Served as lead defense counsel for BioDelivery Sciences Int’l, Inc. (BDSI) in two patent litigations, after BDSI was acquired by Collegium Pharmaceutical, Inc. in March of 2022. Cases were pending in the Eastern District of North Carolina where BDSI’s products Bunavail® (buprenorphine and naloxone) buccal film and Belbuca® (buprenorphine) buccal film were accused of infringing Aquestive Therapeutic’s U.S. Patent No. 8,765,167. The parties had been litigating for nearly a decade in federal district courts and in multiple proceedings before the Patent Trial and Appeal Board. After appearing as substitute counsel for BDSI, Robins Kaplan developed and asserted strategic patent infringement defenses and—in a little over eight months—reached a favorable settlement achieving complete freedom to market for BDSI. Aquestive Therapeutics, Inc. v. BioDelivery Sciences Int’l, Inc., Civ. No. 19-505-D (E.D.N.C.); Indivior Inc. v. BioDelivery Sciences Int’l, Inc., Civ. No. 15-350-D (E.D.N.C.)

Represented Bioeq AG with respect to intellectual property matters and licensing for Biologics License Application Number 761165 for the proposed biosimilar ranibizumab product, including a license agreement among Bioeq, Coherus, and Genentech, Inc. Coherus owns the BLA for CIMERLI (ranibizumab-egrn) and commercial rights in the U.S. and its territories. Coherus licensed CIMERLI from Bioeq AG, a joint venture between Polpharma Biologics Group B.V. and Formycon AG. Coherus announced the commercial availability, beginning October 3, 2022, of CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection) for all approved indications. CIMERLI is an anti-VEGF therapy within a class of biologics that has been revolutionary in helping retinal patients maintain or gain vision.

As court-appointed co-lead trial counsel, Mr. Holdreith led a trial team that achieved settlements in excess of $118 million on behalf of U.S. contact lens purchasers in an expansive antitrust class action against the four dominant manufacturers and the largest nationwide distributor of contact lenses. The action alleged a conspiracy by Johnson & Johnson, CooperVision, Alcon, Bausch + Lomb, and wholesale distributor ABB Optical Group to stifle competition from discount retailers and fix prices in the $4 billion contact lens market serving 40 million Americans. Plaintiffs alleged that defendants illegally imposed minimum retail prices for many popular brands of contact lenses, and that in doing so, they violated federal antitrust laws, as well as state consumer protection and antitrust laws. In March of 2022, days before trial was scheduled to begin, we reached settlements totaling $75 million with the final two defendants—Johnson & Johnson Vision Care and Alcon Vision. In re: Disposable Contact Lens Antitrust Litigation, 15-md-02626 (M.D. Fla.)

Trial Counsel to the Trustees of the University of Pennsylvania in a patent infringement action against Eli Lilly and ImClone related to the manufacture and sale of Erbitux. Penn asserted US Patent No. 7,625,558 related to treatment of certain cancers using antibodies to erbB receptors followed by radiation therapy. The action was in the Federal District Court for the Eastern District of Pennsylvania. The case was resolved on confidential terms. THE TRUSTEES OF THE UNIVERSITY OF PENNSYLVANIA v. ELI LILLY AND COMPANY, IMCLONE LLC and BRISTOL-MYERS SQUIBB COMPANY, No. 15-6133

Trial counsel to Collegium Pharmaceutical in a Hatch-Waxman litigation matter involving 14 Orange Book-listed patents for the oxycodone product Xtampza ER. The case resulted in a settlement in which defendant Teva agreed to a consent judgment confirming that its proposed generic products infringe on Collegium’s asserted patents. Under the settlement, Collegium will grant Teva a license to market its generic version of Xtampza ER in the United States beginning on or after September 2, 2033. Collegium Pharmaceutical Inc. v. Teva Pharmaceuticals USA

Mr. Holdreith has handled jury verdicts of $34.7 million (St. Clair v. Canon); $25 million (St. Clair v. Sony) and $8 million (Personal Audio v. Apple), as well as defense wins including a successful defense of non-infringement after trial in an ANDA case involving the blockbuster drug Sensipar (Amgen v. Amneal), a judgment dismissing claims of infringement of three Orange Book listed patents leading to the launch of an abuse-deterrent formulation of oxycodone (Purdue v. Collegium), a summary judgement of non-infringement of ten patents (Auxilium v. Upsher Smith Labs), a trial judgment of invalidity of three patents (Purdue v. Actavis), and denial of an injunction after a bench trial, which later resulted in invalidity of the asserted patent (Medicis Pharm. Corp. v Upsher-Smith Labs).

