Arnold & Porter

In the IP space, Arnold & Porter is notable for its work in general patent litigation, Hatch-Waxman disputes and patent strategy. The firm services a number of high-profile life sciences clients on their patent matters, some including Pfizer, Sanofi and Boston Scientific.

Leading litigators David Barr and Matthew Wolf were involved in the closely watched case Amgen v Sanofi, which most recently saw a permanent injunction against clients Sanofi and Regeneron vacated and a jury verdict reversed by the Federal Circuit. A retrial of the case is expected in February 2019. Daniel DiNapoli and Aaron Stiefel are both involved in multiple ongoing Hatch-Waxman suits for Pfizer related to its branded pharmaceutical products, one including blockbuster drug Viagra. Deborah Fishman recently secured an affirmance from the Federal Circuit for client Elan Pharmaceuticals in a dispute related to Alzheimer's disease therapies.

David Marsh is one of the firm's standout patent strategists, who is involved in prosecution, Patent Office disputes and counseling on issues related to the Hatch-Waxman statute. He currently advises Monsanto on its IP portfolio related to plant genetics and Bruin Biometrics on patents related to its medical device technologies.

Arnold & Porter maintains a substantial presence in the life sciences space, with a practice that encompasses all legal areas needed to support a product's life cycle. The firm ranks highest in pricing and reimbursement and antitrust litigation, but is also a significant player in patent litigation, patent strategy, M&A and FDA counseling. The firm offers roughly 200 attorneys dedicated to the industry area, nearly half of whom hold scientific degrees.

A peer says about the firm's regulatory practice: "They do a lot of work in the drug space [with] Dan Kracov there, a leading practitioner for a number of years." Kracov strategizes with leading companies on their pathways to FDA approval. He handles FDA submissions, subpoena responses and post-market issues, among other areas. Jeffrey Handwerker expertly advises companies and associations in price reporting and transparency, Anti-Kickback matters, and issues regarding Medicaid and Medicare, including the 340b program. His clients includes Pharmaceutical Manufacturers Association (PhRMA) as well as multiple major drug companies.

In IP, the firm is equally strong in contentious patent matters and strategic counseling, evidenced by a significant body of work over the past year from the firm's patent-focused attorneys. David Barr is considered "excellent in the field" by a peer, whose practice is focused on Hatch-Waxman litigation and other patent disputes. He and leading IP trial lawyer Matthew Wolf were involved in the newsworthy case Amgen v Sanofi, which recently saw a permanent injunction against clients Sanofi and Regeneron vacated and a jury verdict reversed by the Federal Circuit. Other notable patent litigators include Daniel DiNapoli and Aaron Stiefel, who both represent Pfizer in multiple patent suits, and Deborah Fishman who won at the Federal Circuit for Elan Pharmaceuticals. David Marsh is one of the firm's leading patent strategists, who currently handles IP portfolios for notable clients including Monsanto and Bruin Biometrics.

In litigation and enforcement, Arnold & Porter receives a top rating for its capabilities in competition and antitrust matters. One of the standouts in the area is Saul Morgenstern from the New York office, who recently defended King Pharmaceuticals in several federal and state class actions valued at $300 million, related to the company's product Skelaxin. DC-based Laura Shores is described by a peer as a "hard-nosed antitrust trial lawyer," and has recently been active for Pfizer and its subsidiary Warner-Lambert in a defense against antitrust claims. In product liability, Anand Agneshwar, Andrew Solow and Pamela Yates are leading individuals in the practice. Solow and Yates have been representing Endo as national counsel in litigations related to its testosterone products since 2013.

Derek Stoldt serves as co-head of the firm's M&A and life sciences transactions practice groups from the New York office. He was recently part of a team that advised Novartis in a licensing agreement with Spark Therapeutics related to gene therapy technology. Julia Vax is a standout in the firm's corporate practice, whose representations include medical device, diagnostics and biopharmaceutical companies. Aaron Gardner recently acted for Novartis in the acquisition of a priority review voucher from BioMarin.

"Classic old-line DC firm" Arnold & Porter doubled down on its already unassailable status in the antitrust arena by assuming national firm Kaye Scholer over the past two years, bringing a whole new roster of antitrust stars into the fold from that firm, and adding a vibrant product liability practice (spanning the DC, New York and California offices) to boot.

New York's Saul Morgenstern defended King Pharmaceuticals in several federal and state class actions, valued at $300 million, brought on behalf of direct purchasers, indirect purchasers for resale and end-payor purchasers of Skelaxin, a brand-name prescription drug, in cases in which the plaintiffs allege that King and a co-defendant entity conspired to prevent or delay generic competition for Skelaxin. Morgenstern and DC-based "hard-nosed antitrust trial lawyer" Laura Shores defended Pfizer and its subsidiary Warner-Lambert in an antitrust action. The State of Louisiana alleges that the clients improperly listed certain patents covering Neurontin, a brand-name anti-seizure medicine, in the FDA Orange book and enforced those patents against manufacturers of potential generic gabapentin, delaying generic entry and causing the state to pay higher prices for branded Neurontin. The matter was resolved by a settlement in May 2017, in which Pfizer will donate to certain state agencies a drug used to treat opiate overdoses.

New York's Andrew Solow and Los Angeles' Pamela Yates have been providing national counsel to Endo Pharmaceuticals in product liability litigation involving testosterone products since 2013. The first bellwether victory came in October 2017, when Solow secured a Daubert/summary judgment win. In May 2018, the firm argued plaintiff's appeal before the Seventh Circuit, and that decision is pending. The second victory came in November 2017, when the firm trial team (led by Pamela Yates, and co-counsel Jim Herschlein and Andrew Solow) secured a defense verdict in the first MDL bellwether jury trial. Following these two major victories, in early 2018, the firm then negotiated a case management order that required all plaintiffs to produced affirmative evidence of product usage and contemporaneous injury, an order that has resulted in a significant number of dismissals in the litigation.

Full-service firm Arnold & Porter offers an established regulatory practice dedicated to assisting pharmaceutical and medical device clients. In particular, the team is especially skilled in handling matters with the FDA, as well as pricing and reimbursement issues.

The firm is frequently mentioned by peers for its pharmaceutical representations, as one peer says, "They do a lot of work in the drug space [with] Dan Kracov there, a leading practitioner for a number of years." Kracov assists pharmaceutical companies in launching products in the US and the EU as well. He skillfully strategizes with leading companies on their pathways to FDA approval. In assisting clients throughout the approval process, Kracov handles FDA submissions, subpoena responses and post-market issues, among many other matters that may come up during the process.

Jeffrey Handwerker is a prominent lawyer in the healthcare pricing and reimbursement space. His clients includes the Pharmaceutical Manufacturers Association (PhRMA) as well as multiple other major drug companies. Handwerker expertly advises these companies and associations in price reporting and transparency, Anti-Kickback matters, and issues regarding Medicaid and Medicare, including the 340b program. A peer knows Handwerker for his "very unique skillset."