on sale and public use bars to patentability: leveraging recent...

On Sale and Public Use Bars to Patentability:

Leveraging Recent Developments Minimizing Risk of Patent Ineligibility or Invalidation

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THURSDAY, SEPTEMBER 15, 2016

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

Daniel G. Brown, Partner, Latham & Watkins, New York

Doris Johnson Hines, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C.

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

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The Public Use Bar to Patentability: Recent Developments and the Impact of the AIA

Daniel G. Brown Latham & Watkins for Strafford September 15, 2016

• A person shall be entitled to a patent unless -

(b) the invention was patented or described in a printed

publication in this or a foreign country or in public use or

on sale in this country, more than one year prior to the

date of application for patent in the United States.

Public Use (Pre-AIA Statute, 35 U.S.C. § 102(b))

5

• “INVENTION”

• Invitrogen:

• Pfaff v. Wells Elec. held that “invention” for on-sale bar within

§ 102(b)need not be reduced to practice, need only be “ready

for patenting” Pfaff, 525 U.S. at 60, 67.

• Since “invention” modifies both public use and on-sale, court

held that “ready for patenting” standard applies to public use

as well as on sale bar. 424 F.3d at 1379.

• Rejected previous “totality of the circumstances” test: stage of

invention not a consideration if it meets ready for patenting

test.

Invitrogen Corp. v. Biocrest Manufacturing, L.P., 424 F.3d 1374,

1380 (Fed.Cir. 2005).

Public Use

6

• Policies behind Pfaff apply to Public Use:

• “We originally held that an inventor loses his right to a patent if

he puts his invention into public use before filing a patent

application…. A similar reluctance to allow an inventor to

remove existing knowledge from public use undergirds the on-

sale bar.” Pfaff, 525 U.S. at 64.

• “Petitioner’s argument …does not persuade us that it is

necessary to engraft a reduction to practice element into the

meaning of the term “invention” as used in §102(b).”

Invitrogen/Pfaff

7

• “[I]t is a condition upon an inventor’s right to a patent

that he shall not exploit his discovery competitively

after it is ready for patenting; he must content himself

with either secrecy, or legal monopoly.” Pfaff,(quoting

Metallizing Engineering Co. v. Kenyon Bearing & Auto

Parts Co., 153 F.2d 516, 520 (2d Cir. 1946)).

Invitrogen/Pfaff

8

“The proper test for the public use prong of the § 102(b)

statutory bar is whether the purported use: (1) was

accessible to the public; or (2) was commercially

exploited.”

• Factors (inter alia):

• evidence relevant to experimentation

• nature of the activity that occurred in public

• public access to the use

• confidentiality obligations imposed on members of the public

who observed the use

• commercial exploitation

Invitrogen Test

9

• Is there a separate requirement that the use be “for its

intended purpose”?

• Pronova Biopharma Norge A/S v. Teva Pharms. USA,

Inc., 549 Fed.Appx. 934 (Fed. Cir. 2013):

• Patentee shipped sample liquid vials containing the claimed

pharmaceutical invention to a third-party researcher in the

U.S.;

• imposed no confidentiality requirements or other restrictions

on researcher’s use of the samples; and

• disclosed the contents in an accompanying certificate of

analysis;

• Researcher confirmed composition by his own analytical

testing

Invitrogen Standard

10

• Scope of Disclosure

• Restrictions on Use

• Control of Invention

• Sophistication of those to whom disclosure made

Public Accessibility

11

• Completeness of disclosure required for § 102(b) bar:

• WL Gore v. Garlock, 721 F2d 1540, 1549 (Fed. Cir. 1983)

• Dey, L.P. v. Sunovion Pharmaceuticals, Inc., 715 F.3d 1351,

1357 (Fed. Cir. 2013)

• Motionless Keyboard v. Microsoft, 486 F.3d 1376, 1385 (Fed.

Cir. 2007).

Public Accessibility - Scope of Disclosure

12

• But incomplete disclosures can still be used for § 103

purposes:

• “In order for a use to be public within the meaning of § 102(b),

there must be a public use with all of the claim limitations.”

***

• “We have held that the public use bar applies to obvious

variants of the demonstrated public use.”

Netscape Comc'ns Corp. v. Konrad, 295 F.3d 1315, 1321 (Fed.

Cir. 2002)”


13

• Third-party uses of third-party’s invention:

• Dey, LP v. Sunovion Pharm., Inc., 715 F.3d 1351 (Fed.

Cir. 2013)

• Public Accessibility:

• “Secret third-party use is not invalidating”

• “A reasonable jury could conclude that if members of the

public are not informed of, and cannot readily discern, the

claimed features of the invention in the allegedly invalidating

prior art, the public has not been put in possession of those

features.”

Public Accessibility - Scope of Third Party Disclosure

14

• Third-party commercialization of third-party invention is

also treated differently. Dey:

• “Secret commercialization” by a third party is not public use,

even if it might have resulted in forfeiture were the third party

the one filing the patent application, W.L. Gore, 721 F.2d at

1550.”

Third-Party Public Use

15

• Egbert v. Lippmann, 104 U.S. 333, 336 (1881):

“If an inventor, having made his device, gives or sells it to

another, to be used by the donee or vendee, without limitation or

restriction, or injunction of secrecy, and it is so used, such use is

public, even though the use and the knowledge of the use may

be confined to one person.”

• Public: a member of public vs. general public


16

• Enablement not required:

• See Dey, 715 F.3d at 1358:

“Although … we do not ask for an ‘enablement-type inquiry’

under section 102(b), a court still must decide whether the

‘claimed features of the patents [were placed] in the public’s

possession.’ Konrad, 295 F.3d at 1323.”


17

• Egbert: no restriction = public use

• Lough v. Brunswick, 86 F.3d 1113 (Fed. Cir. 1996):

lack of supervision and control defeats experimental

use

• Eloas v. Microsoft, 399 F.3d 1325 (Fed. Cir. 2005):

demonstration without confidentiality agreement

results in public use

Public Accessibility - Restrictions on Use

18

• Beachcombers vs. Moleculon Research:

• Beachcombers: demonstration to friends at party public use.

