Bryan S. Hales, P.C.

Astellas Pharma Inc. et al v. Ascent Pharmaceuticals, Inc. et al. (D. Del. 2025) — Lead trial counsel for Astellas in Hatch-Waxman litigation against Ascent Pharmaceuticals and MSN Laboratories related to Astellas’ Myrbetriq®, used to treat overactive bladder. Following a bench trial in October 2025, obtained a directed verdict that Ascent would infringe the claims of the four asserted patents. Following post-trial briefing, the claims of the asserted patents were also found not invalid and not unenforceable, resulting in a complete victory for Astellas. Received “Litigator of the Week” runner-up recognition from The American Lawyer for the win.

Astellas Pharma Inc. et al v. Zydus and Lupin (D. Del. 2026) — Lead trial counsel for Astellas in Hatch-Waxman litigation against Zydus and Lupin related to Astellas’ Myrbetriq®, used to treat overactive bladder. After jury selection in a February 2026 trial, the case settled with Astellas receiving several hundred million dollars and ongoing payments for further product sales.

Boehringer Ingelheim Pharmaceuticals, Inc., et al. v. HEC Pharmaceuticals Inc., et al. — Representing Boehringer Ingelheim in Hatch-Waxman litigation filed against Mylan and Aurobindo related to BI’s Tradjenta® (linagliptin) anti-diabetic tablets.

Boehringer Ingelheim Pharmaceuticals Inc., et al. v. Mankind Pharma Ltd., et al. — Representing Boehringer Ingelheim in Hatch-Waxman litigation arising from more than a dozen Defendants’ submissions of ANDAs seeking approval to manufacture and sell generic versions of Boehringer’s Jardiance® (empagliflozin) products used to treat type II diabetes.

Biedermann Motech. v. K2, Inc. (E.D. Va. 2022) — Trial counsel for Biedermann, winning a two-week patent infringement jury trial regarding spinal implant technology.

Par Pharmaceutical, Inc., et al. v. Eagle Pharmaceuticals, Inc. (D. Del. 2021) — Lead trial counsel for Eagle regarding Eagle’s ANDA for generic Vasostrict® (vasopressin injection) for the treatment of hypotension/low blood pressure in patients experiencing vasodilatory shock. After a bench trial, the Court found that Eagle’s ANDA product did not infringe.

Janssen Biotech, Inc. v. Celltrion Healthcare Co., Ltd. et al. (D. Mass. 2018) — Trial counsel for Celltrion and Hospira, winning summary judgment of noninfringement. Cross-examined one of plaintiff’s experts in a Daubert hearing with live witnesses, developing evidence that led to summary judgment of noninfringement due to ensnarement.

Leading pharmaceutical company (AAA Arbitration 2018) — Lead trial counsel for major pharmaceutical company in a confidential arbitration with several hundred million dollars at stake related to a joint development agreement. Won a complete victory.

ZimmerBiomet (AAA Arbitration 2018) — Lead trial counsel for ZimmerBiomet in an arbitration in which the claimant alleged breach of a development contract and license, and sought several hundred million dollars in royalties on sales of ZimmerBiomet’s Persona Knee System. Won a complete victory for ZimmerBiomet after a 10-day trial.

Allergan v. Sandoz (E.D. Tex. 2016, Fed. Cir. 2017) — Lead trial counsel in three patent case related to ophthalmologic drug for treating ocular hypertension. One patent found valid and infringed in prior trial, which was affirmed by Federal Circuit. Took over this case five weeks before trial and won noninfringement of two of the three patents, including the one previously found infringed. On appeal, the Federal Circuit affirmed the noninfringement decision regarding the two patents, and reversed the finding of infringement as to the third, resulting in noninfringement for all three patents.

Leading pharmaceutical company (AAA Arbitration 2017) — Trial counsel for a major pharmaceutical company in a confidential arbitration in which the claimant sought $1.5 billion in damages for breach of contract and misappropriation of trade secrets and confidential information relating to a blockbuster new drug, under an agreement between the parties. Won a complete victory for our client after a multiday hearing.

