Preparing for Pharma PGRs: Lessons for Patent Owners From PGR Denials

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Preparing for Pharma PGRs: Lessons for Patent Owners From PGR Denials Leveraging Successful IPR Arguments, Strengthening Patent Applications to Survive PGR Petitions THURSDAY, JANUARY 19, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Thomas L. Irving, Partner, Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. Amanda K. Murphy, Ph.D., Finnegan Henderson Farabow Garrett & Dunner, Washington, D.C. Kerry Flynn, Vice President, Chief IP Counsel, Vertex Pharmaceuticals, Boston The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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4 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), and Vertex Pharmaceuticals 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. 4

5 NUTS & BOLTS COMPARISON: IPRS AND PGRs When Threshold showing Post-Grant Review (PGR) Within nine months of grant More likely than not or novel legal question Inter Partes Review (IPR) More than nine months after grant (but one exception) Reasonable likelihood of success Grounds 101, 102, 103, , 103 (Pats/pubs only) Time at PTO months months Anonymity No No 5

6 NUTS & BOLTS COMPARISON: IPRS AND PGRs (con t) Post-Grant Review (PGR) Inter Partes Review (IPR) Estoppel Issues raised or reasonably could have been raised Issues raised or reasonably could have been raised Before whom PTAB PTAB Discovery/ evidence Declaration and discovery Declaration and discovery Appeal Both parties may appeal to Federal Circuit* Both parties may appeal to Federal Circuit* Note: Phigenix, Inc. v. Immunogen, Inc., --F.3d (Fed. Cir. Jan. 9, 2017) that right to appeal does not automatically confer standing. 6

7 NUTS & BOLTS COMPARISON: IPRS AND PGRs (con t) Post-Grant Review (PGR) Inter Partes Review (IPR) Petition grant rate* Final decisions** 55% (16/29)* (FY2014-FY2017 to date) 83% all instituted claims unpatentable (5/6) 17% all instituted claims survived (1/6) 70% (2566/3690)* (2335 granted joinder) (FY2014-FY2017 to date) 69.63% all instituted claims unpatentable 16.79% all instituted claims survived 13.59% mixed outcome *As of Jan. 9, Finnegan research **As of Jan. 11, 2017 (by case). *As of Nov. 30, r2016.pdf ** Mixed outcome : at least one instituted claims survived and at least one instituted claim was canceled. **As of Dec. 1, (by case) Source: Finnegan research, 7

8 PGR PETITION FILING STILL LOW COMPARED TO IPR PETITION FILING As of Nov. 30,

9 BUT GROWING As of Nov. 30,

10 PETITIONS BY TECHNOLOGY Source of IPR data: Average of FY 2015, 2016, and 2017 to date; As of Nov. 30, 2016 Source of PGR data: Finnegan research; 36 PGR Petitions filed. As of Sept. 23, 2016; 10

11 PGR PETITION ASSERTED GROUNDS As of Jan. 9, 2017; Finnegan research; 38 PGR Petitions filed. Note, more than one ground may be asserted per petition. 11

12 PGR INSTITUTED GROUNDS As of Jan. 9, 2017; Finnegan research; 16 instituted PGRs. Note: 5 FWDs holding all instituted claims unpatentable so far; 3 based on 101; 1 based on 102, 112(a); 1 based on 112(b). As of Jan. 9,

13 PGR INSTITUTION RATE LOWER THAN IPRs, BUT NUMBERS STILL VERY SMALL (16 granted/partially granted) (FY2014-FY2017 to date) Finnegan research (2335 granted joinder) (FY2014-FY2017 to date) USPTO stats 13

14 PGR INSTITUTION RATE Trial going ahead in 55% of petitions filed As of Jan. 9, 2017; Finnegan research; 29 institution decisions. An additional 3 petitions terminated prior to an institution decision (2 settled and 1 was dismissed as an improperly-filed PGR). Partially granted means instituted on fewer than all challenged claims. 14

15 PGR CLAIM SURVIVAL RATE (BY CASE) SAME AS IPRs 16.7% 1/6 As of Jan. 4, 2017; Finnegan research; 6 Final Written Decisions on the merits. In addition, 2 instituted PGRs settled prior to FWD. As of Dec. 1, Source: Finnegan research, all instituted claims survived Also, 13.59% (153/1126) cases had mixed outcome (some instituted claims survived, some held unpatentable) 15

16 PGR FWDs American Simmental Assoc. v. Leachman Cattle of Colorado, LLC, , Paper 56 (P.T.A.B. June 13, 2016) Claim 16. A computer-implemented method to determine relative market value of a sale group, the sale group including cattle that are fed and harvested for beef production, the method comprising:... PGR instituted on 101 and 103 grounds. PTAB: FWD all instituted claims unpatentable for failing to recite statutory subject matter. Unpersuaded that Petitioner showed obviousness by a preponderance of the evidence. Found that the claims were directed to a patent-ineligible abstract idea and did not recite something more. Denied Patent Owner s Motion to Amend. 16

