INTRODUCTION TO INTELLECTUAL PROPERTY LAW

INTRODUCTION TO INTELLECTUAL PROPERTY LAW I. What is IP? a. A term that was crated by the World Patent Organization b. Draws upon fundamental property laws i. Tends to reward those capture ii. Provides exclusivity rights c. Protects i. The idea ii. The original and its spirit iii. Trade secrets iv. Trade marks, to ensure consistency II. What distinguishes IP? a. It is a private good that is inherently public i. Taking a public good (a light from a flame) does no harm ii. But, taking a private good does (a lick from an ice cream) b. Implications i. Legal protection is needed to promote intellectual creativity ii. Once in place, IP laws are only meant to protect future innovation, by providing the incentive for people to create iii. Once something is created though, there is little to no cost of sharing 1. This create a central tension in IP: want to give away the rights to the thought once created, but need strong protection in order for it to be created in the first place 2. Think patents for medical procedures debate III. Philosophical Perspectives a. Natural Rights, via John Locke i. One acquires property by applying labor to a physical object ii. This has been applied to intellectual pursuits as well 1. Think discovering a natural compound iii. Lockeian theory is not sufficient to justify all IP law though 1. Patents are limited in time 2. And, what about the problem of accidental discovery? a. The creator of Post-Its did it accidentally, yet still got IP protection for the discovery. It would be hard to justify this on Locke s theory b. Personhood via Margaret Radin i. What we own, develop and create is a fundamental part of who we are ii. Spectrum of property 1. Personal: art, ring, music 2. Fungible: Money, inventions iii. This theory seems to be more influential throughout most of Europe c. Utilitarian, via Jeremy Bentham i. Greatest good for the greatest number ii. Manifested in the U.S. Constitution iii. Key question to consider: does the IP law lead to and promote innovation? 1

IV. Proper Promotion of Innovation a. IP Law is fundamentally a response to a market failure i. It s expensive to create new ideas there is a huge upfront cost for R&D ii. But, that innovation is usually reproducible at a much lower cost once it is reduced to a product iii. The market would drive costs down as far as they could go, without concern to recouping the R&D iv. IP helps to make sure that this investment in researching and seeking out new ideas is protected and gets rewarded 1. There are other market solution possibilities, however a. Lead time, secrecy, other ancillary means of appropriating a ROI b. Policies to Promote Innovation i. Government Subsidies (Gov t-backed research funding) 1. Mech: Political, typically ex ante 2. Pros: No deadweight loss, no impediment to cumulative inventions 3. Cons: Information- how do you properly allocate and pick winners? Also, corruption and rent seeking problems ii. Prizes (Nobel) 1. Mech: Political, ex post 2. Pros: No deadweight loss, no impediment to cumulative inventions 3. Cons: Information, corruption iii. IP (Constructs an artificial fence around an invention) 1. Mech: modestly political, market valuation 2. Pros: Reduces information costs, less prone to political manipulation 3. Cons: deadweight loss, exclusion iv. Usually, all of these systems are at work all at once V. Optimal IP Protection a. Balance between protection design to spur innovation and allowing development b. Needs to be considered in light of how inventions occur i. Not probable that most inventions are a flash of genius ii. Most inventions are the product of cumulative work over time 1. This creates a risk: if IP protection is given to the person at the bottom, could prevent people from adding on at the top, and creating a better product 2. If protection (esp. patents) are too strong, than later artistic derivatives could be limiting c. IP can be tailored through a variety of methods to create stronger/weaker protection i. Acquisition requirements, duration, scope, rules, institutions VI. Constitutional Guidance for Patents and Copyright i. Constitution only says 20 words relating both patents and ii. Gives a monopoly to promote advances in the sciences and arts 1. Sciences at the time meant language, arts meant machines VII. Patent Law a. Basics: Policy, History and Components i. Patents are around because Congress created them 1. Wanted to promote innovation a. Bait metaphor: Hand the bait of monopoly out there, and people will expand the intellectual sphere 2

