Patent Term Adjustments and Extensions: Recent …media.straffordpub.com/.../presentation.pdf2012/04/18 · 3-month period for PTA calculation – Any day over 3-month period is deducted

Patent Term Adjustments and Extensions: Recent Developments Leveraging USPTO Rule Changes and Court Decisions to Maximize PTA and PTE

Today’s faculty features:

1pm Eastern | 12pm Central | 11am Mountain | 10am Pacific

The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions emailed to registrants for additional information. If you have any questions, please contact Customer Service at 1-800-926-7926 ext. 10.

WEDNESDAY, APRIL 18, 2012

Presenting a live 90-minute webinar with interactive Q&A

Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

Margaret J. Sampson, Partner, Vinson & Elkins, Palo Alto, Calif.

Conference Materials

If you have not printed the conference materials for this program, please complete the following steps:

• Click on the + sign next to “Conference Materials” in the middle of the left-hand column on your screen.

• Click on the tab labeled “Handouts” that appears, and there you will see a PDF of the slides for today's program.

• Double click on the PDF and a separate page will open.

• Print the slides by clicking on the printer icon.

Continuing Education Credits

For CLE purposes, please let us know how many people are listening at your location by completing each of the following steps:

• In the chat box, type (1) your company name and (2) the number of attendees at your location

• Click the SEND button beside the box

FOR LIVE EVENT ONLY

Tips for Optimal Quality

Sound Quality If you are listening via your computer speakers, please note that the quality of your sound will vary depending on the speed and quality of your internet connection. If the sound quality is not satisfactory and you are listening via your computer speakers, you may listen via the phone: dial 1-866-570-7602 and enter your PIN -when prompted. Otherwise, please send us a chat or e-mail [email protected] immediately so we can address the problem. If you dialed in and have any difficulties during the call, press *0 for assistance. Viewing Quality To maximize your screen, press the F11 key on your keyboard. To exit full screen, press the F11 key again.

Patent Term Adjustment Recent Developments and Strategies for Avoiding Applicant PTA Delays and Pitfalls

Margaret Sampson Vinson & Elkins, LLP April 18, 2012

4/18/2012 6

Patent Term Guarantee Act of 1999

35 U.S.C. § 154(b): • Provides PTA should certain USPTO actions take

longer than decreed periods of time – Guarantee of prompt USPTO responses (“A-Delays”)

– Guarantee of no more than 3-year application pendency (“B-Delays”)

– Guarantee or adjustment for delays due to interferences, secrecy orders, and appeals (“C-Delays”)

• Adjustments are day for day for the amount of delay

4/18/2012 7

Patent Term Guarantee Act of 1999

35 U.S.C. § 154(b): • Applies to original utility and plant applications

filed on or after May 29, 2000 – Includes continuation, divisional and continuation-in-part

applications filed after May 29, 2000 – A CPA that is filed after May 29, 2000 for an application

filed before May 29, 2000 is eligible for PTA – However, an RCE that is filed for an application filed before

May 29, 2000 is not eligible for PTA • Patent term extension provisions (37 C.F.R. § 1.701) will

apply to utility and plant applications filed on or after June 8, 1995 and before May 29, 2000

4/18/2012 8

A-Delays - Guarantee of Prompt USPTO Responses

A-Delays occur if the USPTO does not: • Provide at least one notification within 14 months from filing

date, e.g.: – Office Action – Restriction Requirement – Notice of Allowance – For national stage applications under 35 U.S.C. § 371, the 14-month

clock does not start until all § 371 requirements are complete

• Respond within 4 months for other actions, e.g.: – Respond to a reply – Respond when an appeal is taken – Act on a decision by BPAI – Issue a patent after issue fee paid

4/18/2012 9

B-Delays - Guarantee of No More Than 3-Year Application Pendency

B-Delays occur if the USPTO does not: • Issue a patent within 3 years of the actual filing date

But B-Delays do not include: – time after request for continued examination (RCE) – time consumed by an interference – time consumed by imposition of a secrecy order – time consumed by BPAI or Federal court review – any delay at the request of the applicant

4/18/2012 10

B-Delay –RCE Rule Challenged

Abbott has challenged calculation of B-Delays: • asserts USPTO’s interpretation of § 154(b)(1)(B)(i) is

incorrect: – “time consumed by continued examination of the application”

does not include time after allowance – “continued examination” is not occurring after allowance –

examination is complete – time after notice of allowance is B-delay, regardless of

whether an RCE was filed • A district court decision could occur this year

– Abbott Biotherapeutics Corp. v. Kappos, 1:2010cv01853 (D.D.C. filed October 29, 2010)

4/18/2012 11

C-Delays - Adjustments for Delays Due To Interferences and Appeals

C-Delays occur as a result of: • Interference proceedings • Secrecy orders • Successful appellate review

– Currently, C-Delay accrues from date of Notice of Appeal until decision is handed down or prosecution reopens

– Successful appellate review means: • Reversing an adverse determination of patentability for at

least one claim • Certain remands by the panel of the BPAI (see 37 C.F.R.

