US PATENT LAW OUTLINE I. INTRODUCTION: The Patent Bargain for the Inventor: Disclosure of a technological advance [for] Right to exclude others from making-limited time & corresponding benefit to the public Title 35 USC: http://www.law.cornell.edu/uscode/usc_sup_01_35.html § 101: Scope of subject matter (4 categories of Patentable subject matter) (New & Useful): 1. Process 2. Machine 3. Manufacture 4. Composition of Matter 3 Doors – Need 3 Keys: 1. Statutory Subject Matter 2. Novelty 3. Nonobvious to a Person of ordinary skill in the Art (technological Arts) Specifications: descriptions of the technical problem to overcome and background of invention Claims: Primary source of proprietary rights, establishes the ‘metes and bounds’ of the invention Constitutional Provision: Art I, § 8, cl 8 – Promote the Science (interpreted as Information/knowledge or literature) and Useful Arts (technological arts) for Limited Times by giving authors and inventors Exclusive Rights 1 Ultimate Policy Goal of Patent Law: To bring new designs and technologies into the public domain through disclosure ~ Bonito Boats - want to provide knowledge to the general public to build and promote – to start at a higher level each time - thus, once the knowledge or material is in the Public Domain No-One can get exclusive rights Default Rule is always the Free Exploitation of Ideas ~ the Protection of a Federal Patent Grant is an Exception - Do not have an automatic right to a Patent, must satisfy the requirements (unless- in §102) Novelty & Nonobviousness – combine to make stringent requirements to ensure: - that ideas in the public domain remain there for the use of the public Patent Clause Balances: need to encourage innovation & the avoidance of monopolies which stifle competition ~ Bonito Boats How patents promote scientific progress: 1. Incentive to Invent – prospect of obtaining a patent monopoly, Market Incentives – leads to headstart in market (disadv=overinvestment); 2. Promotes disclosures of new inventions – increases overall public knowledge 2 II. PATENT ELIGILBILITY What Subject Matter can be patented ? ~ Different from “Patentability” – Based upon: Novelty/Non-obviousness - a product must be more than new and useful to be patented, it must also satisfy the requirements of invention or discovery w/i the meaning of the statutes A. A patent can only issue if an invention achieves a tangible, practical result - Excludes speculative & the abstract & articulation of a scientific principle B. § 101 Inventions Patentable: Whoever invents or discovers any new and useful (or any new and useful improvement): 1. Process: a series of acts which are performed upon subject matter in order to produce a given result; or so the SM can be transformed & reduced to a different state or thing - a mode of treatment of certain materials to achieve a certain result - result of an inventive process need not be an invention itself 2. Machine: any inventive apparatus or thing that does something 3. Manufacture: any thing or article that is human made that has inventive characteristics 4. Composition of Matter: things (chemicals combined), Essential is that the inventor’s discovery is not nature’s handiwork, but the inventor’s own. Diamond v. Chakrabarty … may obtain a Patent Thereof. C. Laws of Nature: Any artificially created product that is identical to a product found in nature is NOT Patentable. 1. - Patents can NOT issue for the discovery of the phenomena of nature. Funk Bros. - But Manipulation of a natural discovery may fall w/i the terms of the Patent Act – may attempt to claim new discoveries following some human intervention, ie, the application of known chemicals (or a law of nature) in a previously unknown fashion - Living organisms are patentable: the products created by a genetically engineered object and the processes of genetic engineering are patentable (ie, oil eating bacteria/cloned dog). 2. A mathematical formula or algorithms, having no substantial practical application except in connection with a digital computer, can NOT be patented. - BUT, A process claim that is otherwise patentable should not be rejected b/c the application describes an apparatus that will inherently carry out the process. - Patentable claims do not become invalid b/c they include mathematical formulas, Diamond - Unpatentable mathematical algorithms are IDed by showing they are merely abstract ideas constituting disembodied concepts or truths - To be Patentable an algorithm must be applied in a Useful way Things Generally NOT Patentable: 1. Natural Laws 2. Natural Phenomenon 3. Abstract Ideas 3 4 III. UTILITY A. Derived from the Patent Clause of Constitution & Patent Act § 101 B. An Invention must be of some benefit qualitatively (can not patent if the invention is a mere novelty or curiosity) – quality concept from Lowell: usefulness satisfied as long as the invention is not frivolous or injurious to the well-being, good policy, or sound morals of society. C. Utility can Not be presumed, it must be disclosed an integral part of the patent specification §112 - to hold otherwise would be to grant a patent on an unknown range of applications - Inventor must ID a specific Utility: - Product: must have a demonstrable utility specified in the patent application - Process: must demonstrate utility wrt its product (b/c a process that results in a useless product does not increase the fund of useful knowledge nor confer a real benefit) - A process or a product which has no known use or is useful only in the sense that It may be the object of scientific research is not patentable b/c it is NOT “Useful” – Brenner v. Manson - Policy Not to allow patents for speculative utility: such patents threaten “a monopoly of knowledge” - Ct clearly wants to prevent industry attempts to carve out large technical areas – making them immune to research by competitors One need not show proven utility to gain patent protection; it is sufficient to show a reasonable expectation of utility - Generally low standard (liberal interpretation given by Fed Circuit) and is seldom litigated, mostly in Chemical/Biological cases. - Initial Burden is normally on the PTO to reasonably rebut the presumptive assertion of utility 5 IV. STATUTORY BAR (§ 102) - (Single Reference Rule for all 102) Statutory Bar {§ 102 (b)&(d)} focuses on events that may occur more than 12 months prior to the inventor’s patent application and which, if they do, prohibit patentability – absolute bar. - Inventor is given a grace period of 12 months from the event w/i which he may still apply for (filing date) an invention: After grace period - statutory bar occurs and inventor loses what might be termed his application priority and right to a patent, even though the invention still has novelty, etc. * Critical Period for Statutory Bar is 1 Year prior to the Filing Date (date of invention not relative). * If an inventor is the first to invent but waits more than 1 year to apply for a patent after someone else, or the inventor describes, publicly uses, sells or patents the invention in this country, the invention is unpatentable by the inventor, even though he was truly the one who invented first! * A patentable invention is one that must distinguish in some fashion from all that went before; it must be new relative to the prior art. - 102(b) Bars may be due to the acts of anyone, normally the applicant – Filing Date - 102(a) 3rd Party Activities – Date of Invention - Policy behind Statutory Bar – Legislature will Not grant a valuable property right to one who is dilatory in bringing their invention to the public in the form of a published patent. - Pushes inventors to get their invention into the PTO promptly or face loosing rights. A. Events Raising Statutory Bar, if they occur more than 12 months prior to application: - Usually the Inventor Responsible For / Doing the Event: 1. Domestic: Public Use, Prior patent by anyone, Printed Publication, On Sale 2. Foreign: Prior patent by anyone, Printed Publication, Prior patent application by the applicant (but only if a patent is granted prior to domestic application). Note: if Public Sale Abroad then NO Bar B. All Events Limited by the Principle of Substantial Identity – (the event) must be so substantially the same as the invention as to accomplish the disclosure. 6 C. Applicant Activities – 102(b): Public Use & On Sale 1. PUBLIC USE: What degree of publicity is required? Generally, only a minimum level, corresponding to the fact that statutory bar does not require publicity sufficient to inform the public but, rather, sufficient to demonstrate unacceptable conduct on the part of the inventor. a. A single Use for Profit, not purposely hidden, even when not visible to the public, is a Public Use. Electric Storage b. Any Commercial Exploitation of an invention , even done in secret, constitutes a “public use” under 102b of the Patent Act. Metallizing Eng. Co - esp. if invention is a process and not a product where others could not readily find out the process, this prevents extending the life of the patent. - key is whether the public use discloses the invention’s benefits – even if the use does not disclose the secrets of the invention. c. Secret or Hidden Public Uses (Unobservable) When an inventor gives or sells a device to another w/o limitation or restriction (to include privacy agreements) and the invention is used, such use is Public and places the invention in “Public Use”. Egbert (Corset) - an invention whose use and operation are not clearly viewable by the public, is in public use if used in the ordinary manner (even if 1 sample & 1 person) - some inventions are only capable of being used where they cannot be seen or observed by the ordinary public - What effort has the inventor taken to keep the use confidential, even if used in a private setting? What intention/obligation did the party using the device have to keep it hidden? - May be public use if the consumer is using a method in some manner even though the precise invention (claimed algorithm) is unknown to and unobservable by the user. d. Experimental Use: Controlled Public Experimentation does NOT put an invention in “public use” so long as the experiments were performed solely for the purpose of perfecting or further refining the invention. City of Elizabeth - Look to necessity to demonstrate the workability of the invention for its intended purpose. - If a use is limited or restricted so as intentionally to prevent disclosure, as in a test, such limited or restricted use will not trigger the statutory bar. - Designed to give the inventor incentive and time to perfect invention. This limited public use does not trigger the bar of 102b. - Balancing Process is used to determine whether the purpose of use is truly experimental: [ Degree of Public Use ] v. [ Actual Testing ] is public use dominant as to contradict the argument that its purpose is testing 7 - Factors: Confidentiality - attempts to maintain secrecy, - main purpose of the use/test & its necessity - lengths of time test(s) continue & the # of tests performed - Does inventor maintain Control? - Is payment made for the Device - Are Records Kept of the Progress? - Also a Defense to the “On Sale” Bar below. - But No Invention yet, at all, if NO Reduction to Practice, so Experimental Use would not be necessary to argue. Key – When was the invention actually reduced to practice (whether invention was in existence). 