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Double Patenting: Defeating Double Patenting

Rejections and Avoiding Terminal Disclaimers

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THURSDAY, APRIL 20, 2017

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

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

Leslie A. McDonell, Partner, Finnegan Henderson Farabow Garrett & Dunner, Boston

Margaret J. Sampson, Partner, Baker Botts, Austin, Tex.

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4

DOCTRINE OF DOUBLE PATENTING

• To prevent the “unjustified extension of patent exclusivity

beyond the term of a patent.”

• Expectation of public that upon the expiration of the

patent it will be free to use the claimed invention and

obvious modifications or variants.

5

Types: • Same-invention. • Obviousness-type.

Prohibition against double patenting applies to pre-AIA and AIA patent claims. • Grounds for examiner rejection; and • Grounds for allegation of invalidity in litigation. • Not grounds for AIA Post Grant Proceedings according to PTAB because

not a statutory basis for invalidity (See Apple Inc. v. SightSound Techs., CBM2013-00021, Paper 13, at 25 (Oct. 8, 2013)).

Generally, can file a terminal disclaimer to overcome an obviousness-type double-patenting rejection.

DOUBLE PATENTING

6

Applications with all claims having an effective filing date before March 16, 2013.

•Double patenting rejection authorized where an applicant invokes the provisions of pre-AIA 35 U.S.C. §103(c) (joint research agreements), even though there is neither a common inventor nor a common patent owner.

• “[T]he application or patent and the subject matter disqualified under

[amended] 35 U.S.C. 103(c)…will be treated as commonly owned for purposes of double patenting analysis. …This double patenting rejection may be obviated by filing a terminal disclaimer in accordance with §1.321(d).” 70 Fed. Reg. 54,261 (Sept. 14, 2005).

DOUBLE PATENTING FOR PRE-AIA APPLICATIONS

7

Applications with all claims having an effective filing date after March 15, 2013, and applications with mixed pre-March 16, 2013, and post-March 15, 2013 effective filing dates.

• Note: pre-AIA 35 U.S.C. §103(c) will not apply because according to AIA

SEC. 3(n)(2), only pre-AIA §102(g) “crosses the line” AIA §102(b)(2)(C) and §102(c) now apply to commonly-assigned and joint research inventions.

• Protection will only shield the prior effectively filed invention from being

considered as §102(a)(2) prior art against the later invention, but will, under those limited circumstances, shield the later invention from both novelty and obviousness attack.

• But that protection may not shield later invention from obviousness double-patenting over earlier.

DOUBLE PATENTING FOR AIA AND MIXED APPLICATIONS

8

9

•Anticipation type (statutory “same-invention” double patenting) •No requirement that the first patent disclosure qualify as “prior art,” but requirement for identity of claimed subject matter makes it analogous to anticipation.

•A species anticipates a genus under §102, but in same-invention double patenting, the species and genus are not the same invention.

•Non-statutory obviousness-type double patenting

•Prohibits claims in a second patent or application that are not patentably distinct from claims in a first patent but Gilead opens up date of expiration vs. date of grant.

•Provisional v. actual rejections

• Actual ODP rejection - to a pending application in view of a first-issued patent or in view of another pending application. •Provisional ODP rejection - in view of a pending application when there are two pending applications by the same inventor or assignee claiming conflicting subject matter.

•See MPEP §804 (2000).

EXAMINER REJECTIONS

CASE LAW DEVELOPMENTS

10

A claim to a method of using a compound is not patentably distinct from an earlier claim to the identical compound in a patent disclosing the identical use.

In other words, the specification of the OTDP reference can be consulted to identify a compound’s disclosed utility when evaluating OTDP.

11

Take home message: without a restriction requirement to provide § 121 protection, a method of treatment is not patentably distinct from a compound claim if that method is disclosed in the compound patent – despite the fact that the USPTO routinely says that it is.

12

• The Federal Circuit expanded the holding

articulated in Geneva to OTDP references that

specifically include a utility in the claims - so

arguably no review of spec needed.

• Held - if the specification discloses multiple uses,

that disclosure can be used to invalidate a later

commonly-owned method patent with claims

directed to any of those uses.

Sun Pharm. Indus., Ltd. v. Eli Lilly and Co. 611 F.3d 1381 (Fed. Cir. 2010)

13

• Lilly’s ’614 patent claimed compound gemcitabine and methods of using gemcitabine to treat viral infections.

• Lilly’s ’826 patent claimed a methods of using gemcitabine to treat cancer.

• Original parent app. to ’614 claimed only antiviral utility; ’614 specification included both antiviral and anticancer utilities.


No T.D. Filed

14

• The specification’s disclosure may be used to determine whether a claim to:

• determine whether a claim “merely define[s] an obvious variation of what is earlier claimed”

• “learn the meaning of the [claim] terms,” and

• “interpret [] the coverage of [a] claim”

citing, In re Basell, 547 F.3d 1371, 1378 (Fed. Cir. 2008).


15

• Claims of an earlier patent alone are to be considered for

determining obviousness-type double patenting, except

• insofar as the disclosure of the earlier patent is necessary

to construe the scope of the earlier claims, or

• unless the later application claims a use for a composition

claimed in an earlier patent wherein the use itself is

disclosed but not claimed in the earlier patent.

Eli Lilly v Teva Parenteral Medicines, Inc.,

689 F.3d 1368 (Fed. Cir. 2012)

16

‘947 App. filed in 1985 with 15 claims

RR: Comp groups I-V, Process groups VI-VII, MOT groups VIII-X

DIV-1 App. ‘086 patent issued 06/27/89

ELECTED: MOT GROUPS VII I-X WITH COMPS OTHER THAN GROUP II

DIV-2 App. filed 10/12/88

‘812 patent issued 12/12/89

ELECTED: COMP GROUPS I, III, IV, AND V

‘947 - issued 03/15/88

ELECTED: COMP GROUP II AND MOT GROUP IX

divisional

divisional

TD filed after

‘086 patent

expired

10 way restriction requirement

(GROUPS I – X)

17

• Issues on appeal:

• (1) whether §121 can ever apply to a divisional of a divisional application of an application in which a restriction requirement was entered; and

• (2) whether the “as a result of” requirement of §121 applies to the DIV-2 patent and is satisfied here.

