Pharmaceutical companies facing the challenge of protecting their intellectual property (IP) from generic competition under the Hatch-Waxman Act have seen the patent litigation landscape evolve significantly in recent years. To defend market position and maximize investment in core patents and products, you need agile, sophisticated trial counsel on your side. McDermott’s life sciences patent litigation team develops innovative, solutions-oriented strategies to help you mitigate risk, capitalize on opportunity and stay ahead of the competition. Our life sciences industry group includes over 140 attorneys with demonstrated success and experience in intellectual property matters.
We are relentless advocates for clients who call on us for bet-the-company Hatch-Waxman litigation. To protect your critical innovations and investments in R&D, we mobilize technically oriented teams. Members of our team have advanced degrees and industry experience in life sciences disciplines including cellular and molecular biology, chemistry and organic chemistry, biochemistry, biomedical engineering, chemical engineering, immunology, pharmacology and genetics, as well as small and large molecules, biosimilars and hybrids. Furthermore, we have litigated cases involving a number of revolutionary drugs, including Bryhali®, Duobri®, Tyvaso®, Myrbetriq®, Lexiscan®, Glumetza®, Gralise®, Xospata®, Hetlioz®, and Orenitram®, among others. Leveraging our technical expertise with our strong trial litigation bench, we can effectively explain complex technology and IP legal principles to judges and juries in a way that greatly increases the likelihood of achieving favorable results.
Our lawyers have litigated cases involving flagship products for industry-leading life sciences companies, earning major litigation victories in dozens of federal courts, particularly in those relevant to life sciences companies such as the District of Delaware and in the District of New Jersey. We also have experience successfully coordinating parallel PTAB proceedings and protecting and opposing outcomes before the Federal Circuit. Additionally, unlike other firms who typically use the resources of external local counsel—who may have conflict issues, untested results and duplicative fees—our team leverages our Wilmington office location to provide on-the-ground local Delaware counsel intrinsically tied to the McDermott platform.
We collaborate with our FDA team to help you develop a comprehensive strategy that not only protects your patent assets, but also takes into account potential regulatory challenges to your drug products during development. In tandem with strategic regulatory submissions, our team can help you develop a patent portfolio and overall product strategy to maximize market exclusivity.
Recommended for its “excellent track record in representing life sciences and hi-tech clients in contentious cases.”
“An exceptional team which develops innovative solutions that align with our business needs and is not solely focused on the litigation at hand. Open to taking a holistic approach when developing a litigation strategy.”
Representing Astellas Pharma in a patent infringement case in the US District Court for New Jersey regarding its XOSPATA® product, used for the treatment of acute myeloid lymphoma (AML) in patients who have relapsed or refractory AML with FLT3 mutations.
Representing biotechnology giant United Therapeutics Corporation in its Hatch-Waxman litigation against Liquidia Technologies, a late-stage clinical biopharmaceutical company. Following the bench trial, Judge Andrews issued an opinion finding that Liquidia’s generic version of Tyvaso infringes (directly and indirectly) one of UTC’s asserted patents.
Delivered a complete victory for client Bausch Health Companies against would-be generic entrant Padagis LLC when the US District Court for the District of New Jersey issued its 77-page opinion finding that Bausch’s patents covering its commercial psoriasis lotions, Bryhali® and Duobrii®, were valid and infringed.
Representing a global pharmaceutical company in an ANDA litigation oral capsules, used for the treatment of circadian rhythm disorders.
Representing Astellas Pharma in patent infringement suit filed against over twenty generic companies involving the formulations found in their leading drug for the treatment of overactive bladder, as well as in multiple district court cases against nine generic groups asserting infringement of patents that cover Astellas’s Myrbetriq® product.
Achieved a favorable settlement for biotechnology giant, United Therapeutics, in its 12-patent infringement suit against ANI Pharmaceuticals regarding UTC’s Orenitram extended-release tablets.
Representing Astellas Pharma in multiple patent infringement cases regarding its Lexiscan® product. Lexiscan® is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress. McDermott was retained by Astellas to replace another firm.
Represented Bausch Health Companies in Hatch-Waxman litigation against Apotex in the US District Court for New Jersey related to two of Bausch’s patents covering controlled release dosage forms for Glumetza®.
Represented Assertio Therapeutics (formerly Depomed) in protecting its flagship pharmaceutical product Gralise® in Hatch-Waxman litigation in the US District Court for New Jersey. Five of the six generic defendants withdrew their attempt to market a generic product or settled. Depomed and remaining entity, Actavis, went to trial, where a sweeping victory was secured for Depomed, finding infringement by Actavis and upholding the validity on all asserted patents.
Obtained favorable settlements on behalf of Bausch Health in Hatch-Waxman litigation involving the assertion of twelve patents against 19 generic ANDA filers.