RESEARCH EXEMPTION AND EU

TECHNOLOGY TRANSFER BLOCK

EXEMPTION

Axon Seminar12 February 2014

Arber Gjunkshiwww.axonadvocaten.nl

Research Exemption

• Owner (or exclusive licensee that has been granted such rights from

patent holder) can enforce patent against infringement;

• Exceptions (i.e. no infringement):

• Prior use

• Research Exemption

• Experimental use privilege

• Regulatory approval privilege (Bolar);

• Research Tools

• Exceptions are on country-by-country basis (and all differ) !!!

• Unitary Patent Convention (UPC) on Research Exemption;

Research Exemption & Research Tools

Countries Research Exemption Research Tools

The Netherlands -Experimental use DPA 53(3) & case-law

(second medical use):

- Regulatory Approval 53(4)

No

U.S.A. -Bolar-type exemption,

-Reasonably related,

-Lead to FDA approval;

Yes,

depends

France -Experimental use;

-Regulatory Approval – very broad;

unclear

Germany - Clinical Trials I;

- Clinical Trials II;

Yes, if leads to a dependent

patent

UK -Experimental use- adopted Clinical Trials I

in a restricted way;

-Considerations to include innovative drugs

under Research exemption.

No

Belgium -BPA 28(1)(b): “scientific purposes on and/

or with”;

-BAMP 6bis(1)(12): generic drugs.

Yes

UPC on Research Exemption

• Article 27 UPC: “the rights conferred by a patent shall not extend to:

• (b) acts done for experimental purposes relating to the subject matter of

the patented invention;

• (d) the acts allowed pursuant to Article 13(6) of Directive 2001/82/EC or

Article 10(6) of Directive 2001/83/EC (Article 10(3) of Directive

2004/27/EC relating to medicinal products for human use) in respect of

any patent covering the product within the meaning of either of those

Directives; “

• Unified Patent Court to decide;

• But: for other European patents: national law remains applicable

EU Technology Transfer Block Exemption Regulation 772/2004

• EU Competition law and TFEU Article 101(1) & 101(3);

• EU Technology Transfer Block Exemption Regulation 772/2004

• importance for Spin-offs

• to expire on April 30th 2014

• proposed amendments:

- market-share threshold for non-competing undertakings;

- passive-sales restrictions between non-comp. und.;

- exclusive grant-backs;

- termination clauses;

- settlement and non-assertion;

- technology pools;

Amendment of TTBE Reg.772/2004 & Guidelines

Subject Current Proposal

Market-share

Each not to exceed 30% of

relevant market share

If licensee owns substitutable

technology, 20% combined market-

share applies

Exclusive

grant-backs

Exempted: non-severable

improvements under an exclusive

license

- Not automatically exempted: non-

severable improvements under an

exclusive license

- Individual assessment on case-

by-case basis

Termination

Clauses

Termination right in invalidity

proceedings

No Termination right in invalidity

proceedings

Axon seminar 12 February 2014

www.axonlawyers.com

THANKS FOR YOUR ATTENTION

Arber Gjunkshi

Axon Lawyers

T +31 88 650 6500

M +31 6 1749 0560

E arber.gjunkshi@axonlawyers.com