Pharmaceuticals & Healthcare | White & Case
Pharmaceuticals & Healthcare Law

Pharmaceuticals & Healthcare

Global pharmaceutical and healthcare companies face a range of challenges: disputes over intellectual property (IP), adherence to evolving government regulation and parallel trade challenges, to name only a few. Great opportunity exists as well. Growth is possible through strategic acquisitions, joint ventures, licensing, distribution, supply agreements and international trade.

With our unique worldwide capabilities, including deep experience in the US, UK and EU regimes, we understand the business and legal intricacies that pharmaceutical and healthcare companies face on a daily basis. We work with many of the leading global players in the pharmaceutical and healthcare sector on their dispute resolution, corporate and transactional needs (major financings, M&A transactions, litigation, etc.).

We advise pharmaceutical multinationals on the full range of IP, antitrust, commercial litigation and M&A issues across the United States, Europe and Asia.

Our lawyers have litigated and won some of the biggest pharmaceutical cases in history. We successfully litigate high-profile patent cases, and advise on the full spectrum of IP-related work. In the US, we are the most experienced of any law firm in so-called "reverse payment" cases brought by the Federal Trade Commission and/or private plaintiffs. We try high-stakes pharmaceutical cases in the US and represent pharmaceutical clients in some of the most-watched matters of the day. In Europe, we have led the way on parallel trade and other issues in the sector.We also offer clients strong capabilities in other areas such as the Foreign Corrupt Practices Act, the False Claims Act, international arbitration, tax, environmental and international trade.  We have deep connections with relevant national and international regulatory bodies in the pharmaceuticals and healthcare sector.

We offer clients unparalleled experience in defending branded, specialty, and generic pharmaceutical firms against antitrust-based challenges. Our experience includes government and private litigation, trials and appeals. Our work on behalf of pharmaceutical clients includes defending claims such as "product-hopping," Walker Process fraud before the United States Patent and Trademark Office (USPTO), "sham" IP enforcements and Food and Drug Administration (FDA) petitioning, and other allegations of improper conduct to delay or inhibit generic competition.

Our deep and longstanding connections with our clients ensure that our lawyers bring genuine commercial knowledge in the sector to each challenge. Our singular focus on understanding our clients' success and long-term strategies sets us apart. We commit to fully understanding our clients' businesses–their financial considerations and risk tolerance, as well as the competitive and regulatory environments in which they operate.

 

AWARDS

Impact Case of the Year–Pfizer
LMG Life Sciences Awards 2014

Life Sciences Group of the Year
Law360 2014

Antitrust Group of the Year
Law360 2014, 2013, 2012 and 2011

"Sources appreciate the firm's strong cross-border capabilities in addition to its sector-specific knowledge which extends to the pharmaceutical and ‘other’ industries."
Chambers Global 2013

" …contributed a very high level of effort and creativity on our case, backed up by his long-term experience and profound expertise"
Chambers Global 2011

" …famed for…work in the pharmaceutical sector"
Chambers Global 2011

Pfizer Inc., ongoing
We represent Pfizer on a broad range of intellectual property matters: patent infringement cases, cases involving antitrust claims based on patent settlements, and cases accusing Pfizer of copyright infringement. We also conduct US clearance investigations relating to branding of future US products.

We achieved a significant victory for Pfizer Inc. and its co-plaintiff Northwestern University in their patent infringement litigation against multiple generic drug companies involving patents covering Pfizer's blockbuster drug LYRICA® and certain of its therapeutic uses.

In an antitrust case (based on settlement of a patent case) involving the largest-selling pharmaceutical product in history, LIPITOR (US$125 billion per year), the trial court granted our motion to dismiss with prejudice in its entirety.

UCB, ongoing
We represent UCB, a Belgium-based, global biopharma company, in US patent infringement cases.  A recent significant victory, upheld by the US Court of Appeals for the Federal Circuit, involved defending UCB against patent infringement claims brought by Apotex, a generic drug manufacturer, in the US District Court for the Southern District of Florida. After a three-day bench trial on mostly equitable claims, the court held that Apotex's patent was unenforceable, in addition to other decisions favorable to UCB.

Sandoz, ongoing
We represent Sandoz, a major pharmaceutical manufacturer, in the long-running Average Wholesale Prices (AWP) litigation, which has included numerous federal and state court cases brought by state Attorneys General and a qui tam relator alleging false claims act, fraud and consumer protection claims. Plaintiffs claim that pharmaceutical manufacturers reported false and inflated prices, which allegedly caused state Medicaid agencies to overpay for prescription drugs. We achieved significant wins in the two actions litigated to completion when, in each instance, the appellate court reversed substantial jury verdicts for the plaintiff state and issued a judgment in favor of Sandoz. These appellate victories combined to reverse more than US$100 million in judgments and set important precedents. Our counsel to Sandoz is ongoing.

