TRIPS flexibility: patentability standards. Novelty (relative/absolute) Inventive step/non obviosuness Industrial applicability/utility

Transcription

1 TRIPS flexibility: patentability standards Novelty (relative/absolute) Inventive step/non obviosuness Industrial applicability/utility

2 TRIPS flexibility: what is an invention? Article 27.1 of the TRIPS Agreement: patents shall be available for any inventions, whether products or processes, in all fields of technology.. Invention vs. discovery

3 Flexibility about novelty A person shall be entitled to a patent unless the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of the application for patent in the United States... (35 United States Code, Section 102).

4 Inventive step Person with ordinary skills in the art How ordinary the skills should be? General knowledge (manuals, etc.) Specialized knowledge, practical experience

5 What is inventive? A new device, to be patentable, must reveal a flash of creative genius Juez Douglas en Cuno Engineering Corp., 314 U.S. 84, 51 U.S.P.Q. 1, 1941) The only valid patents are those this Court has not put its hands on Juez Jackson en Junguersen v. Ostby & Barton Co., 335 U.S. 560, 80 U.S.P.Q. 32 (1949)dissenting opinion

6 Sealed crustless sandwich: US 6,004,596 (1999)

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9 Pillow with retractable umbrella: US 6,711,769 (3/3/04)

10 Method of exercising a cat: US 5,443,036

11 Method of putting golfer s hand US Patent 5,616,989 A method of putting the golfer s dominant hand so that the golfer can improve control over putting speed and direction. The golfer s non-dominant hand stabilizes the dominant hand and the orientation of the putter blade, but does not otherwise substantially interfere with the putting stroke. In particular, a right-handed golfer grips the putter grip with their right handing a conventional manner so that the thumb on the right hand is placed straight down the top surface of the putter grip.

12 On-line price comparison of competitor s goods and/or services over a computer network US Patent 6,076,070 A method comprising the steps of: Requesting through said computer network from a competitor s database a price for an item sold by the competitor over said computer network; Decreasing the price of said item sold by the vendor by a predetermined amount to create a new price if said competitor s price is less than said item price

13 US August 8, 2000 A unique painting process and an associated kit including the materials required for practicing the method. The method includes the acts of preparing a protective covering on a work surface, preparing a background media by placing it on the protective covering on the work surface, placing a reservoir on the protective covering, filling the reservoir with a paint, dipping the posterior of the infant in the paint, and stamping the posterior on the background media to create stamping prints

14 Painting kit and related method

15 Mouth Appliance for Assisting in Weight Control Patent Number: 4,883,072 Date of Patent. Nov. 28, 1989 Inventor: Edward W. Bessler, Fort Mitchell, KY

16 Animal Hat Apparatus and Metbod Patent Number: 4,969,317 Date of Patent: Nov. 13, 1990 Inventor: April Ode, Lake Havasu City, AZ

17 British Patent of Sam Houghton

18 US Supreme Court decision in KSR v. Teleflex A person of ordinary skill is also a person of ordinary creativity, not an automaton.

19 New chemical entities Source: US FDA

20 PATENTS IN PHARMACEUTICALS Formulations/dosage forms Salts Processes of manufacture/analogue processes Combinations Polymorphs Optical isomers New indications (therapeutic methods)

21 Patenting strategies Blanketing. a jungle or a minefield of patents, for example, mining or bombing every step in a manufacturing process. Flooding taking out multiple patents, major as well as minor, in a field. Fencing. a series of patents, ordered in some way, block certain lines or directions of R&D. Surrounding. an important central patent, can be fenced in or surrounded by other patents, which are individually less important but collectively block the effective commercial use of the central patent, even after its expiration. Combination into patent networks. building of a patent portfolio consciously used to strengthen bargaining power. (Granstrand, 1999, p ).

22 Barriers to generics Our Message to brand name manufacturers is clear; you deserve the fair rewards of your research and development; you do not have the right to keep generic drugs off the market for frivolous reasons Generic Drugs make American health care far more affordable. President Bush, October 21, 2000

23 US v. Bristol Myers Through Bristol's decade-long pattern of alleged anticompetitive acts, Bristol avoided competition by abusing federal regulations in order to block generic entry; deceived the U.S. Patent and Trademark Office (PTO) to obtain unwarranted patent protection; paid a would-be generic rival over $70 million not to bring any competing products to market; and filed baseless patent infringement lawsuits to deter entry by generics US Federal Trade Commission,

24 The role of patent offices The patent office should function as a steward of the public interest, not as a servant of patent applicants. The PTO must protect the public against the issuance of invalid patents that add unnecessary costs and may confer market power Federal Trade Commission (2003), To promote innovation: the proper balance of competition and patent law policy, available at htpp:// p. 14.

25 What policy about pharmaceutical inventions? WTO Members are allowed to exclude from patentabiliy therapeutic, surgical and diagnostic methods There is no obligation to protect new uses (second indications) ["Use of X for the manufacture of a medicine to treat Y" ]

26 What policy about inventive step? Innovation/development policy: balance of interests Competition policy: use of provisional/border measures Public health policy: increase access to drugs