Patenting Protein Therapeutics: In the Shadow of Uncertainty 4th Protein Discovery and Therapeutics Global Technology Community

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Paradise Point Resort & Spa San Diego, CA October 19-21, 2011 Patenting Protein Therapeutics: In the Shadow of Uncertainty 4th Protein Discovery and Therapeutics Global Technology Community Baltimore, MD October 25, 2013 Big Changes in Patent Law: The America Invents Act (“AIA”) Society of Women Engineers Annual Conference 2013 Speaker: Carla Todenhagen

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America Invents Act: Purpose Harmonize US law with other jurisdictions Everywhere else: first to file Other jurisdictions have a post-grant opposition system Addresses concerns of many different groups Provisions discussed over the course of five Congresses Discussion in the courts and in industry on what needs to be addressed Address significant backlog at the USPTO

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America Invents Act: Goals Encourage innovation and job creation Support USPTO's efforts to improve patent quality and reduce backlog Establish secure funding mechanism Provide greater certainty for patent rights Provide less costly, time-limited administrative alternatives to litigation

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List of (Some) of the Effects “First to File” replaces “First to Invent” Derivation proceedings replace interference proceedings Inventor’s oath or declaration – easier for assignee to file Supplemental Examination can be requested by patent owner Post-grant review within 9 months of issuance “Inter partes review” replaces “inter partes reexamination” 3rd party submission of prior art (pre-issuance) Citation of prior art in a patent file (post-issuance)

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List of (Some) of the Effects Patents with claims “directed to or encompassing a human organism” prohibited (methods of treatment OK) New routes of expedited examination Best mode no longer a defense to patent infringement Establishment of micro-entities 75% reduction in fees Heightened bar for granting inter partes reexamination (New “reasonable likelihood of success” standard) Virtual marking changes False marking changes Prioritized examination established

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First to File – New 102 Summary First inventor to file is entitled to patent Prior art is established as of effective filing date Date of invention is no longer relevant to prior art E.g., can’t swear behind a reference published within a year before filing Public use or sale of the invention in a foreign country is now prior art Prior statute limited prior art to public use or sale in the U.S. One-year grace now limited only to inventors that disclose “subject matter” before date of prior art.

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Pre-AIA: First to Invent

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Post AIA: First to Invent File

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Prior Art What is Prior Art? (New types of PA shown in red) Patent or printed publication anywhere In public use in US In public use in foreign countries On sale in US On sale in foreign countries Available to public in US (“known or used by others”) Available to public in foreign countries US patents and published applications as of EFD, including foreign priority dates

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“First to File” - Prior Art, Examples

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First to File – Tips File early and often. Consider quickly filing provisional application, especially in fast-moving technologies, before preparing more detailed application. Risk: Non-enabled disclosures not entitled to priority date. Balance filing with less enablement and risk that someone else beats you to USPTO. Consider filing multiple applications directed to improvements or variations to protect against filing or disclosure by others.

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First To File: Removing Prior Art by Disclosure If inventor is 1st to disclose invention: One year grace period to file application. This starts the clock. You have one year to file a patent application once you disclose. More generous than Europe. A third-party disclosure within one year of applicant’s filing date is NOT prior art if the inventor disclosed first.

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First to File-Disclosure Example A publishes SUBJECT MATTER A Jan. 2014 A files app for SUBJECT MATTER A Dec. 2014 (<1 year from A’s publication) B publishes SUBJECT MATTER A Mar. 2014 B’s publication is NOT prior art to A (But would be prior art to anyone else)

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First to File-Disclosure Example 2 B’s publication is NOT prior art to A as to SUBJECT MATTER X. But SUBJECT MATTER Y is prior art. Claims to Y cannot be obtained. A publishes SUBJECT MATTER X Jan. 2014 A files app for SUBJECT MATTER X + Y Dec. 2014 (<1 year from A’s publication) B publishes SUBJECT MATTER X + Y Mar. 2014

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First To File: Tips to Remove Prior Art Must “disclose” to get one-year grace period. But what is a “disclosure” under new law? No guidance in the AIA Does a disclosure have to be enabling? Likely. Does an offer for sale or public use without details of invention count? If you want to rely on “disclosure” grace period consider providing details of “subject matter” of invention

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CONS! Foreign rights will be lost in some countries by disclosing before filing. Loss of trade secret rights. Unclear how “disclosures” will be treated by courts. Gives competitors the chance to begin “improving” upon your ideas. Can a competitor file on SUBJECT MATTER A+B if you disclose SUBJECT MATTER A? Extra cost associated with proving first disclosure. PROS? Cheaper than filing a provisional or other patent application? Ensures prior art effect as of publication. Abandoned provisional applications don’t publish. Prevents others from filing on the same invention while providing the potential to file on the subject matter in the future. First To File: Balancing Disclosure

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First To File: Removing Prior Art A third party disclosure within one-year of applicant's filing date is NOT prior art if: the inventor already disclosed the invention prior to the third party disclosure. derivation occurred.