Zimmer Holdings, 2014

US$13.35 billion acquisition of Biomet
We represent Zimmer Holdings, Inc., a world leader in musculoskeletal health solutions, in its US$13.35 billion acquisition of Biomet, Inc., one of the world's leading medical device manufacturers.

Shenzhen Hepalink, 2014

Acquisition of Scientific Protein Laboratories
We represented Shenzhen Hepalink Pharmaceutical Co., Ltd., a Chinese company listed on the Shenzhen Stock Exchange, and its US subsidiary, Hepalink USA Inc., in its US$337.5 million acquisition of Scientific Protein Laboratories, LLC, one of the leading global independent manufacturers and suppliers of active pharmaceutical ingredients. This transaction is one of a few acquisitions by a People’s Republic of China public company of a US privately held target and constituted a major reorganization for our client pursuant to the relevant Chinese listing rules, with the involvement of multiple consultants and agencies in the US and China.

Wellpoint, Inc., 2014

Sale of 1-800 CONTACTS
We represented WellPoint, Inc., one of the nation's largest health benefits companies, in its sale of its 1-800 Contacts subsidiary to private equity firm Thomas H. Lee Partners and its related asset sale of 1-800’s glasses.com business to international optical conglomerate Luxottica.

Hikma Pharmaceuticals
We represented Hikma Pharmaceuticals in the acquisition of assets of Bedford Laboratories, a generic sterile injectables company with the third-largest portfolio of generic injectable products in the United States, from Ben Venue Laboratories, Inc., a member of the Boehringer Ingelheim group of companies. Hikma is a fast-growing multinational pharmaceutical group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.

Par Pharmaceuticals and Paddock Holdings
We represented Par Pharmaceuticals and Paddock Holdings in a Federal Trade Commission (FTC) challenge to settlement agreements regarding AndroGel®. The Eleventh Circuit forcefully reaffirmed the principle that brand-generic patent settlement agreements are not actionable if they do not exceed the scope of the patent, handing the FTC its first "payment for delay" loss on a motion to dismiss posture. White & Case was the only firm to have opposed the grant of certiorari among defense counsel; the others supported certiorari. On appeal to the Supreme Court, the court rejected the position of the FTC automatically condemning "reverse payment" settlement agreements as per se illegal (the Third Circuit position). The court held that challenges to such agreements are subject to the rule of reason, and we are currently handling cases for a variety of clients in the lower courts interpreting the Supreme Court's opinion.

Pharmaceuticals & Healthcare
About

Global pharmaceutical and healthcare companies face a range of challenges: disputes over intellectual property (IP), adherence to evolving government regulation and parallel trade challenges, to name only a few. Great opportunity exists as well. Growth is possible through strategic acquisitions, joint ventures, licensing, distribution, supply agreements and international trade.

With our unique worldwide capabilities, including deep experience in the US, UK and EU regimes, we understand the business and legal intricacies that pharmaceutical and healthcare companies face on a daily basis. We work with many of the leading global players in the pharmaceutical and healthcare sector on their dispute resolution, corporate and transactional needs (major financings, M&A transactions, litigation, etc.).

We advise pharmaceutical multinationals on the full range of IP, antitrust, commercial litigation and M&A issues across the United States, Europe and Asia.

Our lawyers have litigated and won some of the biggest pharmaceutical cases in history. We successfully litigate high-profile patent cases, and advise on the full spectrum of IP-related work. In the US, we are the most experienced of any law firm in so-called "reverse payment" cases brought by the Federal Trade Commission and/or private plaintiffs. We try high-stakes pharmaceutical cases in the US and represent pharmaceutical clients in some of the most-watched matters of the day. In Europe, we have led the way on parallel trade and other issues in the sector.We also offer clients strong capabilities in other areas such as the Foreign Corrupt Practices Act, the False Claims Act, international arbitration, tax, environmental and international trade.  We have deep connections with relevant national and international regulatory bodies in the pharmaceuticals and healthcare sector.

We offer clients unparalleled experience in defending branded, specialty, and generic pharmaceutical firms against antitrust-based challenges. Our experience includes government and private litigation, trials and appeals. Our work on behalf of pharmaceutical clients includes defending claims such as "product-hopping," Walker Process fraud before the United States Patent and Trademark Office (USPTO), "sham" IP enforcements and Food and Drug Administration (FDA) petitioning, and other allegations of improper conduct to delay or inhibit generic competition.

Our deep and longstanding connections with our clients ensure that our lawyers bring genuine commercial knowledge in the sector to each challenge. Our singular focus on understanding our clients' success and long-term strategies sets us apart. We commit to fully understanding our clients' businesses–their financial considerations and risk tolerance, as well as the competitive and regulatory environments in which they operate.

