Data/Working Examples: Role in Acquiring and Protecting a Patent Tina Williams McKeon April 12, 2012

Roadmap Basics of patentability Basics of patent process Data in the various stages of the patent process Preparing the patent application Prosecuting the patent application Litigating about the patent application

Basics of Patentability Novelty Non-obviousness Usefulness Sufficient Disclosure Written Description Enablement Best Mode

Stages of the Patent Process US Supreme Court Federal Circuit US District CourtUS PTO Patent Acquisition Administrative 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 Examples Working examples Prophetic examples US versus EP and JP Relevant 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 prosecution Proof of enablement Proof 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 enablement Proof 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) Types Working examples – result of actual research (past tense) Prophetic example – proposed (present or future tense) Correlative examples Animal data for human treatment In vitro proof of in vivo method

Data in the Patent Application (continued) Purpose of Data/Working Examples Enablement How to make and/or use the invention without undue experimentation One of the “Wands” factors - presence or absence of working examples

Data in the Patent Application (continued) Proof of non-obviousness Negative data Surprising or unexpected results Substantiate a genus Disclosure of best mode Avoid 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 examples Examples not necessarily limiting (Or are they?) Contrast with EP

Step 2: Filing Data During Patent Prosecution Lack of enablement Application 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 – reference showed unpredictability of viruses)

Data Provided During Patent Prosecution (continued) Obviousness Proof of surprising and unexpected results Negative data during experimentation Duty of disclosure Bristol-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 filing Failure to provide during prosecution was inequitable conduct

Step 3: Data Provided During Litigation (Janssen v. Teva) Proof of enablement based on post-filing data Janssen v. Teva (Fed. Cir. 2009) Factual background Invention - Reminyl use for treatment of Alzheimers Disease Inventor saw a paper related to use of drug as an antidote for a powerful drug relaxant Inventor recognized cause of action may be useful in AD Drug unavailable in US for testing until post-issuance Commercial success

Data Provided During Litigation (Janssen v. Teva) (continued) Application Specification -1 page No experimental data Summarized 6 articles related to administration of Reminyl to animals or human (not for AD treatment) Described an animal model of AD Claims Treating and diagnosing AD and other dementias by administering Reminyl or its salt

Data Provided During Litigation (Janssen v. Teva) (continued) Prosecution Obviousness rejection – Response that animal experiments underway No enablement rejection District Court Held 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 party Human trials not needed In vitro tests can be enough BUT Test 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 results Genetics 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 domains Binds 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) Novartis Claims to DNA encoding truncated Factor VIII that retains a portion of the domain that binds vWF Filed about 9 months after GI priority date

Data Provided During Litigation (Genetics Institute v. Novartis Vaccines and Diagnostics) (continued) Procedural status Genetics 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 portion District court granted Novartis’s motion to dismiss GI 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 matter GI asserted Novartis’s claims obvious because their deletion narrower than GI claims Novartis truncations based on known cleavage points Court 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 inseparable Every property of a claimed compound need not be fully recognized as of filing date Evidence of unexpected properties developed after patent grant can be considered in obviousness analysis Dissent Should not look at a feature no one appreciated at time of filing to establish non-obviousness – Hindsight

Data Provided During Litigation (continued ) Conclusions Evidence 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 required Animal tests acceptable if accepted animal model In vitro tests acceptable if reasonable correlation Include negative data in application (with explanation?) or in IDS If 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 McKeon McKeon Meunier Carlin & Curfman (office)