31 F.3d 1154 (Fed. Cir. 1994).

• Moleculon Research: demonstration to several friends over

course of five years not public use despite no express

confidentiality agreement. 793 F.2d 1261 (Fed. Cir. 1986)

• Note: Both cases affirmed district court fact findings.

Public Accessibility – Control over Invention

19

• Dey, L.P. v. Sunovion Pharmaceuticals, Inc., 715 F.3d 1351 (Fed.

Cir. 2013): “uninformed” clinical trial subjects supported finding

that use not public

• Netscape Commc'ns Corp. v. Konrad, 295 F.3d 1315, 1321

(Fed.Cir.2002): even limited disclosure to those who are skilled

enough to understand and ‘easily demonstrate’ the invention to

others implies no expectation of secrecy and supports public use;

• Pronova Biopharma Norge A/S v. Teva Pharms. USA, Inc., 549

Fed.Appx. 934 (Fed. Cir. 2013)(not published): recipient “highly

skilled in the art, with the full ability to know, understand, and fully

disclose the invention to others.”

Public Accessibility – Sophistication of Recipients

20

Commercial exploitation is a public use despite secrecy:

• Kinzenbaw v. Deere & Co., 741 F.2d 383, 391, 222 USPQ 929, 934

(Fed. Cir. 1984) (“A commercial use is a public use even if it is kept

secret.”);

• D.L. Auld Co. v. Chroma Graphics Corp., 714 F.2d 1144, 1147, 219

USPQ 13, 15 (Fed. Cir. 1983) ('[T]he intent of [invalidating claims

based on commercial use] is to preclude attempts by the inventor or

his assignee to profit from commercial use of an invention for more

than a year before an application for patent is filed.');

• Metallizing Eng'g Co. v. Kenyon Bearing & Auto Parts Co., 153 F.2d

516, 520, 68 USPQ 54, 58 (2d Cir. 1946)(use of process in secret to

manufacture commercial product was public use, despite not

disclosing patented process)

Commercial Exploitation

21

• Harrington Manufacturing Co., Inc. v. Powell Manufacturing Co., 815 F.2d 1478, 1480 (Fed. Cir. 1986): finding public use where an inventor demonstrated a prototype harvester to a journalist for purpose of gaining public recognition, which the court found to be commercial exploitation. Id. at 1481 & n.3.

• In re Smith, 714 F.2d 1127, 1129, 1135 (Fed. Cir. 1983): applying public use bar where inventors gave consumers samples to test in their homes and “dominant purpose” was “to determine whether potential consumers would buy the product and how much they would pay for it—commercial exploitation.”);

• Netscape Communications Corp. v. Konrad, 295 F.3d 1315, 1322 (Fed. Cir. 2002) (finding inventor’s activity geared toward increasing commercial attractiveness of invention “with endorsement from outside technical people”)

Commercial Exploitation

22

EZ Dock v. Schafer, 276 F3d 1347, 1355-57 (Linn, J, Concurring):

• “The experimental use doctrine permits an inventor to conduct

testing to refine his invention without losing the right to obtain a

patent, even if such testing occurs in the public eye.”

• “Once the invention is reduced to practice, there can be no

experimental use negation.”

• Pfaff destroyed symmetry between experimental use and 102(b)

bars, since 102(b) bar can occur at “ready for patenting”, while

experimental use ends with reduction to practice.

Experimental Use

23

• What about trials to gain regulatory approval?

• Pennwalt Corp. v. Akzona Inc., 740 F.2d 1573 (Fed. Cir.

1984): Sales were made under a temporary EPA permit

issued by the agency “only for bona fide experimental

programs.” Id. at 1576. Since “real goal” of the activities

under the temporary permit was “to obtain a commercial

label,” not experimental use. Id. at 1581.

Commercial Exploitation vs. Experimental Use

24

Pharmaceutical Clinical Trial cases:

• Dey: Third-party clinical trial, not public; case did not address commercial exploitation;

• Bayer Schering Pharma AG v. Barr Labs., Inc., No. 05-CV-2308 (PGS), 2008 U.S. Dist.

LEXIS 15917, 2008 WL 628592, at *11-12, *38-42 (D.N.J. Mar. 3, 2008);

• Eli Lilly & Co. v. Zenith Goldline Pharms., Inc., 364 F. Supp. 2d 820, 873-75, 912-13

(S.D. Ind. 2005), aff'd, 471 F.3d 1369, 1380-81 (Fed. Cir. 2006);

• Janssen Pharmaceutica N.V. v. Eon Labs Mfg., Inc., 374 F. Supp. 2d 263, 276

(E.D.N.Y. 2004), aff'd, 134 F. App'x 425, 430-31 (Fed. Cir. 2005);

• In re Omeprazole Patent Litig., 490 F. Supp. 2d 381, 508 (S.D.N.Y. 2007)

• Sanofi v. Glenmark Pharm, Inc., --- F.Supp. 3d ---- (D. Del. August 31, 2016).

Commercial Exploitation vs. Experimental Use

25

• Pharmaceutical Clinical trials:

• Inventor involvement?

• Commercial exploitation vs. public accessibility analysis?

• Timing vs. reduction to practice?

• Policy vs. patent term extension provisions of Hatch-Waxman

Amendments?

26

35 USC 102(b) AIA 35 USC 102(a)

A person shall be entitled to a patent

unless -

(b) the invention was patented or

described in a printed publication in

this or a foreign country or in public

use or on sale in this country, more

than one year prior to the date of

application for patent in the United

States.

NOVELTY; PRIOR ART.--A person

shall be entitled to a patent unless--

(1) the claimed invention was

patented, described in a printed

publication, or in public use, on

sale, or otherwise available to the

public before the effective filing date

of the claimed invention; or

Impact of AIA?

27

(b) EXCEPTIONS.--

(1) ***A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention ***if--

(A) the disclosure was made by the inventor or joint inventor or by another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

(B) the subject matter disclosed had, before such disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.

Impact of AIA?

28

• Key Facial Effects of AIA on public use:

• Foreign activity

• Third-party activities judged against disclosure by

inventors, not 1-year bar date or invention under

existing section 102(a)

Impact of AIA?