• A patent issuing on an application with respect to which a requirement for restriction under this section has been made, or on an application filed as a result of such a requirement, shall not be used as [an OTDP] reference . . .

18

• “The most straightforward reading of the statutory text is that the safe harbor of § 121 applies even when the PTO issues a restriction requirement that leads to more than two separate applications.”

• “Moreover, § 121 refers broadly to ‘a divisional application,’ and does not state that the divisional must be a direct divisional of the original application. Had Congress intended to limit the safe harbor only to a divisional of the application in which the restriction requirement was entered, it could have said ‘a divisional application of the original application,” rather than simply “a divisional application.’”

19

• “An overlap of claims to independent and distinct inventions

within a given divisional application is neither contrary to the

restriction requirement nor relevant to the requirements of

the third sentence of §121.”

• “Rather, what consonance requires is that the claims

prosecuted in two or more applications having common

lineage in a divisional chain honor, as between applications,

the lines of demarcation drawn by the examiner to what he or

she considered independent and distinct inventions in the

restriction requirement.”

20

• To bring a divisional application within the purview of the

statute, the claims of the divisional must be limited to the

non-elected invention or inventions. “The divisions need not

be limited to a single one of the examiner’s demarcated

inventions to preserve safe harbor.”

• But see St. Jude Medical, Inc. v. Access Closure, Inc., 729 F.3d

1369 (Fed. Cir. 2013)

• where consonance not maintained, no safe harbor

protection

21

G.D. Searle LLC v. Lupin Pharms., Inc., 790 F.3d 1349 (Fed. Cir. 2015)

Original application filed 1993 08/160,594 (“the ’594 application”)

disclosed and claimed compounds, compositions, and methods of use regarding the treatment of pain

and inflammation

Divisional application on composition claims filed June

1995, issued Oct. 1996 5,563,165

Compound claims Issued Nov. 1995

5,466,823

April 1994 CIP 08/223,629 (“the ’629 application”) contained all

3 classes of claims Issued as 5,521,207 in May 1996

PCT application filed Nov. 1994 PCT/US94/12720 (“the PCT ’720 application”),

Designated CIP of the ’629 application and a CIP of the original ’594 application. Contained all three classes of claims

U.S. Patent Application No. 08/648,113 (“the ’113 application”).

Divisional: method-of-use claims

5,760,068 issued June 1998

Before restriction requirement in original

‘594 application!

July 12, 1994 3-way restriction requirement

(compound, composition, method –of-use)

3-way restriction requirement (compound, composition,

method –of-use) ’068 patent invalid for ODP in

light of the earlier issued ’165

patent; safe harbor protects

divisionals; ‘068 was a CIP. see Pfizer, Inc. v. Teva

Pharmaceuticals USA,

Inc., 518 F.3d 1353

(Fed.Cir.2008)

22

In Pfizer v Teva, Fed. Cir. had held that the § 121 did not apply to

CIP’s - protection for applications filed “as a result of” a

restriction requirement is limited to divisional applications

Pfizer filed for reissue of the ’068 patent

• alleging err in prosecuting the application leading up to the

’068 patent as a continuation-in-part, rather than as a

divisional application.

after initially rejecting the reexam petition saying that the error

was not correctable in reissue, PTO eventually allowed the

claims as RE 44,048 on March 5, 2013.


23

Holding:

REISSUE invalid for OTDP

• not entitled to safe harbor protection because its not a divisional or a descendant of a divisional. “Simply deleting that new matter from the reissue patent does not retroactively alter the nature of the ’113 application.”

• “Section 121 is inapplicable to the RE ’048 patent for a second reason

as well: The RE ’048 patent (the challenged patent) and the ’165 patent (the reference patent) are not “derived from the same restriction requirement.”


24

Pfizer argued that under BI v. Barr, if the claims at issue would have been prosecuted in the original application but for the restriction requirement, they must be deemed to have been derived from that restriction requirement.

Court said Boehringer does not go that far -- §121 applies to a patent that issues from an application that is a divisional of a divisional of the application where the restriction requirement was imposed and the lines of demarcation drawn by the examiner are preserved as between applications


25

Ex Parte Sauerberg, Appeal 2015-007064 (Jan. 12, 2017)

RR: (1) compounds and

: (2) methods of use

compounds elected

‘613 patent issued 05-17-11

CON-1 to compounds ‘016 patent issued 01-29-

13

CON to compounds ‘016 patent

CON-2 to compounds ‘993 patent issued 10-08-

13

‘016 patent issued 01-29-13

DIV to methods of use OTDP rejection appealed

26

• § 121 Safe Harbor provisions to not apply -- the ‘993

application was not filed “as a result of” the restriction

requirement because it was not filed during the pendency of

the restricted application.

• “The safe harbor provision expressly states that it only

applies ‘if the divisional application is filed before the

issuance of the patent on the other application.’”

• Citing G.D. Searle v. Lupin: “We apply ‘a strict test’ for

application of section 121, ‘[g]iven the potential windfall

[a] patent term extension could provide to a patentee.’”

Ex Parte Sauerberg, Appeal 2015-007064 (Jan. 12, 2017)

27

• OTDP issue on appeal: whether a patent that issues

after but expires before another commonly-owned

patent qualify as a double patenting reference for

the other patent.

• Pre-Gilead landscape:

• Cases measured double patenting based on which

patent issued first, and invalidated only the

second-issued patent.

Gilead Sciences, Inc. v. Natco Pharma Ltd. 753 F.3d 1208 (Fed. Cir. 2014)

28

• Gilead’s ’483 and ’375 patents were unrelated and did not claim priority to any common patent.

• Patents claimed Tamiflu® (oseltamivir), its metabolite, its formulation, and its method of use to treat the flu.

