August 30, 2016
Law360
By Thomas L. Irving; *Stacy D. Lewis
Nearly four years have passed since the America Invents Act post-grant proceedings came into effect, but patent owners are still struggling with how to successfully present objective evidence of nonobviousness to the Patent Trial and Appeal Board that is sufficiently persuasive to tip the balance in favor of nonobviousness. It has been particularly problematic for patent owners to meet the PTAB’s standard of a sufficient nexus between the objective evidence of nonobviousness and the claimed invention.
This article will examine examples of successful reliance on objective evidence of nonobviousness and the necessary link between the evidence and the merits of the claimed invention. Finally, the article will discuss the strategic use of prosecution declarations in the patent owner preliminary response (POPR) to support positions of nonobviousness, which may be helpful in convincing PTAB to deny the institution of an inter partes review or post-grant review.
Objective evidence of nonobviousness, such as commercial success, long-felt and unmet need, failure/skepticism of others, industry acclaim, unexpected results, and copying, may be the "most probative and cogent evidence of nonobviousness in the record."1 If objective evidence of nonobviousness is submitted, as mandated by the U.S. Supreme Court in Graham v. John Deere Co., the PTAB must consider it.2
The requirement of nexus is not new; Court of Customs and Patent Appeals, Federal Circuit and board case law, as well as the Manual of Patent Examining Procedure, have all long recited the requirement since Graham. The PTAB is following this same case law.3
This is familiar territory for patent practitioners, so why aren’t patent owners more successful in using objective evidence of nonobviousness in IPRs? Is the level of factual analysis, for example, that often comes with objective evidence just too big of an imposition on the tight timeline of the IPRs?
The PTAB requires that patent owners establish a nexus between the objective evidence of nonobviousness and the claimed subject matter.4 In some cases, a patent owner will fail based on conclusory statements without any evidentiary support:
Patent Owner argues, without citation of any supporting evidence, that "secondary considerations [of commercial success] support the validity of the claims." … The objective indicia, however, must establish a nexus with the claimed subject matter. … Here, Patent Owner provides argument, but no evidence, of the alleged commercial success.5
A similar misstep can occur in patent owner preliminary responses.6
In Qualtrics Labs Inc. v. OpinionLab Inc., IPR2014-00421, the PTAB described the level of detail required to show sufficient nexus between commercial success and the claimed invention:
To show how commercial success supports nonobviousness, however, Patent Owner must prove that the sales were a direct result of the unique characteristics of the invention, and not a result of economic and commercial factors unrelated to the quality of the patented subject matter. Patent Owner has not so shown. … Patent Owner … does not attempt to tie any of these features to the alleged commercial success.7
In other words, the PTAB is looking for causation of the commercial success by the merits of the claimed invention. A mere correlation between commercial success and elements of the claimed invention may not carry the patent owner to victory.
Similarly, the PTAB rejected the patent owner’s evidence of industry praise for failure to establish sufficient nexus with the claimed invention:
As with commercial success ... evidence of industry praise is only relevant when it is directed to the merits of the invention claimed. … Patent Owner does not identify any praise due to specific features that are present in the claims. Patent Owner has not established a sufficient nexus with the claimed invention.8
Again, correlation between the praise and the claimed invention was not enough. The PTAB was looking for, but not finding, proof that the merits of the claimed invention elicited the industry praise.
The PTAB also rejected the patent owner’s evidence of copying for merely showing "similarities between its products and those offered by Petitioner" without "any analysis or explanation of how other companies, such as Petitioner, allegedly copied its product that allegedly includes the features of the claimed invention."9 In other words, the patent owner failed to analyze and/or explain why the copying was driven by the merits of the claimed invention.
The PTAB held all instituted claims unpatentable.10
In contrast, very recently, there was a decision where the PTAB found that the patent owner showed sufficient nexus and provided an extensive discussion of nexus en route to holding instituted claims were not shown to be unpatentable.11 In the patent owner response (POR) in Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR2015-00660, the patent owner presented objective evidence of nonobviousness, including long-felt need, industry praise, copying, and commercial success, along with expert testimony as to how the commercial method embodied the challenged claims.12
The petitioner argued that the patent owner’s evidence failed to show a nexus to the challenged claims. The PTAB concluded, however, that the patent owner had shown sufficient nexus through the expert testimony:
[W]e find that Mr. Griffiths provides a reasonable and credible walk-though of how the TrueCount service worked that is tied to the recited features of the challenged independent claims.13
[W]e credit Mr.Griffiths’s testimony as evidence that establishes the operation of TrueCount and, in combination with Dr. Almeroth’s testimony, a nexus between Patent Owner’s evidence regarding TrueCount and the challenged independent claims.14
For showing that the commercial embodiment matched the scope of the claimed invention, the PTAB found that the patent owner was entitled to a presumption of nexus, and that the petitioner had failed to rebut that presumption.15 The PTAB then proceeded to analyze the objective evidence of nonobviousness, finding it, on balance, sufficiently persuasive that, in addition to the substantive arguments of nonobviousness presented, the petitioner had not shown that the challenged claims were unpatentable.16
In sum, the patent owner’s success resulted from the time and effort spent establishing nexus.
