ip4inno 1 Content of the module IP for the creative industries Patented computer-implemented inventions Software Biotechnological inventions

Precise details about biotechnologies Definition: a biotechnology is a technology based on biology, especially when used in agriculture, food science and medicine. Applications: in four major industrial areas -health care (medical: pharmaceutical products, genetic testing, gene therapy, cloning…), -crop production and agriculture, -non food (industrial) uses of crops and other products (biodegradable plastics, vegetable oil, biofuels…), -and environmental uses. ip4inno 2

3 Precise details about biotechnological inventions Biotechnological inventions are: –Products consisting of or containing biological material, –Process for: Production of biological material, Processing biological material, Use of biological material. Biological material is: material containing genetic information: capable of reproducing itself, Or being reproduced in a biological system.

ip4inno 4 Patentable inventions Principle : Inventions in all fields of technology are generally patentable, provided that they are: - New, - Involve an inventive step, - Are susceptible of industrial application.

ip4inno Biodirective Purpose: To harmonise the laws and practices of member states on biotechnological inventions. Objective: To clarify the distinction between what is patentable and what is not patentable in biotechnological field. To confirm that the human body* may not be regarded as patentable inventions. Problem: Implementation in national laws: Too late, Different interpretations.

ip4inno 6 General exceptions to patentability discoveries, scientific theories and mathematical, methods, aesthetic creations, schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers, presentations of information.

ip4inno 7 Discoveries in relation to biotechnology (1/2) Rule: Mere discoveries are not regarded as inventions: –Acknowledgment of a novel substance in nature, –Acknowledgment of a novel property of a known substance, –Description of a genomic structure.

ip4inno 8 Discoveries in relation to biotechnology (2/2) Rule: Mere discoveries are not regarded as invention But: A discovery that solves a technical problem can be an invention = can be patentable: –Antibiotics from a natural micro-organism, –Purified proteins for use as medicaments, –Isolated genes with unexpected use.

ip4inno 9 Stakes to patentability In biotechnological field Ethical issues Inventions whose exploitation would be contrary to “ordre public” or morality. For example use of human embryos. Advantages For example the possibility of treating diseases. The stakes to patentability related to biotechnologies are to weight the following aspects: Bioethics Advantages

ip4inno 10 Patentable Biotechnological Inventions (1/4) Biological material which is: –isolated from its natural environment, or –produced by means of a technical process even if it previously occurred in nature.

ip4inno 11 Patentable Biotechnological Inventions (2/4) Plants or animals: –Not a plant variety, a species or a race. Processes for the production of plants and animals which are not essentially biological: –Not crossing, –Not selection.

ip4inno 12 Exception: Plants varieties are not patentable Definition: Plant Variety means any plant grouping within a single botanical taxon of the lowest known rank: genus => species => variety mammal => dog => doberman Varieties of all botanical genera and species, including, inter alia, hybrids between genera or species, are not patentable. Other kind of protection can be applied to plant varieties.

ip4inno 13 Patentable Biotechnological Inventions (3/4) Microbiological process: –process involving microbiological material, –process performed upon microbiological material, –or process resulting in microbiological material. Other technical process. A product obtained by means of such processes (not a plant or animal variety) is patentable.

ip4inno 14 Exception: Some biological processes are not patentable Essentially biological processes* for the production of plants or animals (not microbiological processes or the products thereof) are not patentable. “Broccoli patent” (EP ).

ip4inno 15 Exception: Broccoli patent A patent granting this type of selection methods would also include the selected plant variety. A Biological process: –“consists entirely of natural phenomena such as crossing or selection” –“... ENTIRELY...” ? Now pending at the EPO highest instance Enlarged Board of Appeal. A method of increasing a specific compound in Broccoli, through conventional breeding methods, but unique selection methods

ip4inno 16 Patentable Biotechnological Inventions (4/4) A sequence isolated from the human body, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element. Industrial applicability must explicitly be stated in the application i.e. a beneficial use must be defined. At least one of: –structural function, –molecular function, –cellular function, –biological function. Computer based proof can be accepted as experimental data.

