Category Archives: Patent Trials

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PTAB Not Bound By Prior Court Decisions Upholding Exelon Patents

In Novartis v. Noven Pharmaceuticals, Inc., the Federal Circuit affirmed the USPTO Patent Trial and Appeal Board (PTAB) decisions invalidating certain claims of two Orange Book-listed Exelon patents. This decision has garnered attention because the patents previously were upheld by the U.S. District Court for the District of Delaware in a decision that also was … Continue reading this entry

Federal Circuit Questions Standing For IPR Appeals

As I have written previously, neither the statutes nor the regulations governing Inter Partes Review (IPR) require the party challenging the patent to have been charged with infringement, or even to establish any interest in practicing the claimed subject matter. While the USPTO Patent Trial and Appeal Board (PTAB) has not imposed any standing requirements on … Continue reading this entry

PTAB Holds Oral Hearings In Tecfidera Patent IPR and Interference

On November 30, 2016, the USPTO Patent Trial and Appeal Board (PTAB) held oral hearings in two different inter partes proceedings involving the Biogen Tecfidera® patent with the latest expiation date. First, it heard arguments in the Inter Partes Review (IPR) brought by Kyle Bass and the Coalition for Affordable Drugs, and then it heard … Continue reading this entry

Swearing Behind A Reference With Reasonably Continuous Diligence

In Perfect Surgical Techniques, Inc. v. Olympus America, Inc., the Federal Circuit vacated and remanded a USPTO Patent Trial and Appeal Board decision in an Inter Partes Review proceeding, finding that the PTAB imposed too strict a diligence requirement for swearing behind a reference. This case reminds us that proof of conception and diligence towards … Continue reading this entry

Biogen TYSABRI Patents Spared Inter Partes Review

The USPTO Patent Trial and Appeals Board (PTAB) declined to institute Inter Partes Review (IPR) proceedings against three Biogen Idec TYSABRI patents. The IPR petitions were filed by Swiss Pharma International, and asserted obviousness based on references that disclosed antibody formulations similar to those claimed in the Biogen patents, but did not teach the high antibody … Continue reading this entry

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The decision underscores that obviousness is not established simply because each feature of a claim is found somewhere in the prior art … Continue reading this entry

Federal Circuit Affirms Tygacil Formulation Patent

In a non-precedential decision in Apotex, Inc. v. Wyeth LLC, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) finding that Apotex had failed to show that claims directed to a specific formulation of tigecycline were invalid as obvious. Both the PTAB and Federal Circuit decisions show that while the … Continue reading this entry

PTAB Institutes Post Grant Review Against Chemical Process Patent

The USPTO Patent Trial and Appeal Board has instituted Post Grant Review (PGR) proceedings against a patent directed to a process for treating contaminated media. The petition for PGR challenged that patent on written description, enablement, prior art and eligibility grounds, but the PTAB instituted proceedings only as to written description. This case provides an interesting glimpse into … Continue reading this entry

Amneal's IPR Challenge Of The Jazz Xyrem + Valproate Patent

In decisions dated April 12, 2016, the USPTO Patent Trial and Appeal Board (PTAB) denied institution as to claims 1-18 of Jazz’s U.S. Patent 8,772,306, finding that neither Ranbaxy Inc. nor Par Pharmaceutical, Inc. had shown a reasonable likelihood of establishing obviousness. Amneal Pharmaceuticals LLC also has filed a petition for IPR of the ‘306 patent. Will … Continue reading this entry

Jazz Xyrem + Valproate Patent Claims Avoid IPR

The USPTO Patent Trial and Appeal Board (PTAB) decided not to institute inter partes review (IPR) of key claims of Jazz’s U.S. Patent 8,772,306, which is listed in the Orange Book for Xyrem®. Although the PTAB did institute proceedings for claims 19-34 of the ‘306 patent, claims 1-18 may be more relevant to the Xyrem® prescribing information, … Continue reading this entry

Second Time Is The Charm For Kyle Bass Challenges Of Ampyra Patents

The USPTO Patent Trial and Appeal Board (PTAB) has decided to institute inter partes review (IPR) proceedings against the Ampyra patents based on the second set of petitions filed by Kyle Bass and the Coalition for Affordable Drugs. This decision shows that even patent owners who successfully avoid institution of one IPR may face a subsequent … Continue reading this entry

PTAB Institutes Kyle Bass IPRs Against Juxtapid Patents

The USPTO Patent Trial and Appeal Board (PTAB) decided to institute inter partes review (IPR) proceedings filed by Kyle Bass against two of the five Juxtapid patents listed in the Orange Book. Two of the cited references may qualify as § 102(b) prior art because the provisional application was found not to support certain aspects of the claims.… Continue reading this entry

