Patent Term Adjustments and Extensions Karin L. Ferriter Patent Attorney Office of Intellectual Property Policy and Enforcement USPTO (571) 272-9300 karin.ferriter@uspto.gov November 6, 2007

TRIPs Article 33 - Term of Protection Article 33 provides that the term of protection for a patent shall not end before the expiration of a period of twenty years counted from the filing date. Leaves open the possibility of patent term extensions in instances when circumstances warrant patent extension. Minna will have used this same slide earlier.

Patent Term Adjustment under 35 U.S.C. 154 The patent term adjustment (PTA) provisions of the AIPA are effective May 29, 2000 and apply to utility and plant applications filed on or after May 29, 2000 The patent term extension (PTE) provisions of Public Law 103-465 (URAA) apply to utility and plant applications filed before May 29, 2000 but on or after June 8, 1995 Patent term adjustment or extension under 35 U.S.C. § 154(b) does not apply to design applications or to any application filed before June 8, 1995

Patent Term Adjustment under 35 U.S.C. 154

Patent Term Adjustment Provides three (3) bases for adjustment: USPTO failure to take certain actions within specified time frames (35 U.S.C. § 154(b)(1)(A)) USPTO failure to issue a patent within three years of the actual filing date (35 U.S.C. § 154(b)(1)(B)) Delays due to interference, secrecy order, or successful appellate review (35 U.S.C. § 154(b)(1)(C)) Provides day-for-day adjustment for each failure or delay resulting in adjustment

Patent Term Adjustment Failure to take certain actions within specified time frames (14-4-4-4): Failure to initially act on the application within fourteen (14) months after filing/national stage entry date Failure to act on a reply or appeal brief within four (4) months after date the reply or appeal brief is filed Failure to act on an application within four (4) months after a BPAI or court decision if allowable claims remain in the application Failure to issue the patent within four (4) months of the date the issue fee was paid and all outstanding requirements were satisfied

Patent Term Adjustment USPTO failure to issue a patent within three years of the actual filing date: In an international (PCT) application, “actual filing date” in 35 U.S.C. § 154(b)(1)(B) means the date national stage processing commences The three-year period does not include time consumed by any of-- Continued examination (RCE) under 35 U.S.C. § 132(b) Secrecy order, interference, or any appellate review Applicant-requested delays

Patent Term Adjustment Delays due to interference, secrecy order, or successful appellate review (35 U.S.C. § 154(b)(1)(C)) interference proceeding (35 U.S.C. § 135(a)) imposition of a secrecy order (35 U.S.C. § 181) successful appellate review (requires a BPAI/court decision reversing an adverse patentability determination) all rejections of at least one claim must be reversed In some instances, a remand shall be considered a decision reversing an adverse patentability determination These delays are also the bases for patent term extension under Public Law 103-465 (URAA)

Patent Term Adjustment Limitations on adjustment: No double counting of overlapping delays 16 38 0 14 36 No adjustment beyond any date specified in a terminal disclaimer

Patent Term Adjustment Limitations on adjustment: Reduction of adjustment for period during which applicant failed to engage in reasonable efforts to conclude processing or examination of an application Regulations define what is a failure to engage in reasonable efforts to conclude processing or examination of an application Failure to engage as defined by regulation: Failure to reply to any Office action or notice within three months Regardless of period for reply set in the action or notice Suspension of action or deferral of issuance of a patent at the applicant’s request Abandonment of the application (or failure to file a timely petition to withdraw an improper holding of abandonment) Conversion of a provisional application into a nonprovisional application File a nonprovisional application claiming benefit of the provisional rather than convert the provisional application into a nonprovisional application Submission of a preliminary amendment/paper (1) less than one month before an Office action or notice of allowance (2) that requires the mailing of a supplemental Office action/notice of allowance Submission of an incomplete reply (37 CFR 1.135(c)) Submission of a supplemental reply/paper Except if expressly requested by the examiner Submission of an amendment/paper after a BPAI/court decision (1) less than one month before an Office action or notice of allowance (2) that requires the mailing of a supplemental Office action/notice of allowance Does not include BPAI decisions containing a rejection under 37 CFR 1.196(b) or statement under 37 CFR 1.196(c)

Patent Term Adjustment Tracking patent term adjustment: PALM tracks events/dates giving rise to adjustments and reductions and calculates net patent term adjustment Applicants can check the PALM data concerning these events via PAIR Applicants can contact the TC Customer Service Center to correct PALM data that is in error

