Data/Working Examples: Role in Acquiring and Protecting a PatentTina Williams McKeonApril 12, 2012

Roadmap

Basics of patentabilityBasics of patent processData in the various stages of the patent process

Preparing the patent applicationProsecuting the patent applicationLitigating about the patent application

Basics of Patentability

NoveltyNon-obviousnessUsefulness

Sufficient DisclosureWritten DescriptionEnablementBest Mode

Stages of the Patent Process

US Supreme Court

Federal Circuit

US District Court US PTO

Patent AcquisitionAdministrative Proceedings (Reexam,Interference,Post-Grant Review)

Litigation

Patent Application

Role of Data in the Patent Process - Overview

Step 1: Data in preparation of the patent application

ExamplesWorking examplesProphetic examples

US versus EP and JPRelevant in the decision of when to file

Influenced by shift to first-to-file

Role of Data in the Patent Process - Overview (continued)

Step 2: Data provided during patent prosecutionProof of enablementProof of non-obviousness (e.g., surprising and unexpected results)

Role of Data in the Patent Process – Overview (continued)

Step 3: Data provided during litigation (context: invalidity of granted patent)

Proof of enablementProof of secondary factors of nonobviousness (e.g., surprising and unexpected results)

Step 1: Filing the Application with Data

Examples (supposedly first included in a patent that issued in 1839)

TypesWorking examples – result of actual research (past tense)Prophetic example – proposed (present or future tense)Correlative examples

Animal data for human treatmentIn vitro proof of in vivo method

Data in the Patent Application (continued)

Purpose of Data/Working ExamplesEnablement

How to make and/or use the invention without undue experimentationOne of the “Wands” factors - presence or absence of working examples

Data in the Patent Application (continued)

Proof of non-obviousnessNegative dataSurprising or unexpected results

Substantiate a genusDisclosure of best modeAvoid inequitable conduct

Negative results

Data in Patent Application (continued)

Examples NOT required (or are they?)Particularly common in biotech and chemistry applications because of unpredictability

Amgen v. Chugai (Fed. Cir. 1991) – must make and use enough sequences to justify the breadth of the claim (EPO – provided only a limited number of DNA sequences)In re Wright (Fed. Cir. 1993) – Skilled artisan would be unable to carry out the steps required to full scope (vaccine) to any RNA virus in any animal

Data in Patent Application (continued)

Broader claims/ complex inventions may need more examplesExamples not necessarily limiting (Or are they?)

Contrast with EP

Step 2: Filing Data During Patent Prosecution

Lack of enablementApplication as filed must enable one of skill in the art to make and use the invention – post filing data can be used to support an assertion of enablement (In re Brana)

Declaration (37 CFR §1.132)Publication

Generally examiner should not use post-filing data references to show patent is not enabling – unless later reference provides evidence of what one skilled in the art would have known on or before the filing date (In re Wright (Fed. Cir. 1993 – reference showed unpredictability of viruses)

Data Provided During Patent Prosecution (continued)

Obviousness Proof of surprising and unexpected resultsNegative data during experimentation

Duty of disclosureBristol-Myers Squibb Co. v. Rhone-Poulenc Rorer, Inc. (Fed. Cir. 2003)

Negative data included in publication that served as basis for patent application but that published after filingFailure to provide during prosecution was inequitable conduct

Step 3: Data Provided During Litigation (Janssen v. Teva)

Proof of enablement based on post-filing dataJanssen v. Teva (Fed. Cir. 2009)Factual background

Invention - Reminyl use for treatment of Alzheimers DiseaseInventor saw a paper related to use of drug as an antidote for a powerful drug relaxantInventor recognized cause of action may be useful in ADDrug unavailable in US for testing until post-issuanceCommercial success

Data Provided During Litigation (Janssen v. Teva) (continued)

ApplicationSpecification -1 page

No experimental dataSummarized 6 articles related to administration of Reminyl to animals or human (not for AD treatment)Described an animal model of AD

ClaimsTreating and diagnosing AD and other dementias by administering Reminyl or its salt

Data Provided During Litigation (Janssen v. Teva) (continued)

ProsecutionObviousness rejection – Response that animal experiments underwayNo enablement rejection

District CourtHeld non-obvious but invalid for lack of enablement because no utility demonstrated (“[S]ince plaintiffs rely exclusively on the prior art to establish enablement, the court agrees with defendants that the . . . patent cannot be both non-obvious and enabled.”)