17 PGR FWDs (con t) American Simmental Assoc. v. Leachman Cattle of Colorado, LLC, , Paper 52 (P.T.A.B. June 13, 2016) Claim 8. A computer-implemented method to determine relative market value of a sale group, the computer implemented method comprising the steps of::... PGR instituted on 101 and 103 grounds. PTAB: FWD all instituted claims unpatentable for failing to recite statutory subject matter and obviousness. Petitioner showed obviousness of several claims by a preponderance of the evidence. Rejected Patent Owner s objective evidence of nonobviousness as cursory Found that the claims were directed to a patent-ineligible abstract idea and did not recite something more. Denied Patent Owner s Motion to Amend. 17

18 PGR FWDs (con t) NetSirv v. BoxBee, Inc., , Paper 20 (P.T.A.B. Aug. 2, 2016) Claim 1. A method for stored item distribution to a user, the user associated with a user identifier, the method comprising: PGR instituted on 101 grounds. PTAB: FWD all instituted claims unpatentable for failing to recite statutory subject matter. claim 1 is directed to the abstract idea of a bailment scheme using storage containers. we do not find claim language that recites significantly more than the abstract idea. 18

19 PGR FWDs (con t) Altaire Pharms., Inc. v. Paragon Bioteck, Inc., PGR , Paper 48 (P.T.A.B. Nov. 14, 2016) Claim 1. A method of using an ophthalmic composition for pupil dilation, the composition comprising R-phenylephrine hydrochloride having an initial chiral purity of at least 95% and an aqueous buffer, wherein the chiral purity of R- phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6 months, the method comprising: administering the composition into an eye of an individual in need thereof, wherein the composition is stored between 10 to 10 degree Celsius prior to administration, and wherein the composition comprises R-phenylephrine hydrochloride having a chiral purity of at least 95% when administered after storage. 19

20 Altaire (con t) PGR FWDs (con t) Asserted ground: obviousness over Altaire s Product (phenylephrine hydrochloride ophthalmic solution Lot # and Lot # 11581) PTAB: Preamble phrase, wherein the chiral purity of R- phenylephrine hydrochloride is at least 95% of the initial chiral purity after 6 months describes property of the composition to be administered. It is not a claim limitation requiring an active step of cold storage for six months. PTAB rejected Petitioner s evidence showing the HPLC data of Altaire s Product meets the recited chiral-purity limitations the tests and data submitted with the Petition do not meet the requirements of 37 C.F.R For example, fails to explain how the test was performed and how the data was generated. 20

21 Altaire (con t) PGR FWDs (con t) Similar objections to Petitioner s optical-rotation data: Petitioner does not point to any credible evidence to show the lot number of the phenylephrine hydrochloride P6126 it used as control, when the lot was manufactured, or how long after the manufacturing date Petitioner used it as the control. Indeed, for the optical-rotation data, as for the HPLC data, Petitioner has not provided any affidavit in compliance with 37 C.F.R (b). Patent Owner has presented sufficient evidence to challenge the accuracy of estimating enantiomer purity based on the specific rotation. 21

22 PGR FWDs (con t) US Endodontics, LLC v. Gold Standard Instruments, LLC, PGR , Paper 54 (P.T.A.B. Dec. 28, 2016) 12. A method for manufacturing or modifying an endodontic instrument for use in performing root canal therapy on a tooth, the method comprising: (a) providing an elongate shank having a cutting edge extending from a distal end of the shank along an axial length of the shank, the shank comprising a superelastic nickel titanium alloy, and (b) after step (a), heat-treating the entire shank at a temperature above 25 C. up to but not equal to the melting point of the superelastic nickel titanium alloy, wherein the heat treated shank has an angle greater than 10 degrees of permanent deformation after torque at 45 degrees of flexion when tested in accordance with ISO Standard

23 PGR FWDs (con t) US Endodontics (con t) PGR instituted on 102, 103, and 112 grounds. Patent Owner disputed eligibility for PGR (see slide 29). Issued claims same as application filed Jan. 29, PTAB agreed with Petitioner that no priority to earlier applications for lack of WD and enablement -> claims only entitled to actual filing date. PTAB: All instituted claims unpatentable. Lack of enablement. the guidance the Specification provides regarding how to achieve the deformation characteristic recited in the wherein clause is quite limited compared to the broad scope of claims Specification teaches deformation achieved using heat-treatment at 500 C for 75 minutes or inherent heat-treatment of undisclosed parameters but Claims encompass temperature ranges from above 25 C or 300 C up to but not equal to about 1300 C, and are not limited to any duration. 23

24 PGR FWDs (con t) US Endodontics (con t) PTAB: Lack of enablement (con t) Claims include heat-treatment times and temperatures that do not provide the deformation characteristic (inoperative species relevant though not determinative of lack of enablement). PTAB credited Petitioner s testing evidence. Undue experimentation required for POSITA to practice full scope of claims. Inventor testimony expressing doubt at specific temperatures. PTAB: Lack of written description the Specification does not reasonably convey to those skilled in the art that Dr. Luebke had possession of the subject matter of claims Species disclosed in Ex. 4 does not support genus claimed. 24

25 PGR FWDs (con t) US Endodontics (con t) PTAB: Anticipated. Article qualified as prior art because claims not entitled to priority. 25