§ 1.702(e))

4/18/2012 12

Subtract Applicant Delays

35 U.S.C. § 154(b)(2): • Adjustments are reduced for applicant’s failure to

engage in reasonable efforts to conclude prosecution • 37 C.F.R. § 1.704: Actions that result in loss of PTA

include: – time in excess of 3 months to reply to any action notice – suspension of action – deferral of issuance – abandonment or late payment of issue fees – conversion of a provisional application

4/18/2012 13

Applicant Delays

• 37 C.F.R. § 1.704: Actions that result in loss of PTA include (cont): – submission of a reply having an omission – submission of a supplemental reply

• Note: delays start accruing on day after initial reply was filed not when it was due

– submission of a preliminary amendment less than one-month before mailing of office action

– submission of an amendment after a decision by the BPAI – submission of an amendment after a notice of allowance has

been mailed

4/18/2012 14

Calculating Patent Term Adjustment

• Under 37 C.F.R. § 1.703(f), PTA is calculated by: – Adding any A-Delays, B-Delays and C-Delays together – Subtracting any overlap between A- and B-Delays or A-

and C-Delays • Overlap is calculated by counting delays occurring on the

same calendar days – Wyeth v. Kappos, 591 F.3d 1364 (Fed. Cir. 2010) – Before Wyeth, USPTO interpreted statute as only

allowing greater of A-delays or B-delays, not both – Subtracting any applicant delays

4/18/2012 15

Maximizing PTA: Avoiding Pitfalls

• Respond within 3 months of an action – A shortened or lengthened period has no effect on the

3-month period for PTA calculation – Any day over 3-month period is deducted from PTA

calculation • Arqule v. Kappos, 793 F.Supp.2d 214 (D.D.C. 2011),

held that a timely filed response would not accrue applicant delay (i.e. filed on Tuesday when 3-month period ended on Monday, a federal holiday)

• Double check PTA calculation –USPTO has not appealed this decision, but verify USPTO has calculated correctly

4/18/2012 16


• Make a telephone election – A written restriction requirement is a first action and will stop

the 14-month clock – A first office action usually takes longer to prepare

• File electronically, by Express Mail or FAX – If mailed by first class, clock runs until response is received in

the USPTO, even if includes a certificate of first class mailing – Mail delays can end up amounting to weeks of lost PTA

• Consider filing a CIP rather than a Continuation – First action for a CIP typically takes longer than for a

Continuation

4/18/2012 17


• Make sure replies are complete and do not have an omission – PTA is lost for time needed to correct the omission – Supplemental replies result in the same loss as an omission

• Days are counted from the day after the reply with omission was filed, not the date the reply was due

– Ask examiner if the problem can be corrected in the next reply or by an examiner’s amendment

• Timely file Information Disclosure Statements (IDS) – File an IDS before the first office action or with a reply

• New Rule: Not considered untimely if IDS is filed within 30 days of a communication from the USPTO or a foreign patent office with a certification under 37 C.F.R. § 1.704(d) – Old rule only included foreign office communications – Certification under 37 CFR § 1.97(e)(1) does not prevent

loss of PTA (within 3-months)

4/18/2012 18


• Do not file papers after allowance – Ask examiner to make corrections by examiner’s amendment – If a problem can be corrected by certificate of correction, wait

and file after patent issues • Avoid Terminal Disclaimers

– PTA cannot overcome a terminal disclaimer – Try to ensure a patent with PTA issues first

• Avoid Requests for Continuing Examination – Filing an RCE cuts off any further B-Delays

• Be aggressive and argue against or appeal final rejections – Try to keep prosecution open without filing an RCE

4/18/2012 19


• The USPTO has proposed a new rule for calculating PTA related to the appeals process – Proposal published in the Federal Register Dec. 28, 2011

• Proposed New Rule: C-Delay will not start to accrue until the BPAI takes jurisdiction of the appeal – Defined as when reply brief is filed or time to file has expired – Removes many months of PTA from C-Delay calculation – Good news if B-Delay is still accruing: any loss in C-Delay will be

compensated by an increase in B-Delay (resulting in net increase in PTA)