29

• TBD:

• “Secret” commercial use by inventor and/or third

parties

• Judicially-created distinction between inventor and

third-party activities

• Change in public accessibility jurisprudence in favor

of general public?

Impact of AIA?

30

Although this presentation may provide information concerning potential legal issues, it is not a substitute for legal advice from qualified counsel. Any opinions or conclusions provided in this presentation shall not be ascribed to Latham & Watkins or any clients of the firm.

The presentation is not created or designed to address the unique facts or circumstances that may arise in any specific instance, and you should not and are not authorized to rely on this content as a source of legal advice and this seminar material does not create any attorney-client relationship between you and Latham & Watkins.

© Copyright 2013 Latham & Watkins. All Rights Reserved.

Disclaimer

31

Daniel G. Brown Latham & Watkins

885 Third Avenue

New York, NY

212.906.1742

[email protected]

32

On Sale Bar to Patentability After AIA

by

Dori Hines and Tom Irving

©Copyright Finnegan 2013 33

Disclaimer These materials have been prepared solely for educational and informational purposes to contribute to the understanding of U.S. intellectual property law. These materials reflect only the personal views of the authors and are not individualized legal advice. 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, the authors and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (including Finnegan Europe LLP, and Fei Han Foreign Legal Affairs Law Firm), 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 these authors. While every attempt was made to ensure that these materials are accurate, errors or omissions may be contained therein, for which any liability is disclaimed.

34

What is pre-AIA “Secret” Prior Art?

• Prior filing of patent applications by another (§ 102(e))

• Prior secret invention by another (§ 102(g))

• Prior knowledge transferred from another (§ 102(f))

• Secret on-sale activity (§ 102(b))

35

Pre-AIA § 102(b)

35 U.S.C. 102 Conditions for patentability; novelty and loss of right to patent. A person shall be entitled to a patent unless -

(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.

36

Pre-AIA Secret On-Sale Activity

• “Public” in § 102(b) modifies “use” but not needed for “on sale.”

– Hobbs v. U.S. Atomic Energy Comm’n (5th Cir. 1971) - sale of

a device to be used under conditions of government secrecy evoked the “on sale” bar.

– Buildex v. Kason (Fed. Cir. 1988) & Brasseler v. Stryker (Fed. Cir. 1999) - exclusive selling arrangement between the patentee and its manufacturer evoked the “on sale” bar.

– In re Caveney (Fed. Cir. 1985) - exclusive selling arrangement between third parties unrelated to the patentee evoked the “on sale” bar.

37

Pre-AIA § 102: PFAFF v. WELLS ELECS., INC.

(1998)

• Supreme Court test for on-sale bar: 1) the product must be the subject of a commercial offer for sale; and 2) the invention must be ready for patenting: either proof of reduction

to practice before the critical date or proof that prior to the critical date the inventor prepared drawings or other descriptions of the invention that were sufficiently specific to enable a person skilled in the art to practice the invention.

• No requirement that one step occur before the other.

38

Pre-AIA § 102: “COMMERCIAL OFFER FOR SALE”

• “on sale” = sale or offer for sale of the claimed invention, or an obvious variant thereof, by the inventor or by a third party.

• § 102(b) is only triggered by a commercial offer for sale of the claimed invention more than a year before patent filing.

• “offer for sale” = an offer in the contract law sense.

– Group One, Ltd. v. Hallmark Cards, Inc., 254 F.3d 1041 (Fed. Cir. 2001)

– C.R. Bard Inc. v. M3 Systems Inc., 157 F.3d 1340 (Fed. Cir. 1998)

• “[N]ormally the on-sale bar does not accrue based on customer contacts made while the product is still being developed or tested.”

• Such a communication is informational only. The subject matter of the invention was not yet ready or available.

39

Pre-AIA § 102: “READY FOR PATENTING”

• Fully operational prototype – IGT v. Global Gaming Technology, Inc., 1999 U.S. App. LEXIS 13336

(Fed. Cir. 1999)(unpublished)

• Complete conception

– Robotic Vision Systems, Inc. v. View Engineering, Inc., 249 F.3d 1307, 1311 (Fed. Cir. 2001)

• Could satisfy § 112

– Space Systems/Loral, Inc. v. Lockheed Martin Corp., 271 F.3d 1076 (Fed. Cir. 2001)

• Sufficient grasp of the invention

– STX, LLC v. Brine, Inc., 211 F.3d 588 (Fed. Cir. 2000)

40

• SEC. 3(n)(1) Except as otherwise provided in this section, the amendments made by this section shall take effect upon the expiration of the 18-month period beginning on the date of the enactment of this Act, [March 16, 2013] and shall apply to any application for patent …that contains or contained at any time:

A. a claim to a claimed invention that has an effective filing date as defined in section 100(i) …, that is on or after the effective date described in this paragraph [March 16, 2013]; or

B. a specific reference under §§ 120, 121, 365(c) to any patent or application that contains or contained at any time such claim. [antecedent for “such claim” has to be sub.para. (A)]

What changed with AIA? First AIA Transition Provision:

EFD after 3/15/13

41

• AIA §102 applies to patents and applications where all claims have an effective filing date (“EFD”) after March 15, 2013.

• Pre-AIA §102 applies to patents and application where all claims have an EFD before March 16, 2013.

• AIA §102 and Pre-AIA §102(g)/§135/§291 apply to patents and applications containing or that contained at some time at least one claim with an EFD before March 16, 2013, and at least one claim with an EFD after March 15, 2013. (See Transition Provision 3(n)(2).)

• Until at least 2034, you will have to carefully consider which law applies to claims you are prosecuting/analyzing/enforcing/challenging!

Pre-AIA §102 and AIA §102

42

35 U.S.C. § 102(a)(1) – Defines Prior Art Under AIA

§102 Conditions for patentability (a) NOVELTY; PRIOR ART (teaching edits added)

A person shall be entitled to a patent unless— (1) the claimed invention was patented [anywhere in the

world], described in a printed publication [anywhere in the world], or in public use [anywhere in the world], on sale [anywhere in the world], or otherwise available to the public [anywhere in the world] before the effective filing date of the claimed invention;

43

Enactment: Sept. 16, 2011

PCT

Filing

First to Invent System Applies

Straddling the Effective Date

“First To Invent” System or “FITF” System? (see SEC.