Asset Transferee Cannot Appeal Reexamination

The Federal Circuit dismissed the appeal in Agilent Technologies, Inc. v. Waters Technologies Corp., because the appellant was not a “third-party requester” dissatisfied with the final decision in an inter partes reexamination proceeding, as required by 35 USC § 141. Although Agilent was a transferee of relevant assets, it had not shown that it was the successor-in-interest … Continue reading this entry

PTAB Denies Challenge Of Abbvie Humira Patents

The USPTO Patent Trial and Appeal Board (PTAB) denied institution of two Inter Partes Review challenges brought by Amgen, Inc. against two Humira patents covering stable formulations of anti-human Tumor Necrosis Factor alpha antibodies. The PTAB decisions illustrate the potential importance of establishing unpredictability in the field when defending against obviousness challenges.… Continue reading this entry

PTAB Trial Standard Of Review Requires Affirmance Despite Contrary Evidence

In Merck & Cie v. Gnosis S.p.A., the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that held the challenged claims obvious in an Inter Partes Review (IPR) proceeding. Although the court recognized evidence that undermined the obviousness finding and acknowledged objective evidence of nonobviousness, the court determined that … Continue reading this entry

Did The PTAB Dose The AIA Poison Pill Incorrectly Against Premium Genetics?

In Inguran, LLC v. Premium Genetics (UK) Ltd., the USPTO Patent Trial and Appeal Board (PTAB) instituted Post Grant Review (PGR) proceedings in a patent granted from an AIA transition application based on its finding that at least one of the claims was not entitled to an effective filing date before March 16, 2013. While that aspect … Continue reading this entry

PTAB Institutes Kyle Bass Lialda Patent IPR

After filing over thirty petitions for Inter Partes Review of Orange Book-listed patents for various drugs, Kyle Bass and his Coalition for Affordable Drugs finally has made it over the first hurdle. The USPTO Patent Trial and Appeal Board (PTAB) decided to institute IPR proceedings against U.S. Patent No. 6,773,720, which is listed in Orange Book for … Continue reading this entry

USPTO Won't Stop Kyle Bass

In a concise opinion, the USPTO Patent Trial and Appeal Board (PTAB) refused to sanction Kyle Bass and the Coalition for Affordable Drugs for abusing the IPR process. Celgene Corp. had filed motions for sanctions in IPRs brought against its patents relating to Thalomid® (thalidomide) and Revlamid® (lenalidomide). In denying the motions, the PTAB emphasized the broad language … Continue reading this entry

Board Boots Bass Tecfidera IPR On The Merits

On September 2, 2015, the USPTO Patent Trial and Appeal Board (PTAB) denied institution of another Inter Partes Review brought by Kyle Bass, the Coalition for Affordable Drugs, and other related entities. In denying the Tecfidera IPR petition, The PTAB sidestepped Biogen’s argument that the institution should be denied because its “primary purpose” was to “depress stock prices … Continue reading this entry

PTAB Denies Institution Of Kyle Bass's Ampyra Patent Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has put an end to Kyle Bass’s Ampyra patent challenge, by denying institution of Inter Partes Review (IPR) proceedings. While many were hoping the PTAB would render a decision based on the “improper purpose” of the challenge, the PTAB decisions are based on one of the more … Continue reading this entry

Sanofi Seeks IPR Of Cabilly Patent

On July 27, 2015, Sanofi-aventis U.S. LLC and Regeneron Pharmaceuticals, Inc. filed a petition for Inter Partes Review (IPR) of the “Cabilly II” patent, U.S. Patent No. 6,331,415. The Cabilly II patent granted shortly after I started my career as an attorney, and has stayed in the news almost ever since. Will this IPR make its final headlines?… Continue reading this entry

New Insights On USPTO Patent Trial And Appeal Board Proceedings

I’m pleased to announce that Foley & Lardner LLP has launched a new blog that will focus on USPTO Patent Trial and Appeal Board (PTAB) proceedings, and provide experienced-based insights into Patent Trial proceedings. I’ll still be spending most of my blogging time here, but once in a while I’ll be writing about PTAB issues … Continue reading this entry

Federal Circuit Reverses Unreasonable PTAB Claim Construction, Upholds Idle Free Standard For Motions To Amend

The Federal Circuit decision in Microsoft Corp. v. Proxyconn, Inc., addressed several important issues relating to post-grant patent trials conducted by the USPTO Patent Trial and Appeal Board (PTAB), including the PTAB’s claim construction standard and the requirements for motions to amend the claims. The net result of the decision was to affirm-in-part, reverse-in-part, vacate-in-part and remand–which … Continue reading this entry

Another Sequenom Patent Appeal Heads To The Federal Circuit

While Sequenom’s appeal of the district court’s summary judgment of invalidity of U.S. Patent 6,258,540 under 35 USC § 101 has been pending at the Federal Circuit, the USPTO has been considering the validity of the patent under 35 USC §§ 102 and 103 in an Inter Partes Review proceeding. Now that the decision of the Patent … Continue reading this entry