Presentation on theme: "Elisabeth A. Pimentel University of Connecticut School of Law"— Presentation transcript:
1 Elisabeth A. Pimentel University of Connecticut School of Law Patent Law is Technology Specific: Enablement, Written Description, and BiotechnologyElisabeth A. PimentelUniversity of ConnecticutSchool of Law
2 Introduction: Biotechnology Biotechnology industry began in 1970’s with the advent of recombinant DNA techniques.The Global biotech industry continues to grow despite the economic down turnAs of 3rd Quarter of 2009U.S. Biotech had Net Revenue of $57 billionEuropean Biotech had Net Revenue of € 12 billionIndustry Statistics from Ernst & Young Global Biotechnology Report 2010
3 Biotechnology Industry Economics Aggregate ProfitabilityU.S. Industry Milestone: industry maintained aggregate profitability ($3.7 billion)The European biotech industry has not yet reached aggregate profitability (-€288 million)Number of EmployeesU.S. biotech industry employs 110,000 workersEuropean biotech industry employs 49,000 workers
4 Introduction: Biotechnology Invades many aspects of modern life:Therapies and vaccinesMedical Diagnostic TestingAgricultureEnvironmentalIndustrial applicationsForensic Science
5 Introduction: Biotechnology High cost of innovationExpensive to developLong development timesStringent regulatory oversight
6 Enablement: Predictable Arts PHOSITA can bridge gap between claim and disclosureTypically have only had to show one embodiment to enable a broad claimEven if the claim read on other embodiments that were not adequately disclosedChanging?
7 Enablement: Unpredictable Arts Often the PHOSITA cannot bridge the gap between claim and disclosureCourts have required a much more detailed disclosure, including the disclosure of multiple embodiments.
8 The Problem GenerallyThe U.S. Patent Statute does not distinguish between different fields of invention, but in the application of the Patent Statute the Federal Circuit holds different technologies to different standards.
9 The Problem for Biotechnology Specifically, the Federal Circuit has imposed stringent enablement and written description requirements on biotechnology patents that have not occurred in other technologies.The Federal Circuit has based its decisions on a central maxim that conception for biotechnology requires a definition of structure, formula, or definitive properties.
10 Constructive Reduction to Practice Theory: Invention refers to inventor’s conception of the new idea rather than the physical embodiment of that ideaCourts have ruled that which has not been built, but has been fully conceived is eligible for patent protectionNot for biotechnology and unpredictable arts
11 Biotechnology: Written Description Unusually strict for biotechnology casesFor cases involving DNA the Federal Circuit has required that the written description disclose precise DNA sequences to demonstrate possessionThe inventor does not conceive of a DNA invention until she actually creates it
12 Biotechnology: Written Description In addition to structure, biotechnology inventions can be described by functional characteristicsMust have a previously known or disclosed correlation between structure and functionE.g. Antibody claims: court suggested that could describe an antibody by describing which antigen it binds to
13 Biotechnology: Written Description The Federal Circuit clarified what the written description does NOT require:Examples are not necessaryRequirement may be met even where actual reduction to practice is absentNo per se rule that an invention involving a biological macromolecule must contain a recitation of known structure
14 Biotechnology: Enablement Unusually strict for biotechnology casesAgain, dealing with DNA and disclosure of DNA sequencesAmgen, Inc. v. Chugai Pharmaceutical Co.Claimed nucleic acid sequences that coded for erythropoeitin and other proteins with the same biological function
15 Biotechnology: Enablement Amgen (continued)Court said the few examples provided did not enable the multitude of gene sequences claimedAn example of claiming a genus while only enabling a few species.
16 Biotechnology: Enablement Examples and EmbodimentsWhile not technically required by statute, realistically biotechnology patents must disclose multiple examples and embodiments to fully enable a broad claim.Tension between how many examples or embodiments are necessary and how much experimentation a PHOSITA has to engage in
17 Biotechnology: The Results requiring heightened written description and enablement standards by mostly requiring the claims to be limited to the embodiments and examples disclosed creates an environment where it is easy for imitators to make a minor change and side step the patent, rendering the patent uselessCreation of an anti-commonsPatent Thicket
18 But Isn’t Flexibility a Good Thing? Yes – patent laws were constructed at a time in which inventions were primarily mechanicalYes – practically, in U.S., Congress cannot implement a new statute every time a new technology arisesYes – when properly tailored to incentivize innovation in a particular industry.