Lead counsel to Collegium Pharmaceutical, Inc., in a series of related cases involving nine patents owned by Purdue and related entities related to oxycodone. We obtained a judgment of invalidity of the three Orange Book listed patents in Purdue Pharma LP v. Collegium Pharm. case number MAD-1-15-cv-13099 on February 18, 2016, after succeeding in a motion to transfer the action from the District of Delaware to the District of Massachusetts. As a result, our client was able to obtain final approval for its 505(b)(2) product Xtampza ER and launch the product commercially. We then obtained summary judgment of non-infringement of two additional patents, institution of PGR of an additional patent based on likely invalidity, and continue to represent Collegium in the ongoing litigation of additional patents. Purdue Pharma LP v. Collegium Pharm. case number MAD-1-15-cv-13099

Co-lead trial counsel to Collegium Pharmaceutical, Inc., in a trial for Post-Grant Review before the United States Patent Trial and Appeal Board (“PTAB”). The PTAB instituted trial upon a finding that US Patent No. 9,693,961 owned by Purdue Pharma is likely invalid for lack of a written description, for lack of enablement, and/or indefiniteness, and as being anticipated by prior art.

Counsel to Gurnet Point Capital with respect to certain Hatch-Waxman, regulatory, and scientific diligence in the acquisition by Gurnet Point of Radius Health, in a transaction valued at approximately $890 Million. Radius markets Tymlos twice daily injection indicated for post-menopausal women at risk for osteoporosis. 

Represented Collegium Pharmaceutical, Inc. in its acquisition of BioDelivery Sciences International Inc. (“BDSI”). Performed patent and regulatory diligence for transaction valued at over $600 million. The acquisition included BDSI’s Belbuca, Symproic, and Elyxyb drug products.
 
Represented Collegium Pharmaceutical, Inc. in its purchase of the Nucynta franchise from Assertio Therapeutics, Inc. Performed patent and regulatory diligence for transaction valued at $375 million.

Represented Hikma Pharmaceuticals USA, Inc. in a Hatch-Waxman patent litigation concerning an intravenous medication, used when a patient cannot exercise adequately for a stress test, that increases blood flow through the arteries of the heart. Astellas US LLC v. Hikma Pharmaceuticals USA, Inc., 21-1785-CFC (D. Del.)
 
Served as lead counsel to Upsher-Smith in Hatch-Waxman patent litigation in the District of New Jersey brought by Galephar Pharmaceutical Research, Inc., Cipher Pharmaceuticals Inc., and Sun Pharmaceutical Industries, Inc. asserting infringement of five patents covering Absorica® (Isotretinoin) Capsules. The case settled on September 4, 2020. Upsher-Smith announced the launch of its Isotretinoin Capsules on June 25, 2021, nearly three months before the Orange Book-listed patents’ expiration date. Galephar Pharmaceutical et al. v. Upsher-Smith Laboratories, LLC.

Represented Amneal Pharmaceuticals, Inc. in an 18-patent Hatch-Waxman patent litigation concerning a medication indicated in a woman after menopause to reduce moderate to severe hot flashes. TherapeuticsMD, Inc. v. Amneal Pharmaceuticals, Inc., 20-5256, 20-14933 (D.N.J.).

