Hatch-Waxman Litigation
Crowell & Moring is home to a growing team of patent litigators representing and advising clients in Hatch-Waxman cases. Our Hatch-Waxman litigation group currently consists of IP group litigation partners, counsel and associates, who bring expertise and experience to Paragraph IV litigation. Our group is focused on the successful representation of generic clients in all facets of the process that must be navigated to achieve the successful commercialization of a generic drug following a Paragraph IV challenge.
Lawyers in this group have many years of experience handling these cases for generic companies and have successfully worked to get a number of generic products on the market in recent years. Our group includes first-chair Hatch-Waxman and patent trial litigators (non-jury and jury), lawyers with technical degrees, including advanced degrees in the relevant disciplines, and lawyers experienced in working with experts to develop the relevant testing and opinion testimony that often is critical to success. Our lawyers also have expertise in the specific regulatory framework in which these cases are fought and use that expertise to advance our clients’ interests.
Our experience enables us to identify opportunities and aggressive strategies that focus on what really matters in any specific case, while still keeping an eye on costs and budgets. We focus at the earliest stage of a case on the trial themes and evidence that will maximize our opportunities for success, and we pursue those strategies aggressively. While many of our generic representations have resulted in favorable settlements, we prepare each case to be tried successfully.
The experience of our Hatch-Waxman litigation lawyers includes Paragraph IV patent litigation concerning the following prescription drug products:
- Fentora (fentanyl citrate)
- Lamictal (lamotrigine)
- Seasonique (ethinyl estradiol and levonorgestrel)
- LoSeasonique (ethinyl estradiol and levonorgestrel)
- OxyContin (oxocodone HCl)
- Rythmol SR (Propafenone HCl)
- Exelon (rivastigmine)
- Imitrex (sumatriptan succinate)
- Neurontin (gabapentin)
- Nuvigil (armodafinil)
- Provigil (modafinil)
- Yaz (drospirenone and ethinyl estradiol)
- Yasmin (drospirenone and ethinyl estradiol)
- Tambocor (flecainide acetate)
- Tricor (fenofibrate)
- Adderall XR (mixed amphetamine salts)
- Allegra-D (pseudoephedrine and fexofenadine)
- Xopenex (levalbuterol HCl)
- Carbatrol (carbamazepine), and
- Fortical (calcitonin-salmon rDNA origin).
Further, the litigation experience of our lawyers has encompassed a broad range of technical issues in the pharmaceutical sciences, including:
- API synthesis and characterization
- Racemic and enantiomeric forms of APIs
- Structural similarity of organic compounds
- Polymorphism and other physical characterization issues
- Solid oral dosage forms
- Buccal delivery formulations
- Rapid delivery formulations
- Sustained- and controlled-release dosage forms
- Immediate-release dosage forms
- Enteric coating technologies
- Transdermal drug delivery systems
- Injectable formulations
- Nasal spray formulations
- Pharmaceutical manufacturing processes
- Pharmacokinetic testing and analysis
- Cognitive and pain measurement methods
- Stability testing, and
- Dissolution testing.
Our Hatch-Waxman expertise involves an understanding of regulatory exclusivity and the drug-approval provisions under the Food, Drug, and Cosmetic Act. We assist our clients to navigate the nuanced strategic considerations that often govern the desired outcomes in these litigations. In addition to patent litigation, we also are experienced with Citizen Petitions filed with the FDA on various regulatory issues under the Hatch-Waxman Act that may concern approval, exclusivity, forfeiture or other issues critical to the successful commercialization of a product. Finally, our firm has leading Antitrust and Health Care practices that supplement our Hatch-Waxman litigation practice and provide important resources to our clients.