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Pharmaceuticals

Transactional

  • Provided issuer-side representation to Pieris Pharmaceuticals, Inc. in its $44M follow-on offering underwritten by Jefferies; Cowen and Company; and Evercore ISI and in its $16.5M PIPE underwritten by Cowen and Company; Oppenheimer; and Trout.
  • Provided issuer-side representation to Albireo Pharma, Inc. in multiple offerings, including its $65M follow-on offering underwritten by Cowen and Company; William Blair & Company; Needham & Company; Wedbush Securities; and Roth Capital Partners and its $51.9M follow-on offering underwritten by Cowen and Company; William Blair & Company; Needham & Company; and Wedbush Securities.
  • Served as underwriters’ counsel in the $345M follow-on offering of American Depositary Shares GW Pharmaceuticals plc underwritten by Goldman Sachs; Morgan Stanley; J.P. Morgan and Cowen and Company, the $276M follow-on offering led by Goldman Sachs; Morgan Stanley; BofA Merrill Lynch; and Cowen and Company, the $252M follow-on offering led by Morgan Stanley; BofA Merrill Lynch; and Goldman Sachs, the $179.2M and $169.7M follow-on offerings led by Morgan Stanley; BofA Merrill Lynch; Cowen and Company; and Piper Jaffray & Co., and the $31.1M offering led by Lazard Capital Markets; Cowen and Company; Canaccord Genuity; and Roth Capital Partners.
  • Served as underwriters’ counsel in the $200M follow-on offering of Acceleron Pharma Inc. led by JP Morgan; Citi; and Leerink Partners, the $150M follow-on offering led by Morgan Stanley; Leerink Partners; and UBS, the $138M follow-on offering led by Leerink Partners; Citigroup; Piper Jaffray; and JMP Securities, and the $96.2M initial public offering (IPO) led by Citigroup; Leerink Partners; Piper Jaffray; and Canaccord Genuity.

Intellectual Property

  • Represented plaintiffs Kowa Company, Ltd., Kowa Pharmaceuticals America, Inc. and Nissan Chemical Industries, Ltd. in litigation which involved compound, formulation, and polymorph patents directed toward quinoline-type mevalonolactones (or, pitavastatin calcium) relating to the drug product Livalo®. Several of the cases successfully resolved pre-trial, and after a 10-day trial plaintiffs prevailed on all issues in two court decisions against the remaining defendants, Amneal and Apotex. Mintz Levin represents Kowa and Nissan in the appeal filed by Amneal and Apotex in the Federal Circuit. The team also defeated institution of three inter partes reviews filed by generic manufacturer defendants in these cases.
  • Prepared and filed Preliminary Patent Owner Responses to three inter partes review petitions filed by generic pharmaceutical manufacturers against our client Nissan Chemical. Based on those filings, the PTAB denied all three petitions. The petitioners are defendants in Hatch-Waxman litigation filed by Mintz on behalf of Kowa and Nissan Chemical to protect their market position for Livalo®, an important pharmaceutical which reduces LDL cholesterol. IPR2015-01069, IPR2015-01647, IPR2015-01648
  • Represented Mitsubishi as plaintiff-appellee against Barr Laboratories' appeal of judgment from SDNY. Federal Circuit affirmed that claims in the '052 patent were not anticipated and would not have been obvious. (435 Fed. Appx. 927 (Fed. Cir. Aug. 2, 2011))
  • Represented Jagotec AG, a wholly owned subsidiary of Skyepharma, as co-counsel in this Hatch-Waxman/Paragraph IV litigation. The case was settled on favorable terms.
  • Represent a biopharmaceutical company focused on discovering, developing and commercializing therapeutics to treat autoimmune diseases, inflammatory disorders, and cancer. Working with the company since its IPO, the firm writes, files and prosecutes patents for the company, and recently managed the diligence process in a significant deal with a global strategic partner which resulted in a significant investment.
  • Takeda Chemical Industries Ltd. v. Mylan and Alphapharm; 417 F. Supp. 2d 341, (S.D.N.Y. 2006); aff'd, 492 F.3d 1350 (Fed. Cir. 2007); cert. denied. 552 U.S. 1295 (2008) - Post-KSR case interpreting Supreme Court approach to obviousness and upholding non-obviousness of important pharmaceutical advances.
  • Provide IP due diligence and counseling support when a global pharmaceutical company purchases or licenses technology, including in 2017 handling simultaneous freedom to operate studies in support of three confidential licensing and acquisition programs.
  • Obtained affirmance at Court of Appeals for the Federal Circuit of district court judgment upholding Mitsubishi's patent over anticipation and obviousness challenges brought by Barr Laboratories. (No. 2010-1432, 2011 WL 3288394 (Fed. Cir. Aug. 2, 2011))
  • Mitsubishi Chemical Corp., et al. v. Barr Laboratories, Inc., et al. (SDNY, 1:07cv11614) – Successfully represented Mitsubishi Chemical and Mitsubishi Tanabe Pharma Corp. in a Hatch-Waxman/Paragraph IV litigation regarding formulation of a blood anticoagulant used to treat heparin-induced thrombocytopenia (HIT). The validity of the patent was upheld after a lengthy bench trial, in a 156-page decision. (718 F. Supp. 2d 382 (SDNY 2010))
  • Represent one of the leading providers of treatment for opioid addiction worldwide. The company has partnered with governments, policy makers, payers, and healthcare professionals, and to date, has provided an estimated 5 million patients with effective treatment options. Their portfolio of products is available in over 40 countries around the world and the Mintz team has been responsible for designing and implementing prosecution strategy for one of the company's most successful products, which is not listed in FDA's Orange Book.