26 PGR FWDs (con t) Telebrands Corp. v. Tinnus Enterprises, LLC, PGR , Paper 75 (P.T.A.B. Dec. 30, 2016) Claim 1. An apparatus comprising: a housing ; a plurality of flexible hollow tubes, ; a plurality of containers, ; and a plurality of elastic fasteners, each elastic fastener configured to provide a connecting force that is not less than a weight of one of the containers when substantially filled with water, and to automatically seal its respective one of the plurality of containers upon detaching the container from its corresponding hollow tube, such that shaking the hollow tubes in a state in which the containers are substantially filled with water overcomes the connecting force and causes the containers to detach from the hollow tubes thereby causing the elastic fasteners to automatically seal the containers, wherein the apparatus is configured to fill the containers substantially simultaneously with a fluid. 26

27 Telebrands (con t) PGR FWDs (con t) PTAB instituted PGR on 112(b) and 103 grounds. PTAB FWD: all instituted claims unpatentable for indefiniteness. apply the test for indefiniteness approved by the Federal Circuit in Packard [751 F.3d 1307, 1313 (Fed. Cir. 2014)], i.e., a claim is indefinite when it contains words or phrases whose meaning is unclear. We do not understand Nautilus, however, to mandate the Board s approach to indefiniteness in patent examination or reexamination matters 9 or in AIA proceedings, in which the claims are interpreted under the broadest reasonable interpretation standard, and an opportunity to amend the claims is afforded. 10 FN 10 We need not, and do not, decide in this case the approach to indefiniteness to be applied in Board proceedings where the BRI standard is inapplicable and an opportunity to amend is unavailable, such as when the patent being challenged has expired. See In re CSB-System Int l, Inc., 832 F.3d 1335, 1342 (Fed. Cir. 2016). 27

28 Telebrands (con t) PGR FWDs (con t) PTAB FWD: Claim 1 is indefinite. Specification consistently teaches that whether a container is filled depends, subjectively, on whether a desired size or volume has been reached. the level of water in a substantially filled container is not ascertainable or measurable by reference to any objective standard. Note: Patent Owner warned of need for objective standard in Institution Decision: In our Institution Decision, we informed Patent Owner of the significance of the absence of an objective standard, but Patent Owner did not identify persuasively any such standard in the Patent Owner Response. Neither claim 1 nor the Specification provides an objective standard for measuring the scope of a connecting force that is not less than a weight of one of the containers when substantially filled with water as applied to an expandable container[.] Found Patent Owner s expert s testimony conclusory and unpersuasive as to understanding of a POSITA. 28

29 PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR Front Row Tech., LLC v. MLB Advanced Media, L.P., , Paper 8 (P.T.A.B. Feb. 22, 2016) Filing date Jan. 29, 2010; no claim for priority or benefit. Petitioner said PGR-eligible because of amendments submitted Sept. 23, PTAB: Claims not eligible for PGR. Nowhere does the statute contemplate that the effective filing date might depend on the date of a later-filed amendment to a claim. as a matter of law, if a claim in the application is not entitled to an earlier filing date, then the effective filing date is the actual filing date of the application (per subparagraph (A)), regardless of whether a later-filed amendment to a claim finds sufficient support in the application. 29

30 PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR Mylan Pharms. Inc. v. Yeda Research & Development Co. Ltd., , Paper 9 (P.T.A.B. Aug. 16, 2016) Petitioner: claims PGR-eligible because not entitled to benefit of priority claim to August 20, 2009 (priority applications do not provide written description support for all claim limitations); effective filing date is actual filing date of May 22, PTAB: Claims not eligible for PGR. Examiner specifically addressed that pre-aia applied to claims. Examiner found claims supported by priority document. Petitioner did not show break in priority chain; Petitioner has not demonstrated that it is more likely than not that the 776 patent has at least one claim having an effective filing date on or after March 16,

31 PGR PETITION DENIED BECAUSE CLAIMS NOT ELIGIBLE FOR PGR David O.B.A. Adepbimpe v. Johns Hopkins Univ., , Paper 14 (P.T.A.B. July 25, 2016) Parties filed briefs on PGR eligibility prior to Patent Owner filing POPR. Priority claim to Oct. 4, 2012 and Feb. 25, Amended claims filed March 17, PTAB: Claims not eligible for PGR. Section 100(i)(1) does not make any provision for the effective filing date to be later than the actual filing date of the application in question, even when the application is amended later, and even when thelater amendment introduces claims that lack writtendescription support in the original specification. 31

32 PATENT OWNER UNSUCCESSFUL WITH INELIGIBILITY ARGUMENT US Endodontics, LLC v. Gold Standard Instruments, LLC, PGR PTAB: Instituted PGR over Patent Owner s argument that claims not eligible for PGR because of priority date benefit. Accepted Petitioner s arguments that claims not supported by priority document and therefore only entitled to actual filing date. Claims eligible for PGR a patent that issues from an application filed after March 16 [15 sic], 2013, that claims priority to an application filed before March 16, 2013,3 is available for post-grant review if the patent contains... at least one claim that was not disclosed in compliance with the written description and enablement requirements of 112(a) in the earlier application for which the benefit of an earlier filing date prior to March 16, Inguran, LLC v. Premium Genetics (UK) Ltd., Case PGR , slip op. 11 (PTAB Dec. 22, 2015) (Paper 8). Initial burden on petitioner: a petitioner seeking post-grant review carries the burden to show that the patent is subject to the first-inventor-to-file provisions of the AIA and, therefore, eligible for post-grant review[.] 32

