SOVEREIGN IMMUNITY AND IPR'S: AND NOW, THE REST OF THE STORY

Attorney: J. Derek Mason, Ph.D., CLP
June 14, 2019

Radio great Paul Harvey would always leave listeners hanging during his broadcast, then return from a commercial with "the rest of the story". Previously, I wrote on the Federal Circuit ruling with respect to Tribal Immunity (https://www.oblon.com/publications/tribal-immunity-in-ipr-is-dealt-a-death-blow-by-the-federal-circuit). At the end of that article I stated: "I note, however, that in the final sentence of their analysis, the Federal Circuit explicitly stated that this decision did NOT address whether there is any reason to treat state sovereign immunity differently with respect to IPR proceedings. That will remain to be seen…"... Read more

Written Description In Provisional Application: Perdue Pharma L.P. v. Andrei Iancu.

Attorney: Marina I. Miller, Ph.D.
May 28, 2019

Amneal Pharmaceuticals, LLC. ("Amneal") filed two petitions for inter partes review of claims 1–13 and 16–19 of U.S. Patent No. 9,034,376 ("the '376 patent") of Purdue Pharma L.P., P.F. Laboratories, Inc. and Purdue Pharmaceuticals L.P. ("Purdue"). In the petitions, Amneal argued that claims 1–13 and 16–19 were unpatentable for obviousness over the combinations of multiple prior art references including US 2002/0187192 A1 ("Joshi").... Read more

PTAB Issues Two New Precedential Opinions On Discretion to Deny Review - Implications for Generics

Attorney: Lisa M. Mandrusiak
May 9, 2019

The PTAB designated two decisions as precedential this week (in addition to several in previous weeks), both relevant to the Board's discretion to deny review. These cases illustrate that the PTO is in the process of designating precedential opinions on a number of issues, in line with revised Standard Operating Procedure 2 for designating precedential and informative decisions. See my previous posts on other recent precedential decisions here and here.... Read more

Follow-On IPR Petitions - Institution Is Not Impossible But Difficult

Attorney: Yuki Onoe
April 16, 2019

同一特許に対するIPR申請 ¾審理開始は不可能ではないが難しい<... Read more

Motions to Amend: Is the PTAB's Lectrosonics Order Just of Western Digital?

Attorney: Todd W. Baker
March 11, 2019

Spring gardening season has begun and the USPTO is once again planting its Motion to Amend ("MTA") seeds. In a substantial redux of Western Digital Corporation v. Spex Technologies, IPR2018-00082,-00084, paper 13, the PTAB this past week designated paper 15 of Lectrosonics v. Zaxcom, IPR2018-01129, 01130("Lectrosonics Order") as an informative decision.... Read more

No More IPRs From Generic Drug Makers?

Attorney: Yuki Onoe
February 24, 2019

The USPTO argues that a petitioner who has received a favorable final written decision in an IPR is estopped from reusing the same winning argument in a district court. If the Federal Circuit in BTG International Ltd. v. Amneal Pharmaceuticals LLC, agrees with the PTO, an ANDA sponsor would not take the risk of "winning" at the PTAB and would rather present the best argument in a district court.... Read more

Bioisosterism, by Itself, May Not be Sufficient Motivation to Modify a Lead Compound

Attorney: Stephen G. Baxter, Ph.D.
February 11, 2019

In the recent decision, Mylan Pharmaceuticals Inc. v. Research Corporation Technologies, Inc., the Federal Circuit affirmed the PTAB's finding that Claims 8 to 13 of U.S. Reissue Patent 38,551 ("the '551 patent") owned by Research Corporation Technologies, Inc. ("RCT") are not unpatentable.... Read more

After SAS, Will Estoppel Also Apply to Grounds not Included in Petitions for Inter Partes Review and Post-Grant Review?

December 12, 2018

Since the Supreme Court's decision in SAS Institute Inc. v. Iancu, 138 S. Ct. 1348 (2018), there has been significant discussion on SAS's expected effect on estoppel for IPRs. Essentially universal opinion holds that estoppel will apply to all grounds raised in the IPR petition due to the all-or-nothing institution standard applied by the Patent Trial and Appeal Board ("PTAB") in response to SAS. Post-SAS, final written decisions in IPRs will address all grounds raised in the petition if at least one ground meets the standard for institution, thus making estoppel applicable to all petition grounds as grounds "that the petitioner raised … during that inter partes review" under 35 U.S.C. § 315(e).... Read more