• Federal Circuit assumed for purposes of appeal that ’483 claims were a mere obvious variant of the ’375 claims.


T.D. Filed over ’483

29

• District court granted summary judgment of

infringement to Gilead, concluding that a later-issued

but earlier-expiring patent can never be a double

patenting reference.

• The Federal Circuit reversed in a split decision.

• Holding: a patent that issues after but expires before another patent can qualify as a double patenting reference for the other patent.


30

• Take home message -- expiration date (rather than issue date) is now the key to determining which patent is the “earlier” patent for OTDP analysis.

• Reasoning:

• “[L]ittle import” to the fact that the ’483 patent issued first. Prior cases looked to “issue dates” because they “previously served as a reliable stand-in for the date that really mattered—patent expiration.”

◦ “[Prior cases] those cases dealt with patents to which the URAA did not apply and, critical to a double patenting analysis, to patents for which the expiration date was inextricably intertwined with the issuance date.”


31

• Reasoning (cont’d):

• Focusing on the date of issue could lead to “gamesmanship

during prosecution” (i.e., by arranging for app. with latest

filing date to issue first).

• “[U]sing the expiration date as a benchmark in post-URAA

cases of [OTDP] preserves the ability of inventors to use a

terminal disclaimer of later-expiring patents to create one

expiration date for their term of exclusivity over their

inventions . . . .”


32

• Reasoning (cont’d):

• “[W]hen a patent expires, the public is free to use not only the same invention claimed in the expired patent but also obvious or patentably indistinct modifications of that invention.”

• This “principle is violated when a patent expires and the public is nevertheless barred from practicing obvious modifications of the invention claimed in that patent because the inventor holds another later-expiring patent with claims for obvious modifications of the invention.”


33

• Dissent (Rader):

• The majority’s “expansion” of OTDP “is unwarranted ....”

• Doctrine was used “to curtail [the] practice” of patentees filing successive continuations to obtain additional patent terms for obvious modifications where earlier patents and applications did not qualify as prior art.

• After the URAA, “successive continuations generally do not result in any additional patent term” and thus “a primary motivation behind the doctrine . . . is largely no longer applicable.”


34

• Dissent (cont’d):

• This “case does not raise the policy concern regarding

subsequent extensions of patent term” and “does not

involve the potential for harassment by multiple

assignees” because of TD.

• Interplay between OTDP doctrine and AIA’s “first-

inventor-to-file” provision may produce unwarranted

and “unforeseen consequences . . . .”


35

• OTDP issue on appeal: For applications filed after

the 1995 URA Act, can an applicant choose to file

separate applications for overlapping subject

matter and claim different priority dates without

running afoul of OTDP?

AbbVie Inc. v. Kennedy Inst. of Rheumatology

764 F.3d 1366 (Fed. Cir. 2014)

36

• Background:

• Kennedy’s ’442 and ’766 patents were related but claimed different priority dates.

• District court held asserted claims of ’442 patent invalid over the ’766 patent claims for OTDP and entered partial final judgment under Rule 54(b) in favor of AbbVie.

No T.D. Filed


764 F.3d 1366 (Fed. Cir. 2014)

37

• Genus: ’766 patent claims a method of treating RA by co-administering anti-TNFα antibody and MTX.

• Species: ’442 patent claims a method of treating an individual suffering from RA whose active disease is incompletely controlled despite already receiving MTX (i.e., particularly sick patients).

• Kennedy’s claim of nonobviousness rested on the alleged unexpected results of the species.


764 F.3d 1366 (Fed. Cir. 2014)

38

• Holding:

• Court explained that it was making explicit what was implicit in Gilead: ODTP continues to apply, even to patents that filed after the 1995 URA Act, where two patents that claim the same invention have different expiration dates.

• Reaffirmed rulings in Sun v. Lilly and other cases that OTDP encompasses any use for a compound that is disclosed in the specification of an earlier patent claiming the compound where a separate, later expiring patent claims nothing more than a method of using that compound.


764 F.3d 1366 (Fed. Cir. 2014)

39

• Reasoning:

• OTDP is not designed solely to curb abuses made possible from continuation practice, but to prevent an inventor from securing a second, later-expiring patent for the same invention:

• Patents claiming overlapping subject matter that were filed at

the same time with different patent terms due to examination delays at the PTO (citing to § 154).

• Patents claiming overlapping subject matter that claim different priority dates and have different expiration dates.


764 F.3d 1366 (Fed. Cir. 2014)

40

• “But this argument ignores another crucial purpose of the doctrine: It is designed to prevent an inventor from securing the second, later expiring patent for the same invention. . . . That problem still exists. Patents claiming overlapping subject matter that were filed at the same time can still have different patent terms due to examination delays at the PTO. See 35 U.S.C. § 154(b) (patent term adjustments) . . . . So too where, as here, the applicant chooses to file separate applications for overlapping subject matter and to claim different priority dates for the applications, the separate patents will have different expiration dates since the patent term is measured from the claimed priority date. When such situations arise, the doctrine of obviousness-type double patenting ensures that a particular invention (and obvious variants thereof) does not receive an undue patent term extension.”


764 F.3d 1366 (Fed. Cir. 2014)

41

• Reasoning:

• The demonstration of utility of the ’766 patent relied on the same clinical study that Kennedy relied on to argue that the ’442 patent led to unexpected results and merits a separate patent.

• Thus, the ’442 patent merely claimed a known utility of the ’766 patent.

• “There is no meaningful distinction between examining the disclosed utility of an earlier patent to determine the overall question of obviousness and looking at the disclosed utility of an earlier patent to determine whether the utility of the later patent was unexpected at the time of the earlier patent. Neither involves improper use of the reference patent’s specification as prior art.”


764 F.3d 1366 (Fed. Cir. 2014)

42

• Optical system for controlling car high beam headlamps • Both patents recite control systems, with variations in data

processing techniques.

• Patents have same priority, term differed due to PTA • ‘149 patent filed first and issued first; accrued PTA • ‘786 (CON) filed later and issued later; no PTA.

