This document summarizes key requirements for patent disclosure and enablement, including:
1. Disclosure provides the inventor a monopoly in exchange for sharing information that benefits society. Patents must be limited to the inventor's actual invention to balance property rights and preventing too broad claims.
2. Enablement limits how broadly patent claims can reach by requiring the inventor to disclose their invention in enough detail that a person having ordinary skill in the art can make and use the invention without undue experimentation.
3. In Janssen Pharmaceutica v. Teva Pharms., the court affirmed a lack of enablement where patent claims for a dementia drug provided no evidence the drug was effective for cognitive decline as
This document summarizes key requirements for patent disclosure and enablement, including:
1. Disclosure provides the inventor a monopoly in exchange for sharing information that benefits society. Patents must be limited to the inventor's actual invention to balance property rights and preventing too broad claims.
2. Enablement limits how broadly patent claims can reach by requiring the inventor to disclose their invention in enough detail that a person having ordinary skill in the art can make and use the invention without undue experimentation.
3. In Janssen Pharmaceutica v. Teva Pharms., the court affirmed a lack of enablement where patent claims for a dementia drug provided no evidence the drug was effective for cognitive decline as
This document summarizes key requirements for patent disclosure and enablement, including:
1. Disclosure provides the inventor a monopoly in exchange for sharing information that benefits society. Patents must be limited to the inventor's actual invention to balance property rights and preventing too broad claims.
2. Enablement limits how broadly patent claims can reach by requiring the inventor to disclose their invention in enough detail that a person having ordinary skill in the art can make and use the invention without undue experimentation.
3. In Janssen Pharmaceutica v. Teva Pharms., the court affirmed a lack of enablement where patent claims for a dementia drug provided no evidence the drug was effective for cognitive decline as
A. Disclosure and Enablement 1. Disclosure is the price the inventor pays for the rights to a monopoly a) Disclosure benefits society 2. Logical to limit patent rights to only what is property disclosed 3. Ever present tension = the desire to restrict the patentee’s property right to that which she has actually invented, while at the same time guarding against too skimpy a right, which in fact would be not right at all given the ease of inventing around it 4. Requirements a) Enablement b) Written Description c) Claim Definiteness d) Best Mode B. Enablement 1. Limits how broadly patent claims may reach 2. Regulates what degree of speculation is tolerable 3. Patent Breadth and “Undue Experimentation” 4. The Incandescent Lamp Patent a) Consider context of prior b) What elements exactly were being changed c) Difficulty with lightbulbs were the carbon burners and their too rapid disintegration or evaporation (1) Finding a suitable material d) Claim of infringement goes against the fibrous or textile material, covered by the patent to Sawyer and Man e) Defences (1) Defective on its face in its attempt to monopolize all fibrous and textile materials for the purpose of electrical illumination (2) Sawyer and Man were not the first to discover them f) Would not be too broad if they had listed some underlying characteristic that rendered the benefit from those materials g) Sawyer and Man identified carbonized paper as an effective material (1) Then attempted to broadly patent all fibrous and textile materials (2) Instead should be only limited to the carbonized paper (a) Or whatever the specific quality of fibrous and textile materials that they discovered h) Edison discovered a very particular fiber - bamboo - that worked best because the fibers ran parallel to flow i) If the description is so void that no one can tell, except by independent experiment, then the patent is void j) Unwarranted extension of the monopoly - denies further advancement of the field k) Because paper happens to belong to a particular field does not grant them the entire field l) Holding: (1) Lack of enablement because the patentee claimed the whole category without specifying the particular characteristic that enabled that category (2) Enablement required that they justify their broad patent by identifying the element that underlied the category (a) They did not do so, so they did not justify their possession of the whole field 5. Modern Equivalent: 4 elements a) A written description b) An enabling disclosure c) A disclosure of the best mode for practicing the invention d) Definite claims 6. Sawyer & Man explained a) Claim was that carbonized fibrous or textile worked better than carbon filaments (1) Enablement problem arises because many embodiments would not be useful, i.e. many within that category would not work (2) Specification issue- if they had identified the underlying characteristic of that category, it would not have been too broad (a) Persons must conduct “independent experiments” to find working embodiments of the invention 7. The scope of the patent must be less than or equal to the scope of the enablement a) That way a person could use the patent without undue experimentation 8. Commensurate scope - infringement damages should not be based on what th inventor lost but by how similar the technologies are. a) IP protection should be proportionate to the significance or merit of the creative work protected by the right 9. The 8 Wands factors a) The quantity of experimentation necessary b) The amount of direction or guidance presented c) The presence or absence of working examples d) The nature of the invention e) The state of prior art f) The relative skill of those in the art g) The predictability or unpredictability of the art h) The breadth of the claims C. Speculation and Prophesy D. Janssen Pharmaceutica v. Teva Pharms. USA Inc. 1. Affirm: lack of enablement 2. Facts: a) Dementia drug b) No basis for its stated claim of an effective cognitive enhancing amount of galanthamine c) Specification listed 4 studies of galanthamine improving cognitive ability in a variety of different animals d) Examiner determined that it was an obvious claim then given the discoveries in the studies e) Patentee argues that it was not obvious because none of the studies cover a situation in which the animals had cognitive decline prior to taking galanthamine, as the patentee does in the claim (1) Experimental work will be available in two to three months. And later submitted to the examiner (a) No results were ever submitted 3. Precedent: a) Did not demonstrate utility - relevant animal testings were not finished (1) Included minimal disclosure of utility b) Specifications and claims did not “teach one of skill in the art how to use the claimed method (1) Because the application only surmised how the claimed method would be used 4. Reasoning: a) If a patent claim fails to meet the utility requirement because it is not useful or operative, then it also fails to meet the how-to-use aspect of the enablement requirement b) Neither in vitro test results nor animal test results involving the use of galantamine to treat alzheimer’s like conditions were provided