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European and US Patent Law


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presentation gives a wide overview of US and European Patent Law.

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European and US Patent Law

  2. 2. 11/25/2012 2Agenda• US Patent Regime 1.Patentability of Inventions 2.Utility 3.Anticipation 4.Obviousness 5.Enablement• European Patent regime• Questions
  3. 3. 11/25/2012 3 • US PATENT REGIME I. Title 35 USC & Title 37 CFR II. Patentability
  4. 4. 11/25/2012 4Title 35 of the US Code governsPatent law Consists of 37 chapters (376 sections of which 149 of are used). Title 35 has four parts: Part I—USPTO Part II—Patentability of Inventions and Grant of Patents Part III—Patents and Protection of Patent Rights Part IV--Patent Cooperation Treaty
  5. 5. 11/25/2012 5CFR Title 37 – Patents, TM and © Code of Federal Regulations is the codification of the general and permanent rules and regulations. CFR must have an "enabling statute‖. USC is a codification of legislation; CFR is administrative law. USC precedes the CFR and contains statutes enacted by Congress. CFR spells out in further detail how the executive branch will interpret the law.
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  8. 8. 11/25/2012 6Patentabililty: Eligibility for grant The Applicant must be the inventor. Patentable subject matter (section 101) Novel and the application for a patent on the invention must be timely (section 102) The invention must be non-obvious (section 103) The invention must be sufficiently documented (section 112)
  9. 9. 11/25/2012 7 Patents issued by the USPTO-UTILITY PATENTS - generally permits patentee monopoly over making, using, or selling the invention for 20 years from the date of patent application filing, subject to the payment of maintenance fees.-DESIGN PATENTS-PLANT PATENTS-Reissue patents, defensive publication, statutory inventionregistration
  10. 10. 11/25/2012 835 USC 101 Inventions patentable 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
  11. 11. 11/25/2012 9What is patentable – (102 & 103) An invention must belong to one of these classes: a. Machine (eg. Mechanism with moving parts) b. Article of manufacture (eg. Hand tool or diagnostic kit) c. Composition of matter (eg. Drug) d. Process (eg. Of making nanotubes) PROCESS defined in 35 U.S.C. 100: - means process, art or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material.
  12. 12. 11/25/2012 10What is patentable Contd.e. New use or improvement of existing inventionf. Modified living organism (eg. Transgenic rice)g. Isolated or purified natural materials (eg. Purified proteins) - Mathematical formulae, chemical elements, laws of nature are not patentable. Gene Patents are patent on a specific isolated gene sequence, its chemical composition, the processes for obtaining or using it, or a combination of such claims. Gene patents are a part of the broader category of biological patents.
  13. 13. 11/25/2012 11 CasesFunk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127(1948): Kalo got patents on packaged mutually non-inhibitoryrhizobia species for inoculation into the roots of leguminousplants and for the process. Held unpatentable as:―qualities of these bacteria…are manifestations of laws ofnature‖―aggregation of species‖ISOLATES: The first patent for a human product was grantedon March 20, 1906 for a purified form of adrenaline. It waschallenged and upheld in Parke-Davis v. Mulford [2] JudgeHand argued that natural substances when they are purifiedare more useful than the original natural substances.
  14. 14. 11/25/2012 12 • US PATENT REGIME I. Utility II. Novelty III. Non-obviousness
  15. 15. 11/25/2012 13 Utility 35 USC 101Invention must demonstrate identifiable benefit and use; mustexpress a specific, credible, and substantial utility.• Operability whether the invention actually works or accomplishes the utility that the inventor claims• a beneficial use requires that the patented invention ―not be frivolous or injurious to the well-being, good policy, or sound morals of society‖. An invention is ‗useful‘ under section 101 if it is capable of providing some identifiable benefit.• practical use: in Brenner V. Manson a novel process for making a known steroid did not satisfy the utility requirement because the patent applicants did not show that the steroid served any practical function.
  16. 16. 11/25/2012 14Utility dilutedJuicy Whip, Inc. v. Orange Bang, Inc. dealing with a juicedispenser that arguably deceived the public into believingthat the liquid seen in the attached reservoir was that whichwas being dispensedGamblingToys to enhance sexual pleasure
  17. 17. 11/25/2012 15NoveltyPatent can be granted to an invention unless it(a) was known or 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 patent, or(b) was patented or described in a printed publication in US oranother country or in public use/sale in this country, more than 1year prior to the date of the application for patent in the US(c) Was abandoned by the applicant(d) patented in another country <12 months before US filing(e) the invention was described in - (1) a published US prior patentapplication
  18. 18. 11/25/2012 16(2) A patent granted before the invention or an internationalapplication filed under the PCT in English(f) he did not himself invent the subject matter sought to bepatented(g)(1) during the course of an interference it is established thatthe invention was made by another inventor and notabandoned, suppressed, or concealed. or (2) that the invention was made in this country by anotherinventor who had not abandoned, suppressed, or concealed it.Considerations:dates of conception and reduction to practice of the inventionreasonable diligence of one who was first to conceive and lastto reduce to practice,
  19. 19. 11/25/2012 17Nicholson paving caseCity of Elizabeth V. American Nicholson Paving: Nicholsonsought to patent a process for a system of pavement usingwooden blocks and sued the City of Elizabeth, NJ forinfringement. City claimed that he had publicly used thesystem for 6 years. Court found that he had been testing it inprivate conditions.Nicholson put down a section of his new pavement on aturnpike operated by a private corporation in which Nicholsonwas a shareholder and officer in 1848 in order to test itsdurability and the publics response to it. Supreme Court heldthat while the public use of an invention more than one yearprior to the inventors application for a patent normally causesthe inventor to lose his right to a patent, there is an exceptionto this rule for public uses for experimental purposes.
  20. 20. 11/25/2012 • ANTICIPATION "A claim is anticipated only if each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference."