• OTDP used to override statutory grant of PTA under 35 U.S.C. §154.

Magna Elecs., Inc. v. TRW Auto. Holdings Corp., No. 1:12-cv-654 (W.D. Mich, Dec. 10, 2015)

43

Sept. 4, 2001

‘471 patent issued

Sept. 14, 2004


July 11, 2011

‘444 patent expired

Sept. 4, 2018

471 patent expire

“a later-issuing, earlier-expiring can act as a double-patenting reference for an earlier-issuing, later-expiring patent.”

Janssen Biotech, Inc v. Celltrion Healthcare Co. Inc., 1:15-cv-10698 (D. Mass. Aug. 19,

2016) claims of both patents to generic TNF

Abs - deemed not patentably distinct

44

― DC granted summary judgment of invalidity of ‘471 patent for

ODP in light of the ‘444 patent.

―“The court finds that the reasoning in Gilead applies where,

as here, the later-issued patent expires earlier because of

the change to patent terms resulting from the [URAA]. In

essence, the court concludes that the statute was not

intended to alter the judicial doctrine of obviousness

double-patenting. … Therefore, claims… of the ‘471 Patent

are invalid for obviousness-type double-patenting in light of

the patentably indistinct, earlier-expiring ‘444 Patent.”


2016)

45

― DC also granted MSJ -finding ‘471 patent invalid for ODP in light of the ‘195 and ‘272 patents.

― '471 patent (broader genus patent) and '272 and ‘195 patents (method of treating specific diseases with infliximab) – each filed as a separate CIP of an earlier filed application – no safe harbor.

― “[T]he application for the ‘471 Patent was filed on the same day as the application for the ‘272 Patent. The PTO did not decide the applications in reverse order of filing. Therefore, the two-way test is not applicable…. Plaintiffs acknowledge that under the one-way test, the Asserted Claims are invalid for obviousness-type double-patenting in light of the ‘195 patent and the ‘272 Patent.”

Feb. 4, 1994

‘471 pat app filed as a CIP

Oct. 18, 1994

‘195 pat app filed

Aug. 12, 1997


Dec. 16, 1997


Sept. 4, 2001


Aug. 12, 2014


Dec. 16, 2014


Sept. 4, 2018

471 patent expire

Feb. 4, 1994

‘272 pat app filed

Appeal filed Oct. 28, 2016 Ab genus MOT MOT


2016)

46

STATUTORY LANGUAGE

• 35 USC §154 (b)

• (2) Limitations.—

― (A) In general.— To the extent that periods of delay

attributable to grounds specified in paragraph (1) overlap,

the period of any adjustment granted under this

subsection shall not exceed the actual number of days the

issuance of the patent was delayed.

― (B) Disclaimed term.— No patent the term of which has

been disclaimed beyond a specified date may be adjusted

under this section beyond the expiration date specified in

the disclaimer.

47

REPLACEMENT TERMINAL DISCLAIMER

Example 1:

U.S. Application No. 10/883,042, now U.S. Pat. No. 7,084,302

Terminal Disclaimer filed on Feb. 17, 2006, which includes the following language:

48

REPLACEMENT TERMINAL DISCLAIMER LANGUAGE

Example 2:

U.S. Application No. 13/616,887, now U.S. Pat. No. 8,980,881

Terminal Disclaimer filed on Oct. 30, 2014, which includes the following

language (effective to avoid 35 U.S.C. §154(b)(2)(B)?) :

49

FURTHER PROPOSED LANGUAGE FOR REPLACEMENT TD

• In the event that any patent issued from the subject

application gets an extension of patent term by

patent term adjustment, the owner does not

disclaim the extension of the patent term based on

the patent term adjustment, as the term of any

patent granted on the instant application has not

been disclaimed beyond a specific date.

50

CURRENT LANDSCAPE: AIA CHANGES IMPACTING PATENT

REISSUE • “without any deceptive intention” removed by AIA but still subject

to ODP

• 35 U.S.C. § 251 –

• (a) IN GENERAL.—Whenever any patent is, through error, deemed wholly or partly inoperative or invalid, by reason of a defective specification or drawing, or by reason of the patentee claiming more or less than he had a right to claim in the patent, the Director shall, on the surrender of such patent and the payment of the fee required by law, reissue the patent for the invention disclosed in the original patent, and in accordance with a new and amended application, for the unexpired part of the term of the original patent. No new matter shall be introduced into the application for reissue.

• (d) REISSUE PATENT ENLARGING SCOPE OF CLAIMS.—No reissued patent shall be granted enlarging the scope of the claims of the original patent unless applied for within two years from the grant of the original patent.

51

ODP AND REISSUE PROCEEDINGS

• New Narrow Claims ―New prior art discovered, e.g., in pre-litigation

diligence; ―Old prior art not disclosed during original examination,

e.g., to hedge inequitable conduct (AIA changes); ―No recapture/broadening issues.

• New Dependent Claims

―New prior art; hedge against possible invalidity/unpatentability/ODP attack;

―No recapture/broadening issues.

52

ODP AND REISSUE PROCEEDINGS

New Broader Claims (general two-year limit to

present and recapture to consider)

New products (patent owner or third-party);

Unclaimed embodiments or species;

Heightened support requirement for broader claims?

See Antares Pharma, Inc. v. Medac Pharma Inc., (Fed.

Cir. 2014)

53

• AC Dispensing Equipment, Inc. v. Prince Castle, LLC, IPR2014-00511, Paper (PTAB Oct. 17, 2014)

• Petitioner requested permission to file a motion to stay the prosecution of the continuation patent application.

• PTAB: Denied.

―“Patent Owner will not be permitted to obtain in a patent any claims that are not patentably distinct from any claim that is canceled as a result of this proceeding. But whether any of the claims in the ’497 patent will be canceled is an issue that is not yet decided and will not necessarily be decided until a final written decision is entered in this case and appeals from it are exhausted. To bar Patent Owner from prosecuting claims now that may be patentably indistinct from the claims under review thus would be premature. It is sufficient, under the current circumstances, for Patent Owner to continue to take reasonable steps to apprise the Examiner of the status of this proceeding.”