Lead trial counsel to defendant Amneal Pharmaceuticals in Amgen v. Amneal, a four-day Hatch-Waxman patent infringement trial before Judge Goldberg, sitting specially for the Federal District Court in Delaware. Obtained a defense finding of non-infringement on Amneal unique non-infringement defense that its proposed formulation of the blockbuster drug Sensipar does not infringe Markush limitations of the asserted patent. The trial order and memorandum were issued on July 27, 2018. The case was settled on confidential terms after a remand on appeal. Amgen v. Amneal et al., No. 1:16-cv-00853-MSG

Lead counsel to defendant Collegium Pharmaceutical, Inc., in a patent infringement suit in the District of Delaware. Purdue Pharma asserts that the sale of immediate-release and extended-release Nucynta infringes U.S. Patent Nos. 9,861,583, 9,867,784, and 9,872,836 on our Rule 12(c) Motion for Judgment on the Pleadings. The court issued an order on June 19, 2019, stating that “judgment in Collegium’s favor is warranted under the doctrine of patent exhaustion to the extent Collegium’s alleged infringing activities resulted from sales that fall within the scope of that covenant.”

Lead trial counsel to lead defendant Novel Laboratories in an 11-day Hatch-Waxman patent infringement trial before Judge Jose Linares of the Federal District Court in New Jersey. The case involved three Orange Book listed patents related to zolpidem tartrate, the active ingredient in Intermezzo and Ambien. On March 27, 2015, Judge Linares issued an opinion determining that we had proved all of the asserted patents were invalid. The Federal Circuit Court of Appeals issued a summary affirmance under Rule 36 within days of oral argument on January 8, 2016. The action on appeal was No. 15-1659. Purdue Pharm. Prods. v. Actavis Elizabeth LLC et al

Represented device manufacturer Ypsomed AG as a third-party in a Hatch-Waxman patent litigation concerning a drug and injection pen for treating diabetes. Sanofi-Aventis U.S. LLC v. Merck, Sharp & Dohme Corp., 16-0812-RGA (D. Del.)

Lead counsel to IFS Industries, Inc. and an individual employee in defense of trade secret and related claims in the State District Court of Minnesota, Ramsey County, involving the alleged misappropriation of hot melt adhesive formulations containing amorphous poly-alpha olefins and heterophasic metallocene-catalyzed polypropylene. Obtained early dismissal of a claim seeking to gain ownership of certain IFS Industries patents and patent applications based on plaintiff’s refusal to join an indispensable party. Obtained an order requiring plaintiff to identify its alleged trade secrets with specificity prior to discovery. Following discovery and motion practice, including a motion by plaintiff to withdraw its trade secret count, the case was resolved by settlement. Adherent Laboratories, Inc. v. William Bunnelle and IFS Industries, Inc., No. 62-CV-16-531

Lead trial and appeal counsel for defendant Twin Cities German Immersion charter school in a statutory and constitutional suit to temporarily, preliminarily, and permanently enjoin a building project on historic preservation grounds under the Minnesota Environmental Rights Act. The case was tried to the Ramsey County District Court over three days in July 2019. The District Court entered an order on July 15, 2019 for an injunction bond on a showing of potential damages from delay of the project of up to almost $2 million. In an expedited appeal, a panel of the Minnesota Court of Appeals affirmed the bond by an order dated July 23, 2019. The project proceeded after the bond was not posted and the suit was dismissed as moot on August 27, 2019. State of Minnesota by Friends of Warrendale – Save Historic St. Andrews, LLC v. Twin Cities German Immersion School, 62 CV 19- 3960.

Lead trial counsel to lead defendant in a three-day Hatch-Waxman patent infringement trial before Judge Andrews of the Federal District Court in Delaware. The case involved the validity of claims to oxymorphone hydrochloride with low levels of alpha, beta unsaturated ketones, the active ingredient in Opana. The case was tried July 11-13, 2016. Endo Pharm. v. Amneal Pharm., et al.

Lead counsel for Virtual Radiologic Corporation and Nighthawk Radiology Services in an action for patent infringement, copyright infringement, misappropriation of trade secrets, breach of contract, and interference with contract in the District Court for the District of Arizona. We obtained injunctions in favor of our client on September 19, 2014, including a finding of patent infringement. The case involved our clients’ teleradiology technology and confidential business information. Virtual Radiologic Corp. v. Tandem. The action is civil action number 2:13-cv-01705.

