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 sixty-nine percent of the total prescriptions dispensed in the United States but only sixteen 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, each directed to a different generic product. The vast majority of our cases have either been litigated to a successful conclusion or settled favorably for our generic 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).
Our successful Hatch-Waxman practice extends beyond top-tier patent litigation. To be successful, a generic sponsor also needs expert counsel on regulatory issues. For example, while an ANDA product has to be the same as the reference product in certain respects (e.g., the active ingredient, strength, dosage form, and route of administration), a well-crafted filing strategy with a 505(b)(2) application that changes one or more of these elements may allow market entry more quickly and without being subject to a first applicant’s 180-days of exclusivity. There may even be advantages in pursuing both a conventional ANDA and a 505(b)(2) application simultaneously.
Another regulatory area rife with opportunity is Orange Book patent use codes and data exclusivity descriptions, particularly with respect to what may (or may not) be “carved out” from a generic’s label. A sophisticated approach includes a blend of patent certifications and carve-outs with a view to providing a new market opportunity and/or reducing patent litigation exposure. Our publicly-available record concerning the regulatory facets of Hatch-Waxman includes citizen petitions arguing that:
· select competitors should be required to submit new patent certifications relating to generic Actos® (pioglitazone) and Naropin® (ropivacaine), thereby causing the related thirty month stay to restart;
· FDA should not permit certain label carve-outs for generic Lyrica® (pregabalin);
· the first applicant’s 180-days of market exclusivity should be forfeited because the sponsor voluntarily adopted a packaging change from the reference listed product for generic Hectoral® (doxercalciferol);
· the first applicant’s exclusivity for generic Nexium® (esomeprazole) should be forfeited for failure to obtain tentative approval in good time, even if missed by just by one day, an issue that was reported by The Wall Street Journal and other top news agencies.
As a final example, our team was involved in successfully persuading FDA to overturn its grant of New Chemical Entity (“NCE”) exclusivity for Torisel® (temsirolimus) injection. See Torisel Exclusivity Determination, Administrative and Correspondence Documents, Part 2, dated June 21, 2012, publicly available at Drugs@FDA. The net result gave an ANDA applicant an opportunity for sole possession of the 180-day exclusivity rather than shared exclusivity among several NCE-1 ANDA applicants. To our knowledge, this is the only instance where FDA has reversed itself as to a grant of NCE exclusivity in favor of a generic.
The generic market moves extremely fast and it is constantly changing. Generic 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.