Medicines Patent Pool: a Potent Tool to Address IP Barriers

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A patent pool is a way of facilitating access to intellectual property through which, two or more patent-holders agree to share their intellectual property with each other or with third parties through negotiation of licences.

Off late the pharmaceutical industry is slowly absorbing the idea that patent pools could function as an interesting alternative to exclusive single-firm production, simple bilateral licensing or cross-licensing. Increasingly, patent pools for medicines are being considered as a tool to facilitate access to large numbers of inventions in this sector.

Médecins Sans Frontières[1] (MSF) and Knowledge Ecology International[2] (KEI) first presented the concept of a patent pool for medicines to UNITAID in 2006. In July 2008, the UNITAID Board decided to explore the feasibility of setting up a voluntary HIV/AIDS medicine patent pool, which received approval in December 2009. In July 2010 the Medicine Patent Pool (MPP) was legally created and established as an independent entity with the mission of improving access to HIV medicines in developing countries and became operational in November 2010.

As of late 2011, the MPP has remain restricted to ARVs, despite of strong indications by several MPP proponents that the MPP could be useful for other drugs beyond ARVs in the near future. In 2009, GSK proposed a pool for medicines for neglected tropical diseases for Least Developed Countries (LDCs) as part of its Open Innovation Agenda[3].

MPP is particularly useful in situations where a number of related inventions are patented by many different organizations and where access to these inventions is essential for the development and commercialization of a (new) product. Such situations are commonly referred to as ‘patent thickets’[4] in cases where it is cumbersome to safeguard one’s freedom to operate (FTO) because the commercial production, marketing and use of a new product, process or service is likely to infringe many existing patent rights owned by many third parties (third party patent rights). To gain access to those third party patent rights, one will need to enter into a multitude of licensing negotiations often leading to an accumulation of royalties (royalty stacking). For some companies or researchers this might be a reason to redesign or completely stop a research project[5]. In such situations MPP act as facilitators and its use of one-stop-licenses normally reduce royalties and transaction costs, increases legal certainty and reduces enforcement litigation, thereby mitigating the costs and risks of R&D and reducing significantly the costs for end users.

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[1] http://www.msfaccess.org/

[2] http://keionline.org/; See IGWG Briefing Paper on Patent Pools Collective Management of Intellectual Property -- The use of Patent Pools to expand access to essential medical technologies. KEI Research Note 2007:3 (1) January 23, 2007 available at: http://accessvector.org/oldkei/content/view/65/; EMILA working plan, available at: http://www.keionline.org/index.php?option=com_content&task=view&id=64&Itemid=44

[3] BVGH (2010) Pool for Open Innovation against Neglected TropicalDiseases: Core Principles, BVGH

[4] Shapiro, C. (2001) Navigating the patent thicket: cross licenses, patentpools, and standard-setting. In Innovation Policy and the Economy(Jaffe, A. et al., eds), pp. 119–150, MIT Pres

[5] Heller, M.A. (1998) The tragedy of the anticommons: property in thetransition from Marx to markets. Harv. Law Rev. 111, 621–688; Heller, M.A. (2008) The Gridlock Economy: How Too Much OwnershipWrecks Markets, Stops Innovation, and Costs Lives, Basic Books; Heller, M.A. and Eisenberg, R.S. (1998) Can patents deter innovation?The anticommons in biomedical research. Science 280, 698–701

Change of Name: The detailed procedures to be followed

If any person wants to change his/her name for some or other reasons, which includes (Name after marriage). The procedure might take a minimum of six months considering various reasons.

Procedures to be followed:

File an application to First Class Magistrate (Of your area of residence) Requesting to change the name.

Attest your affidavit by a oath commissioner or notary.

If you are an NRI, then the affidavit needs to be attested by the respective Indian High Commission or Indian Embassy.

In a blank paper  type out the details as specified, which includes your old name, the new name you wish to adopt, your father’s or husband’s name and address, and your employer’s name. You have to sign this Proforma in the presence of two witnesses and have them sign the document as well.

Advertise in any one of the daily local newspapers, mentioning your father’s or husband’s name and address, and your intention to change your name. Be sure to get an original copy of this advertisement as it appears in the paper.

Send by registered post or you may either take in person the following:
1.The original advertisement, 2.Original Performa, 3.Attested affidavit, 4.Two attested passport (address proof) 5.photographs.

                        [Pay the fee for having your change of name published in the Gazette of India Part IV. The amount (in the range of Rs. 700 as of 2009) will need to be submitted in advance, in cash or by Demand Draft/Indian Postal Order drawn in favor of Controller of Publication, Department of Publication, Civil Lines, Delhi-54. All of the above mentioned documents will have to be sent to the same address.]

                        [You have to obtain the copies of official gazette where your change of name has been published and use it as proof of your name change wherever needed. A couple of extra copies can be obtained for an extra fee of around Rs. 35 per copy. For NRI’s, the cost of advertising change of name in the Gazette of India is Rs. 2300/- which includes international postage.]