Counsel to investors and NDA filers under section 505(b)(2) for patent evaluation and litigation strategy resulting in successful financing of development and commercialization.

Counsel to Quest Diagnostics in Mayo Collaborative Services LLC et al. vs Franklin R. Cockerill et al., case number 55-CV-14-6861, in the State District Court of Minnesota, Olmsted County, a matter filed by Mayo Clinic LLC against a former top Mayo executive involving claims of breach of fiduciary duty and trade secret.

Lead defense counsel for Upsher-Smith Laboratories in a Hatch-Waxman patent infringement case in which we obtained a summary judgment of non-infringement of ten Orange Book listed patents claiming a transdermal testosterone gel and method of treating hypogonadism before Judge Sue Robinson of the Federal District Court in Delaware. The opinion was filed on December 4, 2013. The case in the District Court was No. DED-1-13-cv-00148. The technology related to claimed macrocyclic penetration enhancers for increasing the rate of passage of an androgen through the skin. We were successful in demonstrating to the Court that the case warranted an exception to the Court’s ordinary practice of declining to hear summary judgment motions in Hatch-Waxman cases. An appeal was dismissed on September 18, 2014, resulting in a final judgment of non-infringement for our client. Our client Upsher-Smith was able to launch its Vogelxo 505(b)(2) product following the judgment. Auxilium Pharmaceuticals v. Upsher-Smith Laboratories

Trial counsel in a patent infringement case in which a Texas federal jury awarded our client, Personal Audio LLC, $8 million in damages after finding that Apple’s iPods infringed our client’s patent for an audio player that can download or receive navigable playlists. The verdict was announced on July 8, 2011. The court also awarded prejudgment interest in the amount of $4,182,331 for a total judgment of $12,182,331. Personal Audio LLC v. Apple Inc.

Lead defense counsel for Upsher-Smith Laboratories in a copyright, trade dress, and patent action concerning packaging for a pharmaceutical, and a related indemnification dispute. Resolved on confidential terms prior to significant litigation.

Lead defense counsel to Tornier, Inc., in a patent infringement action filed in the Federal District Court in Delaware concerning the Aequalis Intermedullary Nail used for shoulder fractures. The action was resolved on confidential terms prior to significant litigation. Nuvana Medical Innovations LLC v. Tornier, Inc.

Lead counsel for large beverage company in defense of a matter involving multiple patents. Resolved without litigation.

Lead counsel for Upsher-Smith Laboratories in ongoing actions arising under the Hatch-Waxman Act.

Counsel to a Requestor in an action naming the University of Texas at Austin under the Texas Public Information Act seeking disclosure of public records. Following several discovery motions and the depositions of records custodians, the matter was resolved by production of the requested records to our client.

Lead trial counsel defending Upsher-Smith Laboratories in a patent suit to enjoin the sale of a pharmaceutical formulation. Following a two-day bench trial on the issues of infringement, validity and enforceability of the plaintiff's patent, the Court denied a request to temporarily enjoin the client from making and selling its products. All claims asserted against our client were subsequently invalidated during an ex parte re-examination based on the same arguments and evidence we presented during the bench trial. The invalidity of the claims was summarily affirmed on appeal to the CAFC. The district court action is Medicis Pharm. Corp. v. Upsher-Smith Labs., No. CV05-3458 (D. Az. filed October 27, 2005). The re-examination appeal is No. 2009-1291 (Reexamination No. 90/008,068).

Trial counsel in St. Clair Intellectual Property Consultants, Inc. v. Canon, Inc. et al., No. 03-241 (D. Del., filed February 28, 2003) a case in which a federal jury in Wilmington, Delaware awarded Mr. Holdreith's client, St. Clair, $34.7 million after a finding that Canon infringed four patents relating to digital camera technology. The verdict was announced on October 8, 2004.