Patent Application Information Retrieval (PAIR) Interfaces File Content Screen http://pair-direct.uspto.gov/cgi-bin/final/filehist.pl Application Number entry screen

Patent Term Adjustment Procedures for determining adjustment: The patent issue date is needed to calculate the patent term adjustment 35 U.S.C. § 154(b)(3)(B)(i) requires the USPTO to include a patent term adjustment determination with the notice of allowance PALM will calculate the adjustment at time of allowance based upon projected issue date and include that determination in the notice of allowance

Patent Term Adjustment

Patent Term Adjustment PAIR review of PTA calculation: 1889 PAIR review of PTA calculation:

Patent Term Adjustment Procedures for requesting reconsideration: 35 U.S.C. § 154(b)(3)(B)(ii) provides for one request for reconsideration of USPTO’s patent term adjustment determination Requests for reconsideration of USPTO’s patent term adjustment determination must Be filed no later than payment of issue fee Include a $200 fee Set forth specific information concerning the appropriate patent term adjustment

Patent Term Adjustment Specific information required in a requests for reconsideration: The correct patent term adjustment The bases for the adjustment The relevant dates for which an adjustment is sought and the adjustment to which the patent is entitled Whether the patent is subject to a terminal disclaimer (and date in the disclaimer) Any circumstances that constitute a failure to engage in reasonable efforts to conclude processing or examination of such application (or a statement that there were no such circumstances)

Patent Term Adjustment Applicants may also request reinstatement of period reduced due to failure to reply to any USPTO action within three months The reinstatement request must be filed with a request for reconsideration of patent term adjustment and include: An additional $400 fee A showing that the failure to reply to a USPTO action within three months occurred “in spite of all due care”

Patent Term Adjustment Procedures for determining adjustment: PALM will make a final calculation when the patent number and issued date is assigned Patent will include final adjustment determination If this results in the patent term adjustment on the patent differing from that on the notice of allowance, applicant may file a request for reconsideration

Patent Term Adjustment Judicial review of USPTO determination: Applicant (patentee) has 180 days from patent grant to seek judicial review of the USPTO’s adjustment determination Judicial review is not to delay patent grant No third party challenge to USPTO determination prior to patent grant

Patent Term Extension under 35 U.S.C. 156

Patent Term Extension under 35 U.S.C. 156 Conditions for extension: The patent had not expired before an application was filed The patent has never been extended under 35 USC 156(e)(1) The application for extension is submitted within 60 days of FDA approval of the product The product has been subject to a regulatory review before its commercial marketing or use The approval is the first permitted commercial marketing or use of the product (with some exceptions)

Patent Term Extension under 35 U.S.C. 156 “Product” means: The active ingredient of a new human drug, antibiotic drug, or human biological product The active ingredient of a new animal drug or veterinary biological product Any medical device, food additive or color additive subject to regulation under the Federal Food, Drug and Cosmetic Act Drug Product- the active ingredient of a particular new drug in the final dosage form prior to administration of the product to the patient Active Ingredient- the ingredient in the drug product that becomes therapeutically active when administered

Patent Term Extension under 35 U.S.C. 156 A patent is considered to claim the product if the patent claims the active ingredient per se, or claims a composition or formulation which contains the active ingredient(s) and the claim covers the composition or formulation approved for commercial marketing or use

Patent Term Extension under 35 U.S.C. 156 Where a product contains multiple active ingredients, if any one active ingredient has not been previously approved, it can form the basis of an extension of patent term provided the patent claims that ingredient

Patent Term Extension under 35 U.S.C. 156 A new animal drug or veterinary biological product may be extended based on a second or subsequent approval of the active ingredient provided: The patent claims the drug or product The drug or product is not covered in another patent that has been extended The patent term was not extended on the basis of the regulatory review period for use in non-food producing animals The second or subsequent approval was the first permitted commercial marketing or use of the drug or product for administration to a food-producing animal

Application for Patent Term Extension on USPTO Internet Website

Application for Patent Term Extension on USPTO Internet Website

U.S. Patent Term Extension Certificate

“Patent Linkage” In the United States

Overview A mechanism to promote effective and adequate protection of intellectual property rights: Patent Linkage Orange Book patent listings

Objective of TRIPs Desiring to reduce distortions and impediments to international trade, and taking into account the need to promote effective and adequate protection of intellectual property rights, and to ensure that measures and procedures to enforce intellectual property rights do not themselves become barriers to legitimate trade. (Introduction to TRIPS Annex C) Any system of patent linkage should keep this dual goal in mind: promote both IP rights and trade.