  21. 21. 11/25/2012 19AnticipationVerdegaal Bros. v. Union Oil Co. of California, "When a claimcovers several compositions, either generically or as alternatives,the claim is deemed anticipated if any of the structures orcompositions within the scope of the claim is known in the priorart." Brown v. 3M (claim to a system for setting a computer clock toan offset time to address the Year 2000 (Y2K) problem,applicable to records with year date data in "at least one of two-digit, three-digit, or four-digit" representations, was heldanticipated by a system that offsets year dates in only two-digitformats.Richardson v. Suzuki Motor Co., The elements must be arrangedas required by the claim, but identity of terminology is notrequired.
  22. 22. 11/25/2012 20 Anticipation contd.35 U.S.C. 102 rejection over multiple references has beenheld to be proper when the extra references are cited to:(A)Prove the primary reference contains an "enabled disclosure;" In re Donohue, claims were rejected over a publication in view of two patents.• The publication disclosed the claimed compound structure• the patents taught methods of making compounds of that general class.The court held that the publication taught all the elements ofthe claim and thus motivation to combine was not required.
  23. 23. 11/25/2012 21 Anticipation contd.(B) Extrinsic evidence may be used to explain but not expandthe meaning of terms used in the anticipating reference.In re Baxter Travenol Labs. Baxter invented a blood bag systemincorporating a bag containing DEHP.The examiner rejected the claims over a technical progressreport by Becker which taught the same blood bag systemwithout expressly disclosing DEHP but disclosing thecommercial blood bag system as "very similar to Travenols."Extrinsic evidence (depositions, declarations and patenteesadmissions) showed that commercial blood bags containedDEHP. PHOSITA would have known that "commercial bloodbags" meant bags containing DEHP.
  24. 24. 11/25/2012 22 Anticipation contd.(C) Show that a characteristic not disclosed in the reference isinherent.Continental Can Co. USA v. Monsanto Co., accommodatessituations in which the common knowledge of technologists is notrecorded in the reference.Atlas Powder Co. v. IRECO, Inc., Two prior art referencesdisclosed blasting compositions containing water-in-oil emulsionswith identical ingredients to those claimed, in overlapping rangeswith the claimed composition. The only element of the claimsarguably not present in the prior art compositions was "sufficientaeration . . . entrapped to enhance sensitivity to a substantialdegree." The Federal Circuit found that the emulsions describedin both references would inevitably and inherently have "sufficientaeration―.
  25. 25. 11/25/2012 23Plant Patents (161)A plant patent is granted by the Government to an inventorwho has invented or discovered and asexually reproduceda distinct and new variety of plant, other than a tuberpropagated plant or a plant found in an uncultivated state.The grant, which lasts for 20 years from the date of filingthe application, protects the inventors right to excludeothers from asexually reproducing, selling, or using theplant so reproduced. Mutants, hybrids, and transformedplants are comprehended; sports or mutants may bespontaneous or induced.
  26. 26. 11/25/2012 24 Plant Patents Contd.Hybrids may be natural, from a planned breeding program, orsomatic in source. While natural plant mutants might havenaturally occurred, they must have been discovered in acultivated area. Algae and macro fungi are regarded as plants,but bacteria are not.In Pioneer Hi-bred Intl V. J.E.M. Ag Supply : Supreme Courtupheld the validity of sexually reproduced plants as subjectmatter for patent protection.Rejecting the argument that the 1930 Plant Patent Act2 (―PPA‖)and the 1970 Plant Variety Protection Act3 (―PVPA‖) precludedthe patenting of plants under section101
  27. 27. 11/25/2012 INFRINGEMENT A patent provides its proprietor with the right to exclude others from utilizing the invention claimed in that patent. Should a person utilize that invention, without the permission of the patent proprietor, they may infringe that patent.
  28. 28. 11/25/2012 26 Direct infringementA person directly infringes a patent by making, using, offeringto sell, selling, or importing into the US any patented invention,without authority, during the term of the patent.Unlike direct infringement, which does not require knowledgeof the patent or any intent to infringe.While the United States Patent Act does not directly distinguish"direct" and "indirect" infringement, it has become customary torefer to describe infringement under 35 U.S.C. § 271(a) asdirect infringement, while grouping 35 U.S.C. § 271(b) and 35U.S.C. § 271(c) together as "indirect" ways of infringing apatent.,
  29. 29. 11/25/2012 27Indirect InfringementAccused has some knowledge and intent35 U.S.C. § 271(b) "active inducement of infringement ―byencouraging, aiding, or otherwise causing another person toinfringe. Inducer must be aware of the patent and intend.35 U.S.C. § 271(c) "contributory infringement," is triggeredwhen a seller provides a part or component that, while not itselfinfringing of any patent, has a particular use as part of someother machine or composition that is covered by a patent.[3] Ifthere are other valid uses for the product.Only occurs when there has actually been a direct infringementof the patent. There must have been at least one instancewhere the inducement or contribution resulted in the practice ofthe patented art.
  30. 30. 11/25/2012 28 DefensesNon-infringement:to prove infringement, patentee must showthat each and every limitation of the asserted claim is presentin the accused product, either literally or equivalently. If thepatentee fails to show the presence of even a single claimlimitation, that is enough to negate an allegation of infringementof the claim. This is known in patent law as the ―all elementsrule‖.Attack the validity of the Patent and claims. Even if patent isdetermined to be valid, the Plaintiff must prove that everyelement of at least one claim was infringed.
  31. 31. 11/25/2012 29Defenses contd.Safe Harbour defense: Research for "purely philosophical"inquiry is not an infringement, but research directed tocommercial purposes is infringing. 1813 decision inWhittemore v. Cutter, Justice Story wrote that the intent of thelegislature could not have been to punish someone whoinfringes "merely for [scientific] experiments, or for thepurpose of ascertaining the sufficiency of the machine toproduce its described effects.―Hatch-Waxman process – Where research is directedtoward obtaining approval of the Food and DrugAdministration (FDA) for introduction of a generic version of apatented drug
  32. 32. 11/25/2012 30RemediesReasonable royalty determined by the standard practices of theparticular industryLost profits due to infringement"willful" infringement could lead to punitive damages assessedup to 3X actual damages. Legal fees can also be assessed.Injunction and removal of an infringing product from the market.Until the 2006 Supreme Court case of eBay v. MercExchange,plaintiffs routinely sought, and were granted, injunctionsprohibiting infringement of their patents. After 2006, injunctionswere much harder to obtain, leaving plaintiffs to pursueremedies only for damages.