3(n)(1)(A) and (n)(2))

(Even if one claim not supported at priority date is

eventually canceled, still in FITF.)

PCT

Filing

Priority

Date

Enactment: Sept. 16, 2011 Effective Date:

March 16, 2013

Priority

Date

“FITF” System Applies

PCT

Filing

Enactment: Sept. 16, 2011

Scenario 1: no claims entitled to priority date: FITF Scenario 2: all claims entitled to priority date: first-to-invent Scenario:3: at least 1 claim not entitled to priority date: mixed

Assumes “priority date” is ex-US

44

Choice Of Law For On Sale Considerations

Pre-AIA AIA JMM Anticipation Pre-AIA

§102(a)-(g) §102(a)(1) §102(a)(1) and pre-

AIA §§102(g), 135, and 291

45

• Pre-AIA law: – EFD of a claimed invention is determined on a

claim-by-claim basis, not application-by-application.

• AIA law:

– Retains the principle that different claims in the same application may be entitled to different EFDs.

Choice of Law Applies on Application-by-Application Basis

See Examination Guidelines, 78 Fed.Reg. 11,073 (Feb. 14, 2013)

46

• Prior art is applied on a claim-by-claim basis

• BUT whether pre-AIA §102 or AIA §102 apply is on an application-by-application basis.

Choice of Law Applies on Application-by-Application Basis

See Examination Guidelines, 78 Fed.Reg. 11,073 (Feb. 14, 2013)

47

• “Because the changes to 35 U.S.C. 102 and 103 in the AIA apply only to specific applications filed on or after March 16, 2013, determining the effective filing date of a claimed invention for purposes of applying AIA 35 U.S.C. 102 and 103 provisions or pre-AIA 35 U.S.C. 102 and 103 provisions is critical.”

Choice of Law Is Critical To Determine if pre-AIA §102 or AIA §102 Applies

See pp. 11083 of Examination Guidelines (2/14/13)

48

• Enacters: Congress intended to eliminate “secret prior art” of any kind, ANYWHERE.

– Cong. Rec., Sept. 8, 2011, S5431: “Once an invention has entered the public domain, by any means, it can

no longer be withdrawn by anyone.”

• Evidence of an offer to sell anywhere in the world may meet the test of accessibility to

the public, but may be VERY difficult for the applicant to find out about prior to

discovery in litigation.

• Congress could have easily said “publicly on sale” if it intended to make the law clear

that no “secret sale” is prior art? But does public accessibility trump all? USPTO says

YES!

• Pre-AIA case law established that something is “publicly accessible” when “one skilled

in the art exercising reasonable diligence” could find it. (See Voter Verified v. Premier

Election Solutions (Fed. Cir. 2012).)

“Secret” Prior Art: EFD after 3/15/13

49

“Otherwise Available To The Public” Possible Interpretations

• AIA §102(a)(1) bars patenting if, before filing, the invention has been “in public use, on sale, or otherwise available to the public”

• What does “or otherwise available to the public” mean?

View 1: qualifier, limits scope of “in public use” & “on sale” (USPTO’s interpretation) View 2: catch-all, adds unspecified disclosures to the list

50

• “The Office’s interpretation of AIA 35 U.S.C. 102(a)(1) also ensures that the AIA grace period can extend to all of the documents and activities enumerated in AIA 35 U.S.C. 102(a)(1) that would otherwise defeat patentability.”

• “the Office views the ‘or otherwise available to the public’ residual clause of the AIA’s 35 U.S.C. 102(a)(1) as indicating that secret sale or use activity does not qualify as prior art. These examination guidelines also indicate that an activity (such as a sale, offer for sale, or other commercial activity) is secret (non-public) if, for example, it is among individuals having an obligation of confidentiality to the inventor.”

FITF USPTO Examiner Guidelines: “Otherwise Publicly Available” ≠ Secret

See pp. 11062-11063, 11075 of Examination Guidelines (2/14/13)

51

• “the case law on whether material is available and accessible

as discussed in MPEP § 2128 will guide the Office and the

public in making determinations as to whether any particular

disclosure is sufficiently publicly available under the

“otherwise available to the public” clause of AIA 35 U.S.C.

102(a)(1). The Federal Circuit recently reiterated that the

ultimate question is whether the material was “available to

the extent that persons interested and ordinarily skilled in the

subject matter or art[,] exercising reasonable diligence, can

locate it.” (See Voter Verified v. Premier Election Solutions

(Fed. Cir. 2012)).

EFD after 3/15/13: FITF USPTO Examiner Guidelines: Will Look to Pre-AIA Caselaw on “Publicly Available” to

Evaluate “Otherwise Publicly Available”

See pp. 11063-11064 of Examination Guidelines (2/14/13)

52

Using AIA to Shield Pre-AIA Inventions from Secret Prior Art

• File an application containing:

– at least one claim with an effective filing date (EFD) before March 16, 2013; and

– at least one claim with an effective filing date (EFD) after March 15, 2013

• Some call this type of application a “Jedi Master Mixer” (JMM)

53

A Way to Create a JMM Application

• Need a pending application (application 1) filed before March 16, 2013.

• File an application (application 2) after March 15,

2013 claiming priority/benefit of application 1. • Application 2 must contain:

– at least one claim having an EFD before March 16, 2013, and

– at least one claim with an EFD after March 15, 2013.

54

A Way to Create a JMM Application (con’t)

• Application 2 could be a continuation-in-part (CIP).

or

• Application 2 could be a continuation filed along with a preliminary amendment presenting at least one claim with an EFD after March 15, 2013.

• Caution: if a JMM application is not intended, may be prudent to file the preliminary amendment at least one day after the continuation unless the continuation was filed to create a Track I status.

