Overview of the Indian Eqvt. Overview of the Indian Eqvt. to Bayh-Dole Act (USA) to Bayh-Dole Act (USA)

[Protection and Utilization of [Protection and Utilization of Public Funded Intellectual Public Funded Intellectual

property (Bill 2008)].property (Bill 2008)].

ByByDr. Gopakumar G. NairDr. Gopakumar G. NairGopakumar Nair AssociatesGopakumar Nair Associates

((www.gnaipr.comwww.gnaipr.com))

gopanair@gnaipr.netgopanair@gnaipr.net

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Basic Activities in PFRIs (Public Funded Research Institutions)

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Research Innovation/invention

Invention Patentable Patenting

Commercialization

Patent/Patent Applications Licensing

Technology Transfer Assigning

Partnering

Co-development

Technology Transfer

Integral part of TRIPs (Art. 7 & 8). Technology Transfer relates to Transport of information, materials, know-how or Technologies, protected (or otherwise) from Research Labs to interested or preferred parties such as commercial organisations, Corporates or other users.

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The Bayh Dole Act

35 USC §200- §212

§ 200. Policy and objective § 201. Definitions § 202. Disposition of rights § 203. March-in rights § 204. Preference for United States industry § 205. Confidentiality § 206. Uniform clauses and regulations § 207. Domestic and foreign protection of federally owned inventions § 208. Regulations governing Federal licensing § 209. Licensing federally owned inventions § 210. Precedence of chapter § 211. Relationship to antitrust laws § 212. Disposition of rights in educational awards

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IMLEMENTING REGULATIONS FOR BAYH DOLE:

CODE OF FEDERAL REGULATIONS – CFR

FOR 35USC §202- §204:FOR 35USC §202- §204:37 CFR 401 “Rights to inventions made by nonprofit37 CFR 401 “Rights to inventions made by nonprofit

organizations and small business firms organizations and small business firms underunder

government grants, contracts and government grants, contracts and cooperativecooperative agreements”agreements”

FOR 35USC §207- §209:FOR 35USC §207- §209:37 CFR 404 “Licensing of Government owned 37 CFR 404 “Licensing of Government owned inventions”inventions”

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Bayh Dole Act (USA) 1980(Courtesy : NIH , Uri Reichman)

Policy and ObjectivePolicy and Objective

•• Encourages and motives use of patent system to Encourages and motives use of patent system to promote the utilization of inventionspromote the utilization of inventions

• • Incentivices collaboration between commercial Incentivices collaboration between commercial concerns and nonprofit Organizationsconcerns and nonprofit Organizations

•• Leads to commercialization and public Leads to commercialization and public availability of inventionsavailability of inventions

• • Guarantees Government rights in Public Funded Guarantees Government rights in Public Funded Research-based Inventions.Research-based Inventions.

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  The Bayh-Dole Act The Bayh-Dole Act • • Grant Receivers RightsGrant Receivers Rights

- May retain title to - May retain title to inventionsinventions

- May license their inventions- May license their inventions

and profit from themand profit from them

• • Government RightsGovernment Rights

- March-in Rights- March-in Rights

- Rule making (procedures)- Rule making (procedures)GNAs

The Bayh-Dole Act – Grant Receivers Obligations

• • FOLLOW REPORTING REQUIREMENTSFOLLOW REPORTING REQUIREMENTS

• • NOTIFY FUNDING AGENCY OF A NEW INVENTIONNOTIFY FUNDING AGENCY OF A NEW INVENTION

• • NOTIFY AGENCY OF INTENTION TO RETAIN TITLENOTIFY AGENCY OF INTENTION TO RETAIN TITLE

• • FILING PATENT APPLICATION WHENEVERFILING PATENT APPLICATION WHENEVER WARRANTEDWARRANTED

• • EFFORTS TO PROMOTE THE UTILIZATION EFFORTS TO PROMOTE THE UTILIZATION (LICENSING)(LICENSING)

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The Bayh-Dole Act – License Agreements by Grant

Receivers

• • SHARE ROYALTIES WITH INVENTORSSHARE ROYALTIES WITH INVENTORS

• • BALANCE TO SUPPORT SCIENTIFIC BALANCE TO SUPPORT SCIENTIFIC RESEARCHRESEARCH

• • U.S. MANUFACTURING FOR SALES IN U.S. MANUFACTURING FOR SALES IN THE U.S.THE U.S.

• • GOVERNMENT RIGHTS TO PRACTICE GOVERNMENT RIGHTS TO PRACTICE INVENTIONINVENTION

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The Bayh-Dole Act – Government’s Rights

• • TAKE TITLE IN GRANTEES’ INVENTIONS IF GRANTEETAKE TITLE IN GRANTEES’ INVENTIONS IF GRANTEE

DECLINES SUCH TITLE OR NEGLECTS FILINGDECLINES SUCH TITLE OR NEGLECTS FILING

• • RIGHT TO REQUIRE FROM GRANTEE OR ITSRIGHT TO REQUIRE FROM GRANTEE OR ITS

LICENSEES PERIODIC REPORTING ON UTILIZATIONLICENSEES PERIODIC REPORTING ON UTILIZATION

• • MARCH-IN RIGHTSMARCH-IN RIGHTS

- Right to require license to responsible applicant in - Right to require license to responsible applicant in specific fieldspecific field

- Right of Government to grant license if grantee or its - Right of Government to grant license if grantee or its licensee declinelicensee decline

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The Bayh-Dole Act – Government’s Rights

CIRCUMSTANCES WHEN MARCH-CIRCUMSTANCES WHEN MARCH-IN RIGHT MAY BE IN RIGHT MAY BE IMPLEMENTED:IMPLEMENTED:

• • In extreme case of emergency In extreme case of emergency

(pandemic etc.)(pandemic etc.)