8 2. ON SALE: An invention may not be patented if it was operative for any intended purpose when placed on sale more than 1 year before the effective filing date of a patent application - Any Efforts to make a sale, even if unsuccessful, violate the policy of statutory bar against attempts to extend illegitimately the patent monopoly. - Even placing an item out to bid constitutes being “on sale.” *Two Conditions must be met for the ON SALE Bar to Apply: (from Pfaff): 1) The Product must be the Subject of a commercial Sale 2) Invention must be “Ready for Patenting” – so that a person skilled in the art could produce the invention at the time of the Sale. Satisfied in 2 ways: i) Proof of Reduction to Practice before the Critical Date, or ii) Prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention - Does not mean that the inventor (or 3rd Party) must have actually sold her invention, offers of sale count as well, by both the inventor and 3rd Parties. * Application: applied in the sense that a person skilled in the art could produce the invention at the time the invention is placed on sale c. On Sale in a Testing or Experimentation Context: - Mere Transfer of Money does not nec est. a sale or an offer of sale when the main objective is completion or perfection of the claimed invention. Factors to consider: i. Need for testing by one other than the patentee ii. Amount of Control Exercised by the patentee iii. Stage of development of the invention iv. Whether payments were made and the basis thereof (assignment=NO Sale) v. Whether Confidentiality was required & whether tech. changes were made 9 D. Third Party Activities: Informing Uses: 1. A 3rd Party’s innocent use of an invention in its factory to create a commercial product is a public use (may also be the inventor). Electric Storage - A third party’s use of an invention in an experimental lab is a public use Non-Informing Uses: * A user must intentionally conceal the use of a product for such use to be deemed “secret” - A 3rd Party’s Secret commercial use of a process is not a “public use” E. Patents, Printed Publications, & “In This Country” {in both 102 (a) & (b)} 1. Both Patented & Printed Publication documents must be both printed & published if they are to be valid references. (but patenting prior to publication cannot function as 102 a & b prior art – case w/ some foreign countries). Novelty 102(a) * Under Section 102, a patent is barred for lack of Novelty (a) if there is enough in the prior art to enable someone skilled in area to perform the process or produce the product described in the patent application. If Reference found to be an “enabling disclosure” then it bars patentability. Ref is enabling & invention anticipated if it discloses info that would enable one having ordinary skill in the art to duplicate the invention (Enabling comes from §112) - The total combination of prior art can make invention unpatentable if the combo, as a whole, constitutes an enabling disclosure. Policy - Prior art precludes an applicant from obtaining a US patent b/c the invention is in the public domain and constitutes constructive knowledge of that prior art. Printed Publication - (Single Reference Rule for all 102) 2. Accessibility is the touch stone in determining whether a reference constitutes a printed publication. Whatever the medium the one who wishes to characterize the information in whatever form in may be, as a “Printed Publication” – should produce sufficient proof of its dissemination or that it has otherwise been available and accessible to persons concerned w/ the art to which the document relates and thus most likely to avail themselves of its contents. - controlling factor is no longer the form in which the info is presented but rather whether it has been “Published” – form is becomes part of the evidence - Now, “Printed Publication” – means info in a tangible medium of expression that has been published. - Published: Consider Public Availability & Access (Also, distribution to any segment of the public may be enough… no relationship between # of copies distributed) - Date of Publication: Cts will allow evidence of routine business practices, ie. competent evidence of general library cataloging may be used to establish an approx time something is accessible. In re Hall 10 Patents 3. Patents That are “Patented” and Published at Different Times (Sooner/Later): - In some foreign countries, Publication occurs at a time other than the time when the subject matter is patented. --- thus may not correspond to a “printed publication” * The patent document becomes citable as having been “patented” when the application gets sufficient patent-like rights under the laws of the foreign country (often after patent issues after complete examination, but some countries give patent like rights earlier). - Foreign patent rights need not be coextencive w/ US patent rights so long as they are “substantial & exclusive” In re Carlson. - It is the claimed invention of the applicant that must be Patented in order for the patent to be prior art (assuming it was not also a printed pub.) > ie, if the patent discloses applicant’s claimed invention but does not itself claim it, then the patent may NOT be used as prior art (unless it is also a printed pub.) ? - If a country grants patent-like rights before publication the work cannot be considered “Patented” under (102 a or b) unless it is published. 4. “In This Country” … limiting factor or qualifier for (“Public Use or On Sale”) 102b - If goods made in the US but the sale occurs in another country (export) the “in this country” requirement is still met? 5. Abandonment: 102(c) – If the inventor “has abandoned the invention” he is precluded from obtaining a valid patent subsequent to that abandonment. - NO relation to filing date or date of invention * Abandonment of a US patent application claiming invention is not necessarily Abandonment of the Invention. - Aband. if patentee discloses an invention & no file (may regain) - If Abandoned, inventor may later proceed diligently & before another’s Date Of Inv V. NOVELTY Novelty provisions of §102 (a) focus on certain events constituting Anticipation that may occur prior to invention and, if they do, prohibit patentability for lack of Novelty. - Events of Anticipation have no comparable grace period (like 102b): If any Anticipation occurs prior to invention, the inventor has no right to a patent. * Critical Date is the Date of Invention: (US follows the 1st to Invent principle) - Applicant can NOT Trigger a 102a Event. * A patentable invention is one that must distinguish in some fashion from all that went before; it must be new relative to the prior art. Secrets do NOT Comprise prior art. - Rule 131 allows applicants to declare an invention date prior to the date of a prior art reference. > provided the same invention is not claimed in the reference, when the ref. is a US patent. A. Anticipation Events that defeat a claim of novelty if they occur anytime prior to invention: 11 1. Domestic: Prior patent by anyone, Printed Publication, Knowledge or Unabandoned, Unsuppressed/Unconcealed invention by others, Use by Others, or, Description in Another’s Previously Filed and Eventually Granted Application. 2. Foreign: Prior patent by anyone, or, Printed Publication * Text Requires only “known or used” – but challenger must show public knowledge or use, where public means those skilled in the art. B. Anticipation must Encompass the Invention that is Claimed. Enablement Requirement – of 102a from 112 - Reduction to Practice – criteria should be “whether the disclosure is sufficient to enable one skilled in the art to reduce the disclosed invention to practice. - Test = Whether Enough of the Invention has been disclosed to Enable a person skilled in the applicable art to duplicate the product or process. To constitute Prior Art under 102a the disclosure must be such as will give possession of the invention to the person of ordinary skill in the art. Public Uses - Prior Art w/i 102a must be public knowledge, that is knowledge which is reasonably accessible or available to the public. Secret Uses are NOT Public Uses. > Does NOT require actual knowledge or use. - Burden of Proof as to Prior Inventorship – Patent has a presumption of validity, thus the challenger must meet the std of “Clear & Convincing” Evidence. 