1 Hatch-Waxman Boot Camp July 19-20, 2010 Mary C. Till Legal Advisor Office of Patent Legal Administration.

Slides:



Advertisements
Similar presentations
Pharma Workshop IV Patent Linkage in the USA Lawrence T. Welch Eli Lilly and Company.
Advertisements

First Action Interview Pilot Program Overview. Pilot Program Objectives Promote personal interviews prior to issuance of a first Office action on the.
By David W. Hill AIPLA Immediate Past President Partner Finnegan, Henderson, Farabow, Garrett & Dunner, LLP Overview of the America Invents Act.
Michael Neas Supervisor Office of PCT Legal Administration
Update on USPTO Activities November 18, 2014 Drew Hirshfeld Deputy Commissioner for Patent Examination Policy 1.
What You Need to Know About Biosimilars: Products, Recent Deals, IP Issues and Licensing August 2, 2012 Madison C. Jellins 1.
Laura McKelvey, U.S. EPA. 2  CAA Implementation Authority [Section 301(d)] ◦ 1990 CAA Amendments ◦ Tribal air management authority ◦ TAS / TIP.
Patent Term Matters Term and Scope AIPLA 14 May 2009.
September 14, U.S.C. 103(c) as Amended by the Cooperative Research and Technology Enhancement (CREATE) Act (Public Law ) Enacted December.
Robert M. Hansen The Marbury Law Group PLLC AIPLA Practical Patent Prosecution Training for New Lawyers August 2009Alexandria, VA Issuance, Term, Certificates.
Patent Term Adjustments and Extensions
Legislative Rule-Making Process. Three Different Processes Higher Education 29A-3A-1 et seq State Board of Education 29A-3B-1 et seq All other state agencies.
Introduction to Regulation
25-1 Chapter 44 Consumer Protection and Product Safety.
Safekeeping of 35 U.S.C. 156 Extensions
Patent Term Adjustment (Bio/Chem. Partnership) Kery Fries, Sr. Legal Advisor Phone: (571)
Patents 101 April 1, 2002 And now, for something new, useful and not obvious.
A New Pathway for Follow-on Biologics Presented by: Steve Nash May 7, 2010.
Regulation of Generic Drugs Office of Generic Drugs Craig Kiester Regulatory Support Branch.
© 2009 Pharmaceutical Law Group PC Market Exclusivity Paradigm Gregory J. Glover, MD, JD Pharmaceutical Law Group
1 Patent Term Extension under 35 U.S.C. § 156 Mary C. Till Legal Advisor Office of Patent Legal Administration.
The Life Sciences Lawyer’s Guide to PTA and PTE
July 18, Changes to Patent Fees Under the Consolidated Appropriations Act, 2005 (H.R. 4818/P.L ) Topic: Patent Fees Office of Patent Legal.
1 Health Benefits Under COBRA Consolidated Omnibus Budget Reconciliation Act of 1985 U.S. Department of Labor Employee Benefits Security Administration.
December 8, Changes to Patent Fees Under the Consolidated Appropriations Act, 2005 (H.R. 4818)(upon enactment) and 35 U.S.C. 103(c) as Amended by.
1 United States Patent and Trademark Office PETITIONS PRACTICE USPTO Office of Patent Legal Administration PETITIONS PRACTICE COMMON ERRORS.
February 19, Recent Changes and Developments in USPTO Practice Prepared by: Office of Patent Legal Administration (OPLA) Robert J. Spar, DirectorJoni.
Patent Term Adjustment (PTA) Recent Developments in PTA Practice and Strategies for Maximizing PTA Presented to NJIPLA December 9, 2009 Jack Brennan Fish.
FITZPATRICK, CELLA, HARPER & SCINTO © 2011 | 1 ACI's Maximizing Pharmaceutical Patent Life Cycles Conference PTE-PTA Boot Camp.
Subsequent Entry Biologics (SEBs) – Canada Presentation to AIPLA Biotechnology Committee January 25, 2012 Daphne C. Lainson
Korean Patent Practice - Pharmaceutical field - Jonghyeok Park MS., Ph.D.course Jonghyeok Park MS., Ph.D.course Partner Pharmacist Patent Attorney.
Update: “A” “B” “C”s of USPTO Patent Term Adjustment IP Practice in Japan Pre-Meeting Seminar 2013 AIPLA Mid-Winter Institute Ron Harris The Harris Firm.
Frivolous Claims. Introduction  PL (12/22/06) allows attorneys to represent veterans before VA for a fee after NOD is filed.  VA required to.