– But if B-delay is not accruing because an RCE was filed, results in a net loss of PTA

4/18/2012 20


• File Appeals – if grounds exist and record supports – Establish necessary record early in prosecution to support appeal – If examiner reopens prosecution through an office action currently no

C-Delay accrues • no favorable decision by the Board • A-Delay from the Appeal Brief filing until examiner issues an office

action to reopen prosecution (any time over 4 months) • But Proposed New Rule would result in B-delay, if available

– Currently, some extensions of time during the appeal process do not count against the applicant for PTA • For example, filing an Appeal Brief is not considered responding to

a USPTO action, so no reduction of PTA for extensions • However, Proposed New Rule will make an extension for filing an

appeal brief applicant delay

4/18/2012 21

Calculate Your Own PTA

• Notice of Allowance will set forth any PTA as calculated by USPTO

• Check USPTO’s calculation of PTA to ensure that it is correct – based on data found in “PAIR”- but not always accurate

• Final PTA will be indicated on the face of the issued patent

4/18/2012 22

Contesting the Office’s PTA Determination

• 37 C.F.R. § 1.705(b): A request for reconsideration must be filed before the payment of the issue fee – Can include request to reinstate portion of PTA for failure to

respond to an action within 3 months (see MPEP § 2734 for examples)

– Must raise all issues that can be raised, or they will be waived – Time taken by USPTO for consideration may end up as either

A-delay (> 4-months to issue patent) or B-delay (>3 years)

• 37 C.F.R. § 1.705(d): Reconsideration of final PTA must be filed within 2 months of patent issuance – Only new issues can be addressed

• None of these deadlines are extendable

4/18/2012 23

Contesting the Office’s PTA Determination

• 35 U.S.C § 154(b)(4)(A): final determination of PTA by USPTO can be appealed to the U.S. District Court – Appeal must be filed within 180 days of issuance of patent

(AIA changed the venue from D.D.C. to E.D. Va on September 16, 2011) • Applicants must respect the strict time and venue limitations of

the patent statute (Janssen Pharmaceutica N.V. v. Kappos, No. 1:11-cv-969 (E.D. Va. Feb. 10, 2012))

• Cannot raise issues that could have been raised before – 180-day period is tolled pending USPTO’s final determination

of PTA • Bristol-Myers Squibb Company v. Kappos, Civ. No. 09-1330

(D.D.C. Jan. 27, 2012) • USPTO has requested reconsideration of the district court

decision

4/18/2012 24

Examples of Calculating PTA

• Example 1: PTA calculation for a typical patent • Applicant files May 24, 2002 • 14-month date Jul. 25, 2003 • USPTO issues first rejection Dec. 16, 2005

– 876 days of A-Delay • Applicant files RCE Aug. 21, 2007

– 818 days of B-Delay, with 206 days overlapping with A-Delay – RCE cuts off any further B-Delay

• Patent issues Apr. 28, 2010

982 days of PTA lost after RCE filed – no PTA accrues after filing

4/18/2012 25

Patent Term Adjustment – Example 1

A-Delay – 876 Non-overlapping USPTO delays 1488 B-Delay – 818 Applicant Delays 616 C-Delay – 0 Total PTA Adjustments 872

876 + 818 – 206 = 1488 – 616 = 872 days (2.4 years) PTA lost post-RCE = 982 (2.7 years)

File appl. 5-24-2002

14 month 7-25-2003

File RCE 8-21-2007

Issues 4-28-2010

3 Years 5-25-2005

Non-Final 12-16-2005

A-Delay 876 days B-Delay

818 days

Overlap 206 days

4/18/2012 26


• Example 2: PTA calculation with a successful Appeal • Applicant files Nov. 14, 2002 • USPTO issues first rejection Jun. 20, 2006

– 888 days of A-Delay • Applicant files RCE Feb. 1, 2007

– 443 days of B-Delay, with 218 days overlapping with A-Delay – RCE cuts off any further B-Delay

• Applicant files Notice of Appeal Apr. 25, 2008 – Reply Brief filed Nov. 24, 2008 – BPAI gets jurisdiction

• USPTO issues favorable decision Sept. 29, 2010 – 888 days of C-Delay

• Patent issues Feb. 9, 2011

Even though no more B-Delay accrues after RCE filing, because of the Appeal, C-Delay is added to PTA calculation

4/18/2012 27


A Delay – 888 Non-overlapping USPTO delays 2001 B Delay – 443 Applicant Delays 13 C Delay – 888 Total PTA Adjustments 1988 888 + 443 + 888 – 218 = 2001 – 13 = 1988 days (5.4 years)

