1. Intellectual Property Rights (IPR)
Hampus Rystedt
M. Sc. Molecular Biotechnology, Patent attorney
BRANN AB

2. Intellectual Property
Copyright
No registration
Cost free
Protects literary works, works of art, computer programs
Protection: 70 years from the death of the creator
Industrial property
Patents, trademarks, design, plant variety protection
Requires registration
Annuity fees
Protects industrial products and methods
Limited in time (patents, designs, PVPs) or unlimited (trademarks)

3. Brief history ~500 AD: Trade marks for sewing needles in China
567: First copyright case (western world)
15th cent.: Systems resembling patents in Great Britain and Italian city states
1787: Design protection for linnen prints, duration two months
: Great Britain creates a Trademark Act and the first Trademark Register
1883: Paris Convention for the protection of Industrial Property
1970: Patent Cooperation Treaty
1994: TRIPs

4. Industrial property rights
Maximum duration
Protects
Rights
Patent
20 (25) yrs
Technical solution
Commercial use
Trademarks
n x 10 yrs
Name or characteristics of goods
Design
5 x 5 yrs
Plant Variety Protection
25 (30) yrs
Plant variety

5. What is a patent?
Time limited right to stop others from commercially using my invention
Can be considered as a contract between the inventor and the society
The inventor gets a monopoly, and
The society gets to publish the invention
Inventors are encouraged to publish their invention => the technology is disclosed to the public

6. Criteria for patentability
Novelty
International novelty (U.S. has 1 yr grace period)
Objective criterion
Inventive step
”Not obvious in view of the prior art”
Subjective criterion
Industrial applicability
”Made or used in any kind of industry”
Seldom questioned

7. Exceptions to patentability
Methods for medical treatment or diagnosis practised on the human body
What is only:
A discovery
A computer program
Games, methods for doing business, et c.
Plant and animal varieties (plants and animals are patentable, however)
Inventions, the commercial use of which would be contrary to morality or ordre public

8. Ethical exceptions, Patents Act 1 a §
The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions.
An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element.

9. Ethical exceptions, Patents Act 1 b §
Inventions shall be considered unpatentable where their commercial exploitation would be contrary to ordre public or morality.
the following, in particular, shall be considered unpatentable:
(a) processes for cloning human beings;
(b) processes for modifying the germ line genetic identity of human beings;
(c) uses of human embryos for industrial or commercial purposes;
(d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes.
uttnyttjande skall dock inte betraktas som stridande mot allmän ordning eller goda seder endast på den grund att det är förbjudet genom en bestämmelse i lag eller annan författning.

10. Medical special provisions
First medical indication:
A previously known chemical compound may be patented for use as a pharmaceutical
Second medical indication:
A previously known pharmaceutical can be patented for a new indication

11. The exclusive right A right to prevent others from
Manufacturing the invention
Selling, or offering to sell, the invention
Importing the invention
Exceptions
Non-commercial practising
Research on the invention as such
Clinical trials with protected reference medicinal product
Prior use rights
Ex tempore manufacturing of pharmaceuticals

12. Supplementary Protection Certificates
Extension of time of protection if the procedure for marketing approval of a patent protected pharmaceutical takes more than five years.
Maximum extra time of protection is five years.

13. Patents are national rights
Patents must, in principle, be applied for in each individual country where protection is sought.
A local attorney needs to be appointed in each country and the patent application must be translated into the national language.

14. Conventions and treaties
PC, Paris Convention, is the basis for modern patent law internationally. Gives the possibility to claim priority. Establishes the principle of reciprocity.
PCT, Patent Cooperation Treaty, facilitates coordinated international search and examination. Postponement of national phase.
TRIPs, seeks to harmonise patent laws within the WTO.
EPC, European Patent Convention, centralised search, examination and grant of European patent applications.

15. Time line Approximated costs (Euro)
International
application
Filing of arguments
(optional)
Search report and
Examination Opinion
15 mths
Preliminary Report
on Patentability
27 mths
Filing at t=0 mths
Filing of arguments
12 mths
18 mths
Publication
Search and examination report PRV, 6-7 mths
Allowance/
refusal
x mths
Poss. opposition
< x+9 mths
Optionally: Novelty search
National application
Approximated costs (Euro)

16. Structure of a patent application
Description
Claims
Abstract
(Drawings)
(Sequence listing)

17. Description Must be sufficiently detailed to
allow the person skilled in the art to work the invention in the entire claimed scope, and
show that the inventor was in possession of the invention at the time of filing
Should comprise
Technical field of the invention
Background/prior art/known technology
Summary of the invention
Brief description of the drawings
Detailed description of the invention
Examples/experiments

18. Claims The claims define the extent of protection
Thus, it is important that the claims define the invention
May be directed to products, methods or uses (use-claims not accepted in the U.S.)
The claims are interpreted in the light of the description (and file prosecution history in the U.S.)

19. Claim structure
Pharmaceutical composition comprising an analgesic, a central stimulant and optionally pharmaceutically acceptable carriers and/or excipients.
Composition according to claim 1, wherein the analgesic is acetyl salicylic acid.
Composition according to claim 1 or 2, wherein the central stimulant is caffeine.

20. Amendments during prosecution
No substantial amendments may be done after the application has been filed
Data supporting the application may usually be filed, but does not become part of the application

21. Example, omeprazole (Losec)

22. Example, omeprazole, EP 5129, B1

23. Strategy aspects
A patent is a considerable investment in time and money.
It gives
A right to stop others from using the invention for free, but
No right to practice the invention
How can you earn money from this?
Market exclusivity
(cross-) licensing the patent rights
Selling the patent rights
Value of patent determined by value of market
Market exclusivity: Where do you need it geographically