Patent Reform: What MedTech Companies Need to Know

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1 GREENBERG TRAURIG, LLP ATTORNEYS AT LAW Patent Reform: What MedTech Companies Need to Know David J. Dykeman, Esq. Patent Attorney & Shareholder Greenberg Traurig, LLP Boston, MA (617) MassMEDIC November 3, 2011

2 Patent Reform: What MedTech Companies Need to Know AGENDA 1) Overview of Patent Reform 2) The America Invents Act 3) USPTO Rule Changes 4) U.S. Supreme Court Decisions 5) Impact on MedTech Companies Greenberg Traurig, LLP MassMEDIC November 3,

3 An International Network of More than 1,800 Attorneys & Governmental Affairs Professionals Greenberg Traurig Office Strategic Alliance ALBANY AMSTERDAM ATLANTA BOSTON CHICAGO DALLAS DENVER FORT LAUDERDALE HOUSTON LOS ANGELES MIAMI NEW JERSEY ORANGE COUNTY ORLANDO PHILADELPHIA SACRAMENTO SHANGHAI SILICON VALLEY TAMPA TYSONS CORNER WASHINGTON, D.C. WEST PALM BEACH Strategic Alliances With Independent Law Firms* BERLIN BRUSSELS MILAN ROME BOCA RATON DELAWARE LAS VEGAS NEW YORK PHOENIX TALLAHASSEE ZURICH LONDON TOKYO *Greenberg Traurig has entered into Strategic Alliances with the following independent law firms: Olswang in London, Berlin and Brussels; Studio Santa Maria in Milan and Rome; and the Hayabusa Asuka Law Offices in Tokyo. Greenberg Traurig is not responsible for any legal or other services rendered by attorneys employed by the Strategic Alliance firms. Greenberg Traurig, LLP MassMEDIC November 3,

4 Overview of Patent Reform Patent reform addressed by Congress, U.S. Patent and Trademark Office ( USPTO ) and U.S. Supreme Court Patent reform seeks to improve current system, which is poorly suited for modern economy, involves increased litigation and costs, and deviates from healthy balance between promoting innovation and spreading benefits of technological advances MedTech companies must adopt dynamic patent strategies to thrive in this changing patent landscape Greenberg Traurig, LLP MassMEDIC November 3,

5 Opposite Sides of the Fence IT industry has wanted patent reform for many years Medical Device industry has argued against any weakening of the current patent system Greenberg Traurig, LLP MassMEDIC November 3,

6 The America Invents Act On September 16, 2011, President Obama signed the America Invents Act into law, marking first major legislative overhaul of U.S. patent system in 60 years Key changes include: 1. Switching from first-to-invent to first-inventor-to-file 2. Introducing post-grant patent review 3. Allowing third-party prior art submissions 4. Changes in USPTO operations and funding Greenberg Traurig, LLP MassMEDIC November 3,

7 First-Inventor-to-File First-to-invent replaced with first-inventor-to-file Inventing First Effective Date: March 16, 2013 Filing First PROS: U.S. system harmonized with rest of world Clear standards for resolving questions of inventorship CONS: Race to patent office Premature applications when not yet understand technology s full capabilities Harder to obtain VC funding? Bottom line: file early, file often Greenberg Traurig, LLP MassMEDIC November 3,

8 Post-Grant Review and Third-Party Prior Art Submission Post-Grant Review provides 9-month window after patent grants for 3rd parties to challenge patent on any grounds of invalidity Third-Party Prior Art Submission allows 3rd parties to submit references and statements of relevance to USPTO examiner during prosecution Effective Date: September 16, 2012 PROS: Produces higher-quality patents Shifts challenging arena from courts to USPTO, allowing patentability issues to be resolved earlier Minimizes costly litigation CONS: Companies with resources to monitor competitors favored Patents will become harder to get and easier to challenge More uncertainty Bottom line: monitor competitors patents and patent applications Greenberg Traurig, LLP MassMEDIC November 3,

9 Changes in USPTO Operations and Funding Effective September 16, 2011: USPTO gains authorization to set own fees Effective October 1, 2011: New Reserve Fund to collect fees in excess of appropriated amount, for use by USPTO only 3 satellite offices to be established, beginning with Detroit New Micro-Entity status (includes universities) PROS: USPTO gains more control over budget Increased resources will address 700,000 application backlog CONS: Congressional fee diversion still a threat Bottom line: USPTO poised to improve patent process Greenberg Traurig, LLP MassMEDIC November 3,

10 Additional Highlights Effective September 16, 2011: Best Mode: no longer grounds for invalidity NOT Patentable: tax strategies or human organisms Effective September 26, 2011: 15% increase to all fees Prioritized Track I Examination program with $4,800 fee Effective September 16, 2012: Inter Partes Review: replaces Inter Partes reexamination Supplemental Examination: new proceeding at patent owner request Inventorship: assignee can file patent application Effective March 16, 2013: Derivation Proceeding: interferences phased out Greenberg Traurig, LLP MassMEDIC November 3,

11 USPTO Rule Changes Coming Soon USPTO must implement provisions of America Invents Act 10 USPTO Notices of Rulemaking expected Jan/Feb 2012 Implementation Timeline: 9/16/11 9/26/11 10/1/11 9/16/12 3/16/13 Fee setting authority Best mode eliminated Tax strategies & human organisms non-patentable Prioritized Track I Examination 15% fee increase Reserve Fund Third-party prior art submission Post-grant review Supplemental examination Inter partes review Inventorship First-to-file Derivation proceedings Greenberg Traurig, LLP MassMEDIC November 3,

12 Supreme Court Weighs In In Supreme Court has issued far-reaching opinions impacting patents: KSR v. Teleflex, April 2007: patent obviousness Bilski v. Kappos, June 2010: patentability of a process Coming Attractions Recent Court of Appeals Decisions: Therasense v. Dicksinson, Fed. Cir., May 2011: inequitable conduct Mayo v. Prometheus, Fed. Cir., Dec. 2010: patentability of method and diagnostic claims Supreme Court granted petition for certiorari on June 20, 2011 Classen v. Biogen, Fed. Cir., Aug. 2011: patentability of method and diagnostic claims Assoc. for Molecular Pathology v. Myriad, Fed. Cir., July 2011: patentability of genes Motion for Fed. Cir. rehearing denied on Sept. 13, 2011 Greenberg Traurig, LLP MassMEDIC November 3,

13 What MedTech Companies Need to Know 1) File early, file often 2) Monitor competitors patent activity 3) Utilize USPTO initiatives and streamlined processes Track I Examination First Action Interview Request 4) Work with IP counsel to overcome obviousness and patentability challenges 5) Remain vigilant as upcoming USPTO rules and Supreme Court decisions continue to reshape U.S. patent system Greenberg Traurig, LLP MassMEDIC November 3,

14 Questions? USPTO Patent Reform Website: Greenberg Traurig Patent Reform Website: Greenberg Traurig, LLP MassMEDIC November 3,

15 GREENBERG TRAURIG, LLP ATTORNEYS AT LAW Patent Reform: What MedTech Companies Need to Know David J. Dykeman, Esq. Patent Attorney & Shareholder Greenberg Traurig, LLP Boston, MA (617) MassMEDIC November 3, 2011

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