United States: Post-Grant Proceedings As A Freedom-To-Operate Tool

While some may take it as a given that patent owners view America Invents Act post-grant proceedings—inter partes reviews and post-grant reviews—as disadvantageously weakening the U.S. patent system, the attitudes of patent owners may be more nuanced. Many parties, whether themselves patent owners or not, believe that IPRs and PGRs can also strengthen the U.S. patent system by providing less expensive and speedier avenues for rooting out invalid, i.e., unpatentable, patents.

To be sure, many IPR petitions are defensive, filed by petitioners accused of infringing the targets of those IPRs. On the other hand, there are innovative companies that file IPR and/or PGR petitions with an objective of acquiring freedom-to-operate (FTO) in the United States relative to the patent(s) of a third-party patent owner, often itself an innovative company.

For instance, perhaps Company A has just completed an intellectual property due diligence for acquiring Company B, including its products and patent portfolio. Perhaps the due diligence has raised the specter of lack of FTO for Company B's products in view of third-party patents. While ex parte re-examination requests and declaratory judgment actions remain options for Company A, it may well conclude that the least expensive, most timely, way to clear the FTO issue(s) is to challenge the roadblock patents via IPR or PGR. Not only are IPRs and PGRs statutorily mandated to terminate within 12 months,¹ they also offer attractive features, compared to district court litigation, to challengers such as no presumption of validity, a preponderance of the evidence standard, and broadest reasonable claim interpretation. Limited discovery and—as a general rule—no live testimony contribute to keeping the costs and time lower than in district court litigation.

Without passing judgment on the overarching and much-debated question of whether IPRs and PGRs are inherently bad for patent owners, this article accepts the availability of IPRs and PGRs in their present state and explores the use of post-grant proceedings by innovative companies as FTO tools. This article defines innovative companies as those that invent products and protect those products with patents.

No Statutory or Policy Restrictions on Innovator-Filed IPRs or PGRs

Generally speaking, nearly anyone has standing to file IPR and PGR petitions. The relevant statutory provisions are broad, encompassing any person who is "not the owner of the patent" to be challenged.² This is slightly narrowed by further provisions prohibiting filing of a petition by a party who has previously requested a declaratory judgment of invalidity,³ been sued for infringement in district court more than one year earlier (for IPRs only),⁴ and also may be narrowed by statutory and doctrinal estoppel provisions against, for example, the petitioner.⁵

Timing constraints are tied to the differences in scope between IPRs and PGRs. PGR petitions, which can raise any statutory ground of invalidity, may only be filed within nine months from issuance of a patent having at least one claim with an effective filing date after March 15, 2013, and also otherwise qualifying for PGR-attack.⁶ In contrast, in IPRs, only §102 or §103 grounds may be raised, and only on the basis of prior art consisting of patents or printed publications.⁷ IPRs can only be filed, for PGR-eligible patents, after the later of nine months post-issuance or the termination of any PGR instituted on the same claims.⁸ (For patents not eligible for PGR, e.g., pre-AIA patents, IPRs can be filed upon issue.) In addition, as mentioned above, a party who has been sued for infringement is prohibited from filing an IPR more than one year after being served with said suit.⁹

Congress' objectives for AIA post-grant proceedings were discussed in detail in the legislative history, and included providing a faster and less expensive alternative to district court litigation.¹⁰ IPRs and PGRs were purportedly also intended to provide a faster administrative challenge route than the existing reexamination process.¹¹ Reflecting those objectives, both 37 C.F.R. 42.1(b) and the U.S. Patent and Trademark Office "Trial and Practice Guide" direct that the rules shall be "construed to secure the just, speedy, and inexpensive resolution of every proceeding."¹² Using IPRs and PGRs to establish freedom to operate between fellow innovators is within the scope of the IPR and PGR policy goals of "just, speedy, and inexpensive" alternatives to district court litigation and USPTO re-examinations.

Innovators Trying It: Examples of Innovator-Filed IPRs and PGRs in Biotech, Pharma and Life Sciences

There are several representative examples of IPRs filed by innovators in the bio/pharm field:

• Bristol-Myers Squibb Co. filed a petition in IPR2016-00458 against the University of Pennsylvania on its patent relating to compositions and method of treating tumors.
• Pfizer Inc. challenged Genentech Inc. on eight of its patents related to making antibodies and therapies for autoimmune diseases: IPR2017-01923, IPR2017-01488, IPR2017-01489, IPR2017-01726, IPR2017-01727, IPR2017-01923, IPR2017-02019, IPR2017-02020, IPR2017-02063, IPR2017-02126, IPR2017-02127, and IPR2018-00016.
• GlaxoSmithKline PLC filed five IPR petitions against FibroGen Inc. patents related to erythropoiesis and iron metabolism: IPR2016-01318, IPR2016-01319, IPR2016-01320, IPR2016-01322, and IPR2016-01323.
• Purdue Pharma LP filed three IPR petitions against Depomed Inc. patents on extending the duration of drug release: IPR2014-00377, IPR2014-00378, IPR2014-00379.