Trial Counsel in St. Clair Intellectual Property Consultants, Inc. v. Fuji, Ltd. et al., No. 03-241 (D. Del., filed February 28, 2003) a case in which a federal jury in Wilmington, Delaware awarded Mr. Holdreith’s client, St. Clair, $3 million after a finding that Fuji infringed four patents relating to digital camera technology. The verdict was announced on October 25, 2004. After a long and tortured post-trial history the verdict was reversed by the Federal Circuit on a claim construction issue.

Trial counsel in St. Clair Intellectual Property Consultants, Inc. v. Sony Corp. et al., No. 01-557 (D. Del., filed Aug. 14, 2001) a case in which a federal jury in Wilmington, Delaware awarded his client, St. Clair, $25 million after a finding that Sony infringed four patents relating to digital camera technology. The verdict was announced on February 25, 2003. The parties entered into a license agreement two days later, the terms of which are confidential.

Lead counsel in complex patent litigation in several jurisdictions, including cross claims for infringement of seven patents on surgical methods and devices. Matter was settled on confidential terms involving cross-licenses.

Defended ev3, Inc. in an action brought by Boston Scientific Corporation and Boston Scientific Scimed, Inc. for misappropriation of trade secrets and infringement of patents related to medical devices known as embolic protection filters. Also represented ev3, Inc. in patent counterclaims against the Boston Scientific defendants involving embolic protection technology. Claims for misappropriation of trade secrets were dismissed in part. The patent claims and counterclaims were settled before trial on a confidential basis. Boston Scientific v. ev3, Inc.

Lead counsel for individual inventor and related small business in defense of an action by former employer seeking to gain control of our client’s subsequent invention and resulting business. The case was resolved prior to significant litigation through our successful motion on the plaintiff’s failure to join an indispensable party, resulting in a negotiated resolution of the claims.

Member of a team that obtained a ruling of federal preemption in the Ninth Circuit Court of Appeal as counsel to Global diversified technology and financial services company in a putative class action alleging state law claims of hearing loss by workers on locomotives. The Ninth Circuit affirmed a district court ruling that the claims were preempted under the Federal Boiler Inspection Act, and dismissed all claims against our client. Law v. General Motors and Global diversified technology and financial services company, 114 F.3d 908 (9th Cir. 1997).

Appellate counsel to Bicoastal Corporation in appeal of commercial dispute argued before the 11th Circuit Court of Appeals. Obtained summary affirmance for our client in a commercial dispute concerning an acquisition, dismissing claims by an unsuccessful bidder for an aerospace business alleging improper termination of the acquisition agreement and seeking a breakup fee. 87 F.3d 1330 (11th Cir. 1996).

Member of a team that was counsel to Bicoastal Corporation and obtained a recovery of $94 million in complex international litigation to recover royalties due for use for use of the trademarks of the former Singer Sewing Machine Company. The original claim and judgment were decided in the bankruptcy court for the Middle District of Florida. Follow-on collection actions were prosecuted in multiple jurisdictions including the United States and Hong Kong.

Counsel to Metropolitan Airport Commission in regulatory litigation concerning administrative rules promulgated by the Commission under its statutory powers. Obtained judgment that the Commission acted within its authority, and obtained dismissal of claims challenging rules for ground transportation operators as against challenges arising under the applicable statute, as well as claims sounding in due process and equal protection. Hyland v. Metropolitan Airport Com’n, 884 F.Supp. 334 (1995).

Counsel to Wisconsin Central Railroad in regulatory litigation concerning Wisconsin’s “conductor law” governing the qualifications of conductors. Obtained a ruling that the state law challenged by our client is preempted by the Federal Railroad Safety Act. State v. Wisconsin Central Transp. Corp., 200 Wis.2d 450, 546 N.W.2d 206 (Ct. App. 1996).

Lead trial counsel for ATEC associates in contested regulatory matter relater before the State of Minnesota Office Of Administrative Hearings, resulting in significant reduction of penalties under contested Administrative Penalty Order.

Other cases include trial experience in complex, multi-million dollar patent litigation in multiple forums and before the Federal Circuit Court of Appeals. Technologies include, among others, medical devices, surgical methods, computer hardware and software, and pharmaceuticals.