File Appl. 11-14-2002

14 month 1-15-2004

File RCE 2-1-2007

Issues 2-9-2011

3 Years 11-15-2005


443 days

Overlap 218 days

Non-Final 6-20-2006

Notice of Appeal 4-25-2008

Appeal Decision 9-29-2010

C-Delay 888 days

File Reply 11-24-2008

4/18/2012 28


A Delay – 888 Non-overlapping USPTO delays 1788 B Delay – 443 Applicant Delays 13 C Delay – 675 Total PTA Adjustments 1775 888 + 443 + 675 – 218 = 1788 – 13 = 1775 days (4.9 years) Loss of C-Delay under proposed New Rule

File Appl. 11-14-2002

14 month 1-15-2004

File RCE 2-1-2007

Issues 2-9-2011

3 Years 11-15-2005


443 days

Overlap 218 days

Non-Final 6-20-2006



C-Delay 675 days

Proposed New Rule

File Reply 11-24-2008

4/18/2012 29


• Example 3: Complex PTA calculation • Applicant files Jun. 20, 2001 • USPTO issues first rejection Nov. 24, 2004 • Applicant files Notice of Appeal Mar. 31, 2006

– Applicant files Appeal Brief May 30, 2006 • USPTO issues non-final rejection Aug. 30, 2006, reopening prosecution

– No decision in Appeal, so no C-Delay accrues, but B-Delay clock is still ticking • Applicant files second Notice of Appeal Jun. 9, 2007

– Applicant files Appeal Brief August 9, 2007 – Examiner files reply December 9, 2007 – Applicant files reply January 5, 2008 – Jurisdiction passes to BPAI

• USPTO issues favorable decision May 26, 2010 • Patent issues Sept. 22, 2010

– B-Delay clock is still ticking

Prosecution by Appeal: 153 days of PTA did not accrue during first appeal; but because no RCE was filed, an additional 404 days of B-Delay did accrue

4/18/2012 30


A Delay – 838 Non-overlapping USPTO delays 2802 B Delay – 1051 Applicant Delays 205 C Delay – 1081 Total PTA Adjustments 2597

838 + 1051 + 1081 – 168 = 2802 – 205 = 2597 days (7.1 years)

File Appl. 6-20-2001

14 month 8-21-2002

Issues 9-22-2010

3 Years 6-21-2004

A-Delays 838 days

B-Delays 1051 days




C-Delay 1081 days


Non-Final 8-30-2006

Reply Brief 1-5-2008

4/18/2012 31


A Delay – 838 Non-overlapping USPTO delays 2806 B Delay – 1413 Applicant Delays 205 C Delay – 871 Total PTA Adjustments 2601

838 + 1413 + 871 – 168 = 2954 – 205 = 2749 days (7.5 years) B-Delay compensates for C-Delay loss under Proposed New Rule

File Appl. 6-20-2001

14 month 8-21-2002

Issues 9-22-2010

3 Years 6-21-2004

A-Delays 838 days

B-Delays 1413 days




C-Delay 871 days


Non-Final 8-30-2006

Reply Brief 1-5-2008

Proposed New Rule

4/18/2012 32

Conclusions

• Carefully managed prosecution can maximize accrual of Patent Term Adjustment – Do not take any extensions over 3 months for a

reply – If the prosecution record is in order, use appeal

process to further prosecution, instead of RCE – Avoid or manage terminal disclaimers in

applications that accrue time for PTA

Questions?

[email protected] 650.687.8203

Patent Term Extensions

©Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, 2012

T O M I R V I N G A N D D E B H E R Z F E L D W I T H A C K N O W L E D G E M E N T O F S T A C Y L E W I S

APRIL 18 , 2012

For

These materials are public information and have been prepared solely for educational and entertainment purposes to contribute to the understanding of U.S. intellectual property law. These materials reflect only the personal views of the speaker and are not individualized legal advice and do not reflect the views of Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P. It is understood that each case is fact-specific, and that the appropriate solution in any case will vary. Therefore, these materials may or may not be relevant to any particular situation. Thus, Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., and the speaker cannot be bound either philosophically or as representatives of their various present and future clients to the comments expressed in these materials. The presentation of these materials does not establish any form of attorney-client relationship with Finnegan, Henderson, Farabow, Garrett & Dunner, L.L.P., and the speaker. While every attempt was made to insure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

35

Disclaimer

35 U.S.C. § 156

36

35 U.S.C. § 156 provides for patent term extensions for a patent that claims a product, a method of making a product, or a method of using a product that has been subject to premarket regulatory review before it is approved for commercial marketing in the United States.