  33. 33. 11/25/2012 • DOCTRINE OF EQUIVALENTSholds a party liable for patent infringement eventhough the infringing device or process does not fallwithin the literal scope of a patent claim, butnevertheless is equivalent to the claimed invention.
  34. 34. 11/25/2012 32Infringement: Doctrine of Equivalents In the US, the doctrine is applied to individual claim limitations, not to the invention as a whole and is limited by prosecution history estoppel. The difference between the limitation in the accused device and the limitation literally recited in the patent claim may be found to be "insubstantial on the basis of the triple identity test: It performs substantially the same function In substantially the same way To yield substantially the same result
  35. 35. 11/25/2012 33 Prosecution history estoppelIf the patentee abandoned through an amendment to thepatent application certain literal claim coverage (e.g., bynarrowing the literal scope of the patent claim), then thepatentee is estopped from later arguing that the surrenderedcoverage is insubstantially different from the literally claimedlimitation.
  36. 36. 11/25/2012 34Warner-Jenkinson Co. v. Hilton DavisChem. Co. (1997) Hilton Davis Chemical Co. had developed an "ultrafiltration" process to purify dyes. By amendment he specified that a solution used in the process must have a pH level between 6.0 and 9.0, to avoid overlap with prior art which specified lower limit of 9.0; however, the plaintiff was unable to explain why the amendment stated a lower level of 6.0. The defendant had developed a process using a solution with a pH level of 5.0, which was outside the range of the plaintiffs patent. Held estopped.
  37. 37. 11/25/2012 35 Festo Corporation Vs. SMCFesto was marketing a patented industrial device . SMC beganmarketing a device that used one two-way sealing ring and anon-magnetizable sleeve. Festo filed suit claiminginfringement under the doctrine of equivalents. Festos claimhad been amended during prosecution for statutory complianceand SMC claimed that prosecution history estoppel should barFesto .(a) To enable a patent holder to know what he owns, andthe public to know what he does not, the inventor mustdescribe his work in ―full, clear, concise, and exact terms.‖Thus, a patents scope is not limited to its literal terms, butembraces all equivalents to the claims described.
  38. 38. 11/25/2012 36 Festo Corpn. Contd.(b) Prosecution history estoppel requires that patent claimsbe interpreted in light of the proceedings before the Patent andTrademark Office (PTO). When the patentee originally claimedthe subject matter alleged to infringe but then narrowed theclaim in response to a rejection, he may not argue that thesurrendered territory comprised an unforeseen equivalent.Were it otherwise, the inventor might avoid the PTOsgatekeeping role and seek to recapture in an infringementaction the very subject matter surrendered as a condition ofreceiving the patent.
  39. 39. 11/25/2012 37Software/algorithm patentability: trilogy Gottschalk v. Benson method of programming a general- purpose digital computer using an algorithm to convert binary-coded decimals into pure binary numbers. Held the discovery was un-patentable since it was no more than abstract mathematics; granting it would preclude others from using the abstract mathematical principles. Court‘s decision did not preclude patenting of software, only patentability where the only useful characteristic was an algorithm.
  40. 40. 11/25/2012 38Trilogy Contd.Parker v. Flook method of calculating alarm limits by using a"smoothing algorithm" to make the system responsive to trendsbut not momentary fluctuations in process variables (such astemperature).Held Where a patent was sought on an implementation of aprinciple (the algorithm), the implementation itself must beinventive for a patent to issue. Since that was not so, the Courtheld unpatentable.Diamond v. Diehr A method of operating a rubber-mouldingpress for precision molded compounds with the aid of a digitalcomputer. In this case the Court backed away from the analyticdissection approach, and insisted that patent-eligibility must bedecided on the basis of the claim (or invention) considered as awhole, granting the patent. Court studiously avoided statingthat Flook and Benson were overruled or limited.
  41. 41. 11/25/2012 39 Business MethodsThe Federal Circuit has not yet defined what it is thatspecifically characterizes a business method claim andseparates it from other process claims. The Court has statedthat claims drawn to a method of doing business should not becategorized as a ―business method‖ claim, instead they shouldbe treated like any other process claim. State Street Bank &Trust Co. v. Signature Financial Group, 1998: The claimedinvention as a whole must accomplish a practical application. Itmust produce a "useful, concrete and tangible result."A business method may be defined as "a method of operatingany aspect of an economic enterprise". International PatentClassification (IPC), for business methods: "G06Q" (Dataprocessing systems or methods, specially adapted foradministrative, commercial, financial, managerial, supervisoryor forecasting purposes).
  42. 42. 11/25/2012 40 Business Method claimsU.S. Class 705: Automated business data processingtechnologies, applications related to financial data processing.Class 434 Education and Demonstration: methods of teachingare classified inClass 273, Amusement Devices & games: Methods of playinggamesClass 47, Plant Husbandry: Methods of improving cropOther process claims which may be labelled a ―businessmethod‖ are classified and examined according to theirtechnology.
  43. 43. 11/25/2012Drafting Business Method claims - ―Jepson-type‖ claim construction - Limit claims, drawn to a single invention - claims have proper antecedence in the specification - Start with broad claims and then narrow them - Range within a range normally raises 112, 2nd paragraph issues Be aware of 101 issues: • data streams per se (not patentable per se) • non functional data (not patentable per se) Be careful with statements of intended use; ―able‖ or ―adapted for‖ clauses & ―whereby‖ and ―wherein‖ clauses - the limiting effect of the language in the claim
  44. 44. 11/25/2012 42Bilsky: patent-eligibility of a process Bilski v. Kappos - method of hedging the seasonal risks of buying energy On June 28, 2010, the Court ruled] that Bernard Bilskis patent application is an abstract idea and is therefore unpatentable. However, it also said that business methods are not inherently unpatentable, and was silent on the subject of software patents. The majority opinion also said that the Federal Circuits "machine or transformation" test, while useful, is not an exclusive test for determining the patentability of a process.