55

JMM In Play When Patent Owner Wants to Get Rid of pre-AIA §102(a)-(f) Prior Art Events

and Can Live with pre-AIA §102(g) and AIA §102(a)(1), §102(a)(2), and §103

56

JMM In Play When Patent Owner Wants to Get Rid of pre-AIA §102(a)-(f) Prior Art Events and

Can Live with pre-AIA §102(g) and AIA §102(a)(1), §102(a)(2), and §103

57

AIA Transition Provisions Relevant to JMM

58

Note That Under Choice of Law, §102(b) Does Not Apply

59

Interview Getting EFD’s Corrected

60

• The guidelines evidence the Office’s intent to treat the phrase “on sale” in AIA 35 U.S.C. § 102(a)(1) “as having the same meaning as ‘on sale’ in pre-AIA 35 U.S.C. 102(b), except that the sale must make the invention available to the public.” (emphasis added).

PTO: AIA Insulates the Secret Sale

61

• No.

– “The case law provides that the enablement inquiry is

applicable to the question of whether a claimed invention

is described in a patent, published patent application, or

printed publication, but is not applicable to the question of

whether a claimed invention is ‘in public use’ or ‘on sale.’

The Office does not view the AIA as changing this principle

of pre-AIA case law.”

Does An “On Sale” Event Have To Be Enabling To Constitute

Prior Art Under AIA 35 U.S.C. §102(a)(1)?


62

• “To provide support for a claim under 35 U.S.C. 112(a), it is necessary that the specification describe and enable the entire scope of the claimed invention. [...continued...]

• …However, in order for a prior art document to describe a claimed invention under AIA 35 U.S.C. 102(a)(1) or (a)(2), the prior art document need only describe and enable one skilled in the art to make a single species or embodiment of the claimed invention…the disclosure may be cited for all that it would reasonably have made known to a person of ordinary skill…the description requirement of AIA 35 U.S.C. 102(a)(1) and (a)(2) does not preclude an examiner from applying a disclosure in an obviousness rejection under AIA 35 U.S.C. 103 simply because the disclosure is not adequate to anticipate the claimed invention under AIA 35 U.S.C. 102(a)(1) or (a)(2).”

FITF Examination Guidelines: Requirements for § 112 Support v. Requirements for Anticipatory or Obviousness

Prior Art Under §102(a)(1) and (2)/ §103


Emphasis added

63

• Prior art disclosures are removed from consideration IF an exception applies.

• 2 exceptions apply to §102(a)(1) global prior public disclosures (§102(b)(1)(A) and (B))

• 3 exceptions apply to §102(a)(2) patent-filing disclosures (§102(b)(2)(A) - (C))

Exceptions to What Is Considered Prior Art Under AIA

Prior Art

Exception

64

• §102 (b)(1) EXCEPTIONS. (1) DISCLOSURES MADE 1 YEAR OR LESS BEFORE THE EFFECTIVE

FILING DATE OF THE CLAIMED INVENTION.—A disclosure made 1 year or less before the effective filing date of a claimed invention shall not be prior art to the claimed invention under subsection (a)(1) if—

(A) the disclosure was made by the inventor or joint inventor or by

another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor; or

(B) the subject matter [independently?] disclosed had, before such

disclosure, been publicly disclosed by the inventor or a joint inventor or another who obtained the subject matter disclosed directly or indirectly from the inventor or a joint inventor.

New 35 U.S.C. §102(b) – Defines Exceptions to Prior Art

ANY-WHERE IN THE

WORLD

“grace period”

65

Exception ONLY Good For Exact Subject Matter Described?

§102(b)(1) Exception ONLY for the same subject matter earlier disclosed; “related” subject matter could still be used against the patentee under §103 and MIGHT even preclude the claimed invention from being patentable at all because of §103!!! What if inventor discloses X and the disclosee discloses X and Y? See Examination Guidelines pp. 11061

66

• “Offer to license” under pre-AIA 35 U.S.C. §102(b) applicable under AIA 35 U.S.C. § 102(a)(1); “AIA did not amend 35 U.S.C. 102 to change the treatment of the prior art effect of an offer for license.”

• BUT, if offer to license makes invention available to the public before the EFD of the claimed invention, may be AIA 35 U.S.C. §102(a)(1) prior art.

FITF Final Rules Offer to License May be Prior Art, If Public

See pp. 11062 of Examination Guidelines (2/14/13).

67

• “The case law distinguishing between offers for sale and offers for license

under pre-AIA 35 U.S.C. 102(b) is equally applicable under AIA 35 U.S.C.

102(a)(1) as the AIA did not amend 35 U.S.C. 102 to change the treatment of

the prior art effect of an offer for license. … If a transaction or offer with

respect to an invention constitutes licensing within the meaning of these

cases, the offer or transaction does not implicate the on sale bar. However, if

the licensing of an invention makes the invention available to the public,

patentability would be independently barred by the residual clause of AIA 35

U.S.C. 102(a)(1), which precludes patenting of a claimed invention that was

‘available to the public’ more than one year before the effective filing date of

the claimed invention.”

“Offer to license” May Be Prior Art if Means Invention Becomes Publicly Accessible

See pp. 11062 of Examination Guidelines (2/14/13).

68

Section 102(b)(1)(A)

12 Months

Earliest Effective Filing Date PD

PD = public disclosure IW = inventor’s own work DW = work derived from inventor(s)

IW or DW

69

Section 102(b)(1)(B)

12 Months

Earliest Effective Filing Date PD

PD = public disclosure IW = inventor’s own work DW = work derived from inventor(s)

IW or DW

3rd Party Disclosure

70

Section 102(b)(2)(A)

12 Months

Earliest Effective Filing Date

PA/P

PA/P = filing of published application or patent Pub of PA/P = publishing of patent or earlier filed application IW = inventor’s own work DW = work derived from inventor(s)

IW or DW

Pub of PA/P

71

Section 102(b)(2)(B)


PA/P

PD = public disclosure PA/P = filing of published application or patent Pub of PA/P = publishing of patent or earlier filed application IW = inventor’s own work DW = work derived from inventor(s)

IW or DW

Pub of PA/P PD

12 Months

72

Section 102(b)(2)(C)


PA/P

PA/P = filing of published application or patent Pub of PA/P = publishing of patent or earlier filed application OTA = obligation to assign to same entity CRA = common research agreement

Owned, CRA, or OTA

Pub of PA/P

12 Months

73

Federal Circuit Treatment of On-Sale Bar

• Hamilton Beach Brands, Inc. v. Sunbeam Products, Inc., 726 F.3d 1370 (Fed. Cir. 2013)

– District Court: Summary judgment of invalidity for

anticipation. • Hamilton Beach's purchase order with its foreign supplier =

invalidating commercial offer for sale

– Federal Circuit: Affirmed claims invalid under on-sale bar.