• • When licensee cannot meet When licensee cannot meet

public health needspublic health needs

Rights to object and appeal by Rights to object and appeal by licenseeslicensees

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The Bayh-Dole Act – Government owned

Inventions• GRANT NONEXCLUSIVE, EXCLUSIVE OR PARTIALLY EXCLUSIVE LICENSES

• RIGHT OF ENFORCEMENT TO LICENSEE

• CONDITIONS FOR EXCLUSIVE OR PARTIALLY EXCLUSIVE LICENSE - Investment capital required - capabilities and plans of applicant - not lessening competition

• U.S. MANUFACTURING

• SMALL BUSSINES PREFERENCE

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The Bayh-Dole Act – Government owned

Inventions• GOVERNMENT RIGHTS: PAID-UP LICENSE TO PRACTICE

• LICENSEE REPORTING REQUIREMENT ON PROGRESS

• CONDITIONS OF TERMINATION

• REQUIREMENT FOR PUBLIC NOTICE REGARDING INTENT TO GRANT EXCLUSIVE LICENSE

• REQUIREMENT OF DEVELOPMENT PLAN

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The Bayh-Dole Act – Results

• 1980….25 Universities patent and license 2005…350 Universities participating

• 1980….250 University patents 2005…3680 University patents (cumulative) Average Annual filings – 200/400

• 1980….113 AUTM members (only US and Canada) 2005…3200 AUTM members (45 countries)

AUTM – Association of University Technology Managers

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THE PROTECTION AND UTILISATION OF PUBLIC FUNDED INTELLECTUAL PROPERTY

BILL, 2008Proposed Indian Bayh-Dole Act (Bill)

Macro ObjectiveTo create culture of Innovation in India

ObjectivesTo Ensure access to innovation by all stakeholders for public good.To Develop framework for protection and utilization of IP in PFRIs.To Promote creativity & innovation through incentives

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THE PROTECTION AND UTILISATION OF PUBLIC FUNDED INTELLECTUAL PROPERTY

BILL, 2008Proposed Indian Bayh-Dole Act (Bill)

Imposes

Obligations - to promote potential of PFRIsEncourages – InnovationPromotes – Collaboration & Commercialization of IP created by PFRIsEnhances – Awareness of IP in universities, academic & research institutions Increases – Responsibility to encourage innovationGenerates – Funds from Licensing & Commercialization Promotes – Self RelianceMinimises – Dependence on Govt. Funding GNAs

PUPFIP Bill

2) Definitions Ex:- IP

3) Agreement - Prior to funding4) IP Disclosure - 60 days5) IP strategy intimation – 90 days

Proviso – failure – vesting. Refusal grounds

– 90 days6) Non-disclosure – No prior publication7) Obligations of IP Retaining Entity8) Prior permission for Assignment

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PUPFIP Bill (Contd…)

9) Disclosure – chain – Creator Recipient Government

10) IP Management Committee – 180 days from

receipt of grant.11) Sharing of Royalties

Creator N.L.T. 30% After expenses 30% to the IP M. Committee Balance to the Recipient (PFRIs)

12) Manufacture in India – Compulsory (Bayh Dole – Mfr. In USA – Compulsory)18) Duties of Government20 to 22) Penalties, Fines, Estoppels24) Power to make Rules

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PUPFIP Bill

- PFRIs IP/Patent Activities expected to rise

- Improve in Quality/Quantity

- Enhance Licensing/Commercialization

- Tie ups for Licensing expected (ex:- Intellectual Ventures)(www.intellectualventures.com) (International Venture Partners, Inc)(www.ivp2000.com)

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Sec. 12 (of the Proposed Bill)

(Preference for National Industry)Notwithstanding anything contained in this Act, no recipient who has retained title to any public funded intellectual property and no assignee of any such recipient shall grant, to any person, the exclusive right to use or sell any public funded intellectual property in India, unless such person manufactures products using such public funded intellectual property substantially in India:

Provided that the Government may, for reasons to be recorded in writing, allow such sale or use for manufacture in countries other than India.

Sec. 204 of the Bayh Dole Act Preference for United States Industry

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Form 27The Patents Act, 1970

Statement regarding the working of the Patent invention on Commercial scale in India.

[Sec. 146(2); Rule 131(1)]

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The Patents Act, 1970Sec. 146(2)Power of Controller to call for information from patentees.—(1) The Controller may, at any time during the continuance of the patent, by notice in writing, require a patentee or a licensee, exclusive or otherwise, to furnish to him within two months from the date of such notice or within such further time as the Controller may allow, such information or such periodical statements as to the extent to which the patented invention has been commercially worked in India as may be specified in the notice.(2) Without prejudice to the provisions of sub-section (1), every patentee and every licensee (whether exclusive or otherwise) shall furnish in such manner and form and at such intervals (not being less than six months) as may be prescribed statements as to the extent to which the patented invention has been worked on a commercial scale in India.

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The Patents Rules, 2006Rule 131Form and manner in which statements required under section 146(2) to be furnished.—(1) The statements which shall be furnished by every patentee and every licensee under sub-section (2) of section 146 in Form 27 which shall be duly verified by the patentee or the licencee or his authorised agent.(2) The statements referred to in sub-rule (1) shall be furnished in respect of every calendar year within three months of the end of each year.(3) The Controller may publish the information received by him under sub section (1) or sub-section (2) of section 146

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Suggestions * (from GNAs)

Globally, every country is taking steps to protect National interests, reduce unemployment and improve domestic industry and economy.

India (Office of the Controller General of Patents) must implement the Sec.146 and Rule 131 as required under the Act & Rules.

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