There are also PGR examples, such as Merck & Co. Inc. filing petitions against Wyeth in PGR2017-00016 and PGR2017-00017 on an immunogenic composition (institution decisions pending).

We selected 207 innovator-filed bio/pharm IPR petitions and created the following charts to provide a snapshot of how innovator-filed petitions have fared in IPRs so far.¹³

Of these 207 selected innovator-filed bio/pharm IPR petitions, 51 were denied, 83 were granted on at least one claim, 29 were settled prior to an institution decision, and 44 are pending awaiting an institution decision. The grant rate for the 134 institution decisions was 62 percent (83/134) (granted on at least one claim/granted on at least one claim + denied).

Including "no institution" with the "denials" as an outcome favorable for the patent owner because the patent claims remain in force and unchanged, the "win rate" is lower: 49 percent (80/163). A settlement prior to institution may include concessions valuable to the challenger though.

Of the 83 granted IPR petitions, seven are pending awaiting termination, 14 settled after institution, seven had adverse judgments, six had a mixed result (at least one claim survived and at least one claim held unpatentable), one motion to amend was granted, 31 final written decisions held all instituted claims unpatentable, and in 17 final written decisions all instituted claims survived.

Just looking at the final written decisions on the merits, but excluding the mixed outcomes, the patent owner survival rate is 35 percent (17/48), and the innovator petitioner win rate for knocking out the instituted claims is 65 percent (31/48).

Considering the seven adverse judgment cases as a loss for the patent owner (since the instituted claims are canceled), and adding those to the calculation, the win rate for the innovator petitioner is 69 percent (38/55).

For the innovator looking for FTO against one or more third-party patents, a 62 percent chance of having an IPR instituted, and then a 65-69 percent chance of knocking out problematic claims, can be—depending on the circumstances—very appealing odds. In addition, although the 14 instituted cases settled prior to a final written decision (17 percent of the terminated cases) cannot be characterized as a win or loss since the settlement terms are not public, it is likely that the innovator challenger got something of value in the settlement and maybe even achieved FTO.

Evaluation of IPRs and PGRs as FTO Tools

In addition to the general receptiveness the Patent Trial and Appeal Board has displayed so far to petitioners across all technologies,¹⁴ there are specific aspects of IPRs and PGRs that can make the PTAB an appealing venue for innovators seeking FTO. One advantage is the technical training of the PTAB's judges. Another is the (so far) very low chance that the PTAB will grant a motion to amend to allow substituted claims.¹⁵ A PTAB decision on institution is essentially "nonappealable."¹⁶ This is a benefit to the petitioner when the IPR petition is granted and the trial instituted, though is a detriment if the petition is denied. As mentioned earlier, limited discovery and generally no live testimony help keep costs down. Additionally, the lower burden of proof, broadest reasonable interpretation standard for claim construction, and no presumption of patent validity create conditions for a challenger-friendly forum. Fast resolution and direct appeal to the Federal Circuit for final written decisions are two more factors. If the circumstances are such that there is already pending district court litigation on the patent(s) in question, a post-grant proceeding may be the basis for a motion to stay that district court litigation. If the post-grant proceeding is successful and the patent claims are held unpatentable, that outcome may spur settlement in the district court litigation.

Two benefits specific to PGRs and of particular relevance in the bio/pharma context are the opportunity to raise §112 issues, such as claim definiteness, enablement, and written description on the merits,¹⁷ and the opportunity to make non-publication-based §102 challenges, such as prior use or sale.

An innovator considering a post-grant proceeding must recognize, however, that there are possible downsides or at least cautions to integrate into the decision. For example, one aspect unique to innovator-initiated post-grant proceedings is that the most relevant art against the third-party target patent may also be relevant to the innovator's own patents. Careful analysis should be performed prior to filing and arguments should be crafted with attention to their potential relevance to the innovator-petitioner's own portfolio. Similar prudence should be taken when discussing lack of enablement and Wands factors. The innovator-petitioner should take care not to provide blueprints for challenges of its own patents.

Estoppel considerations, the boundaries of which remain uncertain right now, must also be taken into account.¹⁸ For PGRs, the broader grounds of attack allowed also brings the possibility of broader estoppel. The statutes provide that estoppel generally attaches to any ground "that the petitioner raised or reasonably could have raised during" that IPR or PGR.¹⁹ Estoppel applies to any future proceeding before the courts, the patent office, or the U.S. International Trade Commission, but it only attaches if the PTAB issues a final written decision.