33 PTAB GUIDANCE: Precedential Representative Informative 33

34 CAFC/USSC AFFIRMED PTAB S APPROACH In re Cuozzo Speed Technologies, LLC, 793 F.3d 1268 (Fed. Cir. 2015) No jurisdiction to review PTAB s IPR institution decision (See 35 U.S.C. 314(d)). Affirm PTAB s Final Written Decision in full (all instituted claims unpatentable as obvious) No error in PTAB s application of BRI claim construction standard; No error in obviousness determination; and No error in denial of Cuozzo s motion to amend. Lack of written description support; Improper broadening Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct (U.S., June 20, 2016) Affirmed Federal Circuit decision not allowing attack of the decision to institute. In this case, 314(d) bars judicial review of whether PTAB wrongly instituted an IPR on grounds not specifically mentioned in a third party s review request. Affirmed Federal Circuit decision (unanimous), as to the BRI standard. USPTO has authority under 316(a)(4) to enact 37 CFR (b) (BRI is the claim construction standard in IPRs). 34

35 PGR PETITIONS DENIED Dr. Reddy s Laboratories, Ltd. v. Helsinn Healthcare S.A., PGR , Paper 11 (P.T.A.B. Aug. 17, 2016) PTAB: Petition denied. Patent Owner laid the groundwork for defending against the 102 and 112 attacks during prosecution. PTAB: Here, it is undisputed that the specification describes formulations comprising the same ingredients, in the same amounts, concentrations, and combinations required by the challenged claims. Given this disclosure, one of ordinary skill in the art could hardly fail to recognize a description of the claimed formulations in the specification, whether or not the claims recite that the formulations are stable. 35

36 PGR PETITIONS DENIED DRL v. Helsinn, PGR (con t) PTAB: 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). The court in Helsinn Healthcare 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. (issue in Teva v. Helsinn appeal, argued October 4, 2016). 36

37 PGR PETITIONS DENIED DRL v. Helsinn, PGR (con t) PTAB (con t): 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. 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). 37

38 PGR PETITIONS DENIED DRL v. Helsinn, PGR , Paper 12 (P.T.A.B. Aug. 17, 2016) PTAB: Petition denied. Patent Owner laid the groundwork for defending against the 103 attacks during prosecution. At least one of the asserted references was before the examiner during prosecution. 38

39 PGR PETITIONS DENIED DRL v. Helsinn, PGR (con t) PTAB: We agree with Patent Owner that a person of ordinary skill in the art would have considered Tang to be relevant to a palonosetron development project. We need not determine whether Tang actually teaches away from the claimed formulations it is enough that we agree with Patent Owner that Tang would not have led a person of ordinary skill in the art to expect that a solution of palonosetron at a concentration of 0.05 mg/ml would be effective in treating emesis. Id. at 39 (citing Ex. 1008, 466). If anything, Tang would have suggested amounts and concentrations still higher than the highest dose and concentration evaluated by Tang. 39

40 PGR PETITIONS DENIED DRL v. Helsinn, PGR (con t) PTAB: We agree with Patent Owner that Petitioner has not established that one of ordinary skill in the art would have had a reason to formulate a pharmaceutical sterile intravenous solution comprising palonosetron hydrochloride... at a concentration of 0.05 mg/ml, as required by all the challenged claims.. 40

41 USE OF OBJECTIVE EVIDENCE 41

42 LOAD UP ON YOUR EVIDENCE DURING PROSECUTION! The objective evidence of nonobviousness (also known as secondary considerations, as the term was coined in Graham v. John Deere) can, for example, include: Long-felt but unsolved need, Failure of others, Commercial success, Unexpected results created by the claimed invention, and Skepticism of skilled artisans before the invention. See In re Rouffet, 149 F.3d 1q350, 1355 (Fed. Cir. 1998). These objective considerations, when present, are important evidence, as they protect against the prejudice of hindsight bias, which frequently overlooks the fact that [t]he genius of invention is often a combination of known elements which in hindsight seems preordained. McGinley v. Franklin Sports, Inc., 262 F.3d 1339, 1351 (Fed. Cir. 2001). 42

43 LOAD UP ON YOUR EVIDENCE DURING PROSECUTION! Indeed, secondary consideration evidence may be the most probative and cogent evidence in the record. Apple Inc. v. ITC, 725 F.3d 1356, 1366 (Fed. Cir. 2013) (internal quotation marks and citations omitted). Objective evidence of these secondary considerations can establish that an invention appearing to have been obvious in light of the prior art was not. Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983). 43

44 OBJECTIVE EVIDENCE OF NONOBVIOUSNESS: USE EVIDENCE FROM PROSECUTION Strong patentability positions during drafting and prosecution. Analyze carefully considered strong arguments and/or declarations supporting 112 positions (written description and enablement) and 103 positions (nonobviousness) Consider Therasense Careful thought and planning. 44

45 DECLARATIONS Declarations need to be as solid as possible. PTAB has found that defective declarations relied on for patentability during prosecution can form an independent basis for instituting an IPR. K-40 Electronics, LLC v. Escort, Inc., IPR , Paper 6 (PTAB Aug. 29, 2013) PTAB reviewed a declaration from the prosecution, found it deficient, and reapplied the prior art the declaration had antedated, instituting the IPR. Case also had live testimony from inventor at oral hearing. One might want declarations from the inventor during prosecution that can then by referred to by the Patent Owner in the optional Preliminary Response to try to ward off institution. 45

