The Hatch-Waxman Amendments to the Food, Drug & Cosmetic Act, which were passed in 1984, essentially established the current generic drug industry by allowing sponsors to demonstrate bioequivalence without having to conduct costly and time-consuming clinical trials. With that market-entry barrier removed, real competition developed in a previously monopolistic marketplace. Today, generic drugs represent 69 percent of the total prescriptions dispensed in the United States but only 16 percent of all dollars spent on prescription medications, saving American consumers nearly a trillion dollars over the last decade.
From the generics’ perspective, the opportunity to provide life-saving, cost-effective medications was enhanced through Hatch-Waxman’s grant of 180-days of market exclusivity to the first applicant with a so-called Paragraph IV certification in an Abbreviated New Drug Application (ANDA). Innovator companies were equally incentivized with an automatic 30-month stay of approval of the ANDA if they timely sued such an applicant upon receiving from the ANDA applicant the required notice of the Paragraph IV certification. The United States is one of only a few markets in the world linking the regulatory approval of generic pharmaceutical products to its patent system.
At first glance, navigating Hatch-Waxman’s patent certification and regulatory approval process may seem straightforward. But one quickly learns there are many nuances and esoteric issues that require the expert guidance of counsel like Cozen O’Connor. Our team has been lead litigation counsel in scores of Paragraph IV litigations, and we have counseled clients on scores more. The vast majority of our cases have either been litigated to a successful conclusion or settled favorably for our clients. One of our top compliments came from an adversary, the chief patent counsel for a well-known innovator company, who commented that our thorough settlement agreement addressed generic opportunities which the innovator had not even thought about. Our publicly available record of significant victories includes:
· successfully defending the at-risk launch of generic Skelaxin® (metaxalone) with a favorable jury verdict finding the patent invalid and not infringed, with the innovator withdrawing its appeal after our appellate brief was filed;
· obtaining appellate affirmance of judgment on the pleadings for the at-risk launch of generic Yasmin® (drospirenone + ethinyl estradiol);
· resolving favorably at trial the at-risk launch of generic Neurontin® (gabapentin) where the innovator was claiming several billion dollars in damages;
· successfully litigating through appeal a challenge to our client’s launch of a generic version of Taxol® (paclitaxel);
· successfully litigating through appeal a challenge to our client’s launch of a generic version of Zantac® (ranitidine);
· successfully litigating through appeal a challenge to our client’s launch of Megace® (megestrol acetate);
· defending our generic client at trial against two patents asserted against its at risk launch of a generic version of Allegra® (fexofenadine), with the innovator dropping its case and covenanting not to sue our client before the court issued its decision;
· favorably settling a challenge to our client’s launch of a generic version of Diprivan® (propofol) on the very night before trial, with launch proceeding as scheduled;
· defending our generic client against a challenge to its launch of Vasotec® (enalapril), with the innovator dropping its case before trial and covenanting not to sue our client;
· settling favorably other at-risk launches for the generic versions of Biaxin XL® (clarithromycin), Eloxatin® (oxaliplatin), Omnicef® (cefdinir), and Solodyn® (minocycline); and
· securing affirmance of patent invalidity and unenforceability to allow a launch of generic Taxotere® (docetaxel).
The pharmaceutical market moves extremely fast and it is constantly changing. Pharmaceutical companies need top-tier counsel like Cozen O’Connor to help identify and pursue market opportunities without delay. Two recent examples of change are: (1) the Inter Partes Review procedure established by the America Invents Act, which became effective on September 16, 2012, and (2) the impact on 180-day market exclusivity of The Food & Drug Administration Safety and Innovation Act (FDASIA), which was signed into law on July 9, 2012.
Inter Partes Review offers the opportunity to significantly reduce litigation expenses by providing an alternative to conventional Hatch-Waxman litigation for challenging patent validity. We have the experience and expertise to advise our clients as to whether and when to petition for such review. As to the impact of FDASIA, depending on whether or not you are a first ANDA applicant, it may either extend the time permitted to obtain tentative approval to avoid forfeiting the 180-day exclusivity or create an opportunity for early market entry. Either way, we can help.
Hatch-Waxman litigation involves legal, regulatory, marketing, and scientific issues, and the Cozen O’Connor team is well-equipped to counsel you from product selection to launch and beyond. Our attorneys hold advanced degrees in the natural sciences and nearly all members have experience as research scientists in industry or academia, meaning we understand the intersection of law and science. This is true not only for small molecules but also biosimilars and hybrid products in between, such as smaller polysaccharides and peptides. We would welcome the opportunity for a detailed discussion of your particular needs.