Omron Oilfield & Marine Inc. v. MD/Totco, IPR2013-00265, provides an example of a case where the patent owner raised objective evidence of nonobviousness previously presented during a re-examination,17 and used that evidence to defeat a prima facie case of obviousness made out by the petitioner in an IPR. The PTAB analyzed the objective evidence, balanced it against the evidence of prima facie obviousness, and concluded that the objective evidence of nonobviousness carried the day, leading to denial of institution, which is generally very advantageous to the patent owner.18
Significantly, the patent owner filed a POPR and attached the expert declarations, containing objective evidence of nonobviousness, previously presented in the re-examination proceeding. The patent owner linked those declarations to the claimed invention.19 The objective evidence included commercial success, long-felt but unmet need, failure of others, and unexpected results.
The patent owner’s evidence of commercial success was a brochure featuring the invention and trial testimony from earlier litigation that the product was successful due to the patented features. The PTAB found the evidence of commercial success particularly significant in overcoming the prima facie case of obviousness.20
The Omron decision offers guidance on the issue of nexus to the merits of the claimed invention. The decision also demonstrates how to shift the evidentiary burden to the petitioner by establishing a prima facie nexus:
A prima facie case of nexus is established when the patentee shows both that there is commercial success, and that the product that is commercially successful is the invention disclosed and claimed in the patent. Once the patentee demonstrates a prima facie nexus, the burden of coming forward with evidence in rebuttal shifts to the challenger.21
The PTAB found that "[b]ased on the record cited above, we determine that Patent Owner has presented sufficient evidence to establish a prima facie case of nexus."22
In denying the petitioner’s request for rehearing of the institution decision,23 the PTAB noted that the petitioner knew of the evidence presented in the re-examination, and could have addressed it in the petition, but did not.24 Addressing the objective evidence in the rehearing request was too late: "we are not persuaded by Petitioner’s new arguments regarding the merits or admissibility of the evidence of secondary considerations."25
In Lupin Ltd. v. Vertex Pharmaceuticals Inc., IPR2015-00405, the PTAB instituted the IPR on fewer than all challenged claims and fewer than all asserted grounds after the patent owner submitted objective evidence of nonobviousness in its POPR.26 The objective evidence came from a variety of articles, U.S. Food and Drug Administration documents, pre-existing sales data, and deposition testimony of the petitioner’s expert from another IPR.27 The PTAB found the objective evidence of nonobviousness persuasive with respect to certain claims directed to specific compounds and compositions. In particular, scientific literature supporting the patent owner’s nonobviousness arguments had sufficient nexus to the claimed invention:
Patent Owner’s evidence related to fosamprenavir [is] persuasive. The evidence shows, for example, that fosamprenavir, and in particular fosamprenavir calcium, has improved pharmacokinetics, reduced gastrointestinal side effects, and different resistance profile as compared to its parent drug, amprenavir. The evidence presented by Patent Owner further suggests that the development of HIV protease inhibitors prodrugs was not at all predictable, but produced compounds with varying degrees of effectiveness.28
The PTAB determined, however, that the evidence was not "commensurate in scope" with the patent’s broader claims. Noting that "commensurate in scope" did not require "that the proffered evidence must reach every embodiment within the scope of the claims," in this case the objective evidence only related to fosamprenavir, while the scope of claim 1 was broader than just fosamprenavir.29 The PTAB accepted the patent owner’s evidence of nonobviousness only for the subject matter of two claims directed only to the common salts of fosamprenavir.30
The PTAB granted the petition only with respect to the broader claims.31 That was still a victory for patent owner Vertex because the narrower claims, highly useful in Hatch-Waxman litigation, were not thrown into the IPR.
In IntriPlex Technologies Inc. v. Saint–Gobain Performance Plastics Rencol Ltd., IPR2014–00309, the patent owner submitted objective evidence of nonobviousness (commercial success and copying) via a declaration supporting the POR.32 The PTAB found that the objective evidence of nonobviousness had sufficient nexus and was strong enough to tip the balance in favor of the patent owner:
[W]e 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.33
In Phigenix Inc. v. Immunogen Inc., IPR2014-00676, Immunogen presented nonobviousness arguments as well as objective evidence of nonobviousness relating to the claim representing Immunogen’s commercial embodiment in its POR.34 In particular, Immunogen submitted evidence of unexpected superior results, fulfilling a long-felt and unmet need, praise in the field, and commercial success.