12 C. The Elements of “Invention” Under § 102(g) – Interferences & Who was the First to Invent? - Novelty inherently includes the issue of priority since to say that something is NOT novel is also to say that someone or something else has priority. 1. Terms: Senior Party – Party with the earliest effective filing date (Senior inventor – conceives first) Junior Party – Any other party Count – Claim which the interfering parties share (define what the dispute is about – subject matter each party claims they invented first). - Priority Under § 102(g) depends upon 3 factors: 1) The Time of Conception – The moment when the inventor unambiguously had made mental discovery of the invention. The mere formation of the idea, as long as it is definite, permanent, and particular, is enough. (Range of dates = last day of period) 2 part test? > Conception requires: i. idea that a certain desired result may be obtained, & ii. proof that the (Junior Party) knew of the means for effectively carrying out the conc 2) The Time of Reduction to Practice 3) Use of Due Diligence in Pursuing both patent protection and perfection of the discovery > A party that must prove diligence must account for the entire period during which diligence is required and prove reasonable diligence during that time. * General Rule: As between two parties, the first to conceive generally has priority to patent protection. - But, the First party to conceive Must use Due Diligence from the time of Conception – Diligence is NOT measured from the time of his conception, but the second parties’ time > The Requirement of due diligence is not triggered until just prior to conception by the second party to conceive > From that point on diligence must proceed uninterrupted until reduction to practice. * Modified Rules: a. A Claim by the first to conceive based on earlier conception date, if challenged by a second to conceive, is preserved only if accompanied by continuous diligence starting just prior to a second party’s conception. b. But, the second party to conceive can never challenge the first to conceive unless the second to conceive Reduces to Practice FIRST. Reduce to Practice = Occurs either Actual/ 1) At the time when the inventor can prove the product or process was produced or applied successfully, >The standard to determine whether sufficient testing has occurred to show Red to Pract is a common sense assessment of whether the invention in fact solved the problem. Rule of Reasonableness that Depends on type or nature of invention. or Constructive 2) In any event, NO Later than the time of filing of the patent application. * As a Matter of Law – the Time of Application is presumptively the Time of Reduction to Practice, unless the inventor can demonstrate an earlier date. 13 Summarized as: A party who conceives 1st, will have priority over a party who later conceives, unless the second party to conceive reduced to practice first AND the first to conceive did NOT use continuous diligence from a time just prior to the second party’s time of conception up until the time the first to conceives reduces to practice. Party 1st to file will cause (Junior Party) to file application and claim either (norm is 1st to file wins): 1) earlier conception and due diligence thereafter, or 2) earlier conception and due diligence at least from just prior to the time of conception by the (Senior Party) 3) a factually earlier Reduction to Practice despite the presumption of filing date Evidence Required by Junior Party: To make a prima facie showing of priority, a junior party must show independent corroborating evidence (inventor’s own statements/documents not enough). >Policy–prevents fraud, evidence must consist of facts/circumstances independent of inventor - Evidence must say what was done, how it was done and when. 2. Patent Award to the Second Inventor (Abandoned, Suppressed, or Concealed) - mere lapse of time will not prevent the inventor from receiving a patent > but, the first to conceive may loose his rights to the second if the first fails to take reasonable steps to confer the benefit of the invention on the public, such as by filing a patent application. Negate - May renew pursuit of invention by showing due diligence from the date of the renewed Abandonment activity so long as the other party has not yet conceived of the same invention. 3. Disclosure in the US Patent Applications -- § 102(e) * A US Patent disclosing an invention dates from the date of filing of the application for the purpose of anticipating a subsequent invention. > 2nd patent is barred where the 1st filed patent describes the same invention (if claimed then the proceeding would be an interference under 102(g)) > PCT application doesn’t count (will be a printed pub on date of issue for 102a&b) > US patent based upon an international application cannot itself be prior art under 102e, and can only be prior art under 102a or 102b as having been either a printed publication or patented on its date of issue. 4. Derivation – Theft from a Prior Inventor -- § 102 (f) * Bars an applicant “who did not himself invent the subject matter sought to be patentee.” - Must an ‘entire’ conception be communicated to invoke the 102(f) bar? NO, It is enough of a commo if it “enabled an ordinary mechanic, w/o the exercise of any ingenuity and special skill on his part, to construct and put the improvement in successful operation.” 3. In this Country – 102(g)(2) – A person shall be entitled to a patent unless – …before [the applicant’s or patentee’s] invention thereof, the invention was made in this country by another inventor who had not abandoned, suppressed, or concealed it… 14 VI ANTICIPATION (look for genus – species cases) A. * Anticipation under § 102 requires the presence in a single prior art reference of each & every element and limitation of a claimed invention. (References can NOT be combined). > If it is necessary to rely upon a second item of prior art to combine with the principle claim, then the combination of those references may render the claimed invention Obvious, but it will not constitute §102 Anticipation. (Must proceed through 102 before going into 103). * That which would literally infringe if later in time, anticipates if earlier than the date of invention. > Due to the Lack of Novelty * Anticipation occurs only if the subject matter of the claims is found exactly in the prior art ref., or in other words, an infringement claim that would be successful for lack of novelty. B. * When a patent reference is silent about an inherent characteristic, the missing descriptive matter must be necessarily present and recognized by persons of ordinary skill. > has the burden to show that every element of the several claims of the patent were identically described in the anticipatory reference. * A fundamental condition for patentability is that what is sought to be patented, as determined by the claims, must be new. C. Genus / Species: If species is prior art you could not go back and claim the genus, but: Genus = Broad Category. A group of compounds closely related both in structure & in properties Species, to patent, the applicant must demonstrate that the claimed species has improved or distinct properties over other members of the prior art genus. - Whether a Prior Art Genus Anticipates a claimed species is necessarily a case-by-case: Factors (for chemical arts): page 391 15 VII. NON-OBVIOUSNESS (§ 103) (presumption of validity… challenger has burden by clear & convincing std) * Necessary because many things could be deemed ‘novel’ inventions even though they might be obvious to one skilled in the art. (Known before 1952 Act as the “invention” requirement). * Non-obviousness is decided in light of all the prior art. But, unlike the Novelty requirements there is no need for the invention to be “described” in those pubs; it need only furnish one skilled in the art w/ the nec info that would have made the invention obvious. * Does the combination of elements yield a result that anyone skilled in the art could obviously predict, if so the invention fails for lack of Nonobviousness. > But if, A different or unexpected result is obtained by the combination, it frequently is described as synergism. (Evidence of Nonobviousness). A. Synergism: Evidenced by the demonstration of a different function and not simply by the production of “a more striking result than in previous combos.” CAFC – Synergism is only evidence of NonObv, & a lack of does not imply obviousness. (Synerg. nowhere in 35USC) - Also, almost every patent is a combination patent and they are NOT to be treated different B. Modern Standard of Nonobviousness of § 103: Graham v. John Deere * Basic Test is whether the teachings of the prior art, taken as a whole, would have made obvious the claimed invention and what the combined teachings would have suggested to one of ordinary skill in the art. Also, the prior art as a whole must suggest the desirability of making the combination. A matter of law – legal conclusion. The Standard of Nonboviousness is applied in 3+1 Steps: (Factual Inquiries) 1) The scope and content of the prior art are to be determined 2) Differences between the prior art and the claims at issue are to be ascertained 3) The Level of Ordinary Skill in the pertinent art must be determined CAFC add on 4) Secondary Considerations * In the light of that 3-stage process, one can decide whether the differences revealed in the second stage are nonobvious. 1) The scope and content of the prior art are to be determined: a. Prior Art determined from: i. Disclosure by patentee (citations to prior art and a statement of how the invention is a significant advance over the prior art), & ii. PTO cited references b. 1st Step is to survey the Scope and Content of the Prior Art, defining which prior art is both Applicable & Relevant - Relevant/Applicable prior art must be that which is either: i. Pertinent to the Invention, or ii. Analogous to that which is clearly pertinent c. Prior Art is NOT limited to one narrow area or commercial area. >Patent Law prefers the Functional, conceptual, or generic definition (genus not the species that defines prior art). 