The rapidly growing area of biotechnology requires focused capabilities and worldwide resources. Buchanan Ingersoll & Rooney PC has one of the largest biotechnology and food and drug practices in the United States and provides its biotechnology knowledge to multinational businesses at every stage of development.

We represent medical, pharmaceutical and biotechnology companies engaged in international product development and marketing. Our experience has shown that a dual-track approach is extremely effective for biotechnology companies. This approach is designed to position companies in the global marketplace by assisting them in both U.S. and European regulatory approvals, intellectual property protection, and by helping them to secure financing and commercial opportunities both in the United States and abroad.

Our Core Services

Buchanan's lawyers have comprehensive capabilities to meet the needs of biotechnology clients in six core areas:

• Capital formation and corporate finance
• FDA and regulatory strategy
• Intellectual property and patent prosecution
• Licensing, collaboration and strategic alliances
• Government relations
• Medical coverage and reimbursement

We provide traditional representation as well as counseling on business needs. We help identify strategic partners, negotiate transactions and craft agreements that address the intricacies of the industry.

Capital Formation and Corporate Finance

Buchanan Ingersoll & Rooney is a transaction-driven law firm. Our lawyers structure, negotiate, document and complete transactions essential to accomplishing both the operational and strategic objectives of its clients. The firm's services in this area span the full range of public and private capital formation, initial public offerings, mergers and acquisitions and corporate governance, both in the U.S. and in Europe.

Having acquired a working understanding of the function, goals and needs of a client's business, Buchanan tailors its services to produce responsive, creative and cost-efficient capital formation assistance. Across a wide spectrum of planning, transactional, and compliance matters, Buchanan offers an understanding of industry nuances that enable the lawyers to apply technical knowledge practically and productively in the context of individual client needs.

We frequently bring our knowledge and judgment to the design and negotiation of private placements, ranging from initial "angel" rounds of financing to venture capital investments, mezzanine financings and Rule 144A private placements. Our ongoing experience in this area provides our clients with the advantage of being able to gauge market expectations, internal structuring pitfalls and overall risk from the points of view of both issuer as well as investor.

We regularly assist clients in accessing capital markets. The Corporate Finance Institute, Inc., has ranked Buchanan as the leading Pittsburgh law firm in IPOs and, more recently, the CCH's SEC New Registration Report ranked us among the nation's top IPO law firms.

FDA and Regulatory Strategy

Our lawyers assist biotechnology, medical device and pharmaceutical companies and contract organizations with strategic advice on various premarket applications to the FDA and the European regulatory authorities for commercialization of their products. Moreover, we help assemble and shepherd such applications for clinical investigation and ultimately for market authorization through those regulatory bodies in the U.S. and in Europe on a "Dual Track" basis. In the U.S., we represent our clients before the pertinent FDA review branch through formal meetings and informal communications to ensure that applications are being addressed by the FDA in an expeditious manner and to determine potential deficiencies that may slow the approval process. Our lawyers further assist clients with formal or informal dispute resolution with procedural and substantive product approval issues. A few examples have included:

• Establishing cutting edge strategy for biotechnology product development, including clinical trials, manufacturing, etc.
• Supervising all legal and regulatory issues for trial programs for multi-center clinical trial programs.
• Advising on various mechanisms for drug clearance including 505(b)(2) and abbreviated mechanisms for various pharmaceutical firms.
• Drafting and filing an Orphan Drug designation request for a novel use of human growth hormone for infertility.

FDA regulates many aspects of the manufacture, distribution and labeling of drugs, devices, dietary supplements, foods and cosmetic products that are in commercial distribution or that may be undergoing clinical investigation. Our lawyers advise clients on the proper classification, labeling and the allowable claims for such products in promotional material and advertisements.

Our lawyers are also experienced in the required good manufacturing practices and quality system regulations that are applicable to drugs and devices. We can assist in facility audits and review practices and documentation to determine whether companies are adhering to these manufacturing requirements. Our efforts are directed to resolving any enforcement initiatives through negotiation with the FDA; however, if such resolution is not possible administratively, we represent our clients in litigation with the agency.