Data Provided During Litigation (Janssen v. Teva) (continued)

Appeal Tests can be conducted by third partyHuman trials not neededIn vitro tests can be enough

BUTTest results after issuance cannot be used to establish utility/enablement

Data Provided During Litigation (Genetics Institute v. Novartis Vaccines and Diagnostics)

Proof of surprising and unexpected resultsGenetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc (Fed Cir. 2011)Factual basis

Invention related to a truncated form of a blood clotting factor and use in treatment of hemophilia

Factor VIII 2332 amino acid residues and 6 domainsBinds von Willibrand factor- prevents degradation (Not known at time of filing)

GI was first to file

Data Provided During Litigation (Genetics Institute v. Novartis Vaccines and Diagnostics) (continued)

Factual background (continued)Genetics Institute

Claims to DNA encoding truncated Factor VIII, genetically engineered cell that made truncated Factor VIII, method of making truncated Factor VIII, Factor VIII protein (permit but does not require deletion of domain that binds vWF)Received 3.5 years of patent term extension (based on FDA approval process)

NovartisClaims to DNA encoding truncated Factor VIII that retains a portion of the domain that binds vWFFiled about 9 months after GI priority date

Data Provided During Litigation (Genetics Institute v. Novartis Vaccines and Diagnostics) (continued)

Procedural statusGenetics Institute sued Novartis in district court to determine priority of invention (Interfering patents) Novartis moved to dismiss asserting (in part) no interference exists because the Novartis claims are directed to a truncated Factor VIII that retains the von Willibrand binding portionDistrict court granted Novartis’s motion to dismissGI appealed – DC erred in finding no interference in fact

Data Provided During Litigation (Genetics Institute v. Novartis Vaccines and Diagnostics) (continued)

Legal analysis Does an interference in fact exist?

Same or substantially the same subject matterGI asserted

Novartis’s claims obvious because their deletion narrower than GI claims Novartis truncations based on known cleavage pointsCourt erred by relying on post-filing evidence showing unexpected results (domain binds vWF- not appreciated at the time of filing)

Data Provided During Litigation (Genetics Institute v. Novartis Vaccines and Diagnostics) (continued)

Majority The structure of a compound and its properties are inseparableEvery property of a claimed compound need not be fully recognized as of filing dateEvidence of unexpected properties developed after patent grant can be considered in obviousness analysis

DissentShould not look at a feature no one appreciated at time of filing to establish non-obviousness – Hindsight

Data Provided During Litigation (continued)

ConclusionsEvidence of enablement should be provided in the application or during prosecution (may NOT be sufficient if first submitted in litigation)Evidence of unexpected results even if not appreciated at the time of filing or even during prosecution may be sufficient evidence of non-obviousness if first submitted during litigation Some resistance by courts - seem more reluctant to accept post-filing data – watch for tension in future cases

Take-home Messages

In unpredictable arts, provide working examples in application (consider delayed filing – consider upcoming first-to-file standard)

Human tests best but not requiredAnimal tests acceptable if accepted animal modelIn vitro tests acceptable if reasonable correlation

Include negative data in application (with explanation?) or in IDSIf no working examples in application, provide enabling data during prosecution (even if no enablement rejection!)If evidence of unexpected results, watch out for tension in court and potential shift in court’s position – file evidence during prosecution even if no obviousness rejection!

Tina Williams McKeonMcKeon Meunier Carlin &

Curfman

404-645-7701 (office)

tmckeon@m2iplaw.com