Duane Morris LLP

The pharmaceutical, biotechnology, medical device and pharmacy industries have far-reaching scope and are integral to our daily lives. Duane Morris attorneys counsel clients in these industries on IP and regulatory matters in virtually all aspects of their business and at all stages of the client’s product lifecycle, from product selection and bringing new products to market to maintaining pharmacovigilance and regulatory compliance to due diligence on products to be acquired.

Duane Morris has a proven track record of success helping clients in the pharmaceutical and biotechnology industries create coordinated IP and regulatory strategies for products in development, and then implementing those strategies to get products on the market as quickly and efficiently as possible. This holistic approach is focused on solutions that achieve our clients’ business goals. We deliver value to our clients by assisting them in developing unique patent or regulatory strategies to gain a competitive advantage in the marketplace.

Pharmaceutical and Biotechnology IP Strategy and Litigation

We have significant experience helping clients in the biotechnology and pharmaceutical industries to resolve trade secret and patent infringement matters, and developing best practices and strategies for protection of intellectual property to help our clients favorably position themselves within their respective fields. The technical and legal experience of the attorneys in the IP Pharmaceutical group is an invaluable resource to help companies avoid, resolve and where necessary litigate disputes over theft and ownership of intellectual property rights, including rights to trade secrets, patent rights and rights to use of biological material.

Our attorneys handle market-defining pharmaceutical patent litigations for global pharmaceutical manufacturers with decades of experience in trying cases to verdict in industry-defining cases. Many of the best results achieved for our clients, however, were accomplished through resolution before litigation, unique patent and regulatory strategies, and favorable settlements that did not require taking a case all the way through trial. Our clients benefit from this perspective and insight, which can only be gained from years of “on-the-ground” experience in patent trials in virtually every major jurisdiction in the United States.

Duane Morris has established itself as a market leader for inter partes review (IPR) petitions before the Patent Trial and Appeal Board (PTAB). Especially in the pharmaceutical industry, IPRs can present a strong strategy option in the right scenario. We have helped many clients achieve business objectives that may not have otherwise been possible by counseling on strategic timing and choices of patents to challenge through an IPR petition. Our attorneys are experienced in the nuanced intricacies of IPR practice that make for a successful challenge or defense of a patent in front of the PTAB.

Hatch-Waxman Practice and Litigation

Duane Morris lawyers can help clients identify the best regulatory pathway and patent strategy to bring a product to market under the Hatch-Waxman amendments to the Federal Food, Drug and Cosmetic Act. We counsel on drug approvals and market entry strategies—including Abbreviated New Drug Applications (ANDAs), 505(b)(2) NDAs and ANDA suitability petitions—working through answers to questions related to eligibility for the various approval pathways, labeling, patent certifications, the scope of various nonpatent exclusivity provisions and Risk Evaluation and Mitigation Strategies (REMs).

Biologics and Biosimilars (BPCIA)

Biologics and biosimilars products have provided many new opportunities for life sciences companies to develop a product in a multibillion dollar market. Under the Biologics Price Competition and Innovation Act (BPCIA), the pathway for approval of biosimilars in the United States has developed over the last few years, presenting both challenges and opportunities. Our attorneys provide advice on leveraging clients’ technical strengths and capabilities to take advantage of the opportunities in this still developing market.

Regulatory Advice and Counseling

In the pharmaceutical industry, a holistic approach to successful IP strategies necessarily includes regulatory matters involving agencies such as FDA, DEA and state boards of pharmacy. We assist pharmaceutical manufacturers and compounding pharmacies with regulatory compliance and investigations, and help develop policies that avoid regulatory pitfalls that can interfere with an otherwise successful IP strategy.

Antitrust

The pharmaceutical industry is under a microscope more than ever in terms of pricing and overall healthcare costs to consumers. This scrutiny can often give rise to potential antitrust issues. Our attorneys are well-versed in the business of the pharmaceutical industry, and have a depth of knowledge from which to advise clients on avoiding pitfalls of potential antitrust concerns, and also affirmatively seeking remedies from potential antitrust violations from others in the industry.

Technical Experience and Capabilities

Our attorneys collectively have an extraordinary depth of technical insight and practical industry experience in many areas, including chemistry, chemical engineering, organic chemistry, biochemistry, biophysics, pharmacology, pharmacy, molecular biology, genetics, genomics and bioinformatics.

"In my discussions with Duane Morris leaders, they frequently speak about how diversity within their firm has enabled them to better serve their diverse clients. They understand that investing in diversity is a wise business decision that positions them for the marketplace of the future."

Don Liu
Senior VP, General Counsel & Corporate Secretary
Xerox Corporation

At Duane Morris, achieving diversity is paradoxical. By supporting and celebrating the differences of our attorneys - and the individual strengths that they bring - our firm culture expands, fostering creative solutions for our clients. But diversity at Duane Morris does not mean that we have a certain number of diverse attorneys; true diversity means that it is no longer noteworthy to see diverse lawyers leading our practice groups or managing client relationships. Ascending to positions of leadership and greater responsibility and providing the highest levels of client service is simply what is expected of all our lawyers. Diversity is another strong asset that adds to our collective abilities to meet the needs of our clients.