  45. 45. 11/25/2012 43Patenting of life1970s A.M.Chakrabarty of GE developed a geneticallyimproved microorganism that was designed to break downcrude oil rapidly; Process granted but not productIn 1980, 8 years after the initial filing, the Supreme Court heldthat the microorganisms were a new composition of matter, theproduct of human ingenuity and not of nature‘s handiwork, andthus a patentable subject matter. – Human intervention testChakrabarty and Kellogg for ‗‗Bacteria capable of dissimilationof environmentally persistent chemical compounds,‖ in 1985.Kenneth Hibbard, Paul Anderson, and Mellanie Barker for‗‗Tryptophan overproducer mutants of cereal crops,‘‘in 1986.Philip Leder and Timothy Stewart ‗‗Transgenic nonhumanmammals‘‘ in 1988 the ‗‗Harvard Mouse,‘‘
  46. 46. 11/25/2012 44 Human cells patentingHuman cells, expressed sequence tags (ESTs), singlenucleotide polymorphisms (SNPs), and cultivation andisolation of stem cells have also been patented.David Golde and Shirley Quan for ‗‗Unique T-lymphocyte lineand products derived therefrom‘‘ in 1984 for cell line derivedfrom John Moore‘s spleenAnn Tsukamoto, Charles Baum, Ykoh Aihara, and IrvingWeissman for ‗‗Human hematopoetic stem cell,‘‘ isolatedhuman bone marrow stem cells in 1991
  47. 47. 11/25/2012 45Test for patenting lifeThe relevant distinction was not between living and inanimatethings but between products of nature, whether living or not,and human-made inventions. The tests set forth by the Court :(A) "The laws of nature, physical phenomena and abstractideas" are not patentable subject matter(B) A "non-naturally occurring manufacture or composition ofmatter - a product of human ingenuity -having a distinctivename, character, [and] use" is patentable subject matter.(C) "[A] new mineral or Einsteins E=mc2 are manifestations ofnature, free to all men and reserved exclusively to none."(D) Production of articles prepared by giving to raw materialsnew forms, qualities, properties, or combinations whether byhand labour or by machinery" [emphasis added] is a"manufacture" under 35 U.S.C. 101.
  48. 48. 11/25/2012 46 Diamond v. chakrabartyDiamond vs. Chakrabarty:Genetic engineer Ananda Mohan Chakrabarty, working forGeneral Electric, had developed a bacterium (derived from thePseudomonas genus) capable of breaking down crude oil,which he proposed to use in treating oil spills. The applicationfor patent was turned down by the USPTO because the lawdictated that living things were not patentable. The Board ofPatent Appeals and Interferences agreed with the originaldecision; however, the United States Court of Customs andPatent Appeals overturned the case in Chakrabartys favor,writing that "the fact that micro-organisms are alive is withoutlegal significance for purposes of the patent law."
  49. 49. 11/25/2012 47Diamond Vs. Chakrabarty Contd.Sidney A. Diamond, Commissioner of Patents andTrademarks, appealed to the Supreme Court. The SupremeCourt case was argued on March 17, 1980 and decided onJune 16, 1980. In a 5–4 ruling, the court ruled in favor ofChakrabarty, and upheld the patent, holding that: A live,human-made micro-organism is patentable subject matterunder § 101. Respondents micro-organism constitutes a"manufacture" or "composition of matter" within that statute.
  50. 50. 11/25/2012 48Living multicellular organisms Class 800: living multicellular organisms (nonhuman animals and plants) and separated or severed parts thereof that have not undergone any modification or treatment subsequent to their separation. Genetic modification processes are included. Mammals, method of making and using a transgenic nonhuman animal in an in vivo test method (e.g., drug efficacy tests, etc.) & method of using a transgenic nonhuman animal to manufacture a protein which is then to be isolated or extracted are contemplated. Different types of breeding techniques are also provided for.
  51. 51. 11/25/2012 49Harvard OncomouseInventors: Philip Leder, Timothy A. StewartOriginal Assignee: President and Fellows of Harvard CollegeCurrent U.S. Classification: 800/10; 435/6.14; 435/317.1;536/23.5; 800/18International Classification: C12N 100; C12Q 168; C12N 1500;C12N 500Patent number: 4736866Filing date: Jun 22, 1984Issue date: Apr 12, 1988Two patents were issued to Harvard College covering methodsfor providing a cell culture from a transgenic non-human animal(expired Feb 11, 2009) and testing methods using transgenicmice expressing an oncogene (expiring 2016)
  52. 52. 11/25/2012 50Other jurisdictions Canada 2002: Supreme Court rejected the patent in Harvard College v. Canada, overturning a Federal Court of Appeal verdict which ruled in favour of the patent. 2003: Canadian patent 1,341,442 CA 1341442 was granted to Harvard College amended to omit the "composition of matter" claims on the transgenic mice. Canadian patent law allowed the amended claims to grant under pre-GATT rules and the patent remains valid until 2020. EPO 1989: refused in by an Examining EPO as EPC excludes patentability of animals per se. 1992 granted on the ground that varieties were unpatentable not animals per se. 2001, hearing on objections, the patent was maintained in amended form. 2006 revoked for failure to pay the fees and to file translated claims.
  53. 53. 11/25/2012 3. NON-OBVIOUSNESS • If the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.
  54. 54. 11/25/2012 52Non-obviousness(A) Combining prior art elements according to known methods toyield predictable results;(B) Simple substitution to obtain predictable results;(C) Use of known technique to improve similar devices(D) "Obvious to try" - choosing from a finite number of identified,predictable solutions, with a reasonable expectation of success;(E) Known work in one field of endeavor may prompt variationsof it for use in either the same field or a different one based ondesign incentives or other market forces if the variations arepredictable to one of ordinary skill in the art;(F) Some teaching, suggestion, or motivation in the prior art thatwould have led one of ordinary skill to modify the prior artreference or to combine prior art reference teachings to arrive atthe claimed invention.