46 SAMPLE EXPERT DECLARATION DEALING WITH OBJECTIVE EVIDENCE These declarations establish that there would have been no reasonable expectation of success of the claimed subject matter by showing: 1) significant unexpected results in the teeth of strong skepticism by FDA experts and fulfillment of a long-felt need; 2) the claimed subject matter is reasonably commensurate in scope with commercial success, coupled with a nexus between that commercial success and the merits of the claimed invention; 3) the claimed subject matter relating to NMR chemical shifts and solvent used is neither necessarily present or inherently anticipated, nor in any way suggested patent relied on for the ODP rejection. 46

47 OBJECTIVE EVIDENCE MUST BE SUPPORTED WITH MORE THAN CONCLUSORY STATEMENTS In re Ethicon, --F.3d (Fed. Cir. Jan. 3, 2017)(LOURIE, Dyk, Newman; Newman dissenting) PTAB upheld rejection for obviousness. FC: Affirmed. Substantial evidence supported factual findings and conclusion of obviousness. Not outweighed by objective evidence of nonobviousness. Ethicon relied solely on its expert s conclusory testimony to support its copying allegations. Ethicon s expert never even opined that the results pointed to would have been unexpected to a person of ordinary skill in the art. Note: Judge Newman considered that the Board erred in refusing to consider the objective evidence. 47

48 PTAB REQUIRES NEXUS Gnosis S.p.A. v. Merck & Cie, IPR , Paper 71 (P.T.A.B. June 20, 2014) PTAB: Instituted claims held unpatentable (or canceled by Patent Owner) Merck argues, and Gnosis does not dispute, that administration of each of the above Pamlab products to a patient falls within the scope of the claims under review....it is not sufficient, however, that a product or its use merely falls within the scope of a claim in order for objective evidence of nonobviousness tied to that product to be given substantial weight. There must also be a causal relationship, termed a nexus, between the evidence and the claimed invention.... A showing of sufficient nexus is required in order to establish that the evidence relied upon traces its basis to a novel element in the claim, not to something in the prior art.... Objective evidence that results from something that is not both claimed and novel in the claim lacks a nexus to the merits of the invention. [citations omitted] 48

49 PTAB REQUIRES NEXUS (con t) Gnosis (con t) PTAB rejected objective evidence Nexus must exist in relation to all types of objective evidence of nonobviousness. GPAC, 57 F.3d at 1580 (generally); In re Huang, 100 F.3d 135, 140 (Fed. Cir. 1996) (commercial success); In re Antor Media Corp., 689 F.3d 1282, 1293 (Fed. Cir. 2012) (licensing); Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (copying); Ormco Corp. v. Align Tech., Inc., 463 F.3d 1299, 1313 (Fed. Cir. 2006) (failure of others); Rambus Inc. v. Rea, 731 F.3d 1248, 1256 (Fed. Cir. 2013) (long-felt need); Kao, 639 F.3d at 1069 (unexpected results); Stamps.com Inc. v. Endicia, Inc., 437 F. App x 897, 905 (Fed. Cir. 2011) (skepticism); Muniauction, Inc. v. Thomson Corp., 532 F.3d 1318, 1328 (Fed. Cir. 2008) (praise). 49

50 PTAB REQUIRES NEXUS (con t) Gnosis (con t) PTAB rejected objective evidence Thus, for objective evidence to be accorded substantial weight, the record must establish a nexus between the evidence and the merits of the claimed invention..... Moreover, establishing nexus involves a showing that novel elements in the claim, not prior-art elements, account for the objective evidence of nonobviousness.... As the Federal Circuit explains, [t]o the extent that the patentee demonstrates the required nexus, his objective evidence of nonobviousness will be accorded more or less weight.... Thus, the stronger the showing of nexus, the greater the weight accorded the objective evidence of nonobviousness. [citations omitted] 50

51 NEXUS REQUIRED FOR OBJECTIVE EVIDENCE OF NONOBVIOUSNESS IS NOT A NEW CONCEPT CCPA, Federal Circuit, PTAB case law and MPEP: All rely on Graham v. John Deere Co., 383 U.S. 1 (1966): (1) the scope and content of the prior art; (2) differences between the prior art and the claims at issue; (3) the level of ordinary skill in the pertinent art; and (4) evaluation of any relevant secondary considerations. 51

52 RECENT FEDERAL CIRCUIT CASE REITERATING NEXUS REQUIREMENT In re Ethicon, --F.3d (Fed. Cir. Jan. 3, 2017) FC: the evidence relied on by Ethicon to support its claims of commercial success, industry praise, and unexpected results did not establish that any success, praise or unexpected results were due to the 85:15 VDF:HFP coating, rather than to an unclaimed feature such as the drug or stent design, is supported by substantial evidence. 52

53 NEXUS BETWEEN EVIDENCE AND CLAIMED INVENTION Manual of Patent Examining Procedure (b) The term nexus designates a factually and legally sufficient connection between the objective evidence of nonobviousness and the claimed invention so that the evidence is of probative value in the determination of nonobviousness. Demaco Corp. v. F. Von Langsdorff Licensing Ltd., 851 F.2d 1387, 7 USPQ2d 1222 (Fed. Cir.), cert. denied, 488 U.S. 956 (1988). 53