Our vision of diversity at Duane Morris is to realize an environment in which our lawyers' outstanding qualities are not just measured by ethnicity, race, gender and sexual orientation, but more importantly, that our lawyers are remarkable as excellent attorneys above all else. Only then can we celebrate our differences while focusing on the common pursuit of legal excellence which everyone shares at Duane Morris.

To reach this goal, Duane Morris understands that the familiar diversity strategies and policies that most law firms have are needed. Without demanding results from such policies, most law firms are bound to fail in even achieving numerical hiring and retention goals. Duane Morris has been proactive and ambitious in its efforts to improve diversity at the firm, and has set deadlines for reaching the milestones which mark our progress. To create a more diverse law firm, Duane Morris is:

• Committed to strategically increasing our diversity levels, which is currently at 10 percent.
• Bringing together our Diversity Committee and our Hiring and Retention Committee to raise diversity as an important factor in our hiring decisions.
• Dedicated to improving retention by building upon our monitoring and mentoring program for all diverse associates.

Combining new initiatives with our longstanding diversity efforts, Duane Morris has seen increasingly positive results. In the Minority Law Journal's annual diversity survey of the nation's largest 260 firms, Duane Morris continued to improve its regional and national ranking, rising to number 136 of all firms surveyed. Our strides in Philadelphia are encouraging; in a city known for both the racial diversity of its population and the lack thereof in its law firms, Duane Morris is one of only two law firms to exceed the national average of minority partners at all law firms. Additionally, Duane Morris leads all national law firms based in Philadelphia in the number of Latino partners. Nearly 30 percent of all of our attorneys are women, and more than 20 percent of our partners are women.

In our approach to diversity, progress in racial, gender and cultural diversity cannot be measured in numbers alone. Duane Morris has focused our diversity initiatives on both increasing the number of diverse associates and addressing the challenges diverse attorneys face in building lasting careers and rising to senior and leadership positions. While several of our key practice groups are led by diverse partners and female partners, Duane Morris endeavors to create a culture which will foster a deep pool of such attorneys who can then develop into the firm's future leaders. Duane Morris understands that simply hiring diverse associates will not change the diversity of the firm; Duane Morris is working to mentor and retain diverse associates so that our progress in racial, gender and cultural diversity is also reflected at the highest levels of leadership within the firm.

Our progress on gender diversity has been profound. We have no glass ceilings: women hold positions of leadership at all levels of management at the firm. Women lead a number of our key practice groups, including our Energy, Immigration and International practices, and serve on the firm's Executive Committee. The success of our female attorneys at Duane Morris has not gone unnoticed. Barbara Adams was chair of the firm's Finance Practice until her appointment by Pennsylvania Governor Edward Rendell to serve as General Counsel of the Commonwealth. In 2004, our longtime General Counsel, Gene E.K. Pratter, was approved by the United States Senate and is now a judge for the U.S. District Court for the Eastern District of Pennsylvania.

Our efforts to improve diversity extend beyond our firm's walls. The chair of our Diversity Committee, Nolan N. Atkinson, Jr., recognized the lack of diversity in Philadelphia's legal community and formed the Philadelphia Diversity Law Group. Nolan now serves as the chair of the organization, a consortium of 25 law firms and corporations that commits to employing at least one diverse first-year law student each as a summer associate. From this program, law students of diverse backgrounds gain access to what was once an exclusive legal community, and now have the opportunity to learn and develop their legal careers with experience at Philadelphia's top law firms.

In addition to our involvement in the Philadelphia area, Duane Morris has increased our presence at national conferences and events focused on diversity. We sponsor the Hispanic National Bar Association and its job fair. Duane Morris is also a longtime supporter and sponsor of the Equality Forum, a national gay and lesbian rights organization. Duane Morris continues to sponsor the Minority Corporate Counsel Association, and is active in other associations of diverse attorneys including: the Asian American Bar Association of the Delaware Valley; the Charles Houston Bar Association; Cuban Bar Association; Korean American Lawyers Association; National American Indian Housing Counsel and the National Bar Association.

The challenge of improving gender, ethnic and cultural diversity at Duane Morris is an ongoing effort that has the support of the entire firm. Duane Morris has been at the vanguard in supporting gender diversity throughout the firm beginning a generation ago. Our diversity programs are leading to similar success in improving racial and national origin diversity at Duane Morris. But even as we share these examples of Duane Morris attorneys and our involvement in numerous legal events, associations and programs for diversity, our hope is that such examples will no longer be necessary to mention in the future. We hope that through our efforts, and the efforts of other law firms, these stories become so common that they are no longer the remarkable accomplishments they are today, but simply routine aspects of the legal world tomorrow.

• Philadelphia, PA
  30 South 17th Street
  Philadelphia, PA 19103
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