2. Adds fuel to the fire of genius ii. History 1. Patent Act, creates 14-year patents in U.S., 1790 2. Patent Act, replaces exam system, 1793 3. Patent Act, exam system re-introduced, 1836 4. Patent Act, term extended to 17 years, 1870 5. Patent Act, non-obvious requirement added, 1952 6. Federal Courts Improvement Act, Fed. Cir. introduced, 1982 7. Patent Act, Provisional patents added, term adjusted, 1995 8. Patent Reform Act, First Inventors Defense, Prior Art, Reexamination, 1999 iii. Components of a Patent 1. Description: Description of the technical problem faced by the inventor, and how he plans to solve this problem 2. Drawings: If needed 3. Claim: Must follow the single sentence rule. Provides the metes and bounds of protection a. Preamble: Introductory sentence b. Transition i. Comprising = closed ii. Consisting of = open iii. Consisting essentially of = hybrid c. Body i. Elements/restrictions of the claims ii. Each successive element limits and defines the scope of the patent b. Patent Prosecution i. Requirements of initial application 1. Formalities a. Specification b. Drawings, if needed c. Applicant oath d. Fee 2. Needs to be clear on what is seeking to be patented 3. Unity of invention a. Application must be for single invention, not multiple ones 4. Prior art search a. Any references that could anticipate the invention b. Unique to U.S. law: ethical requirement to provide officer with all prior art that is relevant (But, don t have to say how it is relevant 5. Substantive analysis 6. The PTO will publish all non-provisional patent applications 18 months after filing, in order to comply with international standards a. This helps prevents submarine patents which can emerge out of nowhere after several years, resulting in unfair surprise to people who had come to rely on the invention b. If you are not going to file for a patent internationally, can request for publication to be withheld ii. First office action 3

1. Non-substantive actions a. Request for clarification b. Restriction or election requirements: forced to pick which parts of application to pursue 2. Substantive Action a. Rejection, on the grounds of 101, 102, 103, 112 iii. Applicant s Response 1. File divisional application a. Used to elect which part of application to pursue; keep original filing date 2. Argument for rejection a. Amend claims b. Sign affidavit for being first to invent iv. Second office action 1. Allowance, of elected claims 2. Final Rejection v. Applicant s Second Response 1. Abandon patent 2. Appeal a. To Board of Patent Appeals and Interferences, then to Fed. Cir. b. The BPAI is influential, but its decisions do not bind the district courts 3. File Continuation Application a. Must be filed while original patent is still pending approval b. Must refer explicitly to the pending parent application c. ID one common inventor d. Encompass the same disclosure of the parent application without adding any new matter. e. The same invention must be claimed, but the scope of the claims can vary i. Cancel rejected claims; or, alternatively, just pursue rejected claims f. Benefit: get to keep the priority date of the initial application 4. File Continuation-in-Part a. Similar to a Continuation, but adds new material to the application i. May add new data or descriptive material ii. May add improvements made to the invention b. Claims to the new subject matter do not get the advantage of the filling date of the parent application i. An intervening reference is material that comes in between the initial application and the parts added by CIP ii. Will have no effect on claims in the parent application, but additional material can be anticipated by this reference and therefore additional claims denied c. Patent Life Cycle i. Can file for a provisional patent first 1. Grows out of Europe and need to protect invention from academic publishing 2. Have one year from filling to file a full application ii. Filing patent application starts the prosecution process 1. Publication after 18 months, unless only going to be in U.S. a. Patent can be protested before and after publication (more likely after though) 2. Notice of allowance issued before application approved 4

a. Allows for non-substantive edits to the patent 3. Patent granted when issuance fee paid a. Maintenance fees will continue to be due approximately every 4 years iii. Post-allowance amendment 1. Available for 2 years after the grant 2. Allows for non-substantive edits to the patent iv. Patent Reissuance 1. Allow a patentee to correct a substantive defect in the specification or to narrow or broaden the scope of an issued patent. 2. Reissue may occur when, because of error without deceptive intent, a patent is deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent. 251. 3. Broadening Reissue a. Available for 2 years after the grant b. Can broaden the scope of the patent, if original claims did not claim as much as original specification and prior art allows i. The original specification must provide adequate written description for, enable, and disclose the best mode for the broader claim. 4. Narrowing Reissue a. After patent is granted, can narrow the scope of its claims for the life of the patent v. Reexamination 1. Either the holder of a patent or a third party can file for reexamination 2. If the PTO determines that cited art or prior patents and publications raise a substantial new issue of patentability, prosecution is reopened, and proceeds similar to reissuance 3. Limited to questions of validity based on prior art, because this is what the PTO is good at determining (other aspects, like description, are better at trial court level) 4. Two types of reexaminations a. Ex-parte i. Can be requested by anyone, but re-prosecution proceeds between the inventor and the assigned examiner ii. It is not unusual for the in a patent infringement case to file for reexamination, in which case both the district court and the PTO are reconsidering the validity of the patent at the same time 1. The PTO cannot delay its reexamination for the trial; reexaminations must be made with special dispatch b. Inter Parties Reexamination i. Similar to ex parte in that prosecution process is reopened and followed, but allows for the third party to stay involved in the process 1. Can submit one written comment to every official response by the patentee 2. The requesting party can appeal adverse decisions directly to the BPAI or federal courts ii. Third party requester becomes estopped from later raising any issue of invalidity that the party raised, or could have raised, during any prior inter parties examination vi. Interference 5

