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Drug and Medical Device Regulation

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Prosecution & Counseling

Drug and Biologic Regulation
Hatch-Waxman, Orphan Drugs, and Pediatric Exclusivity
Medical Device Approvals and Compliance

Our Drug and Medical Device team delivers regulatory know-how with value added by the scientific expertise of our intellectual property practice. Clients know that when they work with Fish, they need not teach their technology twice, as we offer one-stop shopping for both patent and regulatory work. Unlike most “FDA practices,” we have a unique technical capacity that comes from our world-class patent practice.

One of our unique specialties is advising on the relationship between patent and drug laws to protect patent exclusivity for products worldwide. In the United States, this means understanding the complex relationship between US patent laws and the Drug Price Competition and Patent Term Restoration Act of 1984, better known as the Hatch-Waxman Act.

We advise and counsel clients on the scope and application of the 271(e)(1) safe harbor from patent infringement; Orange Book practice and patent litigation under 271(e)(2); marketing exclusivities for pioneers and generics; and patent term extensions.

Fish also has vast experience with FDA regulation of various products, including small-molecule drugs, biologics, homeopathics, and medical devices.

Drug and Biologic Regulation

Fish’s Regulatory group advises pharmaceutical companies and research institutions throughout all stages of production, including design, development, and marketing of drugs and biologics.

We represent innovative biopharma companies around the world that specialize in some of the most cutting-edge technology, such as stem cell research, gene therapy, and tissue engineering.

Our drug and biologic regulation services include the following:

  • obtaining orphan drug designations and biologics under the Orphan Drug Act
  • aiding clients with the drafting of legal documents for clinical investigator agreements and informed patient consents
  • advising clients on importing and exporting drugs and on product withdrawals
  • advising on labeling and promotional issues that may occur before and after review by regulatory agencies

Hatch-Waxman, Orphan Drugs, and Pediatric Exclusivity

The regulatory and patent attorneys at Fish work closely on the various Hatch-Waxman issues that accompany drug, biologic, and medical device approvals.

We also teach the Patent Resources Group’s “Advanced Patent Law Course, Pharma & Biotech Strategies for Patent Prosecution, Hatch-Waxman, Litigation and Licensing,” a high- level three-day program that covers all aspects of Hatch-Waxman, including Federal Circuit and Supreme Court cases interpreting this complex and important statute.

Our services relating to the Hatch-Waxman Act include the following:

  • advising clients on the marketing exclusivities that are available for new drugs and “first-mover” generics, and on Orange Book issues involving patented drug products
  • counseling and representation on safe harbor exemptions from patent infringement for FDA-related activities and for assistance in securing patent term extensions for drugs, biologics, and Class III medical devices
  • counseling clients on orphan drug approvals and pediatric exclusivity rights

Medical Device Approvals and Compliance

Fish specializes in obtaining marketing authorization from the FDA, without which even the most innovative, lifesaving device cannot be legally marketed in the United States.

In addition, we have been instrumental in helping clients obtain medical device licenses from Health Canada. This service provides a one-stop shopping benefit for both the United States and Canada.

Our contacts around the world can also provide expert advice on the regulations applicable to their markets. Our advanced understanding of the international standards process allows us to help clients streamline the regulatory approval process, both in the United States and abroad.

Our ultimate goal is to ensure that our clients meet all of their regulatory requirements in the least burdensome manner possible. Our medical device approvals and compliance services include the following:

  • navigating the maze of FDA requirements and restrictions for a wide variety of devices, ranging from cutting-edge 3-D X-ray equipment to dental cements
  • advising on FDA regulations, including off-label marketing and other labeling issues, medical device imports and exports, establishment registration, device listing, recalls, corrective actions, and others
  • counseling on the applicability of the FDA’s Quality System Regulation to a company’s activities
  • preparing clients for FDA inspections assisting foreign manufacturers that sell devices in the United States to ensure that they comply with all relevant regulations

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