16 Prior Art = The basic mechanical or scientific field applicable to the claims even though the people in that technical field ordinarily might not work in the relevant commercial area. > thus, includes analogous areas –those arts to which a person skilled in the directly pertinent art reasonably would refer in order to solve the problem. > Analogous Arts – technological areas judged sufficiently germane to that of the claimed invention. 2 Criteria for determining whether prior art is Analogous: 1) Whether the art is from the same field of endeavor 2) If not, then whether the reference still is Reasonably Pertinent to the particular problem w/ which the inventor is involved. d. Novelty (Anticipation § 102) Prior Art may come from any field. e. PTO classification system lends credence to for what prior art can be, but not conclusive f. A Pending Patent Application is prior art for purposes of obviousness (prior art does not nec mean publicly known art) when patent issues, the disclosures date back to filing 2) Differences between the prior art and the claims at issue are to be ascertained: a. Test = Whether the combined teachings of the prior art, taken as a whole suggest the modifications to the person of ordinary skill in the art. - Requires reconstructing the prior art: from the perspective of hindsight? - What the Reasonable person skilled in the art would have known – as of an objective time in the past - “at the time the invention was made.” (Nonobv judged) > dangerous b/c w/ knowledge of the invention, it is easy to believe that certain prior art or knowledge make the invention obvious. > Prior Art must NOT be read into the very teachings of the invention at issue b. Today, How Invention was made really not relative… NO “flash of genius required” could be an accidental or lucky discovery. 3) The Level of Ordinary Skill in the pertinent art must be determined a. The level of skill must be accessed and applied to the invention itself. b. Functional inquiry applying to the invention as a whole. > Even though it may be obvious that a certain object can be constructed in a certain way, its utility and novelty may lie in its functional use, not its construction. c. Nonobviousness is not to be measured by the degree of change over the prior art but “by reference to the purpose sought.” d. CAFC provided the following list of factors to be considered in determining the level of ordinary skill in the art: (Environmental Designs) 1) the educational level of the inventor 2) type of problems encountered in the art 3) prior art solutions to those problems (best indicator overall) 4) rapidity with which inventions are made 5) sophistication of the technology 6) education level of active workers in the field. >Accused Infringer will seek to prove high level of skill in the art: Patent Holder a low level e. What is the Knowledge Base of One skilled in the Art? (In re Winslow) 17 > § 103 Presumes full knowledge by the inventor of the prior art in the field (on wall) 4) Secondary Considerations (Objective Tests of Nonobviousness) … CAFC add on > Factors must be considered (highly relevant), but don’t control the obviousness conclusion. > Objective evidence from the 3 part test will weigh heavier (2d Fs used more in close cases). a. Factors to Consider: > All factors must have some “nexus” to the inventive characteristic. 1) Commercial Success – must be a sufficient relationship between the comm. success & the patented invention (a nexus- A legally & factually sufficient connection) > burden on the patentee to prove: (does NOT matter if success was in foreign nation) > prima facie case if patentee can show the actual thing that is comm. successful is the not coextensive w/ the patented invention (is patented thing only a part of a larger machine… & the larger machine is what is successful?) > if patentee meets burden then burden shifts to challenger to show comm. success was due to extraneous factors other than the invention (advertising, superior workmanship, access to markets) 2) Failure of Others – been deemed “virtually irrefutable” evidence of nonobv, but not persuasive if the person who failed had only scant knowledge of the prior art or, more important was not motivated to succeed due to satisfaction w/ status quo 3) Long Felt Need – did invention solve some long-standing problem 4) Copying of Others – especially when the accused infringer did not copy any other prior art, can be strong evidence of nonobv (how identical are the products?) 5) Licenses–evidence of extensive licensing may be persuasive of industry respect for invent. 6) Unexpected Results – did experts in the field believe the results were possible? > did the prior art teach away from the discovery – known disadvantages in old devices which would naturally discourage the search for new inventions may be taken into account as evidence in determining nonobv 18 VII. SPECIFICATION – OBJECTIVE DISCLOSURE § 112 Applicant must disclose (In order to allow others to practice invention): 1) How to Make (Enablement) 2) How to Use the Claimed Invention 3) Written Description of the invention 4) Best Mode 1) Enablement Requirement: patent itself must enable others skilled in the art to practice the disclosed technology. Rationales for the Enablement requirement: a. to make, construct or use the same so that the public may have the full benefit thereof. > must teach the public how to do it in order to receive the patent award quid pro quo. b. ensures scope of a patent claim accords w/ the extent of the inventor’s technical contribution. If granted Broad Claims and don’t deserve b/c of lack of enabling then No incentive for others to do research and improve. * Enablement Disclosure: Cannot be Indefinite. It must be specific enough to enable a skilled practitioner to accomplish the invention in its best mode or to make an operable device. Question of LAW. > A vague specification, one that requires the skilled practitioner to do the invention by trial & error, is not an enabling disclosure and thus is invalid. > An application must contain clear, sufficient information on how to use the invention. - specification must give a description that is “clear, concise and exact” - broad, unclear or not exact specification would include too much > Patents are NOT production documents, not required to give specs/plans to enable mass production: just enough for one skilled in the art to be able to make c. Critical Date for Enabling Disclosure = Filing Date – must have the enablement requirement met before filing ~ if no enabling then no filing date, or loose filing date. d. Not a function of the claims to specifically Exclude all possible inoperative substances/ combos… But, if # of inoperative combos become significant (leading to excess experimentation) then the claims might be invalid. > Some experimentation is OK to adapt to a to a specific and narrow application. 3) Written Description: A patent requires both a written description of the invention and a written description of how to make and use the invention. > Drawings can be sufficient to provide the “written description” of the invention. 2) How to Use the Claimed Invention: helps ensure a disclosure will truly be enabling. > Typically fulfilled by specifying times, dosages or other details wrt a product > Fairly Subject test, requiring the applicant to reveal what he knows about the invention > But if know how to make something, invention may come later (O-ring) for processes. 4) Best Mode: Flexible requirement. Not nec the best mode that is theoretically possible. It must be the best mode of which the inventor is aware of at the time of filing the application. Specification must satisfy a dual-pronged best mode inquiry: 1. Subjectively, whether the inventor knew of a better method than the one disclosed, & 2. Objectively,whether the disclosure is adequate to direct those skilled in the art of practicing § 132 Introduction of New Matter: (1 yr grace period allows inventors adequate time) > can’t come back (amending) and claim something you didn’t originally disclose > Limitation: can’t freely amend; makes inventors ensure basic patent apps are solid 19 VIII. CLAIMS A. Claims must stand alone to define the invention: § 112, 2 Requires that claims “Particularly point out & distinctively describe the invention.” > Claims define the inventor’s rights, and, in light of the specification illustrate how the invention fulfills the requirements of novelty, utility, and nonobviousness. > Claims can NOT reference specifications or drawings (omnibus claims rejected) B. Claims set forth the proprietary technological rights possessed by the patentee. Establish the ‘metes & bounds’ of the patentees claim. Claims describe the perimeter of the invention. > Important that claims give notice to competitors/public of what the invention covers. C. Claims fulfill the basic functions of the patent laws, protecting the inventor by preventing exploitation while requiring that patentability be clear. D. Language of the claims must be Descriptive and NOT Functional. Functional Language describes the invention’s effect on other things but fails to describe the invention itself. E. Patent Claim Formats: (1 Sentence Rule) 1. Preamble – may or may not constitute a limitation: must look to the entirety of the patent 2. Transition Phase – depending on the words, either expands or narrows the scope of claim; tells the reader the claim is opened or closed to additional elements. a. Comprising – Open Transition – captures technologies w/ all the elements described in the body of the claim; whether the technology has additional elements is irrelevant. > Open terminology is used to capture elements in addition to the enumerated elements. b. Including – Open c. Consisting – Closed – Limits Claim; Closed to additional ingredients. Infringement can occur only when the accused technology has exactly the same elements recited in the claim. (Thus selling a composition with ingredients A+B+C+’X’ is outside the literal scope of the following claim): > A composition consisting of: i. element A; ii. element B; iii. element C > Closed Language helps prevent running into prior art: d. Consisting Essentially of – Partially Closed: Renders the claim open to include additional elements that do not materially affect the basic and novel characteristics of the claimed combination. > If element ‘X’ would not materially change the composition, then A+B+C+’X’ is within the scope of this “consisting essentially of” language. But, if ‘X’ would materially change the properties versus A+B+C alone, then the combo w/ ‘X’ is NOT within the scope of the claim. 