Intellectual Property Rights (IPR) Hampus Rystedt M. Sc. Molecular Biotechnology, Patent attorney BRANN AB hampus.rystedt@brann.se

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)

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 1875-76: 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

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

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

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

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

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.

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.

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

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

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.

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.

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.

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) 1 000-10 000 300 1 000-5 000 0-5 000 10 000-100 000

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

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

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.)

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.

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

Example, omeprazole (Losec)

Example, omeprazole, EP 5129, B1

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