Direct Implementation vs. Adoption of national laws

Self executing vs. Non-self executing international law

Room to manœuvre left to the national legislator

Concept of flexibility

“flexibilities” as a mechanism to consider national policies

further protection (TRIPS violation)

Maximum standards (more extensive protection) patent restoration term,

national exhaustion, exclusion of plant varieties

protection to naturally occurring microorganisms,

Narrow down exceptions and limitations

- - - - - - - - - - - - - - - - - - - -- - - - - - - - - 20 years of protection period,

international exhaustion, exclusion of plants and genetically modified microorganisms,

bolar type exc., research exc., further grounds for CLTRIPS

Minimum standards Below (TRIPS violation)

Flexibilities

Trips Plus

To waive

Flexibility

TRIPS Agreement implementation. Art. 27 and some of its flexibilities

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TRIPS Agreement implementation. Art. 27 and more extensive protection

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III. Overview of Patent Related Flexibilities in the Pharmaceutical field

Exhaustion of rights

Patentability of Substances existing in nature

Compulsory licenses and Government Use

Research exemption

Regulatory review (Bolar) exception

Pharmacy exception

Exhaustion of rights

Territoriality

Patent rights, like other intellectual property rights, are territorial in nature, which means that each patent provides its owner the exclusive right of exploiting the invention within the limits of the country or countries where the patent was granted.

One invention could be the object of patent protection in several countries, creating rights that are independent from each other (Article 4bis Paris Convention)

TRIPS ProvisionsArticle 28 of the TRIPS Agreement (Rights Conferred) enumerates the exclusive rights. It includes among them the “right of importation” because the exclusive right derived from a patent could be affected by the importation of the patented product from another country.Article 28 contains a footnote regarding the right to prevent importation, stating that this right, “like all other rights conferred under this Agreement in respect of the use, sale, importation or other distribution of goods, is subject to the provisions of Article 6.Article 6 of the TRIPS Agreement does not establish which level of exhaustion (i.e., national, regional or international) members shall adopt.

National Exhaustion

National level of exhaustion, the rights of the owner of the patent are exhausted only in respect to goods that have been put on the market in the country with his consent.

It seems that this level of exhaustion has been adopted by several CEECAC countries: Albania, Belarus, Kazakhstan, Kyrgyzstan, Turkey and Uzbekistan.

Exhaustion (national)

ALBANIA : Article 39 of the Patents Act of 07/07/2008

Article 39. Exhaustion of rights. The rights conferred by a patent shall not extend to acts committed in the Republic of Albania with regard to a product protected by the patent after the said product has been put on the market in the Republic of Albania by the patent’s owner or with his consent.

TURKEY : Section 76 of the Decree-Law on the Protection of Patent Rights No. 551 of 27/06/1995

Article 76 : Exhaustion of Rights Conferred by a Patent. Rights conferred by a patent shall not extend to acts committed with regard to a product under patent protection after said product has been put to sale in Turkey by the right holder of the patent or with his consent.

Regional exhaustion

Regional exhaustion takes place when goods are released with the consent of the owner of the patent in any country member of a regional market or union.

An example of regional exhaustion is that of the European Union, based on Articles 28 and 30 of the Treaty of Rome dealing with the free movement of goods.

EU Exhaustion regime

The elaboration of the regional exhaustion doctrine in the European Union goes back to a groundbreaking decision of the European Court of Justice (ECJ) in the early 1970s. Deutsche Grammophon, GmbH v Metro-SB-Grossmarket, GmbH & Co, Case 78/70, [1971].

“the guarantee that the patentee, to reward the creation effort of the inventor, has the exclusive right to use the invention with a view to manufacturing industrial products and putting them into circulation for the first time, either directly or by the grand of licenses to third parties, as well the right to oppose infringements” ECJ, Case 15-74 [1974], Centrafarm BV et Adriaan de Peijper v Sterling Drug Inc.

Provisions of type exist in the patent law of Estonia

ESTONIA: Section 17 of the Patent Act of 16/03/1994, as last amended by the Act of 10/03/2004

§ 17. Exhaustion of rights. The proprietor of a patent has no right to prohibit acquisition (including import), use, distribution, sale or offer for sale of a product containing the patented invention when the product has been put on the market in the territory of the Republic of Estonia or a State party to the Agreement on the European Economic Area by the proprietor of the patent or with the proprietor’s consent.

Provisions of type exist in the patent law of Slovakia

SLOVAKIA (EU) : Article 16 of the Act No. 435/2001 Coll. on Patents, Supplementary Protection Certificates and on Amendment of Some Acts as Amended by Act No. 402/2002 Coll., Act No. 84/2007 Coll. and Act No. 517/2007 Coll.

