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IP BASICS. Patents. PATENTS. International sources of patent law. Paris Convention Right of Priority Independence of patents Compulsory licence T rade- R elated Aspects of I ntellectual P roperty Right s Substantive provisions P atent C ooperation T reaty
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IP BASICS Patents
PATENTS PILA M2 Meeting, 26-27October 2009
International sources of patent law Paris Convention Right of Priority Independence of patents Compulsory licence Trade-Related Aspects of Intellectual Property Rights Substantive provisions Patent Cooperation Treaty Procedures for „international” patent European Patent Convention European patent regulation
General characterisitc PATENT Legal title Exclusive right to: make use of invention (prevent others from making use) Limited territory Limited time
Patents are granted for: • Methods • Description of actions, operations; their parameters, raw materials used • Devices (instruments, machnies, tools) • Description of structure (construction), mutual relations of elements • Products (substances) • Description of components (quantitative and qualitative) • Application (use) • subcategory of methods
Patentable Inventions The legal definition of invention does not exist (in traditional sense) Invention must meet the criteria of: • Technical nature • An invention must have a technical character. • Novelty • An invention can be patented only if it is new. • Inventive step • An invention has an inventive step if it is not obvious (having regard to the state of the art) • Industrial capability • An invention is industrially susceptible if it can be made or used in any kind of industry Art. 27 TRIPS
Novelty Art. 27(1) TRIPS Art. 54 EPC An invention shall be considered to be new if it does not form part of the state of the art. State of art comprises: • everything made available to the public by • written or oral description, use, or any other way, • before the date of filing (priority) Global, local or mixed novetly New medical use of already known substances The state of the art comprises the content of applications filed before the date of filing but notpublished until on or afterthat date
Novelty Priority • First filing with the NPO • Thedaywhen NPO receivedtheapplication (post, fax) • Conventional • duly filed an application for a patent (utility model) for any state party to the Paris Convention for the Protection of Industrial Property • theday of dulyfiledapplication • Fromexhibition • Theday of exhibtion Art. 4 of Paris Convention 12 months 6 months Convention on international exhibitions signed at Paris on 22 November 1928
Novelty Non-prejudical disclosures Disclosures occurred no earlier than six months before the date of filing • as a consequence of an evident abuse in relation to the applicant („abuse grace period”) • displaying at an official international exhibition falling within the terms on international exhibitions US grace period (1 year) 6 months
Inventive step Art. 27(1) TRIPS Art. 56 EPC An invention shall be considered as involving an inventive step if, having regard to the state of the art, it is not obvious to a person skilled in the art. • State of art does not comprise prior applications not yet disclosed (difference to novelty) • Not satisfied if the invention directly results from state of the art • The examination under „problem and solution approach” • identifying the „closest prior art” • assessing the technical results (or effects) achieved • defining the technical problem to be solved • examining whether or not a skilled person would have suggested the claimed technical features for obtaining the results • Who is considered as a „person skilled in the art”? US approach
Inventive step Non-obviousness should assessed by determining the scope of the content of the prior art ascertaining the difference between prior art and applied invention resolving the level of ordinary skill in the pertinent art Art. 103 of Patent Act US approach TSM test
Industrial application Art. 27(1) TRIPS Art. 57 EPC • Non-controversial requirement • „Industry" in the field of industrial property is widely understood in its broadest sense • Liberal interpretation • Always satisfied when industrial exploitation (application) is ensured An invention shall be considered as susceptible of industrial application if it can be made or used in any kind of industry, including agriculture. putting into practice is not necessary
Technical nature Art. 27(1) TRIPS An invention must have a technical character. Art. 52(1) EPC • Requirement now expressly formulated • inventions, in all fields of technology…(EPC 2000) • description should contain specification of the technical fieldto which the invention relates • the claims shall define the matter for which protection is sought in terms of the technical featuresof the invention • technical character test is prior to examination of other requirements • CASE LAW - an invention has a technical character if it provides a technical contributionto the art in a field not excluded from patentability
Non-inventions (as such) Art. 52(2) EPC • discoveries, scientific theories and mathematical methods; • Lack of technical effect • Revealing what already exists • Pure intellectual methods • aesthetic creations; • Non-technical solutions • schemes, rules and methods for performing mental acts, playing games or doing business, • Non-technical solutions • programs for computers; • Specific interpretation of tehcnical contribution • presentations of information • Non-technical solutions DNA gene?
Non-patentable inventions Art. 27(2-3) TRIPS Art. 53 EPC Inventions excluded from patentability: • inventions the publication or exploitation of which would be contrary to "ordre public" or morality, • certain types of ammunition, bombs • certain biotechnological inventions • plant or animal varieties or essentially biological processes for the production of plants or animals; • this provision does not apply to microbiological processes or the products • there exists other form of protection • methods for treatment of the human or animal body by surgery or therapy and diagnostic methods • except substances
Term of protection 20 yrs from the filing date Problem: the term of protection in case of priority: 20 yrs from the priority date or from the filing date? Supplementary Protection Certificate SPC - Pharmaceuticals - Plant protection products
Suplementary Protection Certificate SPC Council Regulation (EEC) No. 1768/92 concerning the creation of a supplementary protection certificate for medicinal products(and 1610/96 for plant protection products) Within the scope of primary patent 15 years from the day of the authorization Additional protection is granted when the product is protected by a basic patent in force; a valid authorization to place the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851/EEC the product has not already been the subject of a certificate; Extension of the term of the protection up to 5 years (maxiumum) depends on the time period between the day of application and the day authorization
Suplementary Protection Certificate How to count?
