1 Patent Term Adjustments and Extensions Karin L. Ferriter Patent Attorney Office of Intellectual...

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Patent Term Adjustments and Extensions

Karin L. Ferriter

Patent Attorney

Office of Intellectual Property Policy and Enforcement

USPTO

(571) 272-9300

[email protected] November 6, 2007

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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.

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Patent Term Adjustment under35 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

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Patent Term Adjustment under35 U.S.C. 154

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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

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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

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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

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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)

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Limitations on adjustment:No double counting of overlapping delays 16 38

0 14 36 No adjustment beyond any date specified in

a terminal disclaimer

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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

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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

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Patent Application Information Retrieval (PAIR) Interfaces

http://pair-direct.uspto.gov/cgi-bin/final/filehist.pl

File Content Screen

Application Number entry screen

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Procedures for determining adjustment:The patent issue date is needed to calculate

the patent term adjustment35 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

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PAIR review of PTA

calculation:


1889

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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

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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)

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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”

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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

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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

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

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Conditions for extension:1) The patent had not expired before an application

was filed2) The patent has never been extended under 35 USC

156(e)(1)3) The application for extension is submitted within

60 days of FDA approval of the product4) The product has been subject to a regulatory

review before its commercial marketing or use5) The approval is the first permitted commercial

marketing or use of the product (with some exceptions)

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“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

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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

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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

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A new animal drug or veterinary biological product may be extended based on a second or subsequent approval of the active ingredient provided:

1) The patent claims the drug or product2) The drug or product is not covered in another patent that has

been extended3) The patent term was not extended on the basis of the

regulatory review period for use in non-food producing animals

4) 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

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Application for Patent Term Extension on USPTO Internet Website

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Application for Patent Term Extension on USPTO Internet Website

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U.S. PatentTerm Extension Certificate

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“Patent Linkage”

In the United States

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Overview

A mechanism to promote effective and adequate protection of intellectual property rights: Patent Linkage

Orange Book patent listings

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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.

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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

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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

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How FDA becomes aware of patents:

Forms 3542 and 3542a (available at www.fda.gov)

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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)

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Must submit signed declaration

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FDA will rely upon the information Submitted

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Orange BookLists Product Name

Patent Number Patent Expiration Date Exclusivity Information

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“Orange Book”

Orange Book 1) Lists:

1) Approved Drugs,

2) Discontinued Drugs

3) Provides Patent and Exclusivity Information

2) Published annually with monthly cumulative supplements

3) Electronic Orange Book also available

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FDA Website

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FDA Website: CDER

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FDA Website: Orange Book

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Electronic Orange Book

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

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Electronic Orange Book

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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

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Generic Drug Applications: The Process

Generic Drug Company must certify when filing Abbreviated New Drug Application (ANDA)

1) That the drug has not been patented;2) That the patent has already expired;3) The date on which the patent will expire, and the generic drug will

not go on the market until that date passes; or 4) That the patent is not infringed or is invalid

Referred to as paragraphs I, II, III and IVcertifications

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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

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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

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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

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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.

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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.

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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

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Thank You!!

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