 

AWARDS

Impact Case of the Year–Pfizer
LMG Life Sciences Awards 2014

Life Sciences Group of the Year
Law360 2014

Antitrust Group of the Year
Law360 2014, 2013, 2012 and 2011

"Sources appreciate the firm's strong cross-border capabilities in addition to its sector-specific knowledge which extends to the pharmaceutical and ‘other’ industries."
Chambers Global 2013

" …contributed a very high level of effort and creativity on our case, backed up by his long-term experience and profound expertise"
Chambers Global 2011

" …famed for…work in the pharmaceutical sector"
Chambers Global 2011

Experience

Pfizer Inc., ongoing
We represent Pfizer on a broad range of intellectual property matters: patent infringement cases, cases involving antitrust claims based on patent settlements, and cases accusing Pfizer of copyright infringement. We also conduct US clearance investigations relating to branding of future US products.

We achieved a significant victory for Pfizer Inc. and its co-plaintiff Northwestern University in their patent infringement litigation against multiple generic drug companies involving patents covering Pfizer's blockbuster drug LYRICA® and certain of its therapeutic uses.

In an antitrust case (based on settlement of a patent case) involving the largest-selling pharmaceutical product in history, LIPITOR (US$125 billion per year), the trial court granted our motion to dismiss with prejudice in its entirety.

UCB, ongoing
We represent UCB, a Belgium-based, global biopharma company, in US patent infringement cases.  A recent significant victory, upheld by the US Court of Appeals for the Federal Circuit, involved defending UCB against patent infringement claims brought by Apotex, a generic drug manufacturer, in the US District Court for the Southern District of Florida. After a three-day bench trial on mostly equitable claims, the court held that Apotex's patent was unenforceable, in addition to other decisions favorable to UCB.

Sandoz, ongoing
We represent Sandoz, a major pharmaceutical manufacturer, in the long-running Average Wholesale Prices (AWP) litigation, which has included numerous federal and state court cases brought by state Attorneys General and a qui tam relator alleging false claims act, fraud and consumer protection claims. Plaintiffs claim that pharmaceutical manufacturers reported false and inflated prices, which allegedly caused state Medicaid agencies to overpay for prescription drugs. We achieved significant wins in the two actions litigated to completion when, in each instance, the appellate court reversed substantial jury verdicts for the plaintiff state and issued a judgment in favor of Sandoz. These appellate victories combined to reverse more than US$100 million in judgments and set important precedents. Our counsel to Sandoz is ongoing.

Zimmer Holdings, 2014

US$13.35 billion acquisition of Biomet
We represent Zimmer Holdings, Inc., a world leader in musculoskeletal health solutions, in its US$13.35 billion acquisition of Biomet, Inc., one of the world's leading medical device manufacturers.

Shenzhen Hepalink, 2014

Acquisition of Scientific Protein Laboratories
We represented Shenzhen Hepalink Pharmaceutical Co., Ltd., a Chinese company listed on the Shenzhen Stock Exchange, and its US subsidiary, Hepalink USA Inc., in its US$337.5 million acquisition of Scientific Protein Laboratories, LLC, one of the leading global independent manufacturers and suppliers of active pharmaceutical ingredients. This transaction is one of a few acquisitions by a People’s Republic of China public company of a US privately held target and constituted a major reorganization for our client pursuant to the relevant Chinese listing rules, with the involvement of multiple consultants and agencies in the US and China.

Wellpoint, Inc., 2014

Sale of 1-800 CONTACTS
We represented WellPoint, Inc., one of the nation's largest health benefits companies, in its sale of its 1-800 Contacts subsidiary to private equity firm Thomas H. Lee Partners and its related asset sale of 1-800’s glasses.com business to international optical conglomerate Luxottica.

Hikma Pharmaceuticals
We represented Hikma Pharmaceuticals in the acquisition of assets of Bedford Laboratories, a generic sterile injectables company with the third-largest portfolio of generic injectable products in the United States, from Ben Venue Laboratories, Inc., a member of the Boehringer Ingelheim group of companies. Hikma is a fast-growing multinational pharmaceutical group focused on developing, manufacturing and marketing a broad range of both branded and non-branded generic and in-licensed products.

Par Pharmaceuticals and Paddock Holdings
We represented Par Pharmaceuticals and Paddock Holdings in a Federal Trade Commission (FTC) challenge to settlement agreements regarding AndroGel®. The Eleventh Circuit forcefully reaffirmed the principle that brand-generic patent settlement agreements are not actionable if they do not exceed the scope of the patent, handing the FTC its first "payment for delay" loss on a motion to dismiss posture. White & Case was the only firm to have opposed the grant of certiorari among defense counsel; the others supported certiorari. On appeal to the Supreme Court, the court rejected the position of the FTC automatically condemning "reverse payment" settlement agreements as per se illegal (the Third Circuit position). The court held that challenges to such agreements are subject to the rule of reason, and we are currently handling cases for a variety of clients in the lower courts interpreting the Supreme Court's opinion.