Hemopet v. Hill’s Pet Nutrition (S.D. Cal 2014, Fed. Cir. 2015) — Lead trial counsel for Hill’s in a case in which the plaintiff alleged infringement of four patents asserted against pet food products designed to affect the expression of targeted genes. Won summary judgment of invalidity for lack of patentable subject matter. The Federal Circuit affirmed and the Supreme Court denied cert.

Leading pharmaceutical company (AAA Arbitration 2015) — Trial counsel for a major pharmaceutical company in a confidential arbitration in which the claimant alleged that a blockbuster new drug would be royalty bearing to the tune of billions of dollars, under an agreement between the parties. Won a complete victory for our client after a multiday hearing.

Scott and Scuderi v. Zimmer (D. Del, AAA Arbitrations 2012) — Lead trial counsel for Zimmer in three trials in 11 months: a five-day trial in Delaware federal court, a 10-day confidential arbitration and a 15-day confidential arbitration. The disputes related to claims by prominent orthopedic surgeons — one was the head physician for the 1992 U.S. Olympic Basketball “Dream Team” and the head physician for the New York Knicks for more than 25 years — seeking to secure lengthy royalty streams on some of Zimmer’s most successful knee implants. In the Delaware trial, they sought to be named as inventors on three Zimmer patents, and one of the surgeons also sought rescission of an agreement that ended a prior royalty stream. If successful, the doctors’ claims would have extended or revived license agreements that they argued supported significant additional royalty payments on knee systems with billions in annual sales. In addition to disputing the merits of the plaintiffs’ correction of inventorship claims, Zimmer argued that both of their claims were barred by releases in prior agreements. The court’s opinion contained detailed findings of fact and law based almost entirely on Zimmer’s trial theories. The court found that the surgeons were not inventors on the Zimmer patents and that they had also released their claims. The arbitration hearings were concluded and then resolved confidentially some months after the Delaware trial.

Magna Donnelly v. Guardian Industries et al. (Ottawa County, Mich. 2010) — Lead trial counsel for Guardian in a three-week jury trial regarding adhesive technology used to attach hardware to automotive windows. Magna Donnelly filed the case in its home jurisdiction, accusing Guardian of trade secret misappropriation and breach of contract. After about 1.5 hours of deliberation, the jury returned a complete defense verdict for Guardian.

A leading computer, mobile device and media player company v. High Tech. Computer Corp. (ITC Inv. No. 337-TA-710) — Represented a leading computer, mobile device and media player company before the ITC in a trial alleging infringement of smart phone feature and operating system patents. After a three-week trial, the Court ruled in favor of client and recommended an exclusion order banning importation of infringing smart phones.

MedIdea v. Zimmer (N.D. Ind. 2009) — Lead counsel for defendant Zimmer in a patent infringement suit brought by patent holding company MedIdea LLC alleging that Zimmer’s hip and shoulder replacement-related products infringe seven patents. In June 2010, the U.S. Court of Appeals for the Federal Circuit granted Zimmer’s petition for a writ of mandamus, ordering the U.S. District Court for the Eastern District of Texas to transfer the case. The ruling vacated the district court’s denial of Zimmer’s motion to transfer and directed it to send the case to the U.S. District Court for the Northern District of Indiana, where Zimmer is headquartered. The case settled favorably not long after transfer to Indiana.

Oxford Gene Technology Ltd. v. Mergen Ltd. (D. Del. 2005) — Trial counsel for OGT, winning summary judgment that Mergen infringed OGT’s patent and summary judgment rejecting several of Mergen’s defenses, leaving for trial only the amount of damages owed to OGT, whether Mergen’s infringement was willful, and Mergen’s sole remaining defense. On the eve of trial, Mergen consented to the entry of judgment against it on the issue of validity, and agreed to take a license to OGT’s patent. The Court entered judgment against Mergen in January 2005.