The PTAB found sufficient nexus between the evidence of commercial success and the claimed invention:
Patent Owner also provides evidence regarding the commercial success of T-DM1/Kadcyla®. [expert testimony analyzing sales and prescription data, and marketing and promotional efforts relating to Kadcyla®]. In view of the specific components recited in claim 8, i.e., a specific antibody, linker, and toxin, which are the same as those in T-DM1/Kadcyla® …, we are persuaded that Patent Owner establishes a sufficient nexus in relation to the cited objective evidence of nonobviousness.35
The PTAB emphasized that it was persuaded because the patent owner had tied the specific disclosure in the specification and claim 8 to the evidence of unexpected results, praise and commercial success.36
Innopharma Licensing Inc. v. Senju Pharmaceutical Co. Ltd., IPR2015-00902 and IPR2015-00903, provide very recent examples of how, even if an IPR is instituted, it is worth the patent owner’s efforts to show why the objective evidence supports a conclusion of nonobviousness in its POR. According to the PTAB, "Upon consideration of the full trial record, … we reach a different final determination."37 The PTAB was persuaded by the patent owner’s specific objective evidence that fully supported its arguments of nonobviousness in the POR.
In IPR2015-00902, the patent owner submitted evidence of unexpected results supported by an expert declaration. The PTAB was "persuaded by [the patent owner’s expert’s] testimony that those results would have been 'entirely unexpected' to one of ordinary skill in the art at the time of the invention."38 Moreover, it held that the evidence of unexpected results was commensurate in scope with the claims.39 The PTAB similarly accepted the patent owner’s evidence of commercial success40 and industry acclaim.41
In its final written decision, the PTAB found that "the objective evidence of nonobviousness outweighs Petitioner’s evidence of obviousness based on the prior art."42 Not only was the patent owner’s objective evidence of nonobviousness supported by "credible and persuasive testimony," but the petitioner’s arguments lacked adequate discussion or explanation why a person of ordinary skill in the art would have expected to be able to substitute the claimed active ingredient for a prior art active ingredient.43 The PTAB concluded the two active ingredients were in fact "structurally and chemically dissimilar." The petitioner’s opinion testimony was "undercut by the best objective evidence on point"44 and the patent owner’s expert’s testimony.
Since the best outcome for a patent owner is to have the petition denied and avoid an IPR/PGR, particularly since denial cannot be judicially reviewed,45 it may be well worth putting in objective evidence of nonobviousness with strong nexus showings in the POPR. An example of this may be found in Dr. Reddy’s Labs. v. Helsinn Healthcase SA, PGR2016-00007, where in the POPR, the patent owner discussed in detail objective evidence of nonobviousness (industry skepticism, unexpected results, commercial success, failure of others, long-felt need, industry praise, and copying), and argued that the petitioner had failed to adequately address this evidence in its petition.46
The PTAB denied the petition in full, agreeing "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."47 The objective evidence helped the PTAB conclude that the claimed invention was not obvious because a POSITA would not have expected success in modifying the asserted references in such a way as to arrive at the claimed invention.48
Even if a denial is not achieved, the POPR may lead to the trial being instituted on fewer grounds and/or fewer claims than challenged in the petition.49 This is still a positive development for the patent owner now faced with a trial narrower in scope.
Earlier this year, the rules governing IPRs were amended to allow "new" testimony with a POPR. Thus, patent owners have more options even if there is no pre-existing objective evidence of nonobviousness from a related prosecution or litigation. The three-month time limit on the POPR creates challenges in gathering this evidence to submit with a POPR in a timely manner.
Patent owners should consider loading evidence into prosecution, along with crisp and compelling arguments to show no prima facie case of obviousness, at least in applications likely to end up in litigation or AIA post-grant proceedings. Solid evidentiary showings and/or declarations, in addition to on-point legal arguments,50 may help to develop strong patentability records. Prudently establishing such records during prosecution could support the patent owner’s later efforts to persuade the PTAB that the petitioner does not have a "reasonable likelihood" of success and thus achieve denial of institution.