1. Examination of who invented first 2. Can take place at any time during the life cycle of the patent, including prosecution vii. Invention enters the public domain 20 years after application filed d. Hurdle Number 1: Subject Matter i. Statutory Source: 101 1. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. ii. History 1. Act of 1793 a. Any new and useful art, machine, manufacture, or composition of matter b. Judicial Interpretation: art is a manufacturing process i. Must product physical effects; very tangible 2. Act of 1952 a. Issued mostly due to housekeeping issues b. Changed art to process i. Meant to avoid confusion, not to expand patentable subject matter ii. Legislative history does not provide clear definition of process (defines itself) iii. House Report states that a person may have invented a machine or manufacture which may include anything under the sun that is made by man 1. Note that the under the sun language is tempered by the connection to machine or manufacture iii. What is NOT patentable? 1. Laws of Nature (Newton s idea of gravity) 2. Physical Phenomena 3. Things Found in Nature 4. Abstract Ideas (Pythagorean theorem) iv. Controversial Areas of Patentability 1. Living Organisms a. Naturally Occurring but Found by Man i. American Wood-Paper v. The Fibre Disintegrating Co 1. Can pure cellulose used to make paper be patented? 2. Court says No, it is something found in nature a. Doesn t matter that it was claimed suitable for the manufacture of paper ii. Parke-Davis v. H.K. Mulford 1. Can the actual physical matter of purified adrenaline be patented? 2. Test: Was invention required to isolate the natural substance into a purified form? 3. Court says that purified adrenaline was essentially a new thing, owing to its commercial viability that comes form human invention. Thus, patent granted. iii. Funk Bros. Seed v. Kalo Inoculant 1. Can a package of bacteria that is used for fertilizer be patented? 2. It is no more the discovery of some of the handiwork of nature and hence is not patentable 3. But, this comes from an anti-trust court; may not really still be relevant b. Man Made Organisms 6

i. Diamond v. Chakrabarty 1. Can man-made bacteria, developed to deal with oil spills, be patented? 2. The Patent Act covers a non-naturally occurring manufacture or composition of matter a product of human ingenuity 3. Places emphasis on that fact that this bacteria was invented a. Not meant to suggest that 101 has no limits. A new mineral discovered n the Earth is still not patentable subject matter 4. Yet, Court is broad at the same time a. Congress intended statutory subject matter to include anything under the sun that is made by man. c. DNA Patents i. A patent on a gene is meant to cover the isolated and purified gene, but does not cover the gene as it occurs in nature ii. Association for Molecular Pathology v. USPTO (SDNY 2010) 1. Can the isolated gene mutation BRCA, which indicates a woman faces a 36 to 95% chance of contracting breast cancer, be patented? Can the method of detecting it be patented? 2. ACLU brought suit; district court said that both are not patentable. But, this will likely be reversed by higher court iii. Need to separate the debate into two parts: can the isolated genes themselves be patented, or just the diagnostic mechanism for finding them? 1. Hard to see why DNA itself should be patentable, given that works of nature are not patentable a. Were granted patents at first because they were hard to isolate; now, not so much. To continue to give ownership to them may clog up discovery 2. But, diagnostic tests are actual human decisions based off a genetic marker; they involve human work through a process a. If presence of A, then diagnosis or treatment B i. Maybe easier/better for these to be patentable as this is like a process ii. But, could be construed as a function that exists in nature 2. Computer Software a. For a time, thought to unpatentable, as it was thought to be a series of mental steps b. But, not a live issue anymore. Computer software is patentable 3. Business Methods a. Bilski v. Kappos i. Can a method for hedging investment in energy costs be patented? ii. While the court throws out all of Bilski s claims because they are too abstract, the Court says that business methods are patentable 1. Overturns Fed. Cir. Machine-or-Transformation Test, which limited patents to those that are tied to a machine or transformed an article to a specified different state (Business methods would not pass this test) 2. J. Kennedy takes a textualist approach, states that the definition of process cannot include a machine/transformation requirement. These are just helpful. a. This, however, ignores legislative history b. Process not meant to expand; meant to keep earlier notion of being tied to physical objects 7