An Efficient Balance with “Patent Linkage” New Drug Application (NDA) must include patent information and the FDA considers the existence of patents as part of the approval process for certain drug applications If a patent exists, marketing approval will not be granted to a generic until the patent has expired or is found to be invalid. This is Patent Linkage: Generic Marketing Approval is “Linked” to the Expiration of the Pioneer Drug Patent

Patent Linkage Patent Information Can be Obtained Efficiently: US FDA Requires Applicant to list patents that cover the drug as part of NDA filing Applicant Must submit signed declaration FDA relies on innovator drug company’s assertion Patent information published in Orange Book

How FDA becomes aware of patents: Forms 3542 and 3542a (available at www.fda.gov) The form is either the 3542 or the 3542a. The 3542 is filed The 3542a is submitted with a New Drug Application.

Required to list patents that cover the drug as part of NDA filing How FDA becomes aware of patents: Forms 3542 and 3542a (available at www.fda.gov) The NDA lists the patent information

Must submit signed declaration

FDA will rely upon the information Submitted The NDA lists the patent information

Orange Book Lists Product Name Patent Number Patent Expiration Date Exclusivity Information FDA relies on innovator drug company’s assertion Patent information published in Orange Book

“Orange Book” Orange Book Lists: Approved Drugs, Discontinued Drugs Provides Patent and Exclusivity Information Published annually with monthly cumulative supplements Electronic Orange Book also available The Orange Book lists a wide variety of drug patents. Sometimes the patents cover the active ingredient in a drug; sometimes they cover an aspect of the formulation, I.e. tablet coating. FDA has had patents listed for scoring patterns and for bottles and drug containers.

FDA Website

FDA Website: CDER

FDA Website: Orange Book

Electronic Orange Book

Electronic Orange Book http://www.fda.gov/cder/orange/default.htm

Electronic Orange Book

Errors in Orange Book Opportunity for generic drug companies to inform FDA that it does not believe a particular listed patent does covers the FDA-approved drug product FDA requests evaluation of complaint by innovator company Innovator company can request de-listing or respond with good-faith belief that listing is proper

Generic Drug Applications: The Process Generic Drug Company must certify when filing Abbreviated New Drug Application (ANDA) That the drug has not been patented; That the patent has already expired; The date on which the patent will expire, and the generic drug will not go on the market until that date passes; or That the patent is not infringed or is invalid Referred to as paragraphs I, II, III and IV certifications

Generic Drug Applications: The Process Paragraph I, II, III certifications relatively straightforward Existence of ANDA normally a secret until approval date Paragraph IV certification more complicated to administer ANDA applicant must notify innovator company of its filing; must describe reasons patent will not be infringed, is invalid, or unenforceable

Generic Drug Applications: The Process Paragraph IV Certification Innovator has 45-days after receipt of notice to file an infringement suit; the submission to FDA of paragraph IV certification in an ANDA creates infringement for purposes of federal court jurisdiction If lawsuit filed FDA approval is stayed for 30-months; at end of period FDA issues tentative approval Most ANDA applicants await resolution of the litigation before going to market to avoid liability for damages

Patent Linkage: Benefits Benefits of patent information: Allows Generic Drug companies to review patent information to determine: When Patent Expires- Generic Drug Company Allowed to use Patented Invention after patent expires What the Patent Covers With information about what patents cover drug product, generic drug companies can more quickly address issue of whether patent is infringed by a competitor’s use of a specific drug product

Patent Linkage: Benefits The system reduces wasteful and unnecessary patent infringement litigation by: (1) requiring generic drug companies to assess whether their drug product is subject to a patent prior to seeking drug approval; and (2) acting as a safeguard for patent rights by preventing potential patent violations.

Patent Linkage: Benefits An adequate linkage system also increases the efficiency and productivity of the research and development sector by: (1) providing transparency and predictability of the process for both the pioneer and the generic company; (2) helping both sides make better and more efficient investment decisions; and (3) encouraging timely redress of disputes. Better and more efficient investment decisions mean faster development for life saving inventions and better healthcare.

Summary Information about patents simple to submit to appropriate government agency Agency Communicates Information to the Public Government agency can make appropriate decisions about approving generic applications. Generic Companies can access information, take appropriate actions, and make better business decisions

Thank You!!