Extension = ½ (testing phase) + approval phase - any time applicant did not act with due diligence Not to exceed 5 years from patent expiration, exclusive of any

regulatory review period occurring before the patent issues § 156(g)(6) or not to exceed 14 years from NDA approval § 156(c)(3), whichever comes first.

How Delay in Patent Issuance Costs PTE

37

How to lose some 900 days of patent term extension because of delayed issuance

Scenario 1: Day 0 - Regulatory review starts

Day 1 – Patent issues

Day 1000 – NDA filed

Day 1500 – FDA approval

Patent gets about 999/2 of PTE for the regulatory review to NDA

period and all 500 days for the regulatory period from NDA to FDA approval, 500 + 500 = 1000 (subject to the 5/14 year caps)

How Delay in Patent Issuance Costs PTE cont.

38

How to lose some 900 days of patent term extension because of delayed issuance

Scenario 2: Same facts but patent issues on Day 998 Patent gets 2/2 of PTE for the regulatory review to NDA period and all 500

days for the regulatory period, from NDA to FDA approval, 1+500 = 501 (subject to the 5/14 year caps).

Scenario 3: Same facts but patent issues on Day 1400 Patent gets 0 of PTE for the regulatory review to NDA period , and only 100

days or so of PTE in the NDA approval time span, 0+100 = 100 (subject to the 5/14 year caps).

39

Hypothetical Example: Patent Term Extension Timeline for U.S. 0,000,001

(broad drug substance)

Patent term (no PTA, no extension) : 20 years from PCT filing, almost 7 years from NDA approval date. Patent term with 5 year extension: 25 years from PCT filing, almost 12 years from NDA approval date. 14 year cap: 24 years from patent grant, 14 years from NDA approval date. 5 year cap is earlier, BUT eat into PTE if grant is after 16 Jul 2004 (AIA Prioritized Track I Exam: from 9/16/11 can accelerate issuance)

39

40

Hypothetical Example Showing LOSS in PTE from taking longer to get the patent Patent Term Extension Timeline for U.S. 0,000,001

(broad drug substance)

This slides shows the actual calculations for the regulatory approval period

40

½ of 2355 days

(1177.5 = 1178) all of days

(605)

41


(narrow drug substance covering approved product and bioequivalents)

Patent term (no PTA, no extension) : almost 17 years from grant, some 8 + years from NDA approval date. Patent term with 5 year extension: almost 22 years from grant, some 13 + years from NDA approval date. 14 year cap: 22 years 5 mos. from patent grant, 14 years from NDA approval date. 5 year cap is earlier. Longer expiration than ‘001 A key: patent issued before 16 July 2004. Issuing thereafter eats into PTE. ‘002: “more enforceable” than ‘001? AIA from September 16, 2011: Track I prioritized exam

41

42


(narrow drug substance covering approved product and bioequivalents)


42

½ of 2355 days (1177.5)

all of days (605)

43


(polymorphic form of the drug substance)

Note that the continuation strategy cost some 2 years of PTE on perhaps the “most enforceable” of the patents ‘001, ‘002, and ‘003. An earlier application in the family could have helped PTE. Track I Prioritized Exam available beginning on 9/16/11 can help get patent earlier and maximize PTE.

‘003: a continuation in the ‘002 family, issued several years later w/narrower but listable claims. -> less extension

43

44


(polymorphic form of the drug substance)


44

½ of 835 days (417.5)

all of days (605)

45


(method of use approved by FDA)

Note that continuation strategy ate into PTE. But ‘004 may not have been the primo patent of the series because generic manufacturer might have been able to seek another indication and might have been able to skinny label.

45

46


(method of use approved by FDA)


46

½ of 1900 days (950)

all of days (605)

Sample PTE Timeline For the Future

47

1-1-15 Earliest effective non-prov. filing date

17-11-13 Approx. IND filing date

17-12-13 Approx. regulat. review start date

23-10-15 ‘001 patent grant 23-10-21

Approx. NDA Filing date

23-10-22 Approx. NDA Approval Date

23-10-26 Approx. Initial ANDA challenge date

23-10-27 Approx. NCE expiration date

1-1-35 original expiration of ‘001 patent

23-10-36

approx. NDA

approval + 14 years

1-1-40 original expiration of ‘001 patent + 5 years

1-01-39 approx. expiration of extended ‘001 patent

Assume Prioritized Exam was used for the ‘001; issued in a little over 9 months ‘001 extension approximately 1460 days; expires 1-01-39, as shown. BUT subject to 14-year cap, 23-10-36, as shown which comes before 5-year cap! Why? Filing after regulatory period began, patent issued quickly.