  55. 55. 11/25/2012 53Structural obviousnessthe motivation of PHOSITA to make a claimed compound,expecting compounds similar in structure will have similarpropertiesIn re Merck & Co., Inc., 1986, claimed and prior art compoundsused in a method of treating depression expected to have similaractivity because the structural difference between thecompounds involved a known bioisosteric replacement.In re Dillon, 1991, The tri-orthoester fuel compositions of theprior art and the claimed tetra-orthoester fuel compositionswould have been expected to have similar properties based onclose structural and chemical similarity between the orthoestersand the fact that both the prior art and applicant used theorthoesters as fuel additives.
  56. 56. 11/25/2012 54FormulationUnigene Labs. and Upsher-Smith Labs v. Apotex, 2011: Unigenesreissued patent covers its Fortical calcitonin nasal spraydeveloped in response to Novartiss Miacalcin calcitonin nasalspray. Content of citric acid, polysorbate 80, phenylethyl alcoholand benzyl alcohol are claimed in Unigenes patent. Citric acidenhances absorption. Novartis product used BZK for the purpose.In 2006, Apotex filed an ANDA to import a generic version ofUnigenes spray. Unigene sued for infringement. Apotex‘sobviousness defense was struck down by Fed.Cir.The court determined that the citric acid in Unigene serves asa substitute for BZK and that at the time of invention, it was not anobvious substitute for BZK.
  57. 57. 11/25/2012 55Process "A process yielding a novel and nonobvious product may nonetheless be obvious; conversely, a process yielding a well-known product may yet be nonobvious." TorPharm, Inc. v. Ranbaxy Pharmaceuticals, Inc., (Fed. Cir. 2003) Brouwer, "highly fact-specific by design― to be assessed on a case-by-case basis. Ochai: flexibility Process of chemically reducing one novel, nonobvious material to obtain another novel, nonobvious material was held obvious because the reduction reaction was old. In re Albertson (CCPA 1964)
  58. 58. 11/25/2012 56 In re DurdenFederal Circuit:[A]n otherwise old process becomes a new process when apreviously unknown starting material is subjected to aconventional manipulation to produce a product which mayalso be new. But it does not necessarily mean that the wholeprocess has become unobvious. If the "use of an unobviousstarting material renders a process unobvious― - every step,for example, dissolving or heating, when performed on a newcompound would result in a patentable process.Applicant claimed the process of making the novelcarbamate products from the novel oxime starting materials
  59. 59. 11/25/2012 57 In re KuehlIn re Kuehl, (CCPA 1973) Process of cracking hydrocarbonsusing novel zeolite catalyst found to be patentable eventhough catalytic cracking process was old. The obviousness ofthe process of cracking hydrocarbons with ZK-22 as a catalystmust be determined without reference to knowledge of ZK-22and its properties.‖ PHOSITA would not only have to able topredict the outcome of using ZK-22, but also find it obvious touse ZK-22 which was not predictable until the invention.
  60. 60. 11/25/2012 58Method of useObviousness-type double patenting appliesApplicants are barred from obtaining multiple patentscovering the same invention by the doctrine of doublepatenting. There are two types of double patenting:statutory double patenting, which prohibits a later patentfrom covering the identical invention, and obviousness-typedouble patenting, which prevents a later patent fromcovering a slight variation of an earlier patented invention.
  61. 61. 11/25/2012 59Sun Pharma V. Eli Lilly Eli Lilly‘s Patent No. 4,808,614 related to Gemzar – which claims both gemcitabine itself, a method of using it to treat viral infections, as well as discloses using gemcitabine to treat cancer. Patent No. 5,464,826 claims a method of treating cancer comprising administering a therapeutically effective amount of gemcitabine. The applications leading to both the 614 (exp. 2010) and 826 (exp. 2012) patents were filed on the same day, December 4, 1984. The 614 was a continuation-in-part of application No. 473,883 which did not disclose using gemcitabine to treat cancer. Obviousness-type of double patenting
  62. 62. 11/25/2012 60Process in biotechnology and chemistryProteins which are the product of biotechnological processesare often known and naturally occurring and therefore productclaims can be subject to rejection during prosecution.Thus process claims can protect the biotechnology product aswell as the process where the product is not patentable forobviousness. A process will prevent a foreign competitor fromimporting the product into US. Based on in re Durden, PTOroutinely rejected claims to process for cultivating a patentedtransformed host cell to produce an unpatentable product.PTO rejected process claims with genetically engineeredstarting materials.
  63. 63. 11/25/2012 61THE BIOTECHNOLOGY PROCESS PATENT ACT,1995 Divided section 103 into three subsections. Section 103(b) now provides that the applicant can elect for patent to proceed under a biotechnological process using or resulting in a composition of matter that is novel under section 102 and nonobvious under section 103(a). Claims to the process and the composition of matter should be contained in either the same application for patent or in separate applications having the same filing date; and the compositions of matter, and the process at the time it was invented should be owned by the same person or subject to an obligation for assignment to the same person.
  64. 64. 11/25/2012 62Contd.The term ―biotechnological process‖ means -(A) a process to genetically alter or otherwise inducing a single-or multi-celled organism to -(i) express and exogenous nucleotide sequence,(ii) inhibit, eliminate, augment, or alter expression of anendogenous nucleotidesequence, or(iii) express a specific physiological characteristic not naturallyassociated withsaid organism;(B) cell fusion procedures yielding a cell line that expresses aspecific protein, such as a monoclonal antibody; and(C) a method of using a product produced by a process definedby subparagraph (A) or (B), or a combination of subparagraphs(A) and (B).
  65. 65. 11/25/2012 63PHOSITAPHOSITA is a legal fiction defined in the Patent Act ofthe United States, based on- educational level of the inventor;- type of problems encountered in the art;- prior art solutions to those problems;- rapidity with which innovations are made;- sophistication of the technology; and-educational level of active workers in the field
  66. 66. 11/25/2012 64 Obviousness: KSR V. TeleflexTeleflex, Inc. sued KSR International, claiming that KSRproducts infringed Teleflexs patent on connecting an adjustablevehicle control pedal to an electronic throttle control. KSRargued that the combination of the two elements was obvious,and the claim was therefore not patentable.The district court ruled in favour of KSR. Federal Circuitreversed in January 2005.On April 30, 2007, the Supreme Court reversed the judgment ofthe Federal Circuit, holding that the disputed claim 4 of thepatent was obvious.Federal Circuit had rigidly applied the "teaching-suggestion-motivation" (TSM) test.