54 SO FAR, ONLY A FEW EXAMPLES OF SUCCESSFUL USE OF OBJECTIVE EVIDENCE OF NONOBVIOUSNESS Objective evidence of nonobviousness must have nexus. Patent Owners not much success so far with objective evidence of nonobviousness - not showing nexus (linking the objective evidence of obviousness to the merits of the claimed invention). 54

55 OBJECTIVE EVIDENCE IN RECORD SUCCESSFULLY USED BY PATENT OWNER TO GET IPR PETITION DENIED Omron Oilfield & Marine, Inc. v. Md/Totco, A Division Of Varco, L.P., IPR , Paper 11 (PTAB Oct. 31, 2013) Patent Owner requested PTAB exercise its discretion to deny the petition because of the same art/arguments before the Office during reexamination. Patent Owner was able to rely on evidence in the record in a reexamination of the patent of commercial success. 55

56 OBJECTIVE EVIDENCE IN RECORD SUCCESSFULLY USED BY PATENT OWNER TO GET IPR PETITION DENIED Omron (con t) PTAB: Petition denied. Found Petitioner established a prima facie case of obviousness, and then reviewed the objective evidence of nonobviousness provided to the examiner during a reexamination, and agreed that it was persuasive. we determine that Patent Owner has presented sufficient evidence to establish a prima facie case of nexus. No rebuttal by Petitioner. We find that the 142 Patent had significant commercial success, which, here, overcomes the prima facie case of obviousness. 56

57 PETITIONER S FAILURE TO ADDRESS OBJECTIVE EVIDENCE BASIS FOR DENIAL Praxair Distribution, Inc. v. Mallinckrodt Hospital Products, IPR , , , , Paper 10 (P.T.A.B. Sept. 22, 2016) PTAB: Denied petitions under 35 U.S.C. 325(d). Patent Owner s evidence of a clinical study showed unexpected results. In prior proceedings, PTAB found the study compelling evidence of nonobviousness. Petitioner did not address any of these arguments in its earlier petitions or in its present petitions. Petitioner does not explain why the many experts in the field would have designed a study that did not exclude patients with pre-existing LVD if it were obvious to do so. Petitioner s argument is substantially the same as before[.] Petitioner s arguments that couldn t find references earlier contradicted by testimony of its own expert. 57

58 OBJECTIVE EVIDENCE SUCCESSFULLY USED BY PATENT OWNER AVOID UNPATENTABILITY DETERMINATION IN FWD Intri Plex Technologies, Inc. v. Saint Gobain Performance Plastics Rencol Ltd., IPR , Paper 83 (PTAB March 23, 2014) Patent Owner submitted objective evidence of nonobviousness via a declaration (prepared for the IPR) supporting the Patent Owner Response. PTAB: Final Written Decision that Intri-Plex did not meet its burden of showing challenged claims unpatentable. we determine that the first three Graham factors favor a determination that the challenged claims are obvious. However, a proper obviousness determination requires a consideration of all factors, and we determine that Saint-Gobain s case for nonobviousness based on secondary considerations is particularly strong, and outweighs the other three factors. In particular, we are persuaded that our finding of commercial success is particularly strong,. Indeed, we determine that commercial success alone sufficiently outweighs the other three factors, and that our finding of copying merely strengthens further our finding that secondary considerations weigh in favor of Saint- Gobain. 58

59 PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE Phigenix, Inc. v. Immunogen, Inc., IPR Petition challenged 8 claims; 8 asserted grounds. Submitted prosecution declarations as exhibits. Argued that the declarations submitted to overcome examiner s rejection did not in fact prove unexpected results and lack of reasonable expectation of success. POPR: Petitioner failed to establish a reason to combine the prior art with a reasonable expectation of success Petitioner failed to properly account for objective indicia of nonobviousness as discussed in prosecution declarations. Unexpected results from clinical trials Praise in the industry long-felt need commercial success Cited Omron Oilfield & Marine, Inc. v. MD/Totco, to support denial because petition fails to "challenge the merits of Patent Owner's secondary consideration evidence" of record. 59

60 PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE Phigenix, Inc. v. Immunogen, Inc., IPR PTAB instituted IPR on all challenged claims on one asserted ground. Petitioner has established a reasonable likelihood that it would prevail in showing prima facie obviousness, i.e., that an ordinary artisan would have had reason to make immunoconjugates as described in Chari 1992 using humab4d5-8 disclosed in the HERCEPTIN Label, with a reasonable expectation of success in making them. Considered objective evidence, but decided that Petitioner had made sufficient showing for institution. The prosecution declarations addressed a rejection during prosecution based on different references than those cited in asserted grounds in the Petition. Maybe could have obtained denial In addition, Patent Owner evidence of record at this time do not address adequately considerations such as whether evidence of objective indicia are reasonably commensurate with the scope of the challenged claims, whether a sufficient nexus exists between such evidence and the merits of the claimed invention, or whether evidence of unexpected results establishes a difference between the results obtained and those of the closest prior art. 60