INSTEAD OF REISSUE, KEEP CONTINUATION PENDING FOR ODP

54

•

CONSIDER, IN KEEPING CONTINUATION APPLICATION

PENDING:

55

BEST PRACTICES TO DEFEAT DOUBLE PATENTING REJECTIONS

• Avoid terminal disclaimers.

• Maintain demarcation in chain of divisionals to keep §121 “safe harbor.”

― Boehringer Ingelheim Int’l GmbH v. Barr Laboratories, Inc., 592 F.3d 1340 (Fed. Cir. 2010)

• Rejection traditionally must be based on what previously claimed, not what previously disclosed.

― Eli Lilly v Teva Parenteral Medicines, Inc., 689 F.3d 1368 (Fed. Cir. 2012)

― But see Sun Pharmaceutical Industries, Ltd. v. Eli Lilly and Co., 611 F.3d 1381(Fed. Cir. 2010)

56

IF HAVE PTA, AND PLAN TO USE TERMINAL DISCLAIMER, CONSIDER NON-DATE-SPECIFIC LANGUAGE

• In the event that any patent issued from the subject application gets an extension of patent term by patent term adjustment, the owner does not disclaim the extension of the patent term based on the patent term adjustment, as the term of any patent granted on the instant application has not been disclaimed beyond a specific date.

• Statutory rights of PTA should not be taken away by ODP, a judicially- created doctrine but not a statutory doctrine.

• But avoid 35 U.S.C. §154(b)(2)(B): “No patent the term of which has been disclaimed beyond a specified date may be adjusted under this section beyond the expiration date specified in the disclaimer.”

57

PRE-AIA: COMMON OWNER HYPOTHETICAL PROBLEM

• A and B work for company X

• A and B have a duty to assign

• all inventions to company X

• A comes up with an invention • Assigned to X

• A and B later come up with another

• invention • Assigned to X

• A and A+B are considered different persons for determination of

availability of A invention as prior art

A

A B

X

58

PRE-AIA: SOLUTIONS TO THE COMMON OWNERSHIP PROBLEM

• 1984 Amendment to §103:

• “Subject matter developed by another person, which qualifies as

prior art only under subsection (f) or (g) of section 102 of this title,

shall not preclude patentability under this section where the

subject matter and the claimed invention were, at the time the

invention was made, owned by the same person or subject to an

obligation of assignment to the same person.”

• 1999 Amendment extended to prior art qualifying under

Section 102(e).

59

PRE-AIA: JRA COLLABORATION PROBLEM

• Oddzon Products, Inc. v. Just Toys, Inc., 122 F.3d 1396 (Fed. Cir. 1997)

• Background • Oddzon sued Just Toys for patent infringement; Just Toys

alleged patent invalidity ― Invention created by researchers from more than one organization ― Two confidential designs disclosed between researchers at the

separate organizations

• Question: Can confidential information shared between the members of a research team be prior art for the purpose of rendering that invention obvious under § 103?

60

PRE-AIA: JRA COLLABORATION PROBLEM

Federal Circuit held:

• Confidential information exchanged between research partners is available as prior art to invalidate a patent.

• Except if rights to the invention were assigned to a single entity before creation of that invention.

Practical effect • Inventions developed through a structured joint research

agreement could be rendered unpatentable because parties at separate organizations had collaborated and exchanged information.

61

PRE-AIA: SOLUTION TO THE JRA COLLABORATION PROBLEM

2004 Cooperative Research and Technology Enhancement Act (“CREATE”):

• Extended safe harbor beyond only common ownership to joint

research agreements.

• Only for 103 rejections based upon prior art qualified under 102 (e), (f), or (g).

62

AIA: SOLUTIONS TO THE COMMON OWNERSHIP PROBLEM

Common Ownership Protection Moved from § 103 to § 102

• 102(b)(2)(C): U.S. patent filing is not prior art if commonly owned with claimed invention

• Only an exception to 102(a)(2) ― U.S. patents, U.S. patent application publications, or WIPO published applications

effectively filed, but not published, before the effective filing date of the claimed invention

• Not an exception to 102(a)(1) (published prior to filing date). • Deadline for common ownership – effective filing date of claimed invention.

• CREATE Act provisions (joint development agreements) moved to §§ 100,

102.

• Common ownership protects against anticipation as well as obviousness rejections (but not against obvious-type double patenting rejections).

63

AIA: JOINT RESEARCH AGREEMENTS

• § 102(c) COMMON OWNERSHIP UNDER JOINT RESEARCH AGREEMENTS.—

• Subject matter disclosed and a claimed invention shall be deemed to have been owned by the same person or subject to an obligation of assignment to the same person in applying the provisions of subsection (b)(2)(C) if—

1) the subject matter disclosed was developed and the claimed

invention was made by, or on behalf of, 1 or more parties to a

joint research agreement that was in effect on or before the

effective filing date of the claimed invention;

2) the claimed invention was made as a result of activities

undertaken within the scope of the joint research agreement;

and

3) the application for patent for the claimed invention discloses or

is amended to disclose the names of the parties to the joint

research agreement.

64

LIMITATIONS OF §102(b)(2)(C) COMMON OWNERSHIP PROTECTION

• §102(b)(2)(C) exception does not remove §102(a)(1) prior

art, or a double-patenting rejection, or a lack of enablement

rejection - a “document need not qualify as prior art to be

applied in the context of double patenting or enablement.”

See pp. 11080 of Examination Guidelines (2/14/13).

65

COMMON OWNERSHIP AND DOUBLE PATENTING

• What about double patenting?

• MPEP § 804(I)(A): "Double patenting may exist between

an:

―issued patent and an application filed by the

same inventive entity, or

―by a different inventive entity having a

common inventor, and/or by a common

assignee/owner."