3. Body of the Claim - Provides the elements of invention, as well as how these elements cooperate either structurally or functionally. - Elements introduced w/ indefinite articles: a, an, one, several, a plurality of. - When noted later in the claim: the, said > if introduced w/ “the” usu rejected as lacking “antecedent basis” - Dependent Claims must recite an earlier claim 20 * Each claim should be read giving the words the meaning and scope which they normally have in the relevant art, unless in particular cases the description gives the words a special meaning. F. Product-by-Process Claims ??? 1. In Some circumstances a new product cannot be defined other than by the process of making it. >Product-by-Process claim specifies a product defined only by several process steps > Standard Rule – A product claim covers that product regardless of how it is made. * Product-by-Process Claims are NOT limited to product prepared by the process set forth in the claims. 2. PTO may treat product-by-process claims more like a product claim for patentability: giving claims broadest possible interpretation > Process terms in product-by-process claims serve as limitations in determining infringement 3. Treatment of in i. Patentability Determinations vs. ii. Infringement. G. Functional Claiming (Mean plus Function Claims) – vs. Traditional Structural Approach § 112 6 1. Permits an inventor to state the function of a particular element generally, w/o specifying it further, instead using the general term “means.” ie, means for generating thrust > Such claims will read to cover every conceivable way of achieving that function > But, these type of claims often run up against prior art 2. In construing means-plus-function language in a claim, one must look to the specification and interpret the claim’s language in light of the description given in the specification. i. Look to Patent Claim ii. Look to Specification & Equivalents iii. Look to Prior Art > Can NOT just read the claim > Patentee only gets what was described in the specific > no distinction between prosecution in the PTO & enforcement in the courts. 3. The Broadest Reasonable Interpretation that an examiner may give means-plus-function language is that statutorily mandated in § 112 6 – Thus, the PTO many NOT disregard the structure disclosed in the specification corresponding to such language when rendering a patentability determination. H. Claim Definiteness, § 112 2 1. A claim is valid under § 112 if those skilled in the art would understand what is claimed when the claim is read in light of the specification. > claim does not have to describe the invention (role of disclosure portion of specifi) 2. “Full, clear, concise, and exact requirement” applies only to the disclosure portion, and not the claims. 21 3. Indefinite words (about, approximately, close to…) are acceptable in certain circumstances, “when serving reasonably to describe the claimed subject matter to those of skill in the field of the invention, and to distinguish the claimed subject mater from prior art.” 22 IX. PROSECUTION A. Administrative Process of acquiring a patent. 2 Major areas of concern: 1) Inventorship 2) Inequitable Conduct B. Overview of Patent Prosecution. 2 Types of Applications: 1) Provisional (P) § 111(b) – simplified requirements – need NOT include patent claims - PTO does NOT examine, and automatic abandonment after 12 months - main importance ~ entitles NP applications of the same invention to the earlier filing date of the P application - allows applicant time to perfect before filing the NP; once NP filed still get full 20 yr 2) Non-Provisional § 111(a): normal process, examined by PTO examiner C. Inventorship: § 102(f) – patentee must be the actual inventor of the patented technology (or else not entitled to a patent) – Question of Law, thus freely reviewable on appeal 1. Joint Inventors: § 116: If two or more inventors they must (shall) apply for patent jointly - May be Joint Inventors even though: 1) they did not physically work together or at the same time 2) each did not make the same type or amount of contribution, or 3) each did not make a contribution to the subject matter of every claim of the patent 2. To constitute a joint invention, each of the inventors must work on the same subject matter and make some contribution to the inventive thought & to the final result: - Some collaboration is required, > But is NOT necessary that each inventor participate in the entire inventive process > Joint inventors can NOT be totally independent of one another D. Inequitable Conduct: 1. Ex Parte process demands candor from applicants in order to work. 2. Applicant must disclose prior art to the PTO Relevant to the pending application. > PTO searches may not be comprehensive – extreme workload (presumed valid) 3. An applicant (& agents) have the affirmative duty to disclose material information. > Applicant must have a “deceitful intent” – more than simple negligence is needed, but something less than conscious fraud is required to constitute a breach of the duty of candor. - Gross negligence may be enough. > Equitable Question reviewed under an Abuse of Discretion standard. 4. Inequitable Conduct is the intentional failure to disclose material prior art – this results in the unenforceability of the resulting patent. (Molins PLC) 5. Material Information: when there is a substantial likelihood that a reasonable examiner would consider it important in deciding whether to allow the application to issue as a patent. 23 - Duty to Disclose Material info codified in 37 CFR § 1.56 (Rule 56): Not adopted by Case Law- Information is material to patentability when it is NOT cumulative to info already of record, or, being made of record in the app., &: 1) it est. a prima facie case of unpatentability of a claim (by itself or w/ other) 2) It refutes or is inconsistent w/ a position the applicant takes in: i) Opposing an argument of unpatentability relied upon by the PTO ii) Asserting an argument of patentability E. Double Patenting: Issuance of only a single patent per invention is allowed. §101 “a” patent. ~ judicially created 1. Policy: Inventors might be enticed to attempt to extend patent protection beyond the stat period. by filing a serious of related patent applications covering the same invention. 2. May attempt to claim only certain features of their inventions and later claim the others 3. Nobody may duplicate a prior invention & obtain a patent for it. > Thus, if an inventor is to obtain an invention related in any way to an earlier invention, it must be clear that the 2nd invention is distinct & substantially different from the 1st. * If the matter sought to be covered in a subsequent patent is inseparably involved in the matter embraced by a former patent, this constitutes “double patenting” and it renders the subsequent patent invalid/void. > ie, normally able to patent both a machine & a composition of matter produced by it if both are independently patentable. But, if it were impossible to produce one w/o inevitably producing the other (that machine only way to produce that matter) then the two inventions are the same and the double-patenting bar would apply. >DP does NOT occur when one makes & patents an improvement on patent invention 4. Analysis of DP requires: (In re Vogel) 1) Determining whether the same invention is being claimed twice, > obj test – whether one of the claims could be literally infringed w/o literally infringing on the other & 2) whether the claim is an obvious variation of an already disclosed invention. 5. Terminal Disclaimer: allows inventors to incorporate later developments into original patent, & clarify the reach of the patent w/o violating DP rule. Inventor agrees to allow the second patent to expire simultaneously w/ the 1st. 24 X. POST GRANT PROCEDURES A. Magnitude of Mistake determines which procedure will by employed: 1. Certificate of Correction: § 254-5: Most frequently used & least onerous (if agents fault fee & proof the error occurred in good faith). ?? 