In short:

·         Advertisement in a local newspaper

·         Affidavit

·         Passport photographs

·         Proforma (typed)

·         Fees in Cash, Postal Order or Demand Draft

Alternate Dispute Resolution Method in Pakistan

The relevant laws (or particular provisions) dealing with the ADR are summarized as under:

·          The Arbitration Act, 1940.

·         Articles 153–154 of the Constitution of Pakistan, 1973 (Council of Common Interest)

·         Article 156 of the Constitution of Pakistan, 1973 (National Economic Council)

·         Article 160 of the Constitution of Pakistan, 1973 (National Finance Commission)

·         Article 184 of the Constitution of Pakistan, 1973 (Original Jurisdiction when federal or provincial governments are at dispute with one another)

·         Sections 102–106 of the Local Government Ordinance, 2001.

·         Sections 10 and 12 of the Family Courts Act, 1964.

Arbitration in Pakistan:

Although no explicit mention of ADR is mentioned in the Constitution of Pakistan, a reference to commercial and financial activities can be pinpointed in the Constitution.

Pakistan has also signed and ratified the New York Convention. The New York Convention is also known as the New York Convention of 1958 and the Convention for the Recognition and Enforcement of Foreign Arbitral Awards. UNCITRAL is a Commission of the UN established by the General Assembly on 17 December 1966 by Resolution 2205 (XXI). Thus, although the New York Convention was adopted in 1958, the Commission’s essential mandate is to promote the Convention further. Furthermore, UNCITRAL serves as the International Trade Law Branch of the Office of Legal Affairs of the UN. Hence, UNCITRAL, under the umbrella of the UN, is the biggest organizational body to prepare rules relating to ADR, namely arbitration and conciliation.

Arbitration in Pakistan is still largely governed by the 1940 Act which was enacted by the British for the undivided Indian colony. Though Pakistan has signed the NYC, the enforceability of foreign arbitral awards is unclear as the NYC has not been implemented. The first attempt to implement the NYC was made in 2005, when the new Arbitration Act was passed as an Ordinance (along with an Ordinance to implement the ICSID Convention in 2006, which is now the Investment Disputes Act) almost 50 years after they signed on the NYC.

Pakistan Engineering Council Islamabad:

PEC Rules of Conciliation and Arbitration is one such document prepared by a team of experts comprising Employers, Constructors and Consultants and Legal Advisors in line with the advice by Planning Commission, Govt. of Pakistan. It is expected that use of this document will provide an equitable and just basis for settlement of disputes pertaining to construction and consultancy contracts expeditiously.

The Rules specified in the this document shall be applicable for all construction  and engineering services (consultancy) contracts to be executed in Pakistan irrespective of their source of financing and/or nationality of the constructors/consultants (engineering service providers).

Any dispute, controversy or claim arising out of or relating to a Contract, or the breach, termination or invalidity thereof, shall be settled by arbitration in  accordance with the PEC rules of Arbitration in-force.

This indicates that there are a number of institutions which are working as an institution for conciliation. And this gives a reference that as contrary to Indian laws, in Pakistan, there is a specific requirement that parties referring to conciliation and the institution will be mentioned in the contract.

Recent Initiatives regarding ADR in Pakistan:

·         Code of Civil Procedure (CPC) which is the primary procedural law for civil matters in Pakistan, has been amended (under AJP) for providing enabling mechanism for Court Annexed ADR in Pakistan (Section 89-A).

·         Small Claims and Minor Offences Ordinance 2002 has been promulgated for providing exclusive forum (at the district level) for facilitating the resolution of smaller disputes. This law also provides ADR mechanism for facilitating the resolution and settlement of disputes within the framework of the formal court system. This could be transformed into an excellent forum for addressing disputes in the emerging justice sector in Pakistan;

·         Under the Access to Justice Program, the review of Arbitration Act represents a significant policy action. This review needs to be undertaken and capacity building initiatives put in place to promote effective arbitration regime in Pakistan.

·         A new local government system has been introduced in Pakistan, establishing elected local governments at the level of Union Council, Tehsil (Sub District Level) and the District level. The institution of Musalihat Anjuman (literally meaning conciliation forums) has been provided at the level of Union Councils for dispute resolution through ADR (including conciliation, mediation and arbitration). The finalization of the rules of Business for these bodies is essential to popularize the use of ADR.

In WAPDA v. Kot Addu Power Company[1] – Provisions of section 290 of the Companies Ordinance, 1984 vested statutory jurisdiction in High Court to take certain measures described there and ordered to resolve dispute inter-se shareholders or directors of a company – High Court dismissed the petition made under section 3 of the Arbitration (Protocol & Convention) Act, 1937 for reference of the dispute under the Act of 1937.