Sample PTE Timeline For the Future: Not to Scale

48

1-1-10 Earliest effective non-prov. filing date

17-11-13 Approx. IND filing date

17-12-13 Approx. regulat. review start date

23-10-15 ‘001 patent grant 23-10-21

Approx. NDA Filing date

23-10-22 Approx. NDA Approval Date

23-10-26 Approx. Initial ANDA challenge date

23-10-27 Approx. NCE expiration date

1-1-30 original expiration of ‘001 patent

23-10-36

approx. NDA

approval + 14 years

1-1-35 original expiration of ‘001 patent + 5 years

‘001 extension approximately 1460 days to ~1-1-34, not shown. BUT does not even hit 5-year cap, 1-1-35, which comes before 14-year cap! Why? Filed patent application before regulatory period began; patent did not issue quickly Constants in slides 14 and 15: start of regulatory period, approx. NDA filing and approval dates, and approx Initial ANDA challenge and NCE expiration dates

Prioritized Examination Referenced in Previous Slides

Important for PTE

49

“Fast-track” examination – goal of “final disposition” within 12 months.

See 76 Fed. Reg. 59,050 (Sept. 23, 2011) “The procedure for prioritized examination does not apply to international applications, design

applications, reissue applications, provisional applications, and reexamination proceedings. Applicants may request prioritized examination for a continuing application (e.g., a continuation or divisional application). …Each application (including each continuing application) must, on its own, meet all requirements for prioritized examination under 37 CFR 1.102(e).”

1 RCE allowed; see next slide.

Must be “complete” and all fees upon filing (specification, claims, drawings, and oath/declaration)

50

Prioritized Examination SEC. 11(h) [125 STAT. 324] (“shall take effect on (Sept. 26, 2011)”)

Lose “fast-track” status if file for an extension of time or file an appeal!! 76 Fed. Reg. 59,051 (Sept. 23, 2011)

Okay to file (one) RCE on or after Dec. 19, 2011 (76 Fed. Reg. 78,566 (Dec. 19, 2011)).

Does not impact existing accelerated examination procedure (see 71 Fed. Reg. 36,323 (June 26, 2006) and MPEP 708.02) (also goal of final determination within 12 months).

51

Prioritized Examination SEC. 11(h) [125 STAT. 324]

(“shall take effect on (Sept. 26, 2011)”)

76 Fed. Reg. 59,051 (Sept. 23, 2011): “The final disposition for the twelve-month goal means that within twelve months from the date prioritized status has been granted that one of the following occur: (1) Mailing of a notice of allowance; (2) mailing of a final Office action; (3) filing of a notice of appeal; (4) completion of examination as defined in 37 CFR 41.102; (5) filing of a second request for continued examination; or (6) abandonment of the application.”

52

“Final Disposition”

SEC. 11(h)(1)(A)(i): Fee of $4,800 for filing a request for prioritized examination of a nonprovisional application for an original utility or plant patent.

SEC. 11(h)(1)(A)(ii): In addition, applicant must pay filing,

search, and examination fees (including any applicable excess claims and application size fees), processing fee, and publication fee for that application.

53

Prioritized Examination Fee

Basic filing fee $380 + prioritized exam fee $4800 + examination fee $250 + $620 search fee-> $6050 for non-provisional patent application (no more than 3 independent claims and no more than 20 claims total) Plus processing and publication fees.

Could get reduction on filing fee for electronic filing.

Takes into account 15% surcharge effective Sept. 26, 2011.

54

Prioritized Examination Example

SEC. 11(h)(1)(B)(i): Director may prescribe conditions for acceptance of a request under subparagraph (A) and a limit on the number of filings for prioritized examination that may be accepted.

SEC. 11(h)(1)(B)(ii): Until regulations say otherwise, no application for which prioritized examination is requested may contain or be amended to contain more than 4 independent claims or more than 30 total claims.

SEC. 11(h)(1)(B)(iii): Until regulations say otherwise, Director may not accept in any fiscal year more than 10,000 prioritization requests.

55

Prioritized Examination Limits

Report in a blog post by Commissioner for Patents Margaret A. Focarino on Jan. 3, 2012: “The Agency's Self-Report on Implementation Performance Through Year-End 2011” During its first three months of Track I accelerated patent

application examination, the agency's goal of rapid time to first office action is being met.

1,694 petitions filed since the fast track option was first made available.

1,218 petitions approved (72%)

56

So Far, So Good says PTO?

