Patent Exclusions

Question 1

Patent monopoly is not absolute

Answer 1

IP system tries to balance the interest of patent holders on the one hand and third parties on the other

Fundamental principle: patent should not give a patent owner more rights than necessary to reward an invention for his intellectual and financial investments involved in the creation of the invention

Question 2

TRIPS “three-step test” for exceptions

Answer 2

• limited
• not unreasonably conflict with the normal exploitation of a patent
• not unreasonably prejudice the legitimate interests of the patent holder

Question 3

Art 27 UPC Agreement

Answer 3

EU level list of exemptions:

• Bolar exemption
• Breeder’s exemption
• Farmer’s privilege
• use of biological material obtaianed from the propagation or multiplication of biological material
• decompilation and interoperability

Question 4

Bolar exemption

Answer 4

the use of patented products for the purposes of providing the clinical trial and experimental evidence required for obtaining regulatory approval

Question 5

Use for private and non-commercial purposes

Answer 5

Exemption included in some national patent regulations.

Case law of some countries confirms (e.g. UK), there may be difficult to distinguishing private use from commercial use in cases where activities have “dual- purpose”

Question 6

Transit exemption

Answer 6

Article 5ter Paris Convention - allows owners of means of transport engaged in international commerce to avoid a patent infringement liability on a national level

Question 7

How is transit exemption usually limited?

Answer 7

Temporal entries of foreign means of transportation into the national territory of patent protection

Question 8

Preparation of a patented medicine in a pharmacy

Answer 8

Allows extemporaneous preparation of a patented medical product in the pharmacy on an individual basis in accordance with a medical prescription

preparation should be performed not by any person, but only a qualified entity: a pharmacy, a pharmacist and a doctor based on physicians’ or doctors’ prescriptions.

Question 9

Research exemption

Answer 9

No uniform national standard. Aimed at allowing further research activities. No uniform approach regarding activities on and with the patent.

Question 10

Discussion in the EU whether Bolar exemption applies to third parties not directly involved in the process of obtaining marketing authorisation

Answer 10

Astellas Pharma v Polfarma - national approach where the exemption only applies to the entity with direct interest

Question 11

Prior User Rights

Answer 11

Art 28 UPC- a patent may be granted for an invention that was previously in use by one or more individuals, provided that such use was not sufficient to make invention available to the public

Question 12

Exhaustion

Answer 12

Once a product protected by an IP right has been marketed, the IP rights of commercial exploitation over this given product can no longer be exercised by the IP owner

Question 13

At least three levels in which the doctrine of exhaustion can be applied

Answer 13

Domestic exhaustion
Regional exhaustion
International exhaustion

Question 14

Art 31 TRIPS

Answer 14

Detailed conditions which must be complied with when a WTO Member chooses to use compulsory licensing

Question 15

EU enacted separate regulation on compulsory licensing of pharmaceuticals for export to countries with public health problems binding from

Answer 15

2006

Question 16

Art 5(2) Paris Convention

Answer 16

Compulsory licensing - not a real license but administrative decision