Group Presentation EDSPE 504 Samia Ahmed Ashley Berger Lindsey Clodfelter Mariam El-Kalay Lorenzo Jarin Emily Johnson.
Judgment on Appeal The Court prepares, not the party.
Prosecution Group Luncheon November, Prioritized Examination—37 CFR “No fault” special status under 1.102(e) Request made with filing of nonprovisional.
July 18, U.S.C. 103(c) as Amended by the Cooperative Research and Technology Enhancement (CREATE) Act (Public Law ) Enacted December 10,
Post-Grant & Inter Partes Review Procedures Presented to AIPPI, Italy February 10, 2012 By Joerg-Uwe Szipl Griffin & Szipl, P.C.
Practice Before the U.S. Patent and Trademark Office Board of Patent Appeals and Interferences.
Prosecution Lunch Patents January Reminder: USPTO Fee Changes- Jan. 1, 2014 Issue Fee Decrease- delay paying if you can –Issue Fee: from $1,780.
BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG LONDON LOS ANGELES NEW YORK SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C. Patent.
1 Rules of Practice Before the BPAI in Ex Parte Appeals 73 Fed. Reg (June 10, 2008) Effective December 10, Fed. Reg (June 10, 2008)
1 United States Patent and Trademark Office PTA Post Wyeth USPTO OPLA - Kery A. Fries PTA Post Wyeth Wyeth v. Kappos (Fed. Cir. Jan. 7, 2010 )
Safe Harbor or Not: Application of 271(e)(1) to Pioneering Drug Discovery Activities Susan Steele October 21, 2003.
Patent Prosecution Luncheon February Defective Priority Claim Means No Priority Claim Each intermediate application in the chain of priority must.
Reexamination at the USPTO Robert A. Clarke Deputy Director Office of Patent Legal Administration USPTO Robert A. Clarke Deputy Director Office of Patent.
LAW OF COMPUTER TECHNOLOGY FALL 2015 © 2015 MICHAEL I. SHAMOS Regulatory Law Michael I. Shamos, Ph.D., J.D. Institute for Software Research School of.
Patent Prosecution May PCT- RCE Zombie 371 National Stage PCT Applications –Not Allowed to file an RCE until signed inventor oath/declaration is.
New Ex Parte Appeal Rules Patent and Trademark Practice Group Meeting January 26, 2012.
Biotechnology Chemical Pharmaceutical Customer Partnership
Chris Fildes FILDES & OUTLAND, P.C. IP Practice in Japan Committee Pre-Meeting AIPLA Annual Meeting, October 20, 2015 USPTO PILOT PROGRAMS 1 © AIPLA 2015.
Andrew B. Freistein Wenderoth, Lind & Ponack, L.L.P. Learning the ABC’s of Patent Term Adjustment 1 © AIPLA 2015.
January 25, Notice of Proposed Rule Making Proposed Changes to Practice for Continuing Applications, Requests for Continued Examination Practice,
Double Patenting Deborah Reynolds SPE Art Unit 1632 Detailee, TC1600 Practice Specialist
Prosecution Lunch October Bits and Pieces from the Patent Side Crowing about reduction in pending cases –From 750K a year ago to about 708K now.
Hatch-Waxman As Amended (MMA) Thomas O. Henteleff Kleinfeld, Kaplan and Becker, LLP November 9, 2005.
Report to the AIPLA’s IP Practice in Japan Committee January 22, 2012 USPTO Appeal Process: Appeal Strategies and New Rules Presented by: Stephen S. Wentsler.
Regulation of Generic Animal Drugs in the United States
1 TOPIC III - PATENT INVALIDATION PROCEDURES EU-CHINA WORKSHOP ON THE CHINESE PATENT LAW HARBIN, SEPTEMBER 2008 Dr. Gillian Davies.
The Life Sciences Lawyer’s Guide to PTA and PTE
PATENT OFFICE PROSECUTION
Patent Term Extension In Israel
Claims and Continuations Final Rule
Biotechnology Chemical Pharmaceutical Customer Partnership
USPTO Appeal Process: Appeal Strategies and New Rules
ENROLLEE DUE PROCESS for Medicaid Managed CARE 42 CFR § 438 et seq.
PATENT LAW TREATY Gena Jones Senior Legal Advisor
SSA Adverse Decisions and Administrative Finality
Pharma Workshop IV Patent Linkage in the USA
Linda M. Chatwin, Esq. RAC Business Manager, UL LLC
Presentation transcript:

1 Hatch-Waxman Boot Camp July 19-20, 2010 Mary C. Till Legal Advisor Office of Patent Legal Administration

2 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration -Patent Term Adjustment-35 U.S.C. § 154(b)-PTA -Office Deductions and Applicant Deductions -Wyeth v. Kappos -Patent Term Extension-35 U.S.C. § 156-PTE -Eligibility and Regulatory Requirements -Wyeth v. Sebelius et al. -Ortho-McNeil v Lupin -Photocure v. Kappos -The Medicines Company v. Kappos

3 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment -Congress changed the law in 1994 to amend 35 U.S.C. § 154 to provide that the term of patent protection begins on the date of patent grant and ends on the date twenty years from the filing date of the application, or the earliest U.S. filing date for which a benefit is claimed. -American Inventors Protection Act in 1999, amended 35 U.S.C. § 154 to provide day-by-day patent term adjustment if the Office fails, within specified time periods, to issue a patent. The Office’s failure to meet certain time periods is offset by the applicant failing to engage in reasonable efforts to conclude prosecution.

4 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment USPTO time period objectives: -Issue an office action within 14 months after the application was filed. -Respond to a reply from the applicant within 4 months of the reply filing date. -Respond to an appeal brief from the applicant within 4 months of the appeal brief being filed. -Issue a patent within 3 years of the actual filing date of the application. -Issue a patent within four months after the date on which the issue fee was paid and all outstanding formal requirements were met.

5 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment Applicant Adjustment Reductions: -Reductions can occur when the applicant “failed to engage in reasonable efforts to conclude processing or examination of an application for the cumulative total of any periods of time in excess of 3 months that are take not respond to a notice from the Office beyond three months making any rejection, objection, argument or other request.” (35 U.S.C. § 154(b)(2)(C)).

6 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment Applicant Adjustment Reductions: -Congress provided that USPTO can prescribe circumstances that constitute the “failure of an applicant to engage in reasonable efforts to conclude processing or examination of an application.” -37 C.F.R. § 1.704(c)(1)-(11) were promulgated.

7 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment Applicant Adjustment Reductions: -37 C.F.R. § 1.704(c)(1)-(11) provides for a reduction in the PTA accumulated because of Office delays, e.g., suspension of action or deferral of issuance of a patent an applicant’s request; (2) abandonment of an application or delay in filing a petition to withdraw abandonment holding; (3) converting a provisional to a non-provisional and (4) submission of papers after notice of allowance.

8 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment -In 2000, the USPTO promulgated rules which implement the statutes from Congress with respect to patent term adjustment. -Rule 1.703(f) provided an interpretation of a specific statutory provision which relates to overlapping days in the periods of delay before the USPTO. The rule provided that to the extent that periods of adjustment overlap, the period of adjustment will not exceed the actual number of days the issuance of the patent was delayed. -Wyeth, dissatisfied with their PTA determination, sued the USPTO under the APA.

9 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment -On January 7 th, 2010,Federal Circuit decided Wyeth v. Kappos. -Federal Circuit determined the statutory construction of 35 USC 154(b)(2)(A). -Federal Circuit determined that the phrase “to the extent that periods of delay attributable to grounds specified in paragraph (1) overlap…” means same calendar days. -Accordingly, “A” delays and “B” delays overlap only if such delays occur on the same calendar day.

10 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Adjustment -Federal Circuit decision means that some patentees may be receiving more patent term adjustment under the CAFC interpretation than under the previous USPTO interpretation of 35 USC 154(b)(2)(A). -USPTO has modified the computer program to be consistent with the Wyeth decision. -USPTO is deciding petitions consistent with the interpretation of Wyeth v. Kappos.

11 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension 35 U.S.C. § 156-titled “patent term extension,” as part of the Hatch-Waxman Act, restores patent term to a patent that was effectively “lost” due to pre-market approval requirements before a regulating agency (the agencies involved are the Food and Drug Administration and the United States Department of Agriculture).

