Acknowledged leaders in their field, our attorneys share a diverse skill set that enables them to view client matters from every angle, allowing them to resolve client IP issues efficiently and effectively. We focus on the pharmaceutical, chemical and biotechnology industries, partnering with both brand and generic companies to navigate the most complex IP and related FDA issues, including the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act (BPCIA).
Our practice is informed by our extensive knowledge of the pharmaceutical sciences, including small molecules and biologics, formulations (oral dosage forms, controlled release, transdermal/topical, ophthalmic, parenteral, etc.), methods of use, polymorphs, enantiomers, drug delivery devices and methods of manufacture.
We help clients build and execute targeted IP strategies from project initiation through litigation, with an eye toward securing market position and overcoming obstacles to new product entry.
Our attorneys have deep experience in patents, trademarks, trade secrets, and other matters involving life science intellectual property.
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We have decades of experience in litigating patent and trade secret cases, especially with respect to cases brought pursuant to the Hatch-Waxman Act, where we represent both brand and generic pharma companies.
Green Griffith litigators have handled cases involving diverse technologies throughout the United States, including all of the district courts known for handling major patent cases, as well as numerous other district courts, the Federal Circuit, the D.C. Court of Appeals and the United States Supreme Court. As a result, our attorneys have broad knowledge of all phases of patent litigation from pre-litigation counseling through Markman hearings, dispositive motions, jury trials, and appeals. We also offer a wide range of services regarding strategic formulation, portfolio and due diligence, as well as handling all stages of trial and appeals concerning IP and related FDA issues affecting 505(b)(1), 505(b)(2) and ANDA applications, and their related drug products and therapies.
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Biologics and Biosimilars
Biologic therapeutics, including vaccines, have entered a new age of competition and related litigation following passage of the Biologics Price Competition and Innovation Act, or “BCPIA.” Our firm relies on our attorneys’ extensive biotech backgrounds and experience in the pharmaceutical space — including resolving Hatch-Waxman disputes — to achieve the best outcomes for clients faced with patent challenges in biologics, whether innovator biologics, biosimilars or biobetters. In this area, our services include opinions, due diligence, client counseling, licensing, patent portfolio analysis and management, pre-litigation strategy, litigation, IPRs and Post-Grant Review proceedings.
We work with chemical industry clients to strategically manage their chemical patent portfolios, protecting and maximizing the value of their intellectual property rights. Our experience includes litigation on behalf of plaintiffs and defendants in multiple venues. We also offer a range of counseling services, including rendering invalidity, non-infringement and freedom-to-operate opinions and conducting intellectual property due diligence and inventorship analyses, as well as drafting and prosecuting patent applications through the U.S. Patent and Trademark Office to issuance. Examples of our areas of expertise are food science, veterinary science, health care products, and beauty products.
We carefully evaluate target IP portfolios to gauge overall strength and market impact, and then deliver a well-considered recommendation that allows an assessment of value and risk in connection with a potential acquisition.
We work with our clients to negotiate licensing agreements for intellectual property, technology and related know-how. We also have extensive experience preparing associated agreements including consulting agreements, collaboration agreements, purchase agreements and development agreements. In conjunction with intellectual property licensing, we advise our clients on ways to optimize their patent position with an eye toward future litigation and ensuring market exclusivity.
IPRs and Post-Grant Proceedings
We have extensive experience with post-grant proceedings, including inter partes review (IPR) proceedings before the Patent Trial and Appeals Board (PTAB). We have successfully represented clients in IPRs alongside related litigation.
With our extensive litigation and PTAB experience, we are well placed to advise clients on strategic considerations when initiating and coordinating such disputes.
In intellectual property litigation, appeals require both meticulous attention to the details of the technologies involved and a thorough understanding of appellate law and practice, as well as strategies necessary for success.
We represent both appellants and appellees in cases covering a wide range of industries and issues, and have won substantial victories in appeals and challenges at the Circuit Courts of Appeals, including the Federal Circuit. In addition, several of our attorneys have represented clients in appeals before the U.S. Supreme Court, where we have also been successful.
Our clients rely on us to deliver sound legal opinions (novelty/patentability, noninfringement, freedom-to-operate) for new products, devices and compositions in the life sciences arena, including oral dosage forms, parenteral dosage forms and topicals, biomedical devices, systems and methods of manufacture.
Portfolio Development, Management & Analysis
IP portfolio management requires consistent review, investment and updating. We thoroughly analyze our client’s existing IP portfolio to understand their technology, scope, strengths and limitations, then help guide the client to develop an IP portfolio that meets their business objectives. Our attorneys are licensed to practice before the U.S. Patent and Trademark Office, and many have decades of experience prosecuting patent applications through allowance.
Our attorneys are highly experienced in managing all aspects of complex trade-secret litigation in the pharmaceutical, chemical and biotech areas, including preliminary injunction and appellate practice. We also advise clients on how to protect, enforce and exploit their trade secrets and other confidential information, providing strategic advice on safeguards, confidentiality policies and restrictive covenants. We are well versed in swift and decisive prosecution and defense of claims under the Defend Trade Secrets Act, as well as claims for common law misappropriation and other claims relating to non-statutory proprietary information.