61 PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE Phigenix, Inc. v. Immunogen, Inc., IPR , Paper 39 (PTAB Oct. 27, 2015) PTAB FWD: All claims survived (not shown to be unpatentable). viewing the record as a whole, Petitioner does not persuade us that a preponderance of the evidence establishes that a skilled artisan would have had a reasonable expectation of success in 2000 that a Herceptin maytansinoid immunoconjugate would be useful in the treatment of breast tumors in humans[.] Petitioner has not established by a preponderance of the evidence that a skilled artisan would have had reason to combine the teaching of the cited references to make the immunoconjugates of claim 6 and 8. Although failure to establish a reason to combine the cited teachings is sufficient, by itself, to conclude non-obviousness, Patent Owner cites substantial evidence of objective indicia of non-obviousness in relation to claim 8, which is directed to the T-DM1/Kadcyla commercial product. 61

62 PROSECUTION DECLARATIONS AND OBJECTIVE EVIDENCE Phigenix, Inc. v. Immunogen, Inc., IPR , Paper 39 (PTAB Oct. 27, 2015) PTAB FWD: (con t) Objective evidence unexpected superior results as compared to closest prior art compositions fulfilling a long-felt and unmet need for an immunoconjugate capable of targeting a solid tumor in patients without excessive toxicity. praise in the field commercial success: sales and prescription data, marketing and promotional efforts. we are persuaded that Patent Owner establishes a sufficient nexus in relation to the cited objective evidence of nonobviousness. The specification of the 856 patent discloses, and claim 8 recites, the very components that led to the unexpected results, praise and commercial success.... Patent Owner sufficiently establishes that it is the exact combination of those components recited in claim 8, rather than different components previously combined in the prior art, that provided the unexpected results at issue, and led to praise and commercial success. 62

63 REMEMBER: parallel and inconsistent outcomes VERY REAL POSSIBILITY AND END OF LITIGATION MAY NOT BE END OF CASE Fresenius v. Baxter (Fed. Cir. 2013) litigation decision was not final, PTAB decision wiped out award. SAP v. Versata (Fed. Cir. 2014) Litigation decision final (because Versata waived injunction), but appeal dismissed after PTAB canceled claims. 63

64 Prosecution issues in view of the opportunities and pitfalls afforded by the AIA, including Jedi-Master-Mixer (JMM), particularly for avoiding certain on-sale bars that could be raised in future PGRs 64

65 AIA TRANSITION PROVISIONS RELEVANT TO JMM 65

66 FITF EXAMINATION GUIDELINES: SEC. 3(n)(2) section 3(n)(2) does indicate that the provisions of 35 U.S.C. 102(g), 135, and 291 as in effect on March 15, 2013, shall apply to each claim of an application for patent, and not simply the claim or claims having an EFD that occurs before March 16, 2013, if the condition specified in section 3(n)(2) occurs. Therefore, each claim of an application presenting a claim to a claimed invention that has an effective filing date before March 16, 2013, but also presenting claims to a claimed invention that has an effective filing date on or after March 16, 2013, is subject to AIA 35 U.S.C. 102 and 103 and is also subject to the provisions of 35 U.S.C. 102(g), 135, and 291 as in effect on March 15, See pp , of Examination Guidelines (2/14/13) 66

67 STRADDLING THE EFFECTIVE DATE PCT Filing First to Invent System Applies Enactment: Sept. 16, 2011 Priority Date PCT Filing 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.) 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 Priority Date PCT Filing FITF System Applies Enactment: Sept. 16, 2011 Effective Date: March 16, 2013 Assumes priority date is ex-us 67

68 SEC. 3(n)(2): JEDI MASTER MIXER! Some may seek out SEC.3(n)(2), owing to advantages of AIA. Elimination of Metallizing Engineering forfeiture (according to USPTO, see p of Examination Guidelines (2/14/13); liberalization of the CREATE ACT and common ownership in 102(c); possible elimination of pre-aia statutory bars that are not AIA prior art!!! Lab notebooks maybe even more important than before! Proving conception still important for antedating references, including in IPRs/PGRs. 68

69 EXPLAIN CHOICE OF LAW TO EXAMINER 69

70 INTERVIEW GETTING EFD S CORRECTED 70

71 CLEARING THE PATH, PARTICULARLY IN ADVANCE, TO FORTIFY AGAINST IPR/PGR 71

72 CONSIDER PURSUING SEVERAL PATENTS FROM ONE APPLICATION Keeping a family member alive may help a patent owner facing IPR or PGR. If PTAB does not allow the patent owner to enter a particular proposed substitute claim, if the subject matter of the proposed substitute claim is patentably distinct from any canceled claims, such subject matter can still be pursued in a pending family member. Perhaps avoid the need to amend claims in an IPR/PGR against potential novelty and obviousness attacks based on patents and printed publications. Divisionals all protected from ODP attacks in litigation and could lead to several patents each having numerous claims of varying scope that a petitioner will have to challenge. Additionally, evidence and arguments submitted in the prosecution history of other applications could be referenced in a POPR or Patent Owner Response (POR) for the patent at issue in the IPR/PGR. 72

73 CONSIDER PURSUING SEVERAL PATENTS FROM ONE APPLICATION (cont.) Caution on keeping a pending application: Study cases discussing unreasonable and unexplained delay. Tafas v. Doll, 559 F.3d 1345 (Fed. Cir. 2009) In re Bogese, 303 F.3d 1362 (Fed. Cir. 2002) Symbol Tech., Inc. v. Lemelson Medical, Educ. & Research Foundation, 422 F.3d 1378 (Fed. Cir. 2005) 73