How Do IPRs and PGRs Fit Into an Innovator's Overall Portfolio Management Strategy?

IPRs and PGRs may be a tool in the armamentarium of innovators looking for FTO. Of course, ex parte re-examinations and declaratory judgments also remain options for innovators. Which is best in a given set of circumstances may depend on the patent term remaining in the patents of interest, the time frame of the innovator's own projects/patents, how quickly a decision is desired, the appropriate budget in light of the innovator's business objectives, and whether there are related court and/or administrative proceedings pending.

Additionally, innovators hoping to make strategic use of PGRs must closely track competitor activity to know when patents of interest are issued (or reissued). Otherwise, the nine-month window for filing the PGR petition may be missed and the grounds available for challenge will be narrowed to those permitted in an IPR.

Clouds on the Horizon

A number of currently unsettled issues could impact innovators' use of IPRs and PGRs for FTO objectives. For example, if the U.S. Supreme Courtholds post-grant proceedings unconstitutional in Oil States Energy Services LLC v. Greene's Energy Group LLC, cert granted June 12, 2017, innovators' options will be back to only declaratory judgment actions and ex parte re-examinations.

The en banc Federal Circuit decision in Aqua Products Inc. v. Matal, No. 2015-1177, 2017 WL 4399000 (Fed. Cir. Oct. 4, 2017), means, at least for now, that any attempt by a patent owner to amend challenged claims will require the petitioner to show those proposed claims are unpatentable as well. The possible increased burden this presents will have to be weighed in an innovator's decision about employing IPRs or PGRs for FTO. It remains to be seen whether more motions to amend proposing substitute claims will be filed, and whether the PTAB will change its course from overwhelmingly rejecting such motions, as it has to date.

In addition, assuming arguendo that Oil States holds that IPRs and PGRs are constitutional, an innovator may yet face uncertainty about its ability to seek FTO via IPR or PGR, depending on the outcome of the St. Regis Mohawk Tribe/Allergan Restasis case involving Native American tribal sovereign immunity, and related legislative proposals. If Allergan's sale of its relevant patents to St. Regis is upheld before the PTAB, and if Congress does not legislatively abrogate Native American tribal immunity in IPRs and PGRs, patent owners may have an option that would render their patents "bulletproof" to IPRs and PGRs. That being said, Sen. Claire McCaskill, D-Mo., proposed a bill on Oct. 5, 2017, that would prohibit an "Indian tribe" from asserting sovereign immunity as a defense to an IPR.²⁰ That bill, however, does not address PGRs or the assertion of sovereign immunity by states, or state universities, which has already been addressed by the PTAB.²¹ And notwithstanding state sovereign immunity, a question remains whether Congress can prohibit the type of agreement entered into by the St. Regis Mohawk tribe and Allergan in the first place.

An Innovator's Freedom-to-Operate Tool

Using IPRs and/or PGRs requires careful consideration, and every case must be weighed on its unique facts of business objectives, stage of product development, timing, and potential estoppel, to name a few. Although a less expensive and more speedy option than litigation, it is prudent not to treat IPRs and PGRs as a quick hatchet job on the competition, and especially so for innovator-petitioners. But in the right circumstances, following a detailed and careful analysis of points raised above, innovators may decide that IPRs and PGRs have their place after all, and can in fact smooth the path to FTO.

Footnotes

1 35 U.S.C. §316(a)(11) and 35 U.S.C. §326(a)(11).

2 35 U.S.C. §311(a) and 35 U.S.C. §321(a).

3 35 U.S.C. §315(a)(1) and 35 U.S.C. § 325(a)(1).

4 35 U.S.C. §315(b).

5 35 U.S.C. §315(e) and 35 U.S.C. §325(e). See also, 35 U.S.C. §325(d) permitting the PTAB to exercise its discretion to deny an IPR or PGR petition if "the same or substantially the same prior art or arguments previously were presented to the Office." There was concern even while the AIA was under debate in Congress that the new post-grant proceedings could be abused and result in harassment of patent owners by the filing of serial petitions. 35 U.S.C. §325(d) was included as a way for the PTAB to keep that from happening. The PTAB has also denied petitions when it considers the petitioner is using previous institution decisions and Patent Owner Preliminary Responses as a "road map" to address gaps. "We disfavor allowing follow-on petitions that attempt to fix deficiencies in a previous petition that were explained in a previous decision on institution." Synaptics, Inc. v. Amkor Tech. Inc., IPR2017-00085, Paper 12 (P.T.A.B. April 18, 2017). See also Conopco, Inc. d/b/a Unilever v. The Procter & Gamble Co., IPR2014-00506, Paper 17 (P.T.A.B. July 7, 2014)(Informative Opinion); ZTE Corp. v. ContentGuard Holdings, Inc., IPR2013-00454, Paper 12 (P.T.A.B. Sept. 25, 2013) (Informative Opinion).