19 How to Attain Flexibility The Person Having Ordinary Skill in the Art (PHOSITA) is a central source of flexibilityWithin the doctrines of the patent statuteBetween different areas of technological artsThe PHOSITA is mentioned in two places in the Patent Statute, in the enablement requirement and the nonobvious requirement
20 PHOSITAWhile not specifically mentioned in any other place, the PHOSITA also plays a role in:Utility: the definition of enablement affects the utility requirement because the invention must operate as described if the PHOSITA is to be enabledWritten Description and Best Mode: compliance with these requirements is measured from the perspective of a PHOSITA
21 PHOSITADefiniteness of patent claims: claims must be written so that a PHOSITA would understand to where the boundaries of the patent right extendDoctrine of equivalents: a fundamental test for equivalence is the whether a PHOSITA would reasonably interchange the elements at issue
22 PHOSITABetween different technologies the PHOSITA is different based on:Comprehension of prior artTime frameLevel of skill in the art in the time frame in which the PHOSITA is placed
23 What the Biotechnology Industry Needs from Patent Law Broader Patent ProtectionsHigh cost of innovationRegulatory OversightEmerging industryRapidly changing technologyInvestment structure of biotechnology
24 PHOSITA in Biotechnology The PHOSITA for biotechnology cases seems to need a very high degree of certainty and explicit instructions before being able to make and use an inventionFederal Circuit focuses on the uncertainty inherent in the field of biotechnologyThe Federal Circuit has continued to view biotechnology as an undeveloped field even though the field has matured
25 How Can the PHOSITA Help? The PHOSITA doctrine can be helpful in navigating among differing technologies if two principles are rigorously adhered to:The level of skill of the PHOSITA must be determined anew in each case.Be mindful of the time frame in which the PHOSITA will be understoodBeware of hindsight bias
26 Broad Can Be Bad Concerns with broad patents Concentration of patentsDecrease in innovationBroad protections do not easily allow for future partitioning within an industryCurrent case law mostly deals with DNAFuture unknownBroader not Broad
27 European Patent Office EPC Article 83: Enablementrequires an inventor disclose the invention in a manner sufficiently clear and complete for it to be carried out by one skilled in the artEPC Article 84 aka Written DescriptionThe claims shall define the matter for which the protection is sought. They shall be clear and concise and supported by the description.
28 European Approach to Biotechnology DirectivesCumbersome process akin to U.S. Congressional processDirective on Legal Protections of BiotechnologiesSignificant step in improving patent climate for biotechnology in EuropeLimitations on technologies associated with transgenic experimentation and human cloning
29 European Approach to Biotechnology More flexible approach to description and enablementFocused on knowledge, not structureAcknowledges the informational link between DNA and proteinClaims cast in functional language are allowed
30 European Approach to Biotechnology Disclosure of a single embodiment is sufficientThe European PHOSITA generally can carry out varying embodiments without undue burdenGenerally require fewer species to be described in order to enable a broad claim to genusMoralityPotential to affect the scope of allowable claimsEurope has less human life-science biotechnology
31 A Timely DigressionOn May 20, 2010 a U.S. biotech company announced a breakthrough in synthetic biology: the formation of a synthetic organismDNA was synthesized, cell was wild type mycoplasma mycoides with original DNA removed: so not entirely syntheticLooks and acts like a naturally occurring cell until examine DNA structure which has embedded in its code names of inventors, websites, and quotations
32 Synthetic GenomeThe big advance is that the genome was productive and self-replicatingThe project took 15 years and $40 million to completeAt least one Nobel LaureateA single base error in the synthetic code caused 3 month delay
33 Synthetic Genome Potential applications Using cells to create fuel Building vaccines to tackle new strains quicklyAgriculture: create plant cells that can grow with little water and fertilization
34 “DNA is the Software of Life” The ability to create viable DNA sequences out of four chemicals has been equated to writing software codeMycoplasma mycoides JCVI-syn 1.0Ironic comparison because written description and enablement requirements of software industry are often contrasted to those of biotechnology because of vast difference.
35 How Might Federal Circuit and EPO Respond? Patent on precursor methods to the synthetic organism is in the midst of prosecution at USPTOWritten description deficienciesEnablement scope deficiencies: very broad claimsWill this reinforce the Federal Circuit’s focus on structure?Will the EPO morality clause prevent this type of biotech from development in Europe?
36 ConclusionModulating the Patent Statute to differentiate between industries is desirableThe American way of splitting up the fieldsTailored to the needs of specific industryBest done by modulating the PHOSITAFederal Circuit needs to re-evaluate its stance toward biotechnology patentsThe EPO may need to address viability of morality clause