• Actual sale not required. • “An attempt to sell is sufficient so long as it is ‘sufficiently

definite that another party could make a binding contract by simple acceptance.’”

• No “supplier exception” to the on-sale bar.

74


• Hamilton Beach (con’t)

– Application filed March 1, 2006, issued Feb. 3, 2009 (‘813 patent)

• discloses “clip” element to seal lid to body of slow cooker • continuation application (‘188) • continuation filed June 4, 2010, issued May 24, 2011 as ‘928 patent

(“grandchild”) – claimed sealing clips attached to the lid

– Sunbeam: • ‘928 claims invalid because could not claim priority to ‘831 patent

– new matter in ‘928 specification, rendered claims anticipated.

• Offered for sale and publicly used commercial embodiment of ‘813 patent more than more year before earliest possible filing date (March 1, 2006)

75


• Hamilton Beach (con’t) – District court’s decision: Hamilton Beach’s February 8,

2005, purchase order with foreign supplier = invalidating commercial offer for sale under 102(b).

• Feb. 8, 2005 purchase order included: – Shipping and billing addresses – specific quantity – part number – unit price – requested delivery date

• Feb. 25, 2005, supplier confirmed receipt of purchase order

and indicated would begin production after receiving Hamilton’s release.

offer to buy is invalidating sale if “offer

accepted and binding

contract to sell is formed.”

DC: assent creating binding contract

76

“Commercial Offer For Sale”

• Hamilton Beach (con’t) – Federal Circuit decision: Claims invalid under pre-AIA

§102(b).

• Pfaff #1 Commercial Offer to Sell

– Hamilton Beach purchase order to supplier listed specific quantity, part number, unit price, and requested delivery date.

– Supplier confirmed it had received the purchase order and noted that it would begin production after receiving Hamilton Beach's release. (=OFFER TO SELL)

» Hamilton Beach could have made into a binding contract by simple

acceptance of supplier’s offer.

77

“Ready For Patenting”

• Hamilton Beach (con’t)

– Pfaff #2 Ready for Patenting

• Detailed drawings and descriptions from Hamilton Beach's meetings, coupled with the communications with its supplier, demonstrated that the invention was ready for patenting.

• Subject of offer was commercial embodiment of patented invention.

• Descriptions and depictions of the slow cooker sufficiently precise to enable a person of ordinary skill to build the invention,

• “‘fine-tuning’ of an invention after the critical date does not mean that the invention was not ready for patenting.”

• Judge Reyna dissented, saying request to build was not “commercial” offer

for sale.

78

• Merck & Cie v. Watson Labs. Inc., 822 F.3d 1347 (Fed. Cir. 2016), application for stay denied by USSC, July 27, 2016.

– DC: Claim not invalid; ready for patenting, but no invalidating

commercial sale or offer for sale. • Communication between parties did not include “important safety and

liability terms.” • not “reduced to writing and signed by both parties,” per Confidentiality

Agreement.

– FC: Reversed.

• Communication sent in direct response to request to purchase and provided essential price, delivery, and payment terms— “all the required elements to qualify as a commercial offer for sale.”

• Failure to deliver is not dispositive - “An offer to sell is sufficient to raise the on-sale bar, regardless of whether that sale is ever consummated.”

Offer to Sell

79

First Judicial Opinion on AIA 35 U.S.C. § 102(a)(1):

Judge Cooper Supplemental Opinion issued March 3, 2016, in Helsinn v. DRL,

Ruling addressed scope of the on-sale defense

80

Helsinn v. DRL

• 4 patents-in-suit listed in the Orange Book.

• Teva: patents-in-suit invalid under on-sale bar of 35 U.S.C. §102(b).

• Each of patents claims priority to original provisional application, but one, the ‘219, was deliberately made into a transition application (at least one claim having an effective filing date before March 16, 2013, and at least one claim having an effective filing date after March 15, 2013), thereby invoking AIA SEC. 3(n)(2).

81

Helsinn v. DRL • Helsinn argued:

– “Plaintiffs argue, as a threshold matter, that the ‘219 patent is

subject to the AIA….Plaintiffs additionally argue that the AIA established a new standard for the on sale bar, i.e., that commercial sales or offers for sale of the invention must now be made available to the public for the on-sale bar to apply. …Plaintiffs argue that the contracts with service providers … and the licensing and supply agreements with [suppliers] were not commercial sales or offers for sale. …Plaintiffs argue in the alternative that even if this Court considers these contracts to be commercial sales or offers for sale, the post-AIA on-sale bar applicable to the ‘219 patent does not apply because the contracts never made the invention available to the public.”

82

Helsinn v. DRL • Teva argued:

– “the AIA did not amend the on-sale bar to include a public sale requirement. … Teva asserts that under the correct interpretation of the AIA, Helsinn violated the on-sale bar by executing a supply agreement for the marketing and sale of Aloxi with MGI. … Teva additionally argues that Helsinn violated the on-sale bar even under Helsinn’s proposed interpretation of the AIA, as the supply agreement was publicized and MGI is a member of the public.”

83

• Judge Cooper: “The Court …concludes that §102(a)(1) requires a public sale or offer for sale of the claimed invention. The new requirement that the on-sale bar apply to public sales comports with the plain language meaning of the amended section, the USPTO’s interpretation of the amendment, the AIA Committee Report, and Congress’s overarching goal to modernize and streamline the United States patent system.”

What Does Public Accessibility Mean?

84

• Alleged on-sale did not place invention in public domain:

– “As this Court has interpreted the post-AIA on-sale bar, the ‘sale’ prong of the onsale bar is satisfied by a public sale or offer for sale of the claimed invention. …The Court further finds that the Oread and SP Agreements were not ‘public’ sales under the post-AIA standard, because they were entirely subject to and performed under confidentiality restrictions.”