  67. 67. 11/25/2012 65Obviousness: TSM Test Winner Intl Royalty Corp. v. Wang, (2000), there must be a suggestion or teaching in the prior art to combine elements shown in the prior art in order to find a patent obvious. Non-obviousness grant of patent requires more than simple novelty. Thomas Jeffersons 1813 letter: changing material to "chain, rope, or leather" was insufficient for patentability. Patent Act of 1952, in part, to reduce the impact of nonobviousness on patentability and to eliminate the flash of genius test.
  68. 68. 11/25/2012 66 Graham FactorsGraham et al. v. John Deere Co. of Kansas City et al., (1966)held that obviousness should be determined by looking atthe scope and content of the prior art;the level of ordinary skill in the art;the differences between the claimed invention and the priorart; andobjective evidence of non-obviousness outlined by:commercial success;long-felt but unsolved needs; andfailure of others.
  69. 69. 11/25/2012 67 Graham Factors contdEnvironmental Designs, Ltd. v. Union Oil Co. of Cal., (Fed.Cir. 1983) considering scepticism or disbelief before theinvention as an indicator of non-obviousness; Allen Archery, Inc. v. Browning Mfg. Co., (Fed. Cir. 1987)considering copying, praise, unexpected results, and industryacceptance as indicators of non-obviousness
  70. 70. 11/25/2012 4. ENABLEMENT • a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same.
  71. 71. 11/25/2012 69In general PRIOR ART IS PRESUMED TO BE OPERABLE/ENABLING When it expressly anticipates or makes obvious all of the elements of the claimed invention, the reference is presumed to be operable. Once such a reference is found, the burden is on applicant to provide facts rebutting the presumption of operability. In re Sasse, (CCPA 1980) WHAT CONSTITUTES AN "ENABLING DISCLOSURE" DOES NOT DEPEND ON THE TYPE OF PRIOR ART THE DISCLOSURE IS CONTAINED IN The level of disclosure required within a reference to make it an "enabling disclosure" is the same no matter what type of prior art is at issue. It does not matter whether the prior art reference is a U.S. patent, foreign patent, a printed publication or other. In re Moreton, (CCPA 1961).
  72. 72. 11/25/2012 70Contd. EFFICACY IS NOT A REQUIREMENT FOR PRIOR ART ENABLEMENT for anticipation. If it in sufficient detail to enable a person of ordinary skill in the art to carry out the claimed invention. Impax Labs. Inc. v. Aventis Pharm.Inc., (Fed. Cir. 2006). REJECTIONS AND USE OF INOPERATIVE PRIOR ART "Even if a reference discloses an inoperative device, it is prior art for all that it teaches." Beckman Instruments v. LKB Produkter AB, (Fed. Cir. 1989). Therefore, "a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103." Symbol Techs. Inc. v. Opticon Inc (Fed. Cir. 1991).
  73. 73. 11/25/2012 71Further requirements (112) Best Mode: Patent must disclose the best mode of practising the invention including preferred materials and methods. Failure may result in patent being declared ‗unenfoceable‘. Duty of Candor: good faith and specifically requires that everyone involved with a patent application must disclose all publications that they know of which may adversely affect the patentability of their invention through out the pendency of the application . Within 3 months all material information must be disclosed.
  74. 74. 11/25/2012 72Further requirements Contd. Oath: The inventor must swear that she understands the patent document, the duty of candour and full disclosure and that the named inventor is the true and first inventor. Inventorship The requirement that the applicant for a patent be the inventor is a characteristic of U.S. patent law. The threshold question in determining inventorship is who conceived the invention. Unless a person contributes to the conception of the invention, he is not an inventor. Conception of atleast one claim.
  75. 75. 11/25/2012 73America Invents Act The Leahy-Smith America Invents Act (AIA) is United States federal legislation that was passed by Congress and was signed into law by President Barack Obama on September 16, 2011. Changes to be implemented with varying dates between Sept. 2012 -13
  76. 76. 11/25/2012 74Substantive Changes• Changes from "First to Invent" to "First to File" System o "Effective Filing Date" o Eliminates One-year Grace Period for 3rd party disclosures o Makes changes to prior art• Provides Derivation Proceedings• Adds Pre-Grant Submissions• Expands Post-Grant Proceedings o Expands on Post-Grant Submissions o Retains Ex Parte Reexamination o Eliminates Inter Partes Reexamination, but…
  77. 77. 11/25/2012 75Substantive Changes II Adds Post-Grant Patent Review Adds Inter Partes Review• Adds Post-Grant Supplemental Examination o Provides Patent Owner with an opportunity to "cure" errors in prosecution• Eliminates Best Mode Failure as a Defense
  78. 78. 11/25/2012 Prior ArtThe Act omits the 102(g) interference and prior art provisions,relating to an invention that was previously made in this country byanother inventor who had not abandoned, suppressed, or concealed it oNo more patent interferences oDerivation proceedings will be available102(a) A person shall be entitled to a patent unless— (1)the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention; or (2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
  79. 79. 11/25/2012 77 Prior Art Exceptions• Exceptions from Prior Art o Applicants own "disclosures" within 1 year before the "effective filing date" of a U.S. application and the information derived therefrom. o Includes Applicants own publications o Grace period is expanded in cases claiming foreign priorities and provisional applications o Subject matter related to a research agreement.