Source: “PTO Reports Quick Turnaround of Fast Track Patent Examination Requests in First Months,” Tony Dutra, reported in BNA's Patent Trademark & Copyright Journal®, Volume 83 Number 2046, Jan. 6, 2012.

Of those approved, 648 have already received first office actions, with 23 of those having patents granted and three receiving final rejections (88% grant rate).

23-3 ratio of grants to rejections is quite high, but Focarino said in the blog: “For those applicants or practitioners concerned about whether Track I applications will be treated differently from others in terms of grant/denial rate, our examiners are being given exactly the same training, credits and incentives to accurately examine Track I cases as for all other cases, and no training, credits or incentives are being given to bias examiner decisions in any way.”

57

So Far?


13 petitions denied, mostly for administrative reasons: the request for prioritized examination was filed before the effective date of the program, all the required fees were not paid on filing of the application, or an executed oath or declaration was not present on filing of the application.

Average time to process a petition = 41 days, and the average time from petition approval to first office action = 31 days.

58

So Far?


Limited Time to Make Request

59

Deadline for filing application for PTE: non-extendible 60-day period from the date the product is approved for commercial marketing.

Genetics & IVF Institute v. Kappos, 801 F.Supp.2d 497 (E.D.Va. 2011)

Genetics’ request for an interim extension was denied.

There are deadlines applying to the filing of patent term extension requests, and

the request was not timely filed. See 37 CFR 1.760.

DC: the extensions “are not automatic.”

Limited Time to Make Requests

60

If the original term of the patent will expire before the product is approved for commercial marketing or use, application for interim PTE must be filed during the period beginning 6 months, and ending 15 days before the term is due to expire. Each subsequent application for interim extension must be filed

during the period beginning sixty days before and ending thirty days before the expiration of the preceding interim extension.

PTE available even where regulatory approval occurs after

the expiration date of the original patent term.

PTE Applies To Entire Patent

61

Any patent term extension granted is for the entire patent, not individual claims. “§ 156 applies to the term of the patent, not individual claim(s).”

Genetics Institute, LLC v. Novartis Vaccines and Diagnostics, Inc., 655 F.3d 1291 (Fed. Cir. 2011)

See, e.g., Sufaxin® and Andara OFS® extension notices as

published in the Oct. 13, 2011, Federal Register, http://pub.bna.com/ptcj/PTOsurfaxinOct13.pdf and http://pub.bna.com/ptcj/PTOandaraOct13.pdf.

PTE Available For Class III Medical Devices Also

62

Medical devices must be approved under § 515 of the Federal Food, Drug and Cosmetic Act to be eligible for term extension. Medical devices approved under § 510(k) are not eligible.

In re Nitinol Medical Technologies, Inc., 17 USPQ 2d 1492

(Comm’r. Pat. & Tm. 1990); Baxter Diagnostics v. AVL Scientific Corp., 798 F.Supp 612, 619-20 (C.D. CA 1992)

Application for PTE

63

Start planning early in the product approval cycle. Avoid last-minute rush. Best practices:

File early to permit US PTO to review the application and identify any potentially fatal errors before the 60-day deadline expires.

And whether or not such early review occurs, file well before the non-extendible 60-day period.

Draft your application (see earlier slides) as soon as FDA approval is obtained so you can see if you have any holes to fill.

File PTE for all Orange Book listable patents and later elect which patent will get the PTE. Hedge your bets against foreign litigation and AIA procedures of PGR and

IPR. Hedge your bets against possible use of Supplemental Examination

Processing a PTE Request

64

Patentee may file multiple applications for PTE based on different patents but the same regulatory approval of a product. Preserve an opportunity to select an appropriate patent until the time that the

Commissioner must grant a certificate of patent term extension. Only one patent may be extended per regulatory review of a particular product.

All papers are available in theory to the public on PAIR once the application for patent term extension is filed.

ABA Panel Comments on Preparing Early for PTE

65

Donna M. Meuth, senior patent counsel for Eisai Inc.:

10 to 15 years and an average of $1B to get a drug through FDA approval.

“Every extra day on the market really counts.”

“the choice of which patent to extend is critical.”


66


Suggestions:

plan ahead, doing all the legwork for PTE in anticipation of approval;

review the patent portfolio related to the product because, even though separate patents may be directed to different aspects of a product, under §156(c)(4), only one patent may receive the benefit of a single regulatory review; a health check is a good idea


67


Suggestions:

consider the strengths and weaknesses of the different patents and ask, is it a strong patent that could block others or is it possible to design around it?

Since patent prosecution occurs early in the product's life cycle, “[y]ou need to …think 10 years down the road, and ask if the particular patent's claims will be tied to a product and whether the patent will be a good basis for a PTE.”