Litigation

  • Represented a pharmaceutical company and its former Board of Directors in claims that the Board breached its fiduciary duty by not maximizing the value of its shares in the merger transaction. The Mintz team negotiated an excellent settlement for the company and the Board.
  • Served as counsel for a pharmaceutical company in a securities class action alleging that our client and certain of its officers and directors violated Rule 10b-5 in connection with the alleged failure to disclose clinical trial results for a product being developed by the company. Case dismissed without prejudice.
  • Represented Vertex Pharmaceuticals, Inc. in a decision crystalizing the standard required to plead scienter in securities fraud cases, the First Circuit affirmed the dismissal of a securities class action complaint filed against Vertex and the company’s senior executives by Local No. 8 IBEW Retirement Plan and Trust.  This decision ends four years of litigation defending against plaintiff’s false and unfounded allegations that Vertex’s disclosures regarding the results of clinical trials assessing the safety and efficacy of the company’s combination drug therapy for the treatment of patients with cystic fibrosis violated the federal securities laws. We successfully rebuffed plaintiffs twice in the District Court, ultimately securing victory in the First Circuit.
  • Served as counsel for a global pharmaceutical company in a lawsuit alleging that a group of pharmaceutical manufacturers conspired to overstate the average wholesale price (“AWP”) for prescription drugs covered by the Medicare program. Plaintiffs advanced claims under §§ 1 and 2 of the Sherman Act and the RICO Act. Through our advocacy, we convinced plaintiffs to drop their claims against our client in their consolidated amended complaint, thereby concluding involvement in the matter without any liability.
  • Defended a public pharmaceutical company and its officers against 10b claims and Section 11 claims arising out of a secondary public offering and successfully obtained a motion to dismiss these claims on behalf of our client.
  • Represented Geneius Biotechnology, Inc in a dispute with a minority shareholder that attempted to gain control of the company. In an expedited matter, we served as lead trial counsel in the Delaware Chancery Court and secured a total victory for the client.
  • Served as Lead California Counsel and on National Trial Team for large pharmaceutical client in massive products liability litigation involving company’s voluntary withdrawal of blockbuster nonsteroidal anti-inflammatory drug alleged to have caused heart attack, strokes and other injuries in thousands of users from the market. Participated in several bellwether trials that went to verdict in NJ and CA.
  • Served as national coordinating and trial counsel for large pharmaceutical company for litigation involving use of synthetic hormones and claims it acted as a trans-placental carcinogen and teratogen and was associated with the development of gynecologic cancers and birth defects in claimants exposed in utero. Tried multiple cases to verdict in CT, PA, CA and other jurisdictions.
  • Represented over 100 chain and independent pharmacies and, following a bench trial, obtained a judgment from the Massachusetts Business Court overturning the state’s pharmacy assessment tax and ordering the Commonwealth to refund $18 million in taxes collected from the pharmacies. The court enjoined any further collection of the tax, resulting in a savings to our clients of over $36 million annually. This case was reported by Massachusetts Lawyers Weekly as one of the largest trial verdicts awarded in Massachusetts in that year.
Case Study
Mintz secured a full release of a biopharmaceutical company in a Louisiana state court case over alleged inflated drug price reporting. The client agreed to a nuisance value settlement of the case, resolving claims its actions cost the state’s Medicaid program more than $20 million.
Case Study
In federal and state cases alleging a large pharmaceutical client and its co-developer failed to adequately warn regarding the risk of personal injury, Mintz delivered wins on every substantive issue, in every case, in every jurisdiction.
Case Study
For Kowa Pharmaceuticals and Nissan Chemical, Mintz sued nine generic drug makers that had filed Abbreviated New Drug Applications (ANDA) with the FDA. The court upheld the validity and infringement of all asserted claims in two patents for the cholesterol drug Livalo®.
Case Study
Mintz protected clients’ patents related to the cholesterol drug Livalo®. Mintz defended against three IPRs filed by generic manufacturers that had filed Abbreviated New Drug Applications (ANDA) with the FDA and secured Patent Trial and Appeal Board denials of institution of the generic companies’ IPR petitions.
Case Study
Mintz secured two MA federal court wins and one at the First Circuit for Vertex Pharmaceuticals, Inc. and several senior executives in a securities case about clinical trial result disclosures. The decision clarified the First Circuit standard for pleading scienter in securities fraud cases.
Case Study
Mintz serves as general counsel to a privately held pharmaceutical R&D company focused on inflammatory, metabolic, and affective disorders. Mintz handles the company’s corporate, transactional, and IP work, including supporting the company’s preclinical and clinical research program.
Case Study
In July 2018 Mintz represented Spero Therapeutics, a multi-asset clinical stage biopharmaceutical company, in its underwritten public offering. The offering included 3,780,000 shares of its common stock and 2,220 shares of its non-voting Series A Convertible Preferred Stock, with the gross proceeds to Spero being $75M prior to the deduction of any underwriting discounts and commissions.
Case Study
Mintz represented clinical-stage biopharmaceutical company Naurex Inc., which develops therapies for central nervous system disorders, in its acquisition by global pharmaceutical company Allergan PLC for $560 million plus potential milestone payments. Naurex’s platform was spun out into a new company.
Case Study
Mintz served on national trial teams for a major pharmaceutical company in defending over 50,000 individual lawsuits, federal multidistrict litigation, and statewide coordinated proceedings alleging personal injury and wrongful death. Mintz's trial results facilitated the $4.85 billion settlement.