66


• If at least one of A+B’s claims is not patentably

distinct from an issued claim in A’s patent then

A+B’s application is subject to a double patenting

rejection, even though A’s patent is not available as

prior art.

• See In re Hubbell, No. 2011-1547 (Fed. Cir. 2013).

67


Hubbell asked:

• Does obviousness-type double patenting (“ODP”) apply where an

application and a conflicting patent have one or more inventors in

common, but the inventive entities are not identical and the

applications were never commonly owned?

• Can a terminal disclaimer be filed to overcome ODP in the absence of

common ownership?

• Should a two-way obviousness test apply to overcome ODP?

68


Background:

• Inventors Hubbell and Schense at CalTech

― Research resulted in ’509 application (earliest priority April 3,

1997)

― ‘509 patent assigned to CalTech.

• Hubbell and Schense left CalTech to join ETHZ.

― Research resulted in ’685 patent (earliest priority August 27,

1998).

― ‘685 patent assigned to ETHZ and Universitat Zurich, and

issued first.

• Examiner rejected ’509 application based on ODP over ’685 patent.

69


• Is ’685 patent available as prior art under §§ 102

or 103 to the ’509 application?

• BPAI: Yes.

― Claims of ’685 patent (species claims)

anticipated representative claim of ’509

application (genus claim).

70


Holding: • Agreed with BPAI, rejecting Hubbell’s argument that ODP should never be

applied in the absence of common ownership.

• Cited In re Fallauz, 564 F.3d 1313, 1315 (Fed. Cir. 2009): ODP is meant to

prevent harassment of an alleged infringer by multiple assignees asserting

essentially the same patented invention.

• No JRA, so terminal disclaimer not available.

• No two-way obviousness analysis: Hubbell partially responsible for delay

that caused ’685 patent to issue first.

71

CONSEQUENCES: JRA TERMINAL DISCLAIMERS Consider consequences of a terminal disclaimer pursuant to

a JRA:

• Can overcome rejection based on ODP;

• BUT might lead to complications with enforcement.

• 37 C.F.R. 1.321(d)(3) – a terminal disclaimer in the context of a JRA

must:

― “Include a provision waiving the right to separately enforce any

patent granted on that application … and the patent … which formed

the basis for the double patenting … and that any patent granted on

that application … shall be enforceable only for and during such

period that said patent and the patent … which formed the basis for

the double patenting are not separately enforced”

72

CONSEQUENCES: JRA TERMINAL DISCLAIMERS

What this means for you?

• JRA-related terminal disclaimers may greatly complicate patent enforcement issues.

• Unless certain patents always enforced together, terminally-disclaimed patents no longer enforceable.

• Potential issues with, e.g., platform technology patents.

73

CONSEQUENCES: JRA TERMINAL DISCLAIMERS

What steps to take?

• Evaluate prosecution strategy, and have a plan.

• Coordinate regarding the filing of any JRA-related terminal disclaimers.

• Separate enforceability could be issue with potential licensees (who controls enforcement?).

74

CONCLUSIONS Be aware of common ownership issues: • Inventors move, important to be aware of prior

applications/patents with common inventors. ― Both an upstream and downstream concern.

― Track prosecution of relevant applications/patents.

― Do not delay, and be thoughtful about order in which

species versus genus claims are prosecuted.

• Under AIA, §102(a)(2) or §§ 102(a)(2) / 103 problem may

be removed by obtaining prior art or entering JRA before filing.

• But be aware of enforcement issues raised by JRA terminal disclaimers. 75

PATENT TERM ADJUSTMENT AND AIA

• AIA SEC. 9: A patentee’s challenge to the USPTO’s

PTA calculation that is filed on or after September 16,

2011, must be filed with the U.S. district court for the

Eastern District of Virginia (“ED VA”), instead of the

U.S. district court for the District of Columbia (“D

DC”).

76

http://www.google.com/url?sa=i&rct=j&q=&esrc=s&frm=1&source=images&cd=&cad=rja&docid=pDcSBSY8GHOJfM&tbnid=sNpegPlTD6kZoM:&ved=0CAUQjRw&url=http://www.vsup.org/&ei=PmAOU-DdFtTI2wWe_YHoCg&bvm=bv.61965928,d.b2I&psig=AFQjCNFnleWDyOJZt5XMFnNHM5n7uW7yNQ&ust=1393537465301695

PTA POSSIBILITIES 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 of adjustment for delays due to interferences, secrecy orders, and appeals (“C-Delays”)

•Adjustments are day for day for the amount of delay.

•For this presentation, the point is don’t lose that PTA through filing a terminal disclaimer.

77

EXAMPLE OF A-DELAY Univ. of Mass. v. Kappos, 903 F.Supp.2d 77 (DDC, Nov. 9, 2012)

• First OA was a restriction requirement.

• PTO and UMass agreed there should be new restriction requirement.

• UMass argued that PTA should include 223 days between 1st and 2nd OA

because the first OA was incorrect.

• District Court: No. ― A-delay clock stops when first OA issues.

― No requirement that the first OA be correct.

― A-delay = 465 days.

File application

Feb. 4, 2005

14-month

April 4, 2006

First Office Action

July 13, 2007

3 Years

Feb. 4, 2008

Second Office Action

Feb. 21, 2008

A-Delay 223 days

78

B-DELAY 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 PTAB or Federal court review; or

• any delay at the request of the applicant.

79

C-DELAYS DELAYS DUE TO INTERFERENCES

AND APPEALS C-Delays: §154(b)(1)(C), Issue of patent delayed due to interferences, secrecy orders, and appeals.

• Appellate review by PTAB or a federal court “in which the…review

revers[ed] an adverse determination of patentability[.]”

• Old: accrues from date Notice of Appeal filed.

• Now: accrues from date jurisdiction over the application passes to the Board until date of a final Board /court decision in favor of the applicant.

• Change applicable to any application in which a notice of allowance is

issued after September 16, 2012, and any patent issuing thereon (and any timely reconsideration request after Sept. 16, 2012).