Howmedica v. Zimmer, Inc. et al. (D.N.J. 2005-2018) — Counsel for defendant Zimmer in defense of a multiple-patent case in which Howmedica sought $2 billion in damages relating to highly-crosslinked ultra high molecular weight polyethylene (UHMPWE) inserts for various orthopaedic implant systems. Won a $14 million fee award after a complete defense victory after 13 years of litigation. Kirkland won summary judgment of invalidity with respect to three of the four patents in suit, summary judgment of noninfringement with respect to half of the fourth patent, and put the fourth patent into inter partes reexamination, where the patent office rejected the claims. The Federal Circuit affirmed the district court’s judgment of invalidity with respect to the first three patents and the Supreme Court denied Howmedica’s cert. petition. The Federal Circuit affirmed the PTO rejection.

Autogenomics, Inc. v. Oxford Gene Technology Ltd. (C.D. Cal.) — Lead counsel for OGT, obtaining a dismissal of the action for lack of personal jurisdiction, which was affirmed by the Federal Circuit.

Guardian Industries Corp. v. Samsung Electronics Co., et al; Guardian Industries Corp. v. Dell, Inc. et al., and Guardian Industries Corp. v. Innolux Corp. (D. Del.) — Lead counsel for Guardian in three patent infringement actions relating to optical compensation films used in LCD devices such as flat-panel computer monitors. In litigation against more than thirty U.S., Japanese, Korean, and Taiwanese companies for patent infringement, won several procedural and substantive hearings and handled about a dozen mediations leading to favorable settlements. The total settlement and license fees are in the high tens of millions.

Interlogix, Inc. v. Honeywell Inc., Honeywell International Inc., Pittway Corporation, System Sensor, Ademco Group, and ADI. (D. Minn.) — Lead counsel for Defendants in patent infringement litigation relating to smoke detector electrical circuitry, seeking correction of inventorship and infringement, and defending against accusations of infringement against Defendants. Briefed and successfully argued a Daubert motion that resulted in the Court precluding plaintiff’s damages expert from testifying that plaintiff was entitled to $24 million in lost profits damages. The case settled favorably.

Schering Corporation v. Three Rivers Pharmaceuticals, LLC (W.D. Pa.); Schering Corporation v. Geneva Pharmaceuticals Technology Corp., (D.N.J.); Schering Corporation v. Teva Pharmaceuticals USA, Inc. (D.N.J.) — Counsel for Schering in patent infringement litigations against generic manufacturers, which submitted Abbreviated New Drug Applications seeking FDA approval for generic versions of Schering’s Rebetol® product. Settled favorably.

IDX Systems Corporation v. Epic Systems Corporation, University of Wisconsin Medical Foundation, Mitchell Quade, and Michael Rosencrance (Seventh Circuit Court of Appeals, W.D. Wis.) — Took on representation of IDX in a complex business litigation matter with rival company Epic Systems Corp. of Wisconsin, for the appeal after IDX had lost on summary judgment in the District Court. Led the team’s efforts relating to the technical issues in the case. After a successful appeal and remand to the District Court, the case settled after a series of positive results in the District Court, including winning summary judgment of breach of contract

The Miller Agency v. General Motors and Ammirati Puris Lintas (N.D. Tex.) — Counsel for General Motors and Ammirati Puris Lintas in copyright, trademark, and misappropriation of ideas case, in litigation and mediation that resulted in favorable settlement.

Henkel Corp. v. Allco Chemical Corp. (D. Del.) — Trial counsel for Allco Chemical in a patent infringement action relating to organic compounds used in the solvent extraction of copper. The case settled on favorable terms after the pretrial conference.

PPG Industries v. Guardian Industries Corp. (W.D. Pa.) — Trial counsel for Guardian in patent infringement litigation involving the composition of automotive windshield glass. In June, 1997 a jury returned a verdict of noninfringement in favor of Guardian. In October, 1998, the Federal Circuit affirmed the jury’s verdict.

Oxford Gene Technology Ltd. v. Affymetrix, Inc. (D. Del.) — Trial counsel for OGT, winning a jury verdict of infringement of all asserted claims by Affymetrix of patent rights relating to oligonucleotide array technology.