PATENT

Intellectual Property Rights (IPR)

Hampus RystedtM. Sc. Molecular Biotechnology, Patent

attorneyBRANN AB

hampus.rystedt@brann.se

PATENT

Intellectual PropertyCopyright

No registration

Cost free

Protects literary works, works of art, computer programs

Protection: 70 years from the death of the creator

Industrial propertyPatents, trademarks, design, plant variety protection

Requires registration

Annuity fees

Protects industrial products and methods

Limited in time (patents, designs, PVPs) or unlimited (trademarks)

PATENT

Brief history~500 AD: Trade marks for sewing needles in China567: First copyright case (western world)15th cent.: Systems resembling patents in Great Britain and

Italian city states1787: Design protection for linnen prints, duration two months1875-76: Great Britain creates a Trademark Act and the first

Trademark Register1883: Paris Convention for the protection of Industrial

Property1970: Patent Cooperation Treaty1994: TRIPs

PATENT

Industrial property rightsMaximum duration

Protects Rights

Patent 20 (25) yrs Technical solution

Commercial use

Trademarks n x 10 yrs Name or characteristics of goods

Commercial use

Design 5 x 5 yrs Design Commercial use

Plant Variety Protection

25 (30) yrs Plant variety Commercial use

PATENT

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

PATENT

Criteria for patentabilityNovelty

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

PATENT

Exceptions to patentability

Methods for medical treatment or diagnosis practised on the human bodyWhat 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

PATENT

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.

PATENT

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.

PATENT

Medical special provisionsFirst 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

PATENT

The exclusive rightA right to prevent others from

Manufacturing the inventionSelling, or offering to sell, the inventionImporting the invention

ExceptionsNon-commercial practisingResearch on the invention as suchClinical trials with protected reference medicinal productPrior use rightsEx tempore manufacturing of pharmaceuticals

PATENT

Supplementary Protection CertificatesExtension 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.

PATENT

Patents are national rightsPatents 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.

PATENT

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.

PATENT

Time line

Optionally: Novelty search

Filing at t=0 mths

Search and examination

report PRV, 6-7 mths

12 mths 18 mthsPublication

Internationalapplication

National application

Search report and Examination Opinion

15 mths

Preliminary Report on Patentability

27 mths

Filing of arguments(optional)

Filing of arguments

Allowance/refusalx mths

Poss. opposition< x+9 mths

Approximated costs (Euro)1 000-10 000 300 1 000-5 000 0-5 000 10 000-100 000

PATENT

Structure of a patent application

DescriptionClaimsAbstract(Drawings)(Sequence listing)

PATENT

DescriptionMust be sufficiently detailed to

allow the person skilled in the art to work the invention in the entire claimed scope, andshow that the inventor was in possession of the invention at the time of filing

Should compriseTechnical field of the inventionBackground/prior art/known technologySummary of the inventionBrief description of the drawingsDetailed description of the inventionExamples/experiments

PATENT

ClaimsThe 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.)

PATENT

Claim structure1. Pharmaceutical composition comprising an

analgesic, a central stimulant and optionally pharmaceutically acceptable carriers and/or excipients.

2. Composition according to claim 1, wherein the analgesic is acetyl salicylic acid.

3. Composition according to claim 1 or 2, wherein the central stimulant is caffeine.

PATENT

Amendments during prosecution

No substantial amendments may be done after the application has been filedData supporting the application may usually be filed, but does not become part of the application

PATENT

Example, omeprazole (Losec)

PATENT

Example, omeprazole, EP 5129, B1

PATENT

Strategy aspectsA patent is a considerable investment in time and money. It gives

A right to stop others from using the invention for free, butNo right to practice the invention

How can you earn money from this?Market exclusivity(cross-) licensing the patent rightsSelling the patent rights

Value of patent determined by value of market