2. Reissue Patents are available to cure defects caused by various errors in the original patent. §251 - allows applicants to correct more significant errors affecting the validity & enforceability of an issued patent. But NO new matter shall be introduced. > Reissued patent will date back to the original patent and therefore (-1 exception) the reissued patent must be identical to the original except for the correction of errors. > Exception: May broaden the scope of claims if applied for w/i 2 yrs of grant original patent * Reissue when (2 Requirements of the statutory oath): 1) Error in Patent: patent is defective or partly inop/invalid b/c of defects in the spec or drawin or b/c patentee has claimed more or less than entitled to (addition of narrower claims, by itself, is NOT an error – then what would be an error ?) & 2) Error in Conduct: that defective inop/invalid patent arose thorough error w/o deceptive intent (by accident, inadvertence or mistake) – Must tell how error occurred, can’t just parrot the statutory language >Invalidation of new claims on reissue does not invalidat the original claims- (open to public) - Broadening Claims on Reissue (expanding the scope): 2 year Statute of Limitations. > If reissue began before the 2 yr SOL, the patentee must have began the proceeding with an intent to broaden in order to introduce broadened claims during the course of the proceeding: > public must be placed on notice of patentee’s intent, ie, a reissue for purpose of changing drawing would not work (couldn’t try to change claims after 2 yrs). - Recapture Rule: prevents a Reissue applicant from broadening a claim that he abandoned in the original application. Can’t recapture in reissue what you ‘gave up’ in prosecution. > comes into play if an applicant cancels claims from the original application, Patentee is free to acquire claims that are narrower in scope than the canceled claims. > this material is already dedicated to the public - Uncorrectable Errors: Some errors are simply too grave to be corrected through reissue: 1) Don’t meet § 112 requirements 2) Applicant Engaged in inequitable conduct (prevents ‘Sandbagging’ the PTO) 3) Invention anticipated under § 102 b. An original patent cannot be infringed once a reissue patent has been issued, for the original patent is surrendered. (Seattle Box Co.) c. Intervening Rights: A Reissue patent shall not abridge or affect certain rights of those who acted before the reissue was granted. § 252. Arise When: 1) Claims have been changed in scope; 2) Offending acts began prior to the issuance of the reissued patent; & 3) Infringement is only of the altered claims (none of infringed claims in original) > Absolute: products already built before the grant of the reissue patent > Equitable: made substantial preparations to make (inventory on hand, machines built) - Ct. has broad discretion to mold a compromise 25 - Claims of reissue normally reach back to the date of original patent issue, but only if those claims are identical to the original patent, wrt new claims, infringer’s liability commences from date reissue is granted. - Infringer may enjoy a “personal intervening right” to continue what would otherwise be infringing activity (Policy – public has right to what was not claimed in original) 3. Reexamination: § 302-7: more limited – allows anyone to request that the PTO reconsiders the validity of a patent over a patent or printed publication NOT before the examiner during the original prosecution. Must cite a patent or printed publication to the PTO for grounds. § 303 * Statute limits reexamination to a substantial new question of patentability & does not authorize repetition of a rejection on grounds resolved in applicant’s favor during the original examination. > Reexamination of the same claims in light of the same references does not create a substantial new question of patentability (Jurisdictional question) > Issues of fraud or breach of the duty of candor are not considered in reexam (as w/ Reissue): Differences between Reissue & Reexamination on page 808. * if no error, patentee may have to choose Reexam route (Reexam no presumption of validity at PTO?) 26 XI. INTERNATIONAL PROSECUTION A. Paris Convention: 1) National Treatment in Article 2 - if a member of the Treaty you have to treat a foreigner as a citizen 2) Article 4 – idea of priority ~ Basic concern of treaty (1yr grace period) 3) Independence of Rights – 4b – no strings to corresponding patents as far as validity - no tying of expiration dates, follow the law of each country * Claims are entitled to the benefit of their foreign priority date under § 119 only if the foreign priority application properly supports them as required by §112. B. Hilmer Rule 1. Hilmer I – The effective date of a US patent used as a prior art reference is the date the application therefore was filed in the US and not a foreign “convention” filing date to which the patentee of the reference is entitled by statute. 2. Hilmer II – The foreign priority date of a US patent cannot be used as the effective filing date of the patent when it is used as a prior art reference. 3. If the foreign filing date is used as a priority date in a US patent interference, the interference decision may be cited as the basis for rejection of further claims. I. Paris Convention 1. Equal treatment to citizens and foreigners 2. Right of priority application in any country bound by the Convention within 12 mon. for patents and utility models, or 6 mon. for industrial designs and trademarks maintain an earlier priority date of initial filing II. Implementation of rules in US 1. Benefit of earlier filing date (Right of Priority) 35 U.S.C.A. § 119 initial application for a patent for the same invention in a foreign country which affords similar privileges, or in a WTO country, US filing w/in 12 mon., same effect as the same application would have if filed in this country on the date 2. Benefit of earlier filing date in US 35 U.S.C.A. § 120 US continuation application – take the original filing date 3. Hilmer Rule (co-pending patent applications – for patent defeating purpose): A filed in X on D1 → filed in US on D3 → obtained US patent on D5 B filed in Y on D2 → filed in US on D4 (1) interference proceedings: A is 1st inventor under §102(e) filing in US; 1 yr grace period under §119 (2) non-obvious issue: prior art status as of the US filing date (D3) under §102(e); B has filing date of D2 under §119 → no prior art 4. Judicial doctrine of interference estoppel A party is precluded from applying for a patent on the subject matter patentably indistinct from that of the interference accounts on which he lost (A first R/P of invention, suppressed until B filed a foreign application, A lost on interference proceedings; patent application containing same claims is barred – 2nd interference involving priority date dispute ← res judicata principle) III. International Agreements 1. Patent Cooperation Treaty (PCT) a) File a PCT application in the home country designating the states protection is desired, b) Prior art search, a) International preliminary examination 19 mon. from priority date, b) National stage w/in 30 mon from priority date 27 2. European Patent Convention (EPC) A single European application in Munich w/in 12 mon. 28 XII. INFRINGEMENT § 271(a) Whenever w/o authority one…. makes, uses, offers to sell. or sell or imports any patented invention they infringe the patent. A. Determination of Patent Infringement is a two-step process: 1) Determination of the meaning of the claims, construed in light of the specification– analyzing the claims by studying all of the relevant patent documents, to find what are the claims’ patentable advances over the prior art: Claims determined in light of the specification - analyzing prosecution history, prior art and other claims. a. Claim Construction is a matter of law for the court to decide and the standard of review on appeal is de novo. Yet, ultimate ? of infringement still to jury. b. If the language of a claim is clear, and a different meaning would render express claim limitations meaningless, there will be no speculative interpretation of claims. c. Limitations from the Specifications is generally not permitted but the claims must be read in light of the specifications (spec can be a source of context for the meaning of a claim). - Strong presumption that claims should be interpreted on the preferred embodiment. d. In construing the meaning of words in a claim, when presented a choice, the narrower meaning of a word in a claim controls. e. Claim Differentiation, assumes that different claims apply to different devices or processes. 2) Read the claims onto the accused structures – Claims must be “read on” the accused device or process. Literal Infringement. For infringement – each & every element of the claim must be found in the alleged infringement (assumes each & every element of a claim is material & essential). > addition of elements beyond recited in a claim – depends on transition phrase > Means that the device or process is examined to see if it is substantially described by the claims; in other words, the claims are tested to see whether they describe the accused infringement. a. Literal Infringement vs. Doctrine of Equivalents Patent = Claims “a+b+c+d” - Literal Infringement ~ must have each and every element ~ must have at least “a+b+c+d” to Infringe - may also have “a+b+c+d+e+f” > this too would infringe > Addition of elements beyond recited in a claim – depends on transition phrase b. Doctrine of Equivalents: that each element of an invention need NOT be identically present in the accused infringement, all that required is a substantial equivalent. ~ does NOT expand the scope of the claims per se, but it has that effect. > Question to ask is whether the structure performs substantially the same function in substantially the same way & for substantially the same purpose 29 * something is substantially equivalent if the skilled practitioner would know of the practical interchangeability of the accused infringement’s elements w/ those specifically ID in the patent specification. * Determination of Equivalence should be applied as an objective inquiry on each individual element of the claim, rather than the process as a whole. > Doct. confined to finding that each and every element of a claim, or its functional equivalent, is found in the alleged infringement (All Elements Rule) Policy for Doctrine of Equivalents: is meant to discount the presence of minor changes and substitutions in the accused infringement. Prevent Fraud. § 112 6 pg. 674 * Different Doctrine of equivalents is used to interpret the scope of a means-plus-function claim. In means-plus-function, what the S. Ct. has characterized as a “limiting” doctrine of equivalents prevents those claims from having unlimited scope (that is, limiting means-plusfunction claims to only equivalents of what appears in the specification). > can only apply claim to what you disclose in the