It also may be advantageous to obtain claims of varying type and scope in a single application so that the extended patent term is as broad as possible.

Sample Patent Term Extension Notice

68

69


• US PTO Explanation of the calculation:

• Patent granted Sept. 3, 2002 • NDA filed Jan. 31, 2003 • NDA approved Dec. 15, 2004 • PTE application Feb. 11, 2005 • Original expiration Jan. 16, 2012 • Term extension 760 days • Extended term expiration Feb. 14, 2014


70

Sample Request for Reconsideration of Patent Term Extension

71

Changing Information in the Orange Book

72

Third Party Has 180 Days After Publication of Regulatory Review Period to Question Due Diligence of PTE Applicant

73

Request Interim Extension When Original Term Will Expire Before PTE Can Be Issued

74

Information Required in PTE Application 37 C.F.R. § 1.740

75


76


77


78


79


80


81


82

Application for PTE

83

Application for PTE must be filed by the patent owner or its agent.

Processing the application for PTE is joint responsibility of the US PTO and regulatory agency responsible for the premarket regulatory review. No required time for response. Keep track and make inquiries as appropriate.

PTE Eligibility

84

Not precluded by terminal disclaimer Merck & Co., Inc. v. Hi-Tech Pharmacal Co., Inc., 482 F.3d 1317 (Fed. Cir.

2007): “The terminal disclaimer is not ignored; the §156 patent term extension is calculated from the terminal disclaimer expiration date. The objectives of two separate policies are fulfilled.”

The original term of the patent must not have expired at the time the application for patent term extension is filed. Keep the foot on the accelerator during regulatory review period.

The term of the patent must not have been previously extended under § 156.

PTE Eligibility (con’t)

85

Only one patent may be extended for the same regulatory review period for any product.

For drug products containing a combination of active ingredients, it must be the first approval for at least one active ingredient.

Term Extension: Protection in Extended Term

Depends on type of patent claim. Approved product - rights in the PTE limited to any use approved for

the product that occurred before the expiration of the term of the patent.

Method of making approved product – rights in the PTE limited to the method of manufacturing as used to make the approved product.

Method of using approved product - rights in the PTE limited to any

use claimed by the patent that has been approved for the product before the expiration of the term of the patent.

86

PTE Eligibility: Filing Request Why Filing Early Can Save So Much Trouble!

87

The Medicines Co. (“TMC”) and their blood-thinning drug, Angiomax® (patent without extension expired March 23, 2010).

TMC received FDA approval on Friday, Dec. 15, 2000 6:17 PM.

TMC filed its extension request on Feb. 14, 2001, which complied with the 60-day deadline if the technical date of FDA approval was Monday, Dec. 18, but is one day late if the date of FDA approval was Dec. 15.


88

US PTO used the Dec. 15 date, and rejected the PTE request.

In addition to suing the US PTO, TMC spent more than $13M on lobbying for relief.

On August 3, 2010, the district court granted TMC’s motion that the US PTO’s decision was “arbitrary and capricious.” The Medicines Company v. Kappos, 731 F.Supp.2d 470 (ED. Va. Aug. 3, 2010): “Congress intended for the applicant to have sixty days. The PTO

interpreted the statute in a manner that deprives an applicant the sixty days that Congress intended for them to receive. For the forgoing reasons, summary judgment should be awarded to the Plaintiff.”


89

AIA amended 35 U.S.C. §156(d)(1) to include directions as to how days are to be counted (and extend the TMC patent no matter what happened further in the litigation). AIA SEC. 37, 125 STAT. 341: ‘‘For purposes of determining the

date on which a product receives permission under the second sentence of this paragraph, if such permission is transmitted after 4:30 P.M., Eastern Time, on a business day, or is transmitted on a day that is not a business day, the product shall be deemed to receive such permission on the next business day. For purposes of the preceding sentence, the term ‘business day’ means any Monday, Tuesday, Wednesday, Thursday, or Friday, excluding any legal holiday under section 6103 of title 5.’’


90

Retroactive: “The amendment made by subsection (a) shall apply

to any application for extension of a patent term under section 156 of title 35, United States Code, that is pending on, that is filed after, or as to which a decision regarding the application is subject to judicial review on, the date of the enactment of this Act.”

Thank you. Tom Irving


Deb Herzfeld


91

mailto:[email protected]�

Documents

Patent Term Adjustments and Extensions: Recent …media.straffordpub.com/.../presentation.pdf2012/04/18 · 3-month period for PTA calculation – Any day over 3-month period is deducted