• 37 C.F.R. 1.703(e). 80

LIMITATIONS ON PTA

No Overlap/Double-counting: applies to all of A, B and C-Delay (35

U.S.C. § 154(b)(2)(A))

Disclaimed term applies to all of A, B and C-Delay: TERMINAL DISCLAIMER (35 U.S.C. § 154(b)(2)(B)).

Applicant-caused delay: applies to all of A, B and C-Delay: EXTENSIONS OF TIME (35 U.S.C. § 154(b)(2)(C)(i): reduced by any time

“applicant failed to engage in reasonable efforts to conclude prosecution of the application.”

Arqule, Inc. v. Kappos, No. 1:10-cv-01904 (D.D.C. June 22, 2011) (weekends/holidays no longer counted against applicant delay).

• USPTO list of “no-no’s” at 37 C.F.R. §1.704

81

CALCULATING PTA

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-Delays, B-Delays 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.

82

CALCULATING PTA: ADD PTE

37 C.F.R. § 1.703(f):

• Patent Term Extension (“PTE”) is in addition to PTA. 35

U.S.C. §156(a): “The term of a patent which claims a

product, a method of using a product, or a method of

manufacturing a product shall be extended in accordance

with this section from the original expiration date of the

patent, which shall include any patent term adjustment

granted under section154(b)[.]

83

Novartis AG v. Lee, 740 F.3d 593 (Fed. Cir. 2014)

and Exelixis, Inc. v. Lee, 2014 WL 128612 (Fed. Cir. 2014)

• PTA determination (reversed-in-part)

― “no adjustment time is available for any time in continued examination, even if the continued examination was initiated more than three calendar years after the application’s filing.”

― “the patent term adjustment time should be calculated by determining the length of the time between application and patent issuance, then subtracting any continued examination time (and other time identified in (i), (ii), and (iii) of (b)(1)(B)) and determining the extent to which the result exceeds three years. Such a reading ensures that applicants recover for any ‘delay[s] due to the failure of the [PTO],’ without allowing the applicant to recover for ‘any time consumed by continued examination,’ as the statute requires. Id. § 154(b)(1)(B)(i).”

84 84

THE FEDERAL CIRCUIT

Novartis AG v. Lee (con’t)

• “...the correct interpretation of the statute is the PTO’s view that

time spent in a continued examination does not deplete the

PTO’s allotment of three years for application processing before

a resulting patent has its term extended, no matter when the

continued examination begins.”

85 85

AFFIRMED TIME AFTER ALLOWANCE UNTIL ISSUANCE SHOULD BE COUNTED

Novartis AG v. Lee (con’t)

• “While we thus disagree with Novartis on its first § 154(b)(1)(B) issue, we agree

with Novartis on its second § 154(b)(1)(B) issue. …We reject the PTO’s view that

the time after allowance, until issuance, is ‘time consumed by continued

examination’ and so is excluded from adjustments given to the patentee. Such

time from allowance to issuance undisputedly would count toward the PTO’s

three-year allotment in a case not involving a continued examination. There is no

basis for distinguishing a continued examination case.”

• “In the present case, time after allowance was not time caused by the continued

examination. Because the PTO applied the contrary view in calculating the patent

term adjustment for the ’155, ’518, and ’631 patents, those calculations must be

corrected.”

86 86

TIME FROM ALLOWANCE TO ISSUE…

Federal Circuit in Novartis: time excluded from B-delay for filing a RCE > 3 years after filing

ends at allowance, not the issue date.

• “allowance-to-issuance time is not to be distinguished according to whether there is a continued

examination in a prosecution. Either way such time is plainly attributable to the PTO.”

• Where PTA did not include days between allowance and issuance, file request that the time from

allowance to issue be included in B-delay.

• As pointed out by Susan J. Mack and Azy S. Kokabi, Sughrue Mion PLLC in IPLaw 360 article,

“Calculating Patent Term Adjustment Post-Novartis” (Feb. 13, 2014): for patents issuing on or after

Jan. 14, 2013, all applications for PTA must be filed within seven months of the issue date (two

months from the grant of the patent plus an additional five months with payment of extension

of time fees).

• Novartis decision Jan. 15, 2014, so includes any patent issuing on or after June 15, 2013.

87 87 87

HYPOTHETICAL IN LIGHT OF GILEAD?

• Earlier-issued genus patent (with PTA), later-issued species patent.

• Does Gilead require filing a TD in the genus based on a later-issued species patent if the two

patents, unlike in Gilead, are in the “same” family ?

• Does In re Berg, 140 F.3d 1428 (Fed. Cir. 1998) provide a counter-argument? ― species issued first so had to file TD in genus.

― Court suggested to file all claims in one application, but raised Goodman, 11 F.3d 1046, 1052

(Fed.Cir.1993).

• Another option, prosecute genus claims first and wait for issuance of species claims until rights

are sorted out in the genus.

Genus patent issues

Species patent issues

Species patent expires

Genus patent + PTA expires

X

?

88

http://www.westlaw.com/Find/Default.wl?rs=dfa1.0&vr=2.0&DB=506&FindType=Y&ReferencePositionType=S&SerialNum=1993228007&ReferencePosition=1052

http://www.westlaw.com/Find/Default.wl?rs=dfa1.0&vr=2.0&DB=506&FindType=Y&ReferencePositionType=S&SerialNum=1993228007&ReferencePosition=1052

CALCULATE YOUR OWN PTA; KNOW WHAT YOU HAVE AND WHAT MIGHT BE AT RISK

THROUGH TERMINAL DISCLAIMER

• PTA as calculated by USPTO is

issued no later than issue date.

• 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.

89

PROCEDURE FOR CHALLENGING PTA

• 37 CFR § 1.705(b)

―A request for reconsideration must be filed no later than two months from date of issuance. usually (A) and (B) delay; could also be (C) delay

• “This two-month time period may be extended under the provisions of

§ 1.136(a).” • Applicable only to patents granted on or after January 14, 2013.