SAS Affects Use of Disclaimer to Obtain Motion to Dismiss

December 6, 2018

In IPR2018-00673, Paper No. 27, the Patent Trial and Appeal Board ("Board") refused to grant patent owner Wi-Lan's motion to dismiss despite its disclaimer of the only claims for which the Board had found petitioner LG as having a reasonable likelihood of success. LG filed an IPR petition seeking to invalidate claims 1-4 and 6-9 of U.S. Patent No. 9,497,743 ("the '743 patent"). The Board's institution decision found that LG had established a reasonable likelihood that LG would prevail in showing the unpatentability of claims 1-4 of the '743 patent, but not for claims 6-9. Pursuant to SAS, however, the Board instituted trial on claims 1-4 as well as claims 6-9.... Read more

Obviousness of a Dosage Regimen: Yeda Research and Development Co., Ltd. v. Mylan Pharmaceuticals Inc. Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.

Attorney: Marina I. Miller, Ph.D.
December 3, 2018

Yeda Research and Development Co., Ltd. ("Yeda") is the assignee of three "Copaxone patents" that describe and claim COPAXONE® 40mg/mL (glatiramer acetate ("GA")), a treatment for relapsing-remitting multiple sclerosis ("RRMS"). For analyzing the obviousness of the Copaxone patents, a key limitation of the claims is the administration of a 40mg GA dose in three subcutaneous injections over seven days. The Patent and Trademark Appeal Board ("the Board") found (and the district court affirmed) that the prior art described all limitations of the claims except for the administration of 40mg GA 3x/week for seven days. However, the Board and the district court concluded that the claimed dosage regiment would have been obvious to a parson of skill in the art (POSITA). Yeda appealed both decisions.... Read more

Hedge Your Bets in TC 1600 PGRs

Attorney: Lisa M. Mandrusiak
November 30, 2018

Post grant reviews (PGRs) have proven to be more popular in the biotechnology space (TC 1600) than any other art unit, with 42—or 28.1%—of the PGRs filed to date classified as TC 1600 patents.[1] By way of comparison, TC 1600 makes up just 10.1% of all IPRs filed to date.  Perhaps not surprisingly, PGRs are appealing for challengers of biotechnology patents because written description, enablement, and indefiniteness can all be raised, and these § 112 hurdles tend to be more challenging in the unpredictable arts of TC 1600. <... Read more

Assignor Estoppel and IPR's: Possible Impact of Arista v. Cisco on Employment Agreements and Assignment Agreements

Attorney: J. Derek Mason, Ph.D., CLP
November 16, 2018

In a November 9, 2018 decision (copy of decision linked below), the U.S. Court of Appeals for the Federal Circuit ruled that the doctrine of assignor estoppel does not apply in the inter partes review (IPR) context (see Arista Networks, Inc. v. Cisco Systems, Inc., (Fed. Cir. 2018)).... Read more

PTAB Confirms It Will Apply Broad Petitioner Estoppel Post-SAS

Attorney: Lisa M. Mandrusiak
November 8, 2018

The IPR estoppel provision was originally intended as a check against patent challengers attacking patents serially in the USPTO or other forums based on grounds that were raised or "reasonably could have been raised" in the original IPR. Although the Federal Circuit has interpreted estoppel narrowly, district courts were split, and estoppel's impact has remained in flux for several years.... Read more

Sufficiency of Invalidity Evidence in IPRs Can Differ for Method and Apparatus Claims

October 5, 2018

Using the same invalidity evidence to address apparatus and corresponding method claims in inter partes review ("IPR") petitions can present difficulties depending on the claim language used in the apparatus claims.... Read more

Two Herceptin® Patents Survive IPR: A Lesson in Separately Arguing Motivation to Combine and Reasonable Expectation of Success

Attorney: Lisa M. Mandrusiak
October 4, 2018

Motivation to combine and reasonable expectation of success are separate requirements that must be independently considered. By capitalizing on shortcomings in the petitions related to separately arguing these issues, Genentech was able to save two of three patents covering its blockbuster drug Herceptin®.... Read more

Travatan Z® Patent Survives IPR: A Lesson in Successfully Arguing Hindsight Bias

Attorney: Lisa M. Mandrusiak
September 27, 2018

Hindsight bias is not simply an old chestnut argued ad infinitum in response to obviousness challenges. In this week's final written decision in IPR2017-01053 upholding all claims of U.S. Patent No. 8,268,299, the PTAB illustrated that—under the right circumstances—this argument can have teeth.... Read more

JTEKT v. GKN: Federal Circuit Finds Competitor Lacks Standing to Appeal PTAB's Final Written Decision