6 35 U.S.C § 321, 37 C.F.R. §42.201 and §42.202.

7 35 U.S.C. §311(b).

8 35 U.S.C. §311(c).

9 35 U.S.C. §315(b).

10 157 CONG. REC. S5411 (daily ed. Sept. 8, 2011) (statement of Sen. Hatch); H.Rept. 112-98: "the purpose of the section as providing quick and cost effective alternatives to litigation."

11 154 CONG. REC. 9988 (2008) (statement of Sen. Kyl).

12 77 Fed. Reg. 48,756, 48, 758 (Aug. 14, 2012).

13 Finnegan research as of Oct. 7, 2017. List of patent owner petitioners in 207 representative bio/pharm IPRs used for calculations: Actelion Pharms., Acura Pharms., Aker BioMarine AS, Alkermes, Allergan, Ambry Genetics, ApaTech, Aragen Bioscience, Ariosa Diagnostics, Benitch Biopharma, BioDelivery Sciences, BioMarin Pharm, BioReference Labs., BMS, Boehringer, Cepheid, Eli Lilly, Elysium Health, Endo DAC, Endo Pharms., Enzo Life Sciences, Enzymotec, Ethicon, Forty Seven, Inc., Galderma SA, Genzyme Corp., Gilead Sciences, GSK, Gnosis Bioresearch SA, Gnosis S.P.A., Guardant Health, Horizon Discovery, Horizon Therapeutics, Illumina, Inc., Intelligent BioSystems, Int'l Flavors, Johns Hopkins Univ., Kamada Ltd., Kite Pharm., Luminex Corp., Merck, Merial, MonoSol Rx, Noven Pharms., Novo Nordisk, Oxford Nanopores, Panacea Biotech, Pfizer, Pharmacosmos, Phigenix, Prism Pharms., Purdue Pharms., Qiagen, Inc., Sanofi-Aventis, Sequenom, St. Jude Medical, Teoxane and Thermo Fisher Scientific.

14 68% (3833/5607) IPR petition grant rate, and at least 65% rate of all instituted claims unpatentable (1153/1771). Another 16% of Final Written Decisions included at least one claim held unpatentable (mixed result). USPTO statistics as of Sept. 2017, https://www.uspto.gov/sites/default/files/documents/Trial_Stats_2017-09-30.pdf

15 Time will tell if the Federal Circuit en banc Aqua Product decision, decided October 4, 2017, changes this. See Aqua Products, Inc. v. Matal, No. 2015-1177, 2017 WL 4399000 (Fed. Cir. Oct. 4, 2017).

16 35 U.S.C. §314(d) and 35 U.S.C. §324(e); Cuozzo Speed Techs., LLC v. Lee, 136 S.Ct. 2131 (2016).

17 The petitioner can raise §112 enablement and written description issues to dislodge the patentee of an earlier priority date in both IPRs and PGRs. See Butamax Advanced Biofuels L.L.C. v. Gevo Inc., IPR2013-00539 (P.T.A.B. Mar. 3, 2015) (establishing that the claim limitations contained in the challenged claim did not have written description support all the way back to the earliest two priority applications, resulting in establishing a later priority date).

18 Shaw Indus. Group, Inc. v. Automated Creel Sys., Inc., 817 F.3d 1293 (Fed. Cir. 2016), is the current Federal Circuit position: that petitioner estoppel only applies to instituted grounds.

19 35 U.S.C. §315(e) and 35 U.S.C. §325(e).

20 Senator McCaskill's bill S.___, introduced Oct. 5, 2017, "to abrogate the sovereign immunity of Indian tribes as a defense in inter partes review of patents."

21 Covidien LP v. Univ. of Florida, IPR2016-01274, IPR2016-01275, IPR2016-01276, Paper 21 (P.T.A.B. Jan. 25, 2017), dismissing three separate IPR petitions challenging patents owned by the University of Florida Research Foundation Incorporated because the University was deemed an arm of the State and therefore entitled to sovereign immunity.

Reactive Surfaces Ltd. v. Toyota Motor Corp., IPR2017-00572, Paper 32 (P.T.A.B. July 13, 2017),
dismissed only with respect to Univ. of Minnesota, case continues with Toyota.

Neochord, Inc. v. Univ. of Maryland, IPR2016-00208, Paper 28 (P.T.A.B. May 23, 2017), entire case
dismissed because Univ. of Maryland retained an interest in the patent.

Originally published in Law360 on October 30, 2017.

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