Intellectual Property and Patent Prosecution

Buchanan Ingersoll & Rooney regularly helps clients obtain, maintain, protect and transfer intellectual property rights for products, processes and services. With a "Dual Track Approach," the firm's lawyers work with clients to maximize and enhance their intellectual property using the various options available for biotechnology products, including patents in the US and abroad, as well as orphan drug and Waxman-Hatch exclusivities.

The firm's lawyers have experience in the following technical fields:

• Medical and diagnostic equipment
• Computer hardware and software
• Genetic research and engineering
• Pharmaceuticals, ethical drugs and drug-delivery systems
• Robotics
• Ultrasound devices

This sampling of activity reflects the firm's solid grounding in the disciplines of biochemistry, microbiology, mathematics, physics, and electrical, mechanical, chemical, computer and genetic engineering.

The experience and capabilities span the spectrum of intellectual property issues, including patents, trademarks, copyrights, trade dress, trade secrets, licensing, technology transfer, and non-disclosure and non-compete agreements.

Buchanan's involvement in patent issues, of course, extends well beyond application and prosecution. Infringement and ownership of patents and trademarks frequently are contested by various parties. These conflicts may pit corporation against corporation, inventor against corporation or employer against employee. Representing both plaintiffs and defendants, in both domestic and international venues, the firm's lawyers are broadly experienced in the litigation of patent-related issues. Buchanan clients rely on the firm's intensely practical, thoroughly prepared approach to matters of patent and trademark infringement, which reflects a recognition that the clients' very ability to compete may be determined by the outcome of the litigation process.

In addition, the firm has conducted due diligence for corporate transactions in the IP area and its lawyers have litigated extensively in patent and Waxman-Hatch litigation.

Licensing, Collaboration and Strategic Alliances

Licensing, collaborations and strategic alliances are three key commercial vehicles used by biotechnology enterprises to unlock the value in their intellectual property. There are numerous commercial models used in this industry. Because of the increasing costs of research and development, collaborations, often with universities or multinational corporations, and strategic alliances have become useful catalysts to share risk and get new ideas to market.

Buchanan Ingersoll & Rooney lawyers craft and negotiate various contractual agreements tailored to the pharmaceutical, biotech and device industries. These include clinical trial agreements, manufacturing and supply agreements, drug and device development agreements, and master services agreements with contract research organizations.

A few examples have included:

• Crafting documents and negotiating a worldwide licensing deal for a series of cardiovascular drugs between a major German drug manufacturer and a Fortune 100 American drug company.
• Developing a series of collaboration and development agreements for an Australian client with breakthrough blood analysis technology.
  
• Developing and negotiating a cooperative venture between a controlled release drug company and drug development company; and providing structure and due diligence review for the acquisition of biotechnology companies.

We also regularly work with research oriented universities and entrepreneurial companies spun out of such institutions in connection with a full range of technology transfer, technology protection and commercialization matters.

Government Relations

Buchanan Ingersoll & Rooney actively represents the interests of its life science clients before Congress and the agencies of the federal government on a variety of legislative, regulatory and appropriations matters. While federal agencies annually allocate billions of dollars to life science programs, it can often be difficult for companies with limited resources to navigate their way through the federal labyrinth. Buchanan's Government Relations group assists life science companies in planning government appropriations strategies, preparing funding requests and designing collaborations with the government – from finding avenues for publicly-funded cooperative research to in-licensing government-owned technology. In conjunction with other members of the Firm's Biotechnology group, the Government Relations group also routinely advocates on behalf of life science companies with regard to proposed legislation before Congress and the adoption and interpretation of regulatory requirements, as well as in raising governmental awareness about areas of special concern to the life sciences industry.

Medical Coverage and Reimbursement

When a life science company gets a product cleared through the FDA, it inevitably faces another important issue: Will anyone pay for the use of the product? In the U.S., this means obtaining reimbursement approval from governmental payors such as Medicare, and commercial insurers such as managed care companies. Buchanan Ingersoll & Rooney's Healthcare group assists life science clients in analyzing health care coverage and reimbursement issues during a product's development stage, and in designing strategies for addressing these issues in order to help ensure financial viability once the product goes to market. The Firm's Healthcare group also advises life science companies on compliance with myriad rules that regulate the marketing and sales of health care related products. These rules can expose the unknowing company to criminal liability. Our Healthcare group can design strategies to address these issues, conduct regulatory audits to assess compliance with the rules, and provide counsel in the event of a governmental investigation.