Submission of this evidence during prosecution requires careful thought and planning. Evidence or a declaration thrown together in haste, or otherwise considered defective, may even be harmful rather than helpful.51 Additionally, inequitable conduct is still alive and well post-Therasense.52
Although inequitable conduct cannot be raised during an IPR or PGR, there is no apparent estoppel precluding a losing IPR or PGR petitioner from raising inequitable conduct in a subsequent litigation. That lack of estoppel reinforces the importance of avoiding inequitable conduct issues related to declaration testimony presented either during prosecution or in an AIA post-grant proceeding.
This article examined some successful attempts to rely on objective evidence of nonobviousness in the POPR and the POR. Patent owners' lack of success using objective evidence so far has often been because the PTAB concludes there is an insufficient showing of nexus between the objective evidence and the claimed invention.
If, as a patent owner, you are fortunate to have good objective evidence of nonobviousness, then it is worth the effort in the POPR and/or POR to present that evidence and explain the nexus between that evidence and the merits of the claimed invention to PTAB in detail. The PTAB panels should be given more than a sentence or two about the nexus being "presumed."
In establishing the prima facie nexus, patent owners should provide detailed explanation and analysis on the nexus issue; why leave such an important point in doubt? The patent owner, whether in the POPR or the POR, should put her best foot forward to link through analysis and explanation any objective evidence to the merits of the claimed invention.
1 Stratoflex, Inc. v. Aeroquip Corp., 713 F.2d 1530, 1538 (Fed. Cir. 1983).
2 Nike, Inc. v. Adidas AG, 812 F.3d 1326, 1339-1340 (Fed. Cir. 2016)("our precedent dictates that the Board is bound to fully consider properly presented evidence on the long-felt need for a claimed invention.").
3 Gnosis S.p.A. v. Merck & Cie, IPR2013-00117, Paper 71, at 31-32 (P.T.A.B. June 20, 2014), aff’d, 808 F.3d 829, 837 (Fed. Cir. Dec. 17, 2015). See also, Tandus Flooring, Inc. v. Interface, Inc., IPR2013-00527, Paper 48, at 46 (P.T.A.B. Feb. 12, 2015); Cardiocom, LLC v. Robert Bosch Healthcare Sys., Inc., IPR2013-00468, Paper 72, at 34 (P.T.A.B. Jan. 27, 2015); Smith & Nephew, Inc. v. Convatec Tech., Inc., IPR2013-00102, Paper 87, at 42-44 (P.T.A.B. May 29, 2014); Kamada, Ltd. v. Grifols Therapeutics Inc., IPR2014-00899, Paper 43, at 33-34 (P.T.A.B. Dec. 14, 2015).
4 ABS Global, Inc. v. XY, LLC, IPR2014-01550, Paper 25, at 27 (P.T.A.B. April 15, 2016). See also, Bio-Rad Laboratories, Inc. v. California Institute of Technology, IPR2015-00009, Paper 32, at 34 (P.T.A.B. April 21, 2016); Torrent Pharms Ltd. v. Novartis AG, IPR201400784, Paper 112, at 24-25 (P.T.A.B. Sept. 24, 2015).
5 Customplay, LLC v. Clearplay, Inc.,IPR2014-00339, Paper 27 (P.T.A.B. July 21, 2015)(internal citations omitted). See also, e.g., Bio-Rad Laboratories, Inc. v. California Institute of Technology, IPR2015-00009, Paper 32, at 30-31 (P.T.A.B. April 21, 2016); Coalition for Affordable Drugs VIII, LLC v. The Trustees of the University of Pennsylvania, IPR2015-01835, Paper 7 (P.T.A.B. March 7, 2016).
6 See, e.g., Chervon North America, Inc. v. Milwaukee Electric Tool Corp., IPR2015-00596, Paper 24 (P.T.A.B. July 31, 2015); Medtronic, Inc. v. Nuvasive, Inc., IPR2014-00074, Paper 15 (P.T.A.B. Apr. 8, 2014).
7 Qualtrics Labs, Inc. v. OpinionLab, Inc., IPR2014-00421, Paper 41, at 30-31 (P.T.A.B. July 24, 2015) (citations omitted).
8 Id. at 31-32 (citations omitted).
9 Id. at 32-33.
10 Id. at 33. See also, LKQ Corporation v. Clearlamp, LLC, IPR2013-00020, Paper 73, at 28 (P.T.A.B. March 27, 2014).
11 Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR2015-00660, Paper 42 (P.T.A.B. Aug. 10, 2016).
12 Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR2015-00660, Paper 24 (P.T.A.B. Oct. 28, 2015).
13 Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR20150-0660, Paper 42, at 37 (P.T.A.B. Aug. 10, 2016).
14 Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR2015-00660, Paper 42, at 40 (P.T.A.B. Aug. 10, 2016).