Article 16. Exhaustion of rights (1) A patent owner shall not be entitled to prohibit third parties to dispose of a product which is a subject-matter of a patent protection after this product has been placed on the market in the member state of the European Union or in the state which is a contracting party to the Agreement on the European Economic Area by a patent owner or with his explicit consent. This shall not apply if there are reasons for extension of rights to a patent for such treatment.

International exhaustion

Under a system of international exhaustion, goods put on the market by or with the consent of the patent owner anywhere in the world would result in the patent owner’s rights being exhausted in the country concerned. Some examples of countries applying international exhaustion are: In Africa, Egypt (Section 10(1) of the Law on the Protection of Intellectual Property Rights no. 82/2002) and South Africa ( Section 15c of the Medicines Act). Also several Latin-American countries have adopted international exhaustion, such as Argentina (Article 36c) of the Patent Law ), the Member countries of the Cartagena Agreement (Art. Decision 486), and Costa Rica (Section16 of its Patent Law of 25/04/1983, No. 6867). In Asia, some examples are: India, Malaysia and China (it seems that Article 63 of the Patent Law, modified in 2009, provides an international exhaustion system).

Exhaustion (international)

PAKISTAN : Section 30 (5) a) of the Patents Ordinance No. LXI of 02/12/2000 (as amended by the Patents Amendment Ordinance of 2002)

(5) The rights under the patent shall not extend to-

(a) acts in respect of articles which have been put on the market anywhere in the world by the owner of the patent or with his consent or by an authorized person or in any other legitimate manner such as compulsory licenses;

No legislative provisions, so case law… Certain countries, such as Japan[1] or the United States of America,[2] have not adopted express legislative provisions on exhaustion, leaving it to jurisprudence to determine the evolution of this matter;

[1] In Japan, a recent decision of the Supreme Court seems to point to an international level of exhaustion (Recycle Assist, Co. Ltd. v Canon, Inc., Japan Supreme Court, Heisei 18 (jyu) 826).

[2] In the U.S.A. the exhaustion doctrine has been developed since the 1873 case Adam v Burke in which the Supreme Court enunciated the principle according to which a patent’s monopoly ends with the first sale or disposition of an article embodying the claimed invention by the patentee, or by a licensee of the patentee acting within the scope of the license. Historically this doctrine seems more oriented towards national exhaustion, but openings to international exhaustion are found in a recent decision of a U.S. federal court of first instance, LG Electronics Inc. v Hitachi, Ltd. (No. 07-6511 CW, ND Cal, 13th March 2009).

IV. WIPO work and discussions (CDIP)

Patent Related Flexibilities Document's in the framework of the CDIP

CDIP/5/4Rev

http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_5/cdip_5_4-main1.pdf

http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_5/cdip_5_4-annex1.pdf

http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_5/cdip_5_4-annex2.pdf

CDIP/7/3 and Add

http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_7/cdip_7_3-main1.pdf

http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_7/cdip_7_3-annex1.pdf

http://www.wipo.int/edocs/mdocs/mdocs/en/cdip_7/cdip_7_3-annex2.pdf

CDIP 13/10

http://www.wipo.int/meetings/en/details.jsp?meeting_id=32087

 

IV. WIPO work and discussions (CDIP)

Regional meetings

• WIPO Seminar for certain Asian countries on the effective implementation and use of several patent related flexibilities, Bangkok, Thailand, February 15 to 17, 2011

http://www.wipo.int/meetings/en/details.jsp?meeting_id=22602

• WIPO Regional Seminar on the Implementation and Use of Several Patent-Related Flexibilities, February 6 to 8, 2012, Bogota, Colombia

http://www.wipo.int/meetings/en/details.jsp?meeting_id=24982

• Seminar for Certain African Countries on the Implementation and Use of Several Patent-related Flexibilities, January 29 to January 31, 2013, Durban, South Africa

http://www.wipo.int/meetings/en/details.jsp?meeting_id=27882

• Regional Seminar for Certain Caucasian, Central Asian and Eastern European Countries and Central European, Baltic and Mediterranean Countries on the Implementation and Use of Several Patent-Related Flexibilities Astana, Kazakhstan, October 16 to 18, 2013

http://www.wipo.int/meetings/en/details.jsp?meeting_id=30346

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SCP since 2008

Report on the International Patent System (SCP/12/3 Rev.2)

Certain aspects of national and regional patent laws

http://www.wipo.int/scp/en/annex_ii.html

Preliminary studies on selected issues, including:

patents and standards (document SCP/13/2)

dissemination of patent information (SCP/13/5 and SCP/14/3)

2010: agreement on five issues for future work

(i) exceptions and limitations (ii) quality of patents (iii) patents and health (sharing session on countries’ use of health-related patent flexibilities during SCP/20)

(iv) transfer of technology (v) client-patent attorney privilege

SCP/20: January 27 to 31, 2014

MANY THANKS !!!

marco.aleman@wipo.int