12 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Statutory Requirements: - The patent claims the product, or a method of using the product or a method of manufacturing the product (35 U.S.C. § 156(a)). -The term of the patent has not expired before the application for PTE has been submitted (35 U.S.C. § 156(a)(1)). -The term has never been extended under 156 before (35 U.S.C. § 156(a)(2)). -The product has been subject to a regulatory review period before its commercial marketing or use (35 U.S.C. § 156(a)(4)).

13 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Statutory Requirements (cont’d): -The permission for the commercial marketing or use of the product after the regulatory review period is the first permitted commercial marketing or use of the product under the provisions of law under which such regulatory review period occurred (35 U.S.C. § 156(a)(5)).

14 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Statutory Requirements (cont’d): -An application for patent term extension must be submitted by the owner or record or its agent to the USPTO (35 U.S.C. § 156(a)(3)) within the sixty day period beginning on the date the product received permission under the provision of law under which the applicable regulatory review period occurred for commercial marketing or use (35 U.S.C. § 156(d)(1)).

15 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension PTE Application: Who: submitted by patent owner or his agent (35 U.S.C. § 156(d)(1)). When: filed with the USPTO within the sixty-day period beginning on the date the product received permission... for commercial marketing or use (35 U.S.C. § 156(d)(1)). What: contents of the application contain information as per 35 U.S.C. § 156(d)(1)(A)-(E).

16 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Eligible Products: -Drug Products (New drugs, antibiotic drugs, human biological products, new animal drugs, or veterinary biological products). -Medical Device -Food Additive -Color Additive

17 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Relevant Regulatory Review Periods: -Section 505 of Federal Food Drug and Cosmetic Act (new drugs). -Section 351 of the Public Health Services Act (human biological products). -Section 515 of the Federal Food Drug and Cosmetic Act (medical devices). -Section 512 of the Federal Food Drug and Cosmetic Act (new animal drugs). -The Virus-Serum Toxin Act, 21 U.S.C. § § (veterinary biological product). - Section the 409 of the Federal Food Drug and Cosmetic Act (food additives and color additives).

18 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Limitations on amount of term extension: -Includes only time after the date the patent is issued (35 U.S.C. § 156(c)). -Time where applicant failed to exercise due diligence is subtracted (35 U.S.C. § 156(c)(1)). -Only one-half of the testing phase is counted (35 U.S.C. § 156(c)(2)). -The total market exclusivity time of a drug cannot exceed 14 years, regardless of how much time was lost to clinical testing and regulatory review. (35 U.S.C. § 156(c)(3)). -The total time of extension is limited to no more than 5 years (35 U.S.C. § 156(g)(6)).

19 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Wyeth v. Sebelius (603 F.3d 1291 (Fed. Cir. 2010)) -When does the approval phase begin for a new animal drug application when the parts of the application are submitted on a rolling basis? The approval phase begins when the Administrative New Animal Drug Application is submitted to FDA referencing all the previously submitted and approved application components.

20 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Ortho-McNeil v. Lupin (603 F.3d 1377 (Fed. Cir. 2010)) -Is a patent claiming a specific enantiomer eligible for patent term extension when a racemate of the enantiomer was previously approved? Yes, a patent claiming the specific enantiomer may be extended under 35 U.S.C. § 156 even though the racemate of the enantiomer was previously approved and a patent claiming the racemate received extension.

21 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension Photocure v. Kappos (603 F.3d 1372 (Fed. Cir. 2010)) -Is a patent claiming an ester of a previously approved active ingredient eligible for patent term extension? Yes, the statutory language recites, “active ingredient including any salt or ester of the active ingredient,” not active moiety. Glaxo II (894 F.2d 392 (Fed. Cir. 1990) is controlling in that the term “product” in 156(a)(5)(A) means “active ingredient,” that is, the substance physically present in the final dosage form.

22 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Patent Term Extension The Medicines Company v. Kappos (E.D. Va. 1:10CV286) -Does the term “date” as used in section 156(d)(1) (“beginning on the date....”) refer to a business day or calendar day? Medicines Company argues business day. Government argues calendar date. Case is pending.

23 Examining Pharmaceutical Patent Extensions: Patent Term Adjustment and Patent Term Restoration Thank you! Contact Information: Mary C. Till Legal Advisor, Office of Patent Legal Administration USPTO