15 Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR2015-00660, Paper 42, at 43 (P.T.A.B. Aug. 10, 2016), citing WBIP, LLC v. Kohler Co, No. 2015-1038, –F.3d –, 2016 WL 3902668, at *6 (Fed. Cir. July 19, 2016).
16 Google Inc. v. At Home Bondholders’ Liquidating Trust, IPR2015-00657, IPR2015-00660, Paper 42, at 60 (P.T.A.B. Aug. 10, 2016).
17 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 10, at 42-46, 52 (P.T.A.B. Aug. 6, 2013).
18 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 14, at 35 (P.T.A.B. Feb. 13, 2014).
19 Omron, IPR2013-00265, Paper 10, at 42 n. 12.
20 Id. at 16.
21 Id. at 14 (citation omitted).
22 Id. at 14-15.
23 Omron Oilfield & Marine, Inc. v. MD/Totco, IPR2013-00265, Paper 14, at 2 (P.T.A.B. Feb. 13, 2014).
24 Id. at 3.
25 Id. at 4.
26 Lupin Ltd. v. Vertex Pharm. Inc., IPR2015-00405, Paper 13, at 26-27 (P.T.A.B. July 9, 2015).
27 Lupin Ltd. v. Vertex Pharm. Inc., IPR2015-00405, Paper 11, at 32-39 (P.T.A.B. Apr. 13, 2015).
28 Lupin, Paper 13, at 21-22 (citations omitted).
29 Id. at 22.
30 Id. at 22.
31 Id. at 22.
32 Intri–Plex Techs., Inc. v. Saint–Gobain Performance Plastics Rencol Ltd., IPR2014–00309, Paper 22, at 11-13 (P.T.A.B. Aug. 11, 2014).
33 Intri–Plex Techs., Inc. v. Saint–Gobain Performance Plastics Rencol Ltd., IPR2014–00309, Paper 83, at 45-46 (P.T.A.B. Mar. 23, 2014).
34 Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper 18 (P.T.A.B. Jan. 22, 2015).
35 Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper 39, at 24 (P.T.A.B. Oct. 27, 2015).
36 Id. at 25 ("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.").
37 IPR2015-00902, Paper 90, at 28 (P.T.A.B. July 28, 2016).
38 IPR2015-00902, Paper 90, at 15 (P.T.A.B. July 28, 2016).
39 Id. at 16.
40 Id. at 21.
41 Id. at 22.
42 Id. at 25.
43 Id.
44 Id. at 27.
45 Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131 (U.S., June 20, 2016).
46 Dr. Reddy’s Labs. v. Helsinn Healthcase S.A., PGR2016-00007, Paper 10, at 53-58 (P.T.A.B. May 18, 2016).
47 Dr. Reddy’s Labs. v. Helsinn Healthcase S.A., PGR2016-00007, Paper 12, at 22 (P.T.A.B. Aug. 17, 2016).
48 Dr. Reddy’s Labs. v. Helsinn Healthcase S.A., PGR2016-00007, Paper 12, at 21 (P.T.A.B. Aug. 17, 2016).
49 See, e.g., Lupin Ltd. v. Vertex Pharm. Inc., IPR2015-00405, Paper 13, at 26-27 (P.T.A.B. July 9, 2015).
50 While an Examiner during prosecution may or may not be an attorney, all members of P.T.A.B. are attorneys. Thus, while writing arguments in responses, it is important to provide citations to both the MPEP, which the Examiner will be familiar with, as well as case law, which bind P.T.A.B.
51 See, e.g., K40 Electronics, LLC v. Escort, Inc., IPR2013-00203, Paper 6, at 6 (P.T.A.B. Aug. 29, 2013) (instituting IPR based on defective declaration submitted during prosecution).
52 See, e.g., Aventis Pharma Société Anonyme [S.A.] v. Hospira, Inc., 675 F.3d 1324 (Fed. Cir. 2012); Apotex Inc. v. Cephalon, Inc., No. 06-cv-2768, 2011 WL 6090696 (E.D. Pa. 2011), aff’d without opinion, No. 2012-1417 (Fed. Cir. Apr. 8, 2013); Intellect Wireless, Inc. v. HTC Corp., 732 F.3d 1339 (Fed. Cir. 2013); Ohio Willow Wood Co. v. Alps South, LLC, 735 F.3d 1333 (Fed. Cir. 2013); Apotex, Inc. v. UCB, Inc., 763 F.3d 1354 (Fed. Cir. 2014); Am. Calcar, Inc. v. Am. Honda Motor Co., 768 F.3d 1185 (Fed. Cir. 2014).
*Stacy Lewis is a law clerk at Finnegan.
Originally printed in Law360 (www.law360.com). Reprinted with permission. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm's clients.
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