Attorney: Lisa M. Mandrusiak
September 7, 2018

After determining that its competitor GKN's patent raised a potential risk of infringement for a product under development, JTEKT[1] challenged the patentability of claims 1–7 of U.S. Patent No. 8,215,440 via inter partes review (IPR2016-00046). When claims 2 and 3 were confirmed as patentable in the final written decision—and thus the risk of infringement remained—JTEKT appealed, and GKN moved to dismiss the appeal based on lack of standing.... Read more

Recent Pharmaceutical House and Senate Bills

Attorney: Tia D. Fenton
August 28, 2018

Over the summer, representatives introduced bills and amendments of interest to the pharmaceutical industry. First, Senator Orrin Hatch, co-author of the Hatch-Waxman Act, filed an amendment in the Senate Judiciary Committee that would require a generic manufacturer wishing to challenge a brand-name drug patent to choose between Hatch-Waxman litigation and IPR, removing the option to use both. According to Senator Hatch, this Hatch-Waxman Integrity Act of 2018 would ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop lower-cost drugs, while at the same time providing innovators a period of exclusivity to recoup investments. Specifically, Senator Hatch commented that the availability of an alternative path to challenge patents through IPRs has threatened to upend the carefully-crafted Hatch-Waxman balance by enabling companies to put added litigation pressure on drug innovators above and beyond what Hatch-Waxman already provides.... Read more

Distribution of Certain Materials to Groups of People Without Restriction May Render Such Materials Printed Publications Under § 102(b)

Attorney: Marina I. Miller, Ph.D.
August 1, 2018

The Federal Circuit affirmed in-part and vacated in-part the PTAB's (the Board) decision that the petitioner, Medtronic, Inc., had not proven that the challenged patent claims were unpatentable. The Court affirmed the Board's determination that challenged claims were not obvious over two prior art references, but vacated and remanded the Board's determination that other references, a video "Thoracic Pedicle Screws for Idiopathic Scoliosis" and slides "Free Hand Thoracic Screw Placement and Clinical Use in Scoliosis and Kyphosis Surgery," were not "publicly accessible" under 35 U.S.C. § 102(b) and therefore were not prior art.... Read more

Tribal Immunity in IPR is Dealt a Death Blow by The Federal Circuit

Attorney: J. Derek Mason, Ph.D., CLP
July 26, 2018

The Federal Circuit issued its decision in Saint Regis Mohawk Tribe et al v. Mylan Pharmaceuticals Inc., et al (18-1638) on July 20, 2018. The central question addressed in the Federal Circuit's decision was whether the principal of sovereign immunity can be asserted by a patent owner to avoid their patent being subjected to the Inter Partes Review (IPR) process. The decision hinged on whether the IPR process is more akin to the civil litigation-like proceedings in adjudications before the Federal Maritime Commission in which state sovereign immunity was held to apply (Fed. Maritime Comm'n v. S.C. State Ports Auth., 535 U.S. 743, 754–56 (2002) ("FMC") or whether IPR is a traditional agency action in which it has been previously held that sovereign immunity does not typically apply (see, for example, Pauma v. NLRB, 888 F.3d 1066 (9th Cir. 2018); Karuk Tribe Hous. Auth., 260 F.3d at 1074; and Fed. Power Comm'n v. Tuscarora Indian Nation, 362 U.S. 99, 122 (1960)). It is important to note, however that there is no blanket rule that immunity does not apply in federal agency proceedings.... Read more

Decs, Slides, and Video[tape]: Utilizing non-patent literature in IPR

Attorney: Todd W. Baker
June 18, 2018

In Medtronic, Inc. v. Barry (2017-1169 and 2017-1170), the Federal Circuit (Circuit Judges Taranto, Plager, and Chen, decision authored by Judge Chen, hereinafter "the panel") vacated the PTAB's finding in IPRs2015-00780 and -00783 that Medtronic's slides and videos constitute "printed publications" within the meaning of 35 U.S.C. §102(b). Since only patents and printed publications are eligible as prior art in inter partes review ("IPR"), the question whether non-patent literature ("NPL") such as slides and videos distributed at a conference constitute printed publications is clearly of interest to those in the medical device field.... Read more

Is Real and Positive Change Coming for Patent Owners?