specification & equivalents thereof B. Prosecution History or File Wrapper Estoppel ~ Festo 1. Limits the Doctrine of Equivalents: Festo Holdings pending S. Ct. > Any Amendment to a claim is presumed to be made for reasons of patentability: a substantial reason for patentability is not limited to overcoming prior art, but includes other reasons related to the statutory requirements for a patent (112 issues !) > Thus, any amendment that narrows the scope of a claim for any reason related to the statutory requirements for a patent will give rise to prosecution history estoppel. > Voluntary claim amendments are treated in the same manner. > When invoked NO Range of Equivalents is available. ~ Festo provides clarity for all, gives a bright line test ~ Notice function given more importance than the prevention of fraud against patentee ~ But the ruling virtually kills the doctrine of equivalents (people may opt out of patent sys.) Policy for Prosecution History Estoppel: NOTICE Requirement – want to tell the public where the line might fall, and in order to determine that line you have to look at the file history to determine infringement. > the inventor should not be entitled to a broader scope if they gave up that opportunity during prosecution. C. Prior Art Limitation to the Doctrine of Equivalents: 1. If the scope of equivalency necessary to find infringement would cover prior art, there can be no infringement. (Wilson) > Can’t extend Doct of Equivalents to cover that which is already in the public domain Policy: Patentee should not be able to obtain, under the Doct of Equivalents coverage, which he could not have obtained from the PTO by literal claims (prior art limits claims). ? 2. Hypothetical Patent Claim: Sufficient in scope to literally cover the infringing product only helpful ii) would the hypo claim be allowed by the PTO over the prior art? Burden on . 3. Whether the Prior Art Made Obvious the invention as a whole for which patentability is 30 claimed, - NOT whether each element existed in prior art. D. Reverse Doctrine of Equivalents: 1. Where a device is so far changed in principle from a patented article that it performs the same or similar function in a substantially different way, but nevertheless falls within the literal words of the claim, the doctrine of equivalents may be used in reverse to restrict the claim & defeat the patentee’s infringement action. 2. Usually results when patentee is granted a very broad claim that Reads upon the accused device literally.(ie, Japanese Bamboo case where prior claim was for all carbon fibers) 3. Patentee has initial burden to prove infringement, then accused may take burden of Revers Policy: Prevents an unfair & unwarranted extension of the claims beyond a fair scope of the patentee’s invention. Application: see notes. pg 983. E. Experimental Use Exemption to Infringement: Medical / Drug problems w/ obtaining FDA ok. pg. 986 1. § 271(e)(1) – exempts otherwise infringing activity that is “solely for uses reasonably related to obtaining FDA approval.” * Sole question is whether the actual uses solely relate to the development & submission of information to the FDA. 2. Objective Test that focuses on actual conduct rather than motive or ultimate aim. 3. “Reasonably Related Standard” = whether it would have been reasonable for a party in the ’s position to believe that there was a decent prospect that the uses in question would contribute (relatively directly) to the generation of information relevant to FDA approval. Policy: Congress elevated the public access to medically beneficial new products at competitive market prices over continuing full protection of patent. F. Indirect Infringement ~ § 271(b) & (f) 1. In order to find active inducement, the court must find intent to cause acts that would result in infringement & an actual awareness of the Patent? > Mental state of the inducer is key, must be an active state of inducement. * Intent = one need only intend “the acts which constitute infringement” to be found liable under the theory of inducement of infringement. > Must be some connection between infringer & inducer. 2. Inducer is liable as an infringer subject to all remedies & damages. - ie, sell plans, tell another how to infringe, sell kit w/ instructions (didn’t put toget) 3. Law can be used against foreigners when inducement occurs in the US but products made outside 4. Agreements to Indemnify est. intent to induce infringement only if they were made for the purpose avoiding the deterrent effect of Patent Law. ~ rarely will this happen. 5. § 271 (b) vs. (c): 271(b) – situations where the technology has multiple uses, only one of which infringes. > 271(c) – addresses situations where only a single substantial infringing use exists. 31 G. Indirect Infringement ~ Right to Replace Unpatented Parts or to Repair 1. Mere Replacement of Individual unpatented parts is no more than the lawful right of the owner to Repair his property & is not infringement. 2. Implied Right to Repair: (Aro): purchaser of patented goods obtains an implied license to repair a patented good. Mere replacement of individual unpatented parts one at a time, whether of the same part repeatedly or different parts successively, is the lawful right of the patent owner to repair his property. > thus, those that sell replacement parts to the patentee’s customers cannot be held to have committed contributory infringement. > doctrine encompasses any repair that is nec. for the maintenance of the ‘use of the whole’ of the patented combination through replacement of a spent, unpatented element. – doesn’t matter if specification teaches that the particular part may be replaced. > Item is spent, effectively, when it is neither practical nor feasible to continue using an element that is intended to be replaced. H. Process Patents ~ Protection under § 271(g) from Foreign Imports - where a process patent exists in the US, then another infringes the process overseas and imports the product into the US > prior to amend. would have been NO infringment - if a product patent as soon as sold in US would have infringed 1. For purposes of the Process Patent Amendments Act 271(g), a “material” change in a compound is a significant change in the compound’s structure & properties. 32 XIII. EQUITABLE DEFENSES ~ § 282 * Time limitation on damages: § 286 – NO recovery for any infringement committed > 6 yrs. A. Laches & Equitable Estoppel: Both are Legitimate defenses to patent infringement suits. 1. Laches: 2 elements: i. the patentee’s delay in bringing suit was unreasonable & inexcusable; & ii. the alleged infringer suffered material prejudice attributable to the delay >Justifications of delay: other suits, negotiations (offering licenses), extent of infringement, dispute over ownership of the patent, poverty and illness under limited circumstances > A presumption of Laches arises if the patentee delayed bringing suit for 6 years after the patentee knew or should have known about the alleged infringement. This presumption shifts the burden of going forward w/ the evidence, not the burden of persuasion. > Laches – not a total defense: not permitted to recover damages prior to suit but is allowed to recover after trial. 2. Equitable Estoppel: 3 elements: i. the patentee through misleading conduct led the alleged infringer to reasonably infer that the patentee did NOT intend to enforce the patent; & ii. the alleged infringer relied upon the conduct of the patentee; & iii. because of its reliance the alleged infringer would be materially prejudiced if the patentee may proceed with its claim. > Estoppel – the gets NOTHING, estoppel may occur quicker & requires some sort of communication directly to infringer * If the reason for the delay is Litigation, ct. may be more lenient, esp if informs of such delay. B. Shop Rights: The right of the employer to utilize the patented invention of an employee, devised and completed during working hours & with the employer’s facilities & equipment, w/o the payment of royalties. 1. Whether an employer has “shop rights” to patented subject matter requires a look at the totality of the circumstances to determine whether principles of equity & fairness demand a finding that a “shop right” exists. > Shop Rights labeled as both a type of implied license & a form of equitable estoppel > look at circumstances of invention; & inventor’s activities; any K?; - did inventor use employer tools & time? - inventor’s inducement, assistance, consent, or acquiescence of use 2. Inventor still maintains rights to exclude all others. 