Invention Must Be Placed In Public Domain

85

• “under a pre-AIA analysis, the Court’s analysis would end here with a conclusion that the MGI Agreement constituted a contract for sale, thus satisfying the ‘sale’ prong of the on-sale bar. However, the post-AIA on-sale bar also requires that the sale or offer for sale make the claimed invention available to the public. …It is not sufficient that a sale or offer for sale merely occur. The Court finds that the MGI Agreement did not make the claimed invention available to the public. … the ‘sale’ prong of the on-sale bar requires that the sale make the claimed invention available to the public one year prior to its critical date. Teva has failed to show how MGI’s Form 8-K or Helsinn’s press releases on the MGI Agreement made Helsinn’s claimed invention, i.e., its palonosetron formulation, available to the public. …The Court finds, for the reasons stated above, that the post-AIA on-sale bar does not apply to the MGI Agreement because the sale or offer or sale did not make Helsinn’s claimed invention available to the public one year prior to the critical date.”

Alleged On-sale Did Not Place Invention In Public Domain

86

• The Medicines Co. v. Hospira Inc., 805 F.3d 1357 (Fed. Cir. 2015), rehearing en banc granted

– Opinion of July 2, 2015: claims invalid because on-sale bar triggered when TMC

hired supplier to prepare three batches of bivalirudin using the eventually patented method more than a year before filing patent applications.

– Vacated, appeal reinstated. • (a) Do the circumstances presented here constitute a commercial sale under

the on-sale bar of 35 U.S.C. §102(b)? – (i) Was there a sale for the purposes of §102(b) despite the absence of a transfer of

title? – (ii) Was the sale commercial in nature for the purposes of §102(b) or an

experimental use?

• (b) Should this court overrule or revise the principle in Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353 (Fed.Cir.2001), that there is no “supplier exception” to the on-sale bar of 35 U.S.C. § 102(b)?

On-sale Bar Of Pre-AIA 35 U.S.C. §102(b)

87

• On rehearing, The Medicines Co. v. Hospira, __F.3d__ (Fed. Cir. July 11, 2016), en banc

– FC: Unanimously overturned earlier panel decision finding an on-sale bar.

• “We conclude that, to be ‘on sale’ under § 102(b), a product must be the subject of a commercial sale or offer for sale, and that a commercial sale is one that bears the general hallmarks of a sale pursuant to Section 2-106 of the Uniform Commercial Code. We conclude, moreover, that no such invalidating commercial sale occurred in this case. We, therefore, affirm the district court's judgment that the transactions at issue did not render the asserted claims …invalid under § 102(b).”

• Distinguished Hamilton Beach


88

https://1.next.westlaw.com/Link/Document/FullText?findType=L&pubNum=1000546&cite=35USCAS102&originatingDoc=I6cd77d0047f511e68e80d394640dd07e&refType=SP&originationContext=document&transitionType=DocumentItem&contextData=(sc.Search)






• On rehearing, TMC (con’t) – FC:

• No “commercial sale” of patented product under Pfaff.

– “the mere sale of manufacturing services by a contract manufacturer to an inventor to create embodiments of a patented product for the inventor does not constitute a ‘commercial sale’ of the invention.”

– “’stockpiling’” by the purchaser of manufacturing services is not improper commercialization under §102(b).”

» “mere preparations for commercial sales are not themselves ‘commercial sales’ or ‘commercial offers for sale’ under the on-sale bar.”

– “commercial benefit—even to both parties in a transaction—is not

enough to trigger the on-sale bar of §102(b); the transaction must be one in which the product is ‘on sale’ in the sense that it is ‘commercially marketed.’”

» “the inventor maintained control of the invention.”


89

• On rehearing, TMC (con’t)

– FC: Still no “supplier exception.” • “We still do not recognize a blanket ‘supplier exception’ to what

would otherwise constitute a commercial sale as we have characterized it today. While the fact that a transaction is between a supplier and inventor is an important indicator that the transaction is not a commercial sale, understood as such in the commercial marketplace, it is not alone determinative. …The focus must be on the commercial character of the transaction, not solely on the identity of the participants.”


90

• “The Court notes that during the bench trial in this case, the Federal Circuit issued an opinion in Medicines Co. v. Hospira, Inc., 791 F.3d 1368 (Fed.Cir. 2015), vacated by Medicines Co. v. Hospira, 805 F.3d 1357 (Fed.Cir. 2015), which addressed the issue of whether a sale for services constitutes a commercial sale under the pre-AIA on-sale bar. …the Federal Circuit vacated its opinion in Medicines Co. and granted that plaintiff’s petition for rehearing en banc. …The Court notes that the issue of what constitutes a commercial sale under the pre-AIA on-sale bar remains in flux at this time.”

Judge Cooper Discussing TMC in Helsinn v. DRL

91

• “The Medicines Company hired Ben Venue to prepare batches of bivalirudin, a synthetic peptide used as an anticoagulant, “using an embodiment of the patented method.” …The batches were for both commercial and clinical packaging. ... The ANDA applicant alleged that the claimed invention was commercially offered for sale before the critical date. …The district court found, inter alia, that the patents-in-suit were not invalid under the on-sale bar because: (1) the patent holder had only contracted with a manufacturing company for the sale of ‘manufacturing services’; and (2) the developmental batches manufactured under the agreement fell under the experimental use exception of the on-sale bar.”


92

• “The facts set forth in Medicines Co. are distinguishable from Trading Technologies International, Inc. v. eSpeed, Inc., 595 F.3d 1340 (Fed. Cir. 2010). In Trading Technologies, an inventor hired Trading Technologies (“TT”) to build trading software in accordance with the inventor’s idea. …The Federal Circuit held that the parties’ consulting agreement was not a sale under the on-sale bar …The court held that ‘[i]nventors can request another entity’s services in developing products embodying the invention without triggering the on-sale bar.’ Id. The court noted, in so holding, that an inventor’s request to manufacture a product for ‘secret, personal use could not constitute a sale under 35 U.S.C. § 102(b).’”


