The pharmaceutical, biotechnology, and medical device industries have become major fields for antitrust litigation and agency enforcement. Life Sciences firms increasingly face lawsuits challenging business tactics as anticompetitive, government investigation of their intellectual property enforcement strategies, and careful scrutiny of their pricing and distribution strategies. Both antitrust attention and a changing regulatory environment have created challenges in designing and executing business strategies that minimize antitrust risks. Overcoming those challenges requires seasoned counseling, a deft understanding of how the regulatory process impacts antitrust analysis, and a demonstrated ability to prevail before the antitrust enforcers and in the courts.

Members of the Antitrust Practice Group at Ropes & Gray have played a central role in helping Life Sciences firms successfully overcome antitrust obstacles. For over a decade, our lawyers have represented numerous leading pharmaceutical, biotechnology, and medical device companies before the antitrust enforcement agencies, in defending (and when necessary, bringing) antitrust litigation, and in devising business strategies. Our lawyers offer a remarkable diversity of experience from both the Federal Trade Commission and the U.S. Department of Justice, as well as from the private sector. Our team is highly skilled in providing effective representation on the full range of antitrust issues that life sciences companies confront.

We succeed for our clients because we learn their business – their people, research, commercial plans, collaborations and challenges. Working seamlessly with Ropes & Gray’s leading FDA, Health Care, Government Enforcement, Life Sciences, and Intellectual Property groups, we also possess the necessary detailed awareness of the regulations that govern our life sciences clients’ activities, as well as other legal and business challenges that inform sound antitrust counseling.

Areas where Ropes & Gray’s lawyers have handled antitrust matters for pharmaceutical, biotechnology, and medical device clients include, among others, the following:

Enforcement of Intellectual Property Rights. Patent litigation frequently involves antitrust counterclaims, ranging from Walker Process and Handgards claims to allegations of anticompetitive marketplace conduct. In life sciences, antitrust counterclaims today frequently also involve allegations of manipulation of regulatory entry requirements (involving, for example, listings in the Orange Book), unlawful “product hopping,” or improper petitioning. Our antitrust and IP litigation groups work closely together to defeat (and when necessary, assert) such claims, which often raise important antitrust-specific issues and can have a significant impact on the course litigation takes. We have defended and brought monopolization claims involving the assertion of patent rights for numerous pharmaceutical companies, advised on the antitrust implications of patent enforcement strategies, and devised successful antitrust strategies that secured jury trials on patent claims.

IP Litigation Settlements. Over the last decade, few issues have given rise to greater antitrust controversy than how antitrust should treat settlements of Hatch-Waxman pharmaceutical patent litigation. At one end of the spectrum, the FTC (and others) contend that many settlement structures raise antitrust suspicions. At the other end, the courts largely have accepted settlements that do not exceed the nominal exclusionary scope of patents-in-suit. At the same time, legislation looms. Members of Ropes & Gray’s antitrust team have played front-and-center roles in navigating and litigating these issues. We have counseled numerous firms on how to structure and file dozens of Hatch-Waxman settlements and have also litigated numerous monopolization claims involving patent settlements. Members of our antitrust team have represented companies in FTC antitrust investigations of settlements, and have avoided FTC challenges on numerous occasions. As in other life sciences antitrust matters, our clients reap the benefit of our closely-integrated approach with Ropes & Gray’s FDA and Intellectual Property groups.

Authorized Generics Agreements. Hatch-Waxman has spawned a variety of agreements between branded and generic pharmaceutical companies that enable introduction of generic versions of a patented product before patent expiration. Depending on their structure, so-called “authorized generic” agreements can attract antitrust scrutiny, both from the FTC and private plaintiffs. Members of the Ropes & Gray antitrust team have represented numerous branded companies on both forms of authorized generic agreements, and also in responding to the FTC's requests for information in their congressionally mandated study of authorized generic agreements.

Petitioning Regulatory Bodies. Working with our leading FDA and other regulatory groups, Ropes & Gray antitrust lawyers have counseled numerous companies on petitions involving the safety of potential generic drugs, on the appropriateness of skinny labels, on the impact of REMS on product distribution and bioequivalence testing, and on the breadth and scope of 2008 amendments to the FDA Act. Our advice helps minimize antitrust exposure while providing clients with a seamless, integrated team.

Licensing and Refusals to License. Life Sciences antitrust firms frequently license intellectual property rights – both in-licenses and licenses to other firms. Refusals to license intellectual property increasingly plays a central role in government investigations. Those investigations range from examining outright denial of licenses, to the alleged refusal to provide adequate cooperation. Members of the Ropes & Gray antitrust team not only counsel on the myriad of antitrust issues licensing arrangements (or refusals to license) can raise, but also have successfully navigated government investigations involving these practices for pharmaceutical and biotechnology clients.

New Product Development. As branded manufacturers face patent expiration on flagship products, many have either developed or licensed innovations that enable them to introduce newer, improved versions of these products that may benefit consumers. Such “ever-greening” (or “product-hopping”) practices, however, increasingly have attracted antitrust attention. Members of Ropes & Gray’s antitrust team have participated in a number of product-hopping matters, including in the context of exclusive licenses, settlement agreements, and mergers. We also have represented parties in litigation and investigations concerning alleged anticompetitive practices in connection with new product introductions.

Pricing and Distribution Practices. Pricing and distribution practices in the pharmaceutical, biotechnology, and medical device industries frequently raise antitrust issues. Distribution practices can raise issues under the Robinson-Patman Act while so-called “loyalty” programs have frequently become a subject of antitrust litigation. Members of the Ropes & Gray antitrust team have been involved in counseling and in litigating all of these issues for a number of leading pharmaceutical, biotechnology, and medical device companies. We have brought and defended monopolization claims, and have advised on developing successful marketing practices that minimize antitrust risk. We have designed antitrust compliance polices and developed antitrust training materials, and have also conducted a number of Robinson-Patman Act reviews.

Collaboration Agreements. The increasing cost and complexity of research, development, and commercialization of pharmaceutical and biotechnology costs have led to increasing pressures on both large and small life sciences companies to collaborate. Members of Ropes & Gray's antitrust team have advised numerous life sciences companies on multiple forms of competitor collaborations, including joint research, co-development, co-promotion, joint marketing, territorial and customer divisions. Our lawyers are leaders in the bar on antitrust issues involving intellectual property and participated in creating the DOJ/FTC Guidelines for Collaborations Among Competitors.

Life Sciences Mergers and Acquisitions. Our antitrust team also provides leading representation of life sciences companies in the merger review process, from Hart-Scott-Rodino filings and counseling to multi-jurisdictional merger investigations. Two of our antitrust partners were among a handful of lawyers in the antitrust bar invited by the Department of Justice and Federal Trade Commission to provide views on revisions to the Horizontal Merger Guidelines. Our lawyers have worked on numerous pharmaceutical, biotechnology, and medical device transactions reviewed by the FTC, building upon our extensive working relationships with those attorneys during previous government service. The Ropes & Gray antitrust team supports and benefits from a close association with, our leading life sciences transactional group.

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