3. General Rule is that (absent a K stating otherwise), an independent discovery is the employee’s unless he was acting w/i the scope & purpose of his employment at the time. - “Shop Right” is the exception C. Prior user rights - offer entities which had employed a technology prior to the priority date of an application the possibility of continuing to employ that technology even after the a patent is issued 33 IX. REMEDIES Remedies for infringement under the Patent Act consist of: 1) Injunctive Relief (§ 283) 2) Damages, Adequate to compensate the but in no case less than what would constitute a reasonable royalty (§ 284) > these damages can be trebled when appropriate 3) Attorney’s fees in Exceptional Cases (§ 285) 4) Costs (§ 284) 1. Injunctive Relief a. Always ask for a Temp. Injunction: Ct. has discretionary authority to grant or deny a preliminary injunction in patent infringement cases. > Applicant for a prelim inj. bears the burden of proving: i) a reasonable probability of success & ii) irreparable injury if the motion is not granted - Ct should take into account, if relevant, the possibility of harm to other interested parties () & the public interest. {balance the hardships} b. Irreparable injury is presumed upon a clear showing of patent validity &infringement 2. Damages. To Obtain Lost Profit/Sales Damages, a patent owner must prove, Panduit 4 factor test: 1) A Demand for the patented product, 2) Absence of Acceptable non-infringing substitutes, 3) Capability to exploit the demand, & 4) The amount of profit he would have made. * Patentee need only show that there was a reasonable probability that the sales would have been made “But For” the Infringement. * If a particular injury was or should have been reasonably foreseeable by an infringing competitor in the relevant market, that injury is compensable–are the consequences too remote to justify this award? (non-patented) * Entire Market Value Rule: Requires that the unpatented component must function together w/ the patented component in some manner to produce a desired end. - separate component parts must constitute a functional unit. (can’t just be marketed together) – did patent substantially create value of other part? > When Lost Profits cannot be proved, the patent owner is entitled to a Reasonable Royalty, which is an amount that a person desiring to make and sell the product would be willing to pay as a royalty and yet be able to make a profit. - Factors that should be considered in determining a Reasonable Royalty: 1) the lack of acceptable non-infringing substitutes 2) Patent holder’s policy of not licensing the patent, 3) Future business & profit patent holder would expect to lose by licensing a competitor, & 4) The Fact that the infringed patent gave the entire market to patent holder 34 3) Treble Damages: whenever it is shown that the plaintiff was damaged to a greater extent * The main determination in deciding to grant damages enhancement is the egregiousness of the ’s conduct. Should be granted in cases of bad faith litigation & “willful infringement” No set standard, but the Ct. will look to several factors: Bott factors - Deliberate copying the designs or ideas of another - Willfulness - Failing to investigate the scope of patent or investigated & formed good faith belief of non - Duration of ’s misconduct ~ & ~ any remedial action by the - ’s attempts at concealment & their motivation for the harm. - “Bad” behavior during litigation – manipulative strategy. * Clear & Convincing is the std. > Design Arounds should be encouraged, also modifications to avoid infringement. 4) Attorney’s Fees: Exceptional Cases (as outlined above). > Either the or may recover attorney’s fees - ie, when a obtains a patent by fraud or brings an infringement suit w/ no good faith belief that his patent is valid & infringed. B. Marking ~ Notice 1) Implied licensees are required to mark the invention under § 287. > such markings fulfill the policy goal of notifying the public concerning the patent status of items in commerce. *If one fails to mark they are precluded from receiving damages prior to the date of notification of infringement. 2) For purposes of § 287, notice must be of the infringement, not merely notice of the patent’s existence or ownership. Actual notice requires the affirmative communication of a specific charge of infringement by a specific accused device. 35 X. PATENT LICENSING * Patents shall have attributes of personal property > among those alienability § 261 Patents are assignable at law by an instrument in writing Ownership – concerns who owns the legal title for, and consequently the right to exercise, the right to exclude defined by the patent. A. 2 Forms of transfers: 1) Assignments – a conveyance of the right to exercise the right to exclude – vests in the assignee a title in the patent w/ a right to sue infringers. 2) Licensees – anything short of an assign. Gives licensee NO title in the patent & NO right to sue in their own name. 1. Assignments: (look at the legal effect of a K) a. If patent rights are assigned they must be Recorded at the PTO w/i 3 months of conveyance or else a later purchaser of the same rights w/o notice of the first sale of rights can void the 1st conveyance. - Subsequent innocent (w/o notice) buyer could obtain title to a patent b. Assignments should indicate a clear intent to pass title to the patent 2. License: merely a promise not to sue usu in exchange for a promise to pay royalties a. Exclusive License: Gives licensee more rights, able to join licensor & sue in federal court under their own name. b. Claiming to be a licensee is an affirmative defense against a suit for patent infringement c. Implied Licenses ~ to sell/use – 1st sell rule allows resell. d. Licensee Agreements (meat of): pg. 1232 e. Compulsory Licensing – Fed Govt’ for Reasonable & entire compensation. pg. 1235. 3. Licensee Estoppel: a. NO longer permitted: the licensee may be the only one with an economic incentive to invalidate the patent. We do not want invalid patents being enforced in the system. b. Lear – held licensee estoppel was preempted by the federal interests favoring free access to inventions. c. Licensee can not invoke the protection of the Lear doctrine until it: i) ctually ceases payment of royalties ii) provides notice to the licensor that the reason for ceasing payment of the royalties is b/c it has deemed the relevant claims to be invalid. 36 d. NO- Contest Clauses & Misuse – Lear holds unenforceable license provisions that purport to deny licensees the ability to contest the validity of a patent – But that is NOT Patent Misue – and patent is not invalidated 4. Assignor Estoppel: (employment situations) a. the assignor who would challenge the patent has already been fully paid for the patent rights that they once claimed were valid & enforceable. b. equitable doct. that prevents injustice & unfairness in order to prevent one from benefiting from his own wrong. Equities outweigh patent policies. B. Misuse & Patent Anti-Trust: § 271(d) – Things that do NOT constitute misuse on behalf of Patent owner Patent Misuse = Equitable defense to a charge of infringement 1. The owner of a patent on a chemical process is not guilty of patent misuse & is NOT barred from seeking relief against contributory infringement of its patent rights, if it exploits the patent only in conjunction w/ the sale of an unpatented article that constitutes a material part of the invention and is not suited for commercial use outside the scope of the patent claim. Dawson: 2. Patent misuse charges should be evaluated under anti-trust principles, and there is no AT prohibition against a patent owner’s using price discrimination to maximize his income. Posner – so long as no anticompetitive effect should allow. Patent misuse doctrine 35 U.S.C. § 271 (c) and (d) a) A patentee’s effort to control the market of unpatented components (selling unpatented articles used w/, or part of patented device = “tie-ins”) staple → misuse nonstaple (narrowly defined) → no misuse (chemical for invented process – no other commercial use, inventor sold chemical w/ instrument → no misuse on inventor, manufactured and sold the chemical → contributory infringement) b) Expressly conditional sale of patented goods (restricted license) i) Test Whether it is reasonable w/in the patent grant, or Whether the patentee has ventured beyond the patent grant and into behavior having an anticompetitive effect not justifiable under the rule of reason ii) Permissible if: not illegal in nature, and agreed by the licensee iii) Per se illegal restrictions (public policy) (1) Resale pricing-fixing (2) Tying-in restrictions (3) Royalties beyond the expiration of the patent (4) Measure royalties by the sales of unpatented end products (5) Require licensees not to make any items competing w/ the patented items (purchase of patented medical device on condition of single use, safety consideration) 37 (license to make and sell amplifier embodying the patented invention fro a specific use, purchased one from the manufacturing licensee w/ knowledge of restriction → illegal) 3. Patent antitrust law a) Any practice impairs competition substantially b) Tying-in sale if patentee has economic power in the market for the tying product – burden on patentee Exception: protection of goodwill (discriminatory royalty schedule – higher royalty rate for sub-license → no evidence on competitive effects, permissible maximizing income from patent) Other Forms of Patents 1. Design patents 35 U.S.C. § 171-3 Any new, original and ornamental design for an article of manufacture (non-utilitarian) a) Test: whether functional aspect or purpose could be accomplished in many ways in this particular design Individual feature may have functions – look at overall design (athletic shoe outer sole) b) Requirement: non-obviousness → one of ordinary skill in the art > Factors: scope and contents of prior art difference between the prior art and claims level of ordinary skill in the art commercial success and copying c) Infringement In the eye of an ordinary observer, where two designs are substantially the same and the resemblance is such as to deceive the observer 2. Plant patents 35 U.S.C. § 161 Asexually reproduces any distinct & new variety of plant A single claim Full and complete disclosure and characteristics that distinguish it from others a) Variety (1) Sports (bud variation and not seed variation), (2) Mutants (seedling variation by self pollenization of species), (3) Hybrids (seedlings of cross pollenizartion of two species), (4) Newly found seedlings Exception: found in an uncultivated state b) Distinct habit immunity from disease resistance to cold, drought, heat, wind or soil conditions color of flower, leaf, fruit, or stems flavor productivity storage qualities perfume form ease of asexual reproduction c) Asexual reproduction Reproduction by grafting, budding, cutting, layering, division, and the like, but not by seed d) Infringement Patentee’s burden to prove: the alleged infringing plant is asexually reproduced, directly or indirectly of the patentee’s original parent plant (actual, physical taking from the plant discovered by the patentee) 3. Plant variety protection Sexual reproduction (bio- or genetically modified hybrids → different plant variety) 38