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First To File: Removing Prior Art by Derivation Disclosures by “another who obtained the subject matter disclosed directly or indirectly from the inventor” have a limited prior art effect. A disclosure derived from the inventor is not available prior art for one year. Patent applications or patents derived from the inventor are not available as prior art as of their “effective filing date” (only prior art as of their publication date). How do you prove derivation?

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First To File: Removing Prior Art by Common Ownership Patent application disclosures exempt as prior art if common ownership or under joint research agreement Old: only applies to obviousness rejections. New: Expanded to cover novelty and obviousness rejections New: Common ownership no longer required at time of invention, but must be in effect on or before the effective filing date.

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Inventor’s Oath or Declaration Citizenship no longer required. Corrected oaths can be filed at any time Patent not invalid or unenforceable if a failure is remedied in this manner. Oath needed before providing Notice of Allowance No more Missing Parts for unexecuted declarations? Separate oath or declaration no longer required. declaration statement can be made in assignment documents. declaration statements can be made before preparation of the application.

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Micro entity status Micro entity receive a 75% reduction of fees. As of today, the standard minimum fee, paid by large entities, when a new utility patent application is filed, is US$1,600.00. For the same application, a small entity pays only US$800.00. A qualifying micro-entity will pay, according to today's fee schedule, only US$400.00. A micro entity is any applicant that: Qualifies as a small entity Has not been named as an inventor on more than 4 previously-filed applications. Does not include foreign applications, provisionals, or international applications where basic national fee was not paid. Applications from prior employment (which were assigned/under an obligation to assign) don’t count. Did not, in calendar year before paying fee, have a gross income exceeding 3 times median household income for that preceding calendar year, as most recently reported by the Bureau of the Census. (Currently about $150k) Not be under an obligation to assign, grant, or convey a license or other ownership to another entity that does not meet the same income requirements as the inventor. U.S. Institutions of Higher Education also qualify as micro entities.

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Prioritized Examination Cost: $4,800 ($2,400 for small entities) Final disposition (i.e., final rejection or allowance) within a year Utilities or plant applications only – not available for national stage application. Request must be present at time of filing 4 independent claims and 30 total claims (subject to excess claims fees) USPTO limit of 10,000 granted requests/year Warning – application converted to regular application if: Extension of time is filed Amendment results in more than 4 independent or 30 total claims RCE filed

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Third Party Pre-Issuance Submissions During prosecution, any third party may submit: Any patent application, patent, or printed publication Concise statement of relevance and fee required Timing restrictions

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Supplemental Examination Patent owner can request to consider, reconsider or correct “information believed to be relevant to the patent.” Inoculates patent against potential inequitable conduct. Within 3 months of request, Director decides if a Substantial New Question of Patentability is raised. A patent shall not be held unenforceable based on information considered in supplemental examination. But Inapplicable to cure existing allegations "If fraud on the Office is determined, disciplinary or criminal actions can be instituted.

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Post Issuance Challenges New Post-Grant Review Available within 9 months of grant “more likely than not” that at least one of the claims challenged is unpatentable Challenge can be based on any ground for invalidity Opportunity for petitioner to file written comments after petition Inter Partes Reexamination becomes Inter Partes Review Available after 9 months of grant “reasonable likelihood that the requester would prevail” Note: change in threshold is effective now for Inter Partes Reexamination Challenge can be based only on patents and printed publications.

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Marking False marking claims restricted Only U.S. government can sue for civil penalty of $500/offense For private suits Must now show "competitive injury“ Damages limited to amount "adequate to compensate for the injury“ No violations for marking with an expired patent. Virtual marking allowed Provide Internet address where full listing provided

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Thank You! Questions? ctodenhagen@klarquist.com