Hatch-Waxman Litigation
Taft has one of the premier Hatch-Waxman Litigation practice groups in the nation, combining several decades of experience among its trial lawyers, Ph.D.-level scientific advisors and staff. Our team has been involved in well over one hundred ANDA patent litigations over the years and numerous others relating to so-called 505(b)(2) applications. We have the experience to execute the best strategy designed to protect the 180-day exclusivity in scenarios where our client is the first paragraph IV applicant or challenge that exclusivity to trigger forfeiture in subsequent-filer cases.
Getting your product to the market is the driving objective, which may include a well-crafted, comprehensive license and settlement agreement. Our attorneys are skilled at drafting settlement agreements that address all types of issues, including certain market contingencies that may impact forecasted revenue. For example, careful thought has to be given to whether an innovator may attempt to alter the market after the settlement date but before the licensed entry date such that the value of a proposed generic equivalent is significantly less than originally considered.
More importantly, we deliver transparency, consistency and predictability to the cost of litigation, which aids our clients in managing their internal budgets. Litigation can be expensive, especially given the market opportunity at risk in an ANDA litigation. We aim to be your business partner, helping you to achieve your commercial objectives on time and within cost. To that end, we are well-versed in alternative fee arrangements, fixed fees, capped fees and other risk-sharing strategies, leaving you to focus on getting your products to your customers.
The Hatch-Waxman paradigm affords an opportunity for an ANDA applicant to launch its product at-risk or before there is a license from the innovator or a favorable, final judgment on the asserted patents. The risk involved is usually at least several million dollars and may even be several-fold higher. Our team has counseled clients on numerous at-risk launches, including the following:
- Counseling on possible damages involved in the at-risk launch of generic Protonix® tablets (pantoprazole), one of the largest such launches in history.
- Settling liability and alleged damages following the at-risk launch of extended-release clarithromycin, referencing Biaxin XL®.
- Defending the at-risk launch of cefdinir, referencing Omnicef®.
- Defending the at-risk launch of injectable oxaliplatin, referencing Eloxatin®.
- Defending the first at-risk launch of generic Skelaxin® (metaxalone) in view of several Orange-Book listed patents.
- Settling all claims relating to the at-risk launch of generic Solodyn® (minocycline).
- Defending the at-risk launches of generic versions of the oral contraceptives Yasmin® and Yaz® (drospirenone + ethinyl estradiol).
- Settling all claims regarding the at-risk launch of generic Neurontin® (gabapentin) where the innovator was claiming several billion dollars in damages.
From a legal perspective, we understand that getting a product successfully to market involves more than a patent strategy. Seasoned guidance on regulatory issues is also needed. 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), an opportunistic strategy may be to file a 505(b)(2) application, changing one or more of these elements and avoiding a first applicant’s 180-days of exclusivity. In some cases, there could be an advantage in having both a conventional ANDA and a 505(b)(2) application.
Regulatory strategies may impact not only the innovator, but also other generic sponsors. There has been increasing activity regarding Orange Book use codes and data exclusivity descriptions, particularly as to what may be permissibly carved-out from a generic label. One approach may be use a blended patent certification and carve-out strategy to reduce patent litigation exposure, creating the ability to market ahead of competitors. Alternatively, sponsors may use the citizen petition process to try and create a market opportunity. Our team has been involved in at least the following public petitions, creatively arguing that:
- Certain ANDA sponsors should be required to submit new patent certifications relating to generic Actos® (pioglitazone) and Naropin® (ropivacaine), thereby causing their respective 30-month stays to restart.
- FDA should not accept proposed section-viii carve-out statements for generic Lyrica® (pregabalin).
- The 180-days of market exclusivity should be forfeited because the first paragraph IV applicant voluntarily changed its packaging for generic Hectorol® (doxercalciferol).
- The first applicant’s 180-days of exclusivity for generic Nexium® (esomeprazole) should be forfeited for failing to obtain tentative approval within the prescribed 30 months, even if missed by a single 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 reverse itself regarding the New Chemical Entity exclusivity for Torisel® (temsirolimus) injection. See Torisel Exclusivity Determination, publicly available at Drugs@FDA. FDA’s adoption of our argument allowed our client the opportunity for sole possession of the 180-day exclusivity rather than sharing that with several others. To our knowledge, this is the only example where FDA has overturned its grant of such exclusivity.
The generic U.S. market is dynamic, competitive, moves extremely fast and is constantly changing. To succeed, generic companies need seasoned counsel regarding the critical patent, regulatory, marketing and scientific issues. 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 other products in between, such as smaller polysaccharides and peptides.
Biologics/Biosimilars
The worldwide market for follow-on biologics or biosimilars is just beginning to evolve. In the United States, that beginning was punctuated with the passage of The Biologics Price Competition and Innovation Act (“BPCIA”), enacted in March 2010 as part of the Affordable Care Act. The BPCIA created a statutory pathway for an applicant to bring a biosimilar product to market — just as the Hatch-Waxman amendments did for generic drugs in 1984. But unlike generic drugs, which are required to have exactly the same active pharmaceutical ingredient as the branded reference drug, biosimilar drugs will naturally have a few differences from their branded counterparts.
Those differences define the battlefield for market competitors — from both regulatory and patent perspectives. Innovators will likely argue that exact identity is required, or at least to the extent that the reference product can be characterized. The analytical techniques are evolving with the market itself. Biosimilar applicants, on the other hand, will argue within the temporal bounds of “biosimilarity” and “interchangeability,” as those terms are used in the statute. Biosimilarity does not mean exact identity but generally only that the proposed product is similar enough to the branded product such that there are no clinically meaningful differences as to safety, purity and potency.
Interchangeability is a higher threshold, meaning that the proposed product satisfies the biosimilarity standard and is also expected to have the same effect as the brand in any patient, with no increased risk of safety or diminished efficacy when switching from the brand product. Importantly, like AB-rated generic drugs, interchangeable biologic products may be substituted for the reference product without the intervention of the prescribing healthcare provider, though several states are pursuing and enacting legislation to restrict this practice. Other states have explicitly rejected such a restriction.
The stakes are high, with the biosimilar market projected to reach tens of billions of dollars in just a few years. To access that market, the cost of development is also quite significant, including investment in talent, analytics, capital expenditures and even perhaps clinical trials to some degree. A price tag of $100 million is not unheard of, which is exponentially higher than the cost to develop a traditional generic drug. To offset that investment risk, the market is revealing brand/generic and other alliances that are not typically seen with small molecules.
Applicants need qualified counsel to minimize risks and maximize returns. Regulatory strategies and patent litigation are inevitable. Taft is well-suited to counsel you from product selection, through development and FDA review, and ultimately to launch, bringing calm to the chaos. We understand the legal, regulatory, economic and scientific issues that guide and influence the biosimilar industry.
We have relevant experience with major biosimilar targets, including insulin, granulocyte colony-stimulating factor, erythropoiesis-stimulating agents, oncology products and anti-tumor necrosis factor products.