93

• “Helsinn first argues that the Oread and SP Agreements were service

contracts, in which Oread and SP provided services like manufacturing,

formulation development, and analytical development to Helsinn. …

Helsinn analogizes this case to Trading Technologies, wherein the Federal

Circuit held that inventors may request another entity to perform services

without violating the on-sale bar. …There is no dispute that Helsinn and

Oread, and later Helsinn and SP, entered into binding contracts for the

manufacture of developmental batches of palonosetron, including

“commercial scale” batches to satisfy NDA requirements. But the Court

finds nothing in these agreements to suggest the contracts contemplated

a commercial sale of any of those batches…. Rather, Helsinn entered into

the Oread and SP Agreements for the purpose of pursuing FDA

approval[.]”


94

• “the Court does not see how supply agreements for

developmental batches can reasonably be considered

commercial exploitation when, particularly in the

pharmaceutical field, the developmental batches are critical

to pre-commercialization steps, like clinical trials, formulation

development, and manufacturing quality requirements.”

• “the Oread and SP Agreements do not constitute sales under

the pre-AIA on-sale bar.”


95

Status of Helsinn v. DRL

• Appeal filed April 4, 2016; no substantive activity yet.

• Meanwhile, PTAB came to same conclusion about what the on-sale bar means under AIA and denied DRL’s petitions in PGR2016-00008.

96

At PTAB: Discuss TMC v. Hospira

• PGR2016-00008, Paper 11 (P.T.A.B. Aug. 17, 2016)

– PTAB FWD: Petition denied.

• “The Court of Appeals for the Federal Circuit has held that commercial sales, even if confidential, trigger the on-sale bar under the pre-AIA § 102. See, e.g., Medicines Co. v. Hospira, Inc., 2016 WL 3670000, at *10 (Fed. Cir. 2016) (en banc) …; Special Devices, Inc. v. OEA, Inc., 270 F.3d 1353, 1357–58 (Fed. Cir. 2001) …; Woodland Trust, 148 F.3d at 1370 …. The AIA enlarged the scope of prior art under § 102 with respect to territory, and also added the clause ‘otherwise available to the public.’ …As an AIA first-inventor-to-file patent, the ’942 patent is subject to AIA § 102(a)(1).”

97

At PTAB: Then Helsinn v. DRL • PGR2016-00008, Paper 11 (P.T.A.B. Aug. 17, 2016)

– PTAB FWD (con’t):

• “Thus, the dispositive issue in this case is whether § 102(a)(1) requires a public sale or offer for sale of the claimed invention to trigger the on-sale bar. This issue was recently addressed in Helsinn Healthcare S.A. v. Dr. Reddy’s Labs., Ltd., No. 11–3962, 2016 WL 832089, at *39 (D.N.J. March 3, 2016), a case involving three pre-AIA patents, and one AIA first-inventor-to-file patent—specifically U.S. Patent No. 8,598,219, the immediate parent of the ’942 patent. The parties in that case, as in this case, disagreed as to ‘whether the last clause of § 102(a)(1), ‘otherwise available to the public,’ modifies the section’s previous clauses or serves as its own category of prior art.’ Helsinn Healthcare, 2016 WL 832089, at *40.”

98

At PTAB: Then Helsinn v. DRL


– PTAB FWD (con’t): • “The court in Helsinn Healthcare, guided at least in part “by the

Supreme Court’s ‘common sense’ approach to statutory interpretation,” the USPTO’s non-binding published “Examination Guidelines for Implementing the First Inventor to File Provisions of the [AIA],” and the legislative history of the AIA, determined that the phrase ‘otherwise available to the public’ does indeed modify the section’s previous clauses. Id. at *40–*44, *51 n.52. Specifically, the court concluded ‘that §102(a)(1) requires a public sale or offer for sale of the claimed invention’ and ‘[t]he new requirement that the on-sale bar apply to public sales comports with the plain language meaning of the amended section, the USPTO’s interpretation of the amendment, and the legislative history of the AIA.” Id. at *45.”

99




• “Moreover, the court emphasized that ‘the post-AIA on-sale bar inquiry is not focused on the public disclosure of the sale or offer for sale; rather, the ‘sale’ prong of the on-sale bar requires that the sale make the claimed invention available to the public one year prior to its critical date.’ Id. at *52.”

100




• “Here, as in Helsinn Healthcare, Petitioner has established that MGI’s Form 8-K SEC filings and Helsinn’s press releases made public the existence of the Supply and Licensing Agreements, but Petitioner has not shown that the heavily redacted SEC filings or the press releases, devoid of detail, made the claimed invention available to the public. Thus, we determine that the Supply and Licensing Agreements did not make the claimed invention available to the public one year prior to the critical date at issue here. Accordingly, we determine that Petitioner has failed to show that it is more likely than not that claims 1–19 are in violation of the on-sale bar under 35 U.S.C. § 102(a)(1).”

101

• Determine which law/prior art should have been applied by USPTO by analyzing EFD of all claims. – AIA – Pre-AIA – Transitional (JMM): AIA plus part of pre-AIA

• Determine whether the correct law was applied by USPTO.

• Determine the outcome under the application of the correct law.

• Note courts likely to use pre-AIA case law to analyze “public accessibility,”

at least for now.

• Consider the JMM when appropriate to constitute a shield against pre-AIA prior art events

Impact on of AIA on § 102: Practice Tips

102

Conclusion

• AIA transition section 3(n)(1) can provide a powerful tool for shielding pre-AIA inventions from certain secret prior art. – But not all secret prior art! – If a JMM, Transition Provision 3(n)(2) preserves pre-AIA § 102(g) secret

prior art and, whether or not a JMM, Transition Provision 3(n)(1) applies the temporally-secret prior art of AIA § 102(a)(2).

• JMM applications that take advantage of those transition

sections should succeed, at least at the USPTO, to eliminate certain types of pre-AIA §102 prior art.

103

Thank you.

Thomas L. Irving Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 202.408.4082 [email protected]

104

Doris Johnson Hines Finnegan, Henderson, Farabow, Garrett & Dunner, LLP 901 New York Avenue, NW Washington, DC 20001-4413 202.408.4250 [email protected]

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