  80. 80. 11/25/2012 78 Post-Grant Patent Review Procedures Summary and Timing Procedure Request Effective Threshold Date Ex parte reexam Anyone In effect Substantial new question of patentability Inter partes Third party request based on Now – Reasonable likelihood that reexam patents and printed 9/2012 petitioner would prevail (upon publications enactment) Inter partes Third party request based on Beginning Reasonable likelihood that review patents and printed 9/2012 petitioner would prevail (upon publications enactment) Post-grant Third party request based on Beginning More likely than not that at least review any ground of invalidity that with 1 challenged claim is could be raised under patents unpatentable paragraph (2) or (3) of § 282 filed after (b) or showing a novel or 3/2013 unsettled legal question that is important to other patents Supplemental Patent owner 9/2012 Substantial new question of examination patentability
  81. 81. 11/25/2012 79Overview of Available Procedures
  82. 82. 11/25/2012 80First to File• "Effective Filing Date"• One year grace period only good for Inventors own disclosures• Broader scope of patent-defeating prior art• Derivation Proceeding- operate only when inventor alleges that the other applicant derived invention from the inventor• Priority based on effective filing date o Effective March 16, 2013 (may be a rush to file for choice of law) and it applies to any patent application that has an "effective filing date" after the 18 month period.
  83. 83. 11/25/2012 81 DerivationsWill replace patent interference 35 U.S.C. § 291(a) In General – when a patentee claims the same invention with an earlier effective filing date, an owner of a patent may have relief by civil action against him, if the former patent was derived from the inventor of the latter patent.(b) Filing Limitation – An action under this section may be filed onlybefore the end of the 1-year period beginning on the date of theissuance of the first patent containing a claim to the allegedly derivedinvention and naming an individual alleged to have derived suchinvention as the inventor or joint inventor.
  84. 84. 11/25/2012 82Pre-grant submissions (3rd party observations)Effective date: September 16, 2012; applies to any pendingpatent application at that time. • When: o Must be filed "before the earlier of–"(A) Date of Notice of Allowance or(B) the later of(i) 6 months after publication date or(ii) date of first Office Action (rejection) • What: Third Party Submissions o Citation to Printed publications (patent, non-patent, or court decision (can likely introduce an argument under §§ 101 and 112)) o "Concise" Description of Relevance
  85. 85. 11/25/2012 83 Post-grant submissions Expands Post-Grant Submissions Retains Ex Parte Reexamination Eliminates Inter Partes Rexamination, but… Adds Post-Grant Patent Review Adds Inter Partes Review Adds Post-Grant Supplemental ExaminationRequest for Ex Parte Reexamination ( 302) Effective date: N/AWho and When: Any person at any timeScope: §§ 102 and 103 Threshold for Initiation: Substantial New Question of Patentability
  86. 86. 11/25/2012 84 Post-grant submissions – IIPost-Grant Submissions ( 301) • When (September 16, 2012) o Any time after patent grant • What o Information Prior Art consisting of patents or printed publications (same as before) or Written Statements made by the patent owner either before a Federal court or the USPTO related to claim scope (new) o Include written explanation that provides reasons why the Prior Art or Written Statements are relevant
  87. 87. 11/25/2012 85Post-grant proceedings Post-Grant Review (§ 321) and Inter Partes Review ( 311)• Effective Date (September 16, 2012). • Post-grant review: Applies only to patents having an effective date on or after 18 months from enactment. • Inter partes review: Applies to any patent issuing before, on, or after that date.• When o Post-grant review: petition filed within 9 months from patent grant date of patent or from grant date of reissued patent (§ 321(c)) o Inter partes review: petition filed after the later of either 9 months after patent grant or termination of a post-grant review ( 311(c))
  88. 88. 11/25/2012 86 Post-Grant Review (§ 321) and Inter Partes Review ( 311) • Scope o Post-grant review: Can challenge any aspect of patentability of any claim including §§ 101 and 112 o Inter partes review: Restricted to patents and printed publications and to issues of novelty and non-obviousness • Patent Owners Right o Post-grant review: Preliminary Response o Inter partes review: Preliminary Response
  89. 89. 11/25/2012 87Post-Grant Review (§ 321) and Inter partes review ( 311) • Threshold for Initiation o Post-grant Review: USPTO must consider petition information and patent owners preliminary response and will initiate post-grant review if it is more likely than not that at least one claim is unpatentable. (§ 324(a), i.e., preponderance of evidence standard). Threshold "may also be satisfied by a showing that the petition raises a novel or unsettled legal question that is important to other patents or patent applications." (§ 324(b)) o Inter partes review: Same as above except that the required showing is a reasonable likelihood that the petitioner would prevail with respect to at least 1 of the claims challenged in the petition. ( 314(a))
  90. 90. 11/25/2012 88Post-Grant Review (§ 321) and Inter partes review ( 311) • Evidentiary Standard o Post-grant Review: The "petitioner shall have the burden of proving a proposition of unpatentability by a preponderance of the evidence." ( 326(e)) o Inter partes review: Same as above. ( 316(e)) • Patent Owners Right to Amend • Post-grant Review: Right to file motion to amend the claims, second motion only possible if both parties agree ( 326(d)) • Inter partes review: Same as above. ( 316(d)) Confidential Settlements are Allowed Intervening Rights ( 252) Apply
  91. 91. 11/25/2012 89Post-Grant Review (§ 321) and Inter partes review ( 311) • Time Limit for Completion o Post-grant Review: Proceeding should be completed within 1 year with one 6 month extension available on a showing of "good cause." ( 326(a)(11)) o Inter partes review: Same as above. ( 316(a)(12)) • Preclusive Effect (Estoppel) • Post-grant Review: Cannot raise issues before the USPTO, District Court, or the ITC if the issues were previously raised or reasonably could have been raised. ( 325(e)) • Inter partes review: Same as above. ( 315(e))
  92. 92. 11/25/2012 90Post-Grant Review (§ 321) and Inter partes review ( 311) • Litigation Limitations o Post-grant Review: Cannot request review if previously filed declaratory judgment ("DJ") action contesting the validity of the patent ( 325(a)(1)) o Inter partes review: Same as above. ( 315(a)(1)) Except that inter partes review cannot occur after 9 months of the filing of the complaint by the patent owner against the petitioner. ( 315(b)) o Post-grant Review: If petitioner files civil action on or after request for review, then civil action automatically stayed unless (i) the patent owner requests to lift the stay, (ii) the patent owner files its own civil action or files a counterclaim, or (iii) the petition requests to dismiss civil action. ( 325(a)) o Inter partes review: Same as above. ( 315(a))