ip4inno 17 Exceptions: the human body and its elements are not patentable The human body: –In the various stages of its formation, Or –Development. Its elements: –The mere discovery of its elements, –For example: sequences or partial sequences of a gene. Are not patentable.

ip4inno 18 Other varied exceptions to patentability 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, –animals resulting from such processes. Are not patentable.

ip4inno 19 Other varied exceptions to patentability Inventions which by commercial exploitation would be contrary to "ordre public" or morality: “BRCA1 case” (EP705902), “Edinburgh stem cell patent” (EP ).

ip4inno 20 Myriad Genetics alias BRCA1 case EPO granted (2001) patents covering all diagnostic and therapeutic applications based on the gene’s sequence. Opponents argued: –Monopoly abuse, –Wide-ranging patent rights prohibits further research on therapies and diagnosis, –Negative for public health. Patent in amended form (finalised in Sep 2007). Concerns methods and materials used to isolate and detect a human breast and ovarian cancer predisposing gene (BRCA1)

ip4inno 21 Edinburgh stem cells patent EPO granted (1999), EPO admitted a mistake: the patent did not exclude human, Applicant changed patent, but further appeals followed. After oral hearing at TBA in 2002: The patent now covered only modified human and animal stem cells other than embryonic stem cells. A hearing will be held at Enlarged Board of Appeal. Concerns a method of genetically modifying animal stem cells to give them a survival advantage over unwanted cells

ip4inno 22 Deposit of biological material Biological material that is nessesary to carry out the invention must either be: –available to the public, –described in such a manner as to enable the invention to be carried out by a person skilled in the art. or –deposited with a recognised depositary institution (the Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of Patent Procedure of 28 April 1977).

ip4inno 23 Compulsory licence and cross-licence Compulsory licence between: A breeder having a plant variety right, and A holder of a patent concerning a biotechnological invention. Cross-licence on reasonable terms.

ip4inno 24 Scope of protection (1/2) The protection conferred by a patent on a biological material possessing specific characteristics as a result of the invention shall be extended to any biological material derived from it through propagation or multiplication in an identical or divergent form and possessing those same characteristics.

ip4inno 25 Scope of protection (2/2) The protection conferred by a patent on a process that enables a biological material to be produced possessing specific characteristics as a result of the invention shall be extended to any biological material directly obtained through that process.

ip4inno 26 First medical use Substance X for use as a medicament: Known substance – no known medical use. Broad claim – “for use as medicament”. Substantiation at least one medical use is needed.

ip4inno 27 Second medical use Swiss-type Claim: Use of substance X, for the manufacture of a medicament, for the treatment of disease Y. EPC 2000 (December 13, 2007): Compound X for the use, in the treatment of a disease Y.

ip4inno 28 Supplementary Protection Certificates (SPC) SPC for a product which constitute: The “active ingredient”, or combination of active ingredients, of a “medicinal product”, or The “active substance”, or combination of active substances, of a “plant protection product”.

ip4inno 29 ANNEX

ip4inno 30 Other varied exceptions to patentability Methods for treatment of the human or animal body by: –Surgery, –Therapy. It is not considered to be in the public interest for patients to be denied life-saving procedures (e.g. CPR), because someone else has a patent on the process. Diagnostic methods practised on the human or animal body. Are not patentable.

ip4inno 31 Possible patent on diagnostic methods Diagnostic methods are patentable provided they: –Comprise at least the following steps: Examination, Analysis, Decision. –Not necessitating the presence of the body (person or animal). –The result does not make an immediate particle medical treatment possible.

ip4inno 32 Possible patent on diagnostic methods Diagnostic methods are patentable provided they: –Comprise at least the following steps: Examination, Analysis, Decision. –Not necessitating the presence of the body (person or animal). –The result does not make an immediate particle medical treatment possible.

ip4inno 33 THANK YOU FOR YOUR ATTENTION!