4. Medical Procedures a. Hospitals have become more profit orientated in recent history, and have sought patents for specific medical procedures, like the method for making incisions for cataract surgery b. The idea of medical procedures being patentable didn t fly: Dr.s should be able to always perform when needed to c. Congress created an exception, 287(c) instead of gutting 101 i. Makes it so that people who hold a patent for medical procedure can t sue other people that use that procedure (making the patent kinda pointless) 5. Sport Methods a. Dick Fosbery might have a valid claim under Bilski for his method of jumping backwards i. It is a new method of doing things ii. Didn t get a patent though b. There is, however, a patent for putting technique i. These kind of things are distracting e. Hurdle #2: Utility i. Statutory Source: Still 101 1. Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. ii. Specific and substantial utility must be shown 1. Brenner v. Manson (SCOTUS 1966) a. Can a molecule that is similar to another that can inhabit tumors in mice be patentable? b. Court says no To get a patent, the inventor has to live up to his side of the bargain, that is, he must disclose a benefit to society of substantial utility c. Unless and until a process is refined and developed to this point where specific benefit exists in currently available form there is insufficient justification for permitting an applicant to [monopolize] what may prove to be a broad field. d. A patent is NOT a hunting license. It is not a reward for the search, but compensation for its successful conclusion 2. Object of scientific research exclusion: an invention that is only useful to study itself lacks 101 utility 3. A process that merely produces an intended product is not useful unless the product is useful 4. Real World utility required: which in the pharma field implies an association with a disease or physiological process of condition iii. Utility Examination Guidelines from PTO 1. Credible Utility a. Whether a person of ordinary skill in the art would accept that the invention is currently available for purported use; accepted as readily possible i. Can t be illogical (perpetual motion) or not factually supported 2. Specific and Substantial Utility a. Must be for a particular practical purpose i. Specific ( high biological activity alone insufficient), substantial (real world use) and not trivial (not use as landfill) 8

iv. What meets utility requirement in chemical/pharma research? 1. Process patents: must yield useful product 2. Drug patents: sufficient criteria depends on predictability of field of invention a. Structural similarity to useful products b. Reasonable correlation between evidence and utility c. Data from animal testing, human clinical data (not required) v. Controversial Utility: Expressed Sequence Tags 1. Are ESTs, which are used as probes to search for genes but whose own physiological function is not known, patentable? 2. Fed. Cir. said no in In re Fisher (2005) a. Majority: No substantial utility unless the function of the underlying gene is known. These ESTs are no more than research intermediates, mere objects of use-testing b. Dissent: Similar to a microscope, both take a researcher one step closer to identifying and understanding a previously unknown and invisible structure vi. Beneficial (Moral) Utility 1. Juicy Whip v. Orange Bang a. Can an invention get a patent, when its only utility is to trick consumers? b. Court states that the fact that one product can be altered to make it look like another is in itself a specific benefit sufficient to satisfy the statutory requirement 2. U.S. Patent 4,736,866 a. Patent on special mouse that is susceptible; granted and allowed by PTO i. PTO will NOT allow patents on cross-species breeding (though this probably has more to do with public policy than a lack a real utility) vii. Hurdle # 3 Novelty 1. The U.S. currently operates on a first to invent basis (but, we don t want people to delay in the filing of their application, so incentives given) a. Current, ongoing to efforts to reform this, make it fit with Europe s first to file requirement b. Balance: want to promote prompt disclosure and preclude term extension, but at the same time, need to provide a reasonable grace period 2. 102: A person shall be entitled to a patent unless-- (a) the invention was (publicly) known or (publicly) used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for the patent a. Assume that the invention was invented on the date it was filled b. In order to qualify as prior art, it must be enabling; it must have all of the key categories of the invention at hand c. Types of References i. Public Knowledge and Public Use 1. Scope/Proof a. Excludes trade secrets and government classified research b. # and credibility of observers c. Intent of presenter (was secrecy implied?) d. # of disclosures e. Extent to which observers understood the invention f. Test: must have been made by public by clear and convincing evidence 9