  93. 93. 11/25/2012 91For both types of proceedings, discoveryrules will be promulgated for:• Setting forth standards and procedures for discovery of relevant evidence, including that such discovery shall be limited to: • PGR: evidence directly related to factual assertions advanced by either party to the proceeding. • IPR: the deposition of witnesses submitting affidavits or declarations; and what is otherwise necessary in the interest of justice.• Prescribing sanctions for abuse of discovery, abuse of process, or any other improper use of the proceeding, such as to harass or to cause unnecessary delay or an unnecessary increase in the cost of the proceeding• Providing for protective orders governing the exchange and submission of confidential information
  94. 94. 11/25/2012 92Supplemental ExaminationSupplemental Examination ( 257)Effective Date: September 16, 2012 – applies to any patentissued before, on, or after that date. • When o Post-Grant • What: Request by Patent Owner Only o Consider, reconsider, or correct information believed to be relevant to the patent o Request must raise substantial new question of patentability • Effect: A mechanism for the patent owner to ward off a potential inequitable conduct defense
  95. 95. 11/25/2012 93 Supplemental Examination (contd)Supplemental Examination (§ 257)Effective Date: 1 year after enactment date • Key Provision • "A patent shall not be held unenforceable on the basis of conduct relating to information that had not been considered, was inadequately considered, or was incorrect in a prior examination of the patent if the information was considered, reconsidered, or corrected during a supplemental examination of a patent. • Exceptions (cannot file request): • Prior allegations (made in a PIV certification letter) • Defense raised in a pending litigation unless Supplemental Examination proceedings concluded prior to the date of litigation
  96. 96. 11/25/2012 • EUROPEAN PATENT REGIME I. European patent convention II. Patentable inventions in European Patent systems III. History of the Broad Definition of Patentability IV. Final form of European Patent system Development of EPO Practice in Relation to Software Industries
  97. 97. 11/25/2012 95 Novelty Art. 54 of EPC(1)An invention shall be considered to be new if it does notform part of the state of the art.(2) The state of the art shall be held to comprise everythingmade available to the public by means of a written or oraldescription, by use, or in any other way, before the date offiling of the European patent application.(3) The content of European patent applications as filed priorto the date referred to, and which were published on or afterthat date
  98. 98. 11/25/2012 96Contd.(4) shall not exclude the patentability of any substance orcomposition, comprised in the state of the art, for use in amethod referred to in Article 53(c), provided that its use forany such method is not comprised in the state of the art.(5) shall also not exclude the patentability of any substancefor any specific use in a method referred to in Article 53(c),provided that such use is not comprised in the state of theart.
  99. 99. 11/25/2012 97Utility (and patentability) Art. 52European patents shall be granted for any inventions, in allfields of technology, provided that they are new, involve aninventive step and are susceptible of industrial application.Art. 57 An invention shall be considered as susceptible ofindustrial application if it can be made or used in any kind ofindustry, including agriculture. Profitable use.Art. 83 Sufficiency of disclosure
  100. 100. 11/25/2012 98 Inventive Step Art. 56An invention shall be considered as involving an inventive stepif, having regard to the state of the art, it is not obvious to aperson skilled in the art. If the state of the art also includesdocuments within the meaning of Article 54, paragraph 3,these documents shall not be considered in deciding whetherthere has been an inventive step.
  101. 101. 11/25/2012 99European Patent Convention,5 October 1973A multilateral treaty instituting the European PatentOrganisation and providing an autonomous legal systemaccording to which European patents are granted.European patent is not a unitary right, but a group ofessentially independent nationally-enforceable, nationally-revocable patents subject to central revocation or narrowing asa group pursuant to two types of unified, post-grantprocedures: a time-limited opposition procedure, which can beinitiated by any person except the patent proprietor, andlimitation and revocation procedures, which can be initiated bythe patent proprietor only.
  102. 102. 11/25/2012 100EPC and exclusions under Article .53 EPCDiscoveries, scientific theories, mathematical methods,aesthetic creations, schemes, rules and methods forperforming mental acts, playing games or doing business,programs for computers and presentations of information – assuchThe second set of exclusions, or exceptions, includeinventions contrary to "ordre public" or morality,plant or animal varieties and essentially biological processesfor the production of plants and animals, andmethods for treatment of the human or animal body by surgeryor therapy, and diagnostic methods practised on the human oranimal body,which have been excluded for "socio-ethicalconsiderations and considerations of public health‖.
  103. 103. 11/25/2012 101SoftwareArt. 52(2) The following in particular shall not be regarded asinventions …(c) schemes, rules and methods for performing mental acts,playing games or doing business, and programs forcomputers;52(3) Paragraph 2 shall exclude the patentability of the subject-matter or activities referred to therein only to the extent towhich a European patent application or European patentrelates to such subject-matter or activities as such.
  104. 104. 11/25/2012 102 T469/03Claim 4 is directed to a computer-readable mediumhaving computer-executable instructions (i.e. a computerprogram) on it to cause the computer system to perform theclaimed method.The subject-matter of claim 4 has technical character since itrelates to a computer-readable medium, i.e. a technicalproduct involving a carrier. Moreover, the computer executableinstructions have the potential of achieving the above-mentioned further technical effect of enhancing the internaloperation of the computer, which goes beyond the elementaryinteraction of any hardware and software of data processing(see T 1173/97 - Computer program product/IBM; OJ EPO1999, 609). The computer program recorded on the medium istherefore not considered to be a computer program as such,
  105. 105. 11/25/2012 103Differences between US and Eu practicesFirst inventor to file system effective March 16, 2013 v. Firstto file .Inventor‘s own personal publications and disclosures will notconstitute prior art so long as they are published no morethan one year prior to the patent application – no such graceperiod in EuBest mode requirementNon-obvious v. inventive step
  106. 106. 11/25/2012 SWAPNA SUNDAR CEO, IP Dome – IP Strategy Advisors No. 7/8 Flowers Road III Lane Purusaiwalkam, Chennai 600084 THANK YOU for your attention