Why Leading Pharmaceutical Companies Turn to Axinn
Axinn offers the leading pharmaceutical practice in the country. Our team combines its deep substantive patent law and litigation experience with its FDA and antitrust expertise to offer clients a unique end-to-end solution. Whether it’s leading a patent trial on a blockbuster product or navigating the complex FDA regulatory regime, Axinn provides a one-stop-shop to enable pharmaceutical clients to bring their products to market in the most economically-beneficial manner.
Axinn’s pharmaceutical practice is among the most experienced in the country. Axinn worked on eight of 2018’s Top 10 Generic Drugs (by savings), according to the AAM Generic Drug & Biosimilars Access & Savings Report. Over the past 10 years alone, Axinn has served as lead trial counsel in over 120 Paragraph IV litigations involving products with over $100 billion in annual sales. Members of the practice apply their profound technical knowledge and hands-on industry experience to provide our clients with an integrated approach to launch their products. Many of the members of the practice have advanced degrees and undergraduate degrees in such areas as biology, molecular biology, chemistry, microbiology, biochemistry, neurobiology, and molecular and cell biology.
We Know Pharma . . . and They Know Us
Our clients have included some of the largest pharmaceutical companies in the world, including:
- Endo Pharmaceuticals
- Hetero USA Inc.
- Mayne Pharma Inc.
- Momenta Pharmaceuticals, Inc.
- Par Pharmaceutical, Inc.
- Teva Pharmaceuticals
- Workhardt USA
- Zydus Pharmaceuticals
Counsel to Generic Pharma on Some of the Industry’s Biggest Products*
* Annual brand sales prior to generic entry
Representative experience includes:
- Taking over as lead trial counsel in an eight-year battle over the multi-billion dollar drug Neurontin after remand from the Federal Circuit and after Actavis’s at-risk launch. Our trial lawyers impeached Plaintiffs’ witnesses at trial and excluded key expert testimony. The case settled on very favorable terms after two weeks of trial.
- Prevailed at trial for Alvogen in patent litigation concerning the ulcerative colitis drug Uceris®. The district court granted Alvogen’s motion for judgment of non-infringement under Rule 52(c) after the close of Plaintiff’s case, and the Federal Circuit affirmed.
- Successfully argued appeal on behalf of pharmaceutical company Natco involving a generic version of Tamiflu®, obtaining a reversal of the trial court’s holding that a later-issued but earlier-expiring patent cannot serve as a double-patenting reference against an earlier-issued but later-expiring patent.
- In what has been described as the first time a court has ordered FDA to approve a product, Axinn obtained summary judgement on behalf of Watson Laboratories in litigation against FDA in relation to 180-day exclusivity period for a multi-billion dollar product Actos®.
- Obtained Federal Circuit affirmance of a district court claim construction and related summary judgment of non-infringement concerning Zydus’s efforts to market a generic version of the blockbuster product Abilify® (aripiprazole).
- Successfully acted as lead counsel for Mutual Pharmaceuticals in a patent dispute over the sleep-aid drug Restoril®, obtaining summary judgment of obviousness by the district court and affirmance of the judgment by the Federal Circuit.
- Defended Alvogen as lead trial counsel before Federal Circuit Judge Bryson, sitting by designation in the District of Delaware, in a patent action brought by Pernix over patents related to extended release hydrocodone capsules (Zohydro®). Obtained decision that Pernix’s patents were invalid as obvious and as failing to meet the written description standard.
Speaking Engagements & Seminars
- GRx+Biosims Conference 2021
- Pharmaceutical CEO Leadership: Collaboration in Pharma – Innovation
- Pharmaceutical CEO Leadership: Collaboration in Pharma – Working Together
- Pharmaceutical CEO Leadership: Collaboration in Pharma
- GRx+Biosims Conference
- ACI 13th Annual Paragraph IV Disputes Conference
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