• Two-month deadline not extendable if old Rule 705 applies (patents granted before January 14, 2013)(old 1.705(e)).

• USPTO–determined-PTA is now provided “no later than date of issuance” of the patent (See §154(b)((3)(B)(i)).

90

CONTESTING THE OFFICE’S PTA DETERMINATION

35 U.S.C § 154(b)(4)(A): Final Determination of PTA by USPTO can be appealed “exclusively” to the U.S. District Court. • Applicant must have received a Final Determination in order to appeal to the

U.S. District Court.

• Appeal must be filed within 180 days of “the date of the Director’s decision on the applicant’s request for reconsideration” (changed from “after grant of patent” by Technical Amendment).

• AIA changed the venue from D.D.C. to E.D. Va on September 16, 2011.

• Appeal “exclusively” to U.S. District Court added in Technical Amendment to AIA (signed Jan. 14, 2013).

― 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.

91

APPEAL CASES

11/06/2007 05/04/2010 12/18/2008 11/05/2004

Proper B Delay = 407 days

Appeal decision unsuccessful

Three Years + 1 day from Filing

Filing Date

First appeal Filed

3-Year Deadline for PTO Action

Notes: • No C delay because appeal unsuccessful, but B delay = 407 days. • Because you filed the appeal after three years, B delay will accrue until jurisdiction

over the application passes to the PTAB for review. • Days from PTA could be deducted for applicant delay if come under list of “no-no’s”

92

PATENT TERM ADJUSTMENT: SUCCESSFUL APPEAL

A Delay = 838 Overlap 156 + 13 = 169 B Delay = 1293 Applicant Delays 205 C Delay = 871 Total PTA Adjustments 2601 838 + 1293 + 871 = 3002 3002 - 169 = 2833 2833 - 205 = 2628 (7.2 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

1293 days

Non-Final

11-24-2004

Notice of

Appeal

6-9-2007

Favorable

Appeal

Decision

5-26-2010 C-Delay

871 days

Notice of

Appeal

3-31-2006

Non-Final

8-30-2006

Reply Brief

1-5-2008

reopen prosecution, but no RCE and no PTAB jurisdiction yet, so B-Delay clock is still ticking

Jurisdiction passes to PTAB

Clock stops B-Delay and

starts C-Delay

Note: PTE, if any, is added to PTA. 93

PATENT TERM ADJUSTMENT:

UNFAVORABLE OUTCOME ON APPEAL

A Delay = 838 Overlap 156 + 13 = 169 B Delay = 1293 Applicant Delays 205 C Delay = none Total PTA Adjustments 1757 838 + 1293 + 0 = 2131 2131 - 169 = 1962 1962 - 205 = 1757 (4.8 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

1293 days

Non-Final

11-24-2004

Notice of

Appeal

6-9-2007

Unfavorable

Appeal

Decision

5-26-2010

Notice of

Appeal

3-31-2006

Non-Final

8-30-2006

Reply Brief

1-5-2008

reopen prosecution, but no RCE and no PTAB jurisdiction yet, so B-Delay clock is still ticking

Jurisdiction passes to PTAB

Clock stops on B-Delay

Note: PTE, if any, is added to PTA.

No C-Delay because appeal

unsuccessful

94

TIPS FOR TRYING TO

MAXIMIZE PTA BUT THEN DO YOUR BEST TO AVOID

REDUCTION OF PTA THROUGH A TERMINAL DISCLAIMER

Review US PTO’s PTA calculation in Notice of Allowance and, if disagree, must act quickly to preserve rights.

• Consider two-prong approach: after patent issues, request

reconsideration in US PTO within 2 months and file district court case within 180 days of issuance.

• If application falls under new guidance, may not need to file suit within 180 days, but there may be questions about which cases fall under new guidance.

• Consider filing another case or amended complaint within 180 days of decision by PTO even if filed earlier.

• Would not want to file too early, get dismissed and then be unable to re-file because deadline had passed.

95

MAXIMIZING PTA: AVOIDING PITFALLS

Respond within 3 months of an action – don’t take extensions. • 37 C.F.R. §1.704(b): >3 months is “failure to engage in reasonable efforts to

conclude processing or examination” and will mean deduction from PTA. • Respond right at end of 3 months??

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.

96

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 if date certain is disclaimed.

• Consider non-date-specific language if have to file a Terminal Disclaimer to

comply with 35 U.S.C. § 154 (b)(2)(B).

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

• Try to keep prosecution open without filing an RCE.

― Be aggressive and argue against or appeal final rejections.

97


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.

98


Timely file Information Disclosure Statements (IDS)

• File an IDS before the first office action or with a reply.

― 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).

― Earlier rule only included foreign office communications.

― Certification under 37 CFR § 1.97(e)(1) does not prevent loss of

PTA (within 3-months).

Once 3-year deadline has passed, consider paying the issue fee at the last

possible moment to maximize (B) delay.

99


File Appeals – if grounds exist and record supports.

• Establish necessary record early in prosecution to support appeal.

• If examiner re-opens 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

re-open prosecution (any time over 4 months).

― But New Rule results in B-Delay, if available.

• Currently, some extensions of time during the appeal process do not count against

the applicant for PTA.

― But New Rule makes an extension for filing an Appeal Brief applicant delay.

100


WHAT SHOULD PRACTITIONERS

BE DOING?

• Identify pending applications that cover inventions that are expected to retain value at end of patent term.

• Carefully analyze USPTO’s PTA calculation and then do your best not to lose that PTA through a terminal disclaimer. • Make sure correct under current law.

• Determine if law not being properly applied by USPTO.

• If disagree, must act quickly to preserve rights.

• After patent issues, request reconsideration in US PTO within 2 months and prepare to file district court case within 180 days of decision on request for reconsideration.

• Must file request for reconsideration prior to paying issue fee.

101

Thank You!

Contact Information:

Tom Irving

[email protected]

Leslie McDonell

[email protected]

Margaret Sampson

[email protected]

102

mailto:[email protected]



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