74 CONSIDER KEEPING CONTINUATION APPLICATION PENDING (con t) Consider estoppel impact on a patent owner receiving an adverse written decision and how it would likely preclude seeking patentability of a claim in the continuation that is not patentably distinct from the claim determined to be unpatentable in the written decision. 37 C.F.R (d)(3): (3) Patent applicant or owner. A patent applicant or owner is precluded from taking action inconsistent with the adverse judgment, including obtaining in any patent: (i) A claim that is not patentably distinct from a finally refused or canceled claim; or (ii) An amendment of a specification or of a drawing that was denied during the trial proceeding, but this provision does not apply to an application or patent that has a different written description. 74

75 KEEP CONTINUATION PENDING AC Dispensing Equipment, Inc. v. Prince Castle, LLC, IPR , 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. 75

76 KEEP CONTINUATION PENDING (con t) PTAB indicated continuation application prosecution will not be stayed. Telebrands Corp. v. Tinnus Enterprises, LLC, PGR , Paper 62 (P.T.A.B. Aug. 29, 2016) PTAB denied Petitioner s request to file a motion to suspend prosecution of 4 pending continuation patent applications. We deny Petitioner s request for authorization to file a motion to suspend prosecution of the co-pending applications. Petitioner has not persuaded us that any of the co-pending patent applications meets the every involved application and patent requirement, which triggers our authority under 42.3(a). During the call, moreover, Petitioner was unable to cite any Board decision granting a request to suspend prosecution of a related application (Ex. 1037, 11), while Patent Owner cited several Board decisions denying such requests (id. at (citing EMC Corp. v. Personal Web Technologies, LLC., Case IPR , slip op. at 3 (PTAB March 19, 2013) (Paper 12); Apotex Inc. v. Wyeth LLC, Case IPR , slip op. at 5 6 (PTAB May 29, 2014) (Paper 19); Chums, Inc. v. Cablz, Inc., Case IPR , slip op. at 2 (PTAB May 8, 2015) (Paper 22))). 76

77 CONTINUATION APPLICATION MAY BE FILED ON DAY PARENT ISSUES Immersion Corp. v. HTC Corp., 826 F.3d 1357 (Fed. Cir. 2016) Immersion filed a continuation application on August 6, 2002, the same day that the parent application issued. DC: Patent invalid. Priority for the continuation was unavailable because it was not filed before the patenting of the parent application. See 35 U.S.C FC: an application may be filed before patenting of the earlier application when both legal acts, filing and patenting, occur on the same day. 77

78 CONSIDER HAVING PATENT OWNER USE REISSUE Patent Owner Estoppel can be quite severe, reminiscent of the body of law of interference estoppel. So maybe Patent Owner doesn t amend claims in IPR/PGR and rather provides a patentably distinct but useful claim amendment in reissue, particularly if no continuation pending. Reissue likely stayed pending disposal of IPR/PGR within the one year period from institution. If claims of patent canceled in IPR/PGR, look for patentably distinct claims in reissue that are enforceable and still infringed. 78

79 REISSUE AND POST-GRANT PROCEDURES Reissue applications can be merged with ex parte reexaminations. Reissue rules govern merged proceeding. Timing with concurrent PGR/IPR: stays? PTAB discretion. PGR/IPR PGR applicable for 9 months after reissue on new reissue claims. Reissue effective filing date is patent filing date. IPR/PGR is available as normal. What may the role of reissue be in these PGR/IPR proceedings? 79

80 PGR/IPR/REISSUE TIMING REQUIREMENTS RELATED TO LITIGATION Cannot file if challenger also filed civil action challenging validity of patent (IPR or PGR, 315(a)/ 325(a)). Petitioner, real party, or privy of petitioner. Does not include counterclaim. Cannot file IPR more than 12 months after the petitioner is served with a complaint alleging infringement of patent. ( 315(b)) If a civil action alleging infringement of a patent is filed within 3 months patent issues, the court may not stay its consideration of the patent owner s motion for a preliminary injunction on the basis that a petition for PGR filed or PGR instituted. ( 325(b)) No such timing requirements on reissue/pending applications other than the normal ones. 80

81 PTAB DISCRETION 35 U.S.C. 315(d)/ 325(d) (d) MULTIPLE PROCEEDINGS. Notwithstanding sections 135(a), 251, and 252, and chapter 30, during the pendency of an inter partes review, if another proceeding or matter involving the patent is before the Office, the Director may determine the manner in which the inter partes review or other proceeding or matter may proceed, including providing for stay, transfer, consolidation, or termination of any such matter or proceeding. 325(d) continues: In determining whether to institute or order a proceeding under this chapter, chapter 30, or chapter 31, the Director may take into account whether, and reject the petition or request because, the same or substantially the same prior art or arguments previously were presented to the Office. (applies to both IPRs and PGRs). 81

82 PETITIONER ESTOPPEL: PGR AND IPR PGR and IPR Becomes effective once the Board issues a final written decision Applies to any ground that petitioner raised or reasonably could have raised Estoppel applies in subsequent proceedings before the PTO, in civil actions, and in ITC proceedings One-way: Only runs from PTAB to PTO/court No estoppel if terminate by settlement 82