Pakistan has entered into Bilateral Investment Treaties with 36 countries which include dispute settlement mechanism between the host country and foreign investor, failing this through mutual consultations, where after the investor can refer the dispute to a competent court of the respective country or an ad-hoc arbitration panel established under rules of the UN Commission on International Trade Law (UNCITRAL) or to the Court of Arbitration of Paris International Chamber of Commerce (ICC). These mechanisms provide transparent, inexpensive, speedy and accessible dispute resolution to foreign investors. The International Center for the Settlement of Investment Disputes (ICSID) also provides facilities for conciliation and arbitration of investment disputes between contracting states and nationals of other states under the Convention for the Settlement of Investment Disputes and Pakistan is a member of the Center.

The Conciliation Courts (West Pakistan Amendment) Ordinance, 1966:

An Ordinance further to amend the Conciliation Courts Ordinance, 1961, in its application to the Province of West Pakistan.“(2-A)   Cases relating to matters falling under Section A of Part I and Section A of Part II of the Schedule, against any Government servant, shall be excluded from conciliation except where a certificate is granted by Government or an officer authorised by Government in that behalf to the effect that the Government servant had not acted in the discharge of his official duties”.

Alternative Dispute Resolution mechanisms and Arbitration provide alternate to litigation by avoiding lengthy and costly proceedings. They are best suited for commercial disputes as the relationship between the parties is expected not to suffer after exhausting such methods and the parties are more likely to settle their differences in a relaxed and friendly manner. In Pakistan, a more frequent use of such methods poses numerous problems which can be overcome by a collective effort by the Government, Judiciary and the Bar Councils.

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[1] 2002 MLD 829

Every Clause For Finality Of Decision Isn’t The Arbitration Clause, There Is No Format For Arbitration, Intention Of Parties Is Important

The Recent decision on the matter of State of Orrisa and Others v Bhagyadhar Dash (4th July, 2011, SC Decision) brings an interesting compilation of the arbitration clause identification in the judgment. The division bench took notice of various prior cases to set the test for the determination of arbitration clause. While going through various decisions, the bench wrote comprehensive judgment and gave opinion on different matter.

Essentials of Arbitration Agreement.

Taking the reference from KK Modi Case, and then Bihar State mineral Corporation v Encon Builders (2003 7SCC 418), court stated following four categories.

(i) There must be a present or a future difference in connection with

Some contemplated affair;

(ii) There must be the intention of the parties to settle such difference

By a private tribunal;

(iii) The parties must agree in writing to be bound by the decision of

Such tribunal; and

(iv)The parties must be ad idem.

The Court also took the principles laid down in Jagdish Chandar v Ram Chandar, which broadly can be stated this

1. The intention of parties to go into the arbitration is to be gathred from the terms of the agreement. A mere possibility doesn’t constitute the arbitration clause or agreement. There should be firm determination.

2. Attributes of arbitration are important, it might not necessarily be using terms connected with arbitration like arbitration per se or arbitral tribunal. The attributes are that the agreement should be in writing, it should have the agreement between parties to go to a private tribunal for adjudication, the private tribunal should be empowered to adjudicate in impartial manner, following natural justice and there should be binding effect as agreed by the parties.

3. Any settlement which excludes any of the attributes of arbitration can’t be called as arbitration. The court however didn’t state the case if the clause states it to be arbitration agreement but it specifically excluded any of the attributes (say hearing) from the process. It is submitted that from the quasi judicial nature of arbitration, such clause might be held to be void. However, it again has to be gathered from the terms and this intention of parties.

4. The contingency on the clause for arbitration would not make it an arbitration clause unless the clause is further approved by the parties.

Test for the Arbitration Agreement:

In KK Modi, it is enunciated, that for the arbitration agreement, emphasis is on

1. The existence of dispute not avoidance of dispute.

2. The judicial action of tribunal in which the dispute is referred.

3. The decision should bind the parties.

In three bench decision of State of Orissa v Damodar Das(1996 (2) SCC 216), Court stated

It would, thereby, be clear that this Court laid down as a rule that the arbitration Agreement must expressly or by implication be spelt out that there is an agreement to refer any dispute or difference for an arbitration and the clause in the contract must contain such an agreement. We are in respectful agreement with the above ratio. It is obvious that for resolution of any dispute or difference arising between two parties to a contract, the agreement must provide expressly or by necessary implication, a reference to an arbitrator named therein or otherwise of any dispute or difference and in its absence it is difficult to spell out existence of such an agreement for reference to an arbitration to resolve the dispute or difference contracted between the parties.

In this decision, Court had to consider the construction of clause

“that if the contractor disputes the rate fixed by the Engineer-in-Charge, the decision of the Superintending Engineer in regard to rate for such non-scheduled item shall be final”

Court going through all the above decisions held that though the clause passes the test laid down from prior decisions, the intention of parties can be gathered from the fact that the government deleted the arbitration clause from the agreement and amended the standard form of agreement. Court held that the clause only provided the limited sphere of determination of the rates to avoid the dispute. There is no reference to the tribunal in regard to dispute between parties, the clause is rather unilateral where contractor disputes the rate and then it shall be finalized by the Superintendent Engineer.