Attorney: Vincent K. Shier, Ph.D.
June 11, 2018

New USPTO Director Andrei Iancu provided the Intellectual Property Track plenary lecture at the 2018 BIO International Convention last week. As has been a common theme since being sworn in to office in February, Director Iancu's focus was on changes to provide greater certainty and quality for applicants and patent owners. Yes, we have heard this before, but the time is ripe for real change that positively impacts applicants and patent owners.... Read more

The POPR and Expert Declarations

Attorney: Richard D. Kelly
June 4, 2018

The PTAB in the past year has loosened rules governing IPR practice. In most cases the changes have been good for the process. However, some of the changes while introducing a greater degree of fairness into the system have created traps for the unwary. One such trap is allowing patentees to submit declarations with the POPR (Patent Owner's Preliminary Response). Contrary to what many practitioners expect, the submission of a declaration actually increases the probability of the petition being instituted. Indeed, it might even guarantee institution.... Read more

Anacor Pharmaceuticals, Inc. v. Iancu

Attorney: Tia D. Fenton
May 17, 2018

On May 14, 2018, in Anacor v. Iancu, the Federal Circuit issued its opinion affirming the Board's invalidation of Anacor's tavaborole patent. The patent-in-suit, U.S. Patent No. 7,582,621, entitled "Boron-containing Small Molecules," is directed to the use of tavaborole to treat fungal infections. According to the disclosure, tavaborole can be used to treat a fungal infection known as onychomycosis, which is a nail disease responsible for approximately half of all nail disorders in humans. In an inter parties review, the Patent Trial and Appeal Board found all of the claims of the '621 patent unpatentable for obviousness. Anacor appealed with respect to only one of the claims and the Federal Circuit affirmed.... Read more

Biosimilars IPRs: Any Lessons From PTAB Institution Decisions On Coherus Petitions?

Attorney: Jeffrey B. McIntyre
May 2, 2018

In March, the PTAB denied institution of Coherus's IPRs against Hoffman-LaRoche (2017-1916 and 2017-2066). Previously, however, the PTAB instituted Coherus's early IPRs against Abbvie (2016-172, 2016-0188, and 2016-0189). Can any lessons be learned from the different outcomes in these cases?... Read more

Can Commercial Success save your TC 1600 patent from IPR? Probably not

Attorney: Lisa M. Mandrusiak
April 9, 2018

In an attempt to understand the frequency of commercial success arguments and the likelihood of success of those arguments in TC 1600 IPRs, I used information from Oblon's TC 1600 library to compile statistics. As seen below, commercial success is not often relied upon, even for IPRs challenging patents covering named drugs. And, digging into the details of the cases reveals that—even when argued—commercial success very rarely wins the day.... Read more

Is Sovereign Immunity Dead with Respect to PTAB Proceedings?

Attorney: J. Derek Mason, Ph.D., CLP
March 13, 2018

There has been a lot of discussion recently regarding claims by the Saint Regis Mohawk Tribe ("Saint Regis") of sovereign immunity as a defense against inter partes review of certain patents owned by Saint Regis. The issue came about as a result of a deal made between Allergan and Saint Regis under which Allergan (the original owner of the six patents involved) paid Saint Regis $13.75 million to take ownerhip of the six patents for Allergan's Restasis drug, and license them back exclusively to Allergan, with the promise of ongoing royalties. When those six patents were challenged in an inter partes review at the Patent Trial and Appeal Board (PTAB), Saint Regis asserted that the patents were shielded from such inter partes review by the theory of tribal sovereign immunity, by extension of a 2017 PTAB ruling that the University of Florida (as a state entity of the state of Florida) was immune to such IPR challenge by Covidien LP. In other decisions, the PTAB has reiterated that state sovereign immunity applies in IPR's.... Read more

Apotex v. OSI Pharmaceuticals: Beware What You Say To The SEC

Attorney: Jeffrey B. McIntyre
February 12, 2018

In a recent IPR between Apotex v. OSI Pharmaceuticals, the PTAB relied on an OSI Securities and Exchange Commission (SEC) filing, a 10-K, to find the challenged claims unpatentable. (A 10-K is an SEC filing that provides a summary of a company's financial performance).... Read more

Rasuvo® Patent Survives IPR: Failure to Properly Frame Arguments Proves Fatal

Attorney: Lisa M. Mandrusiak
February 9, 2018

The PTAB recently reminded Petitioners of the importance of properly framing prior art arguments, upholding all claims of U.S. Patent No. 8,664,231 in IPR2016-01370 in a final written decision issued yesterday. The '231 patent—covering Rasuvo®, a rheumatoid arthritis drug containing high doses of methotrexate formulated for subcutaneous injection—was challenged based on two primary references: Grint (a U.S. patent) and Wyeth (a pharmaceutical label for conventional uses of methotrexate). The primary grounds for each reference were based on anticipation, and the PTAB determined that neither reference anticipated claim 1, the only independent claim of the '231 patent.... Read more