Suplementary Protection Certificate - 3 Effective time of protection: 15 yrs (or less) Example 1: period between application to authorization: 6 yrs. 6yrs – 5 yrs = 1 year 20 yrs – 6 yrs = 14 yrs 14 + 1 = 15 yrs Example 2: the said period: 9 yrs. 9 – 5 = 4 yrs 20 – 9 = 11 11 + 4 = 15 yrs When period is less than 5 yrs (no place for SPC) When period is more than 10 yrs: 11 – 5 = 6 (but SPC cannot exceed 5 yrs). 20 – 11 = 9 9 + 5 = 14 yrs
Scope of protection - 1 Negative sphere Right to prevent third parties from making, using, offering for sale, selling, or importing patented product or product obtained from patented process Monopoly or blocking effect? Positive sphere Right to assign, or transfer by succession Right to conclude licensing contracts.
Scope of protection - 2 Patent claims LITERAL (STRICT) INTERPRETATION VS. BROAD INTERPRETATION: - equivalents - partial protection of invention Art. 69 EPC The extent of the protection shall be determined by the terms of the claims. Nevertheless, the description and drawings shall be used to interpret the claims.
Scope of protection – 3The equivalence Theory of equivalence requires that the other subject-matter must be: objectively equivalent to the technical mean obvious to this skilled in art person Protocol on the Interpretation of Article 69 EPC
Example: The Epilady case EPILADY PATENT REMINGTON PATENT Hair remover for use on ladies' legs with the rotating helical (spring) Hair remover for use on ladies' legs with rotating rubber bar with slits in it. Non-consistent judgements of European courts
Scope of protection – 4. Partial protection of invention No standards - practice differs Example 1: process consists of 10 elements. The competitor omits 1 element. Does he violate the patent? Example 2: the patent protects the construction of a pill. There are 3 ”balls” (spheres) which seem to be necessary (the first holds pharmaceutical, the second: protect this first, the third: taste (eg. orange). The competitor managed to eliminate the second sphere. Does he violate the patent?
Scope of protection – 5Indirect protection of invention 1. The subject matter of a patent is a process for obtaining a product. 2. The defendant is to prove that the process to obtain an identical product is different: If the product obtained by the patented process is new If there is a substantial likelihood that the identical product has been made by patented process and the owner of the patent has been unable through reasonable efforts to determine the process actually used Problem of protection of business secrets of defendant
Scope of protection – 6Indirect protection of invention. The example In country „A” has been patented a process for production of crystalline form of chemical compound „X”. In country „B” (where there is no patent protection of the process) the chemical compound „X” is produced, but not in crystalline but in amorphous (i.e. non-crystalline) form. The company New Age has been imported „X” to the country „A. Does the company violate a patent?
Limitations of patent exclusivity • Transport purposes • patents to means of transport • Important purposes of the state • in particular, safety and public order • must be proportional • Research or scientific purposes • Compulsory licences: • because of dependence of patents • because of patent abuse Conditions for non-authorized use Art. 31 TRIPS
Specific subject-matters Pharmaceuticals Biotech inventions Computer-related inventions
Pharmaceuticals Diagnosis, therapeutic, and surgical methods for the treatment of humans and animals shall not be patented Pharmaceuticals are patented Problem with patenting the 1st and the 2nd medical use of a known product Bolar exemption (exploitation of an invention for a purpose to obtain registration necessary to put the product on the market) Preparation of a medicine in a pharmacy
Biotechnological inventions - 1 Biological material isolated from its natural environment Element isolated from the human body, including sequence of a gen part of EPC Directive 98/44/UE on the legal protection of biotechnological inventions BIOTECHNOLOGICAL INVENTIONS - inventions consisting of a product or containing biological material or a process by means of which biological material is produced, processed or used BIOLOGICAL MATERIAL means any material containing genetic information and capable of reproducing itself or being reproduced in a biological system.
Biotechnological inventions – 2Exclusion from patentability Any biological material as found in nature Natural biological process, as existing in nature
Biotechnological inventions – 3Exclusion from patentability for ethical reasons processes for cloning human beings; processes for modifying the germ-line genetic identityof human beings; uses of human embryos for industrial or commercialpurposes; processes for modifying the genetic identity of animalswhich are likely to cause them suffering without anysubstantial medical benefit to man or animal, and alsoanimals resulting from such processes.
Biotechnological inventions - 4Specific issues Novelty/discoveries problems Industrial application problem Disclosure problems Scope of patent problems
Computer implemented inventions Requirement of technical contribution Met when: the technical effects are obtained by solving the problem underlying in the invention the problem underlying in the invention is of a technical nature the details of the solutions in the invention require technical consideration that imply a technical problem Computer programs are not patentable (as such) Computer implemented business-methods US approach
How to exploit patented invention? • Transfer of rights • Patent • Right to obtaining patent • Written form • Licensing agreements • Exclusive and non-exclusive • Sole licence • Recorded in the patent registry • Full or limited • Depending on the scope of the use • Sublicense • Prohibited on default
End of protection • Lapse of the patent • End of protection period • Forfeiture • Lack of renewal fee • Revocation of the patent • in specific procedure • as a whole or in due part