Working with a trusted legal adviser in patent litigation helps pharmaceutical and biologics manufacturers achieve their business objectives. Schiff Hardin’s pharmaceutical and biologics patent litigation team not only provides high quality lawyering, but also applies sound judgment and efficiently allocates resources to manage such litigation successfully.

Minimizing Uncertainties

Throughout the litigation process, we work with our clients to ensure that their goals and expectations are met and that costs are appropriate and manageable. We appreciate the investments that our clients have made in product development -- and the investment that they will make in Hatch-Waxman and Biologics Act litigation.

While litigation is inherently uncertain, we work closely with clients to identify, mange, reduce or even eliminate uncertainties and achieve value with targeted strategies.

A Leader in Hatch-Waxman Litigation

Schiff Hardin has one of the premier Hatch-Waxman Litigation practices in the nation. We were one of the first law firms to represent generic pharmaceutical companies seeking to make medicine affordable to consumers in Hatch-Waxman matters. Since 2000, we have continued to represent the world’s leading generic companies in ongoing major Hatch-Waxman litigation. This includes inter-partes review, trials and appeals, as well as precedent-setting cases for some of the largest first-to-file (FTF) matters.

Our experience spans the full range of Hatch-Waxman issues, from product screening and selection through trial and appeal. We have handled matters on a budget, including where we were asked by multiple clients to represent them for one product on a joint defense basis. We have handled high-stakes matters as well, where there is one FTF seeking trial on an expedited basis.

Our team has the requisite technology skills to cover the spectrum of patent challenges, including compounds, polymorphs, formulations, compositions, and methods of use. In every case, we work with our client to assemble the right team, knowing we have the bench strength and depth of experience to not only address any need, but top also do so cost-effectively.

We believe we have the “best bang for the buck,” which is why over the years we have been trusted to represent over a dozen generic pharmaceutical companies on more than one hundred pharmaceutical products in abbreviated new drug application (ANDA) patent litigations and 505(b)(2) applications.

At the Forefront of Biologics and Biosimilars Litigation

Having litigated patents related to biotechnology for over 20 years, we are in the forefront of this tradition as the industry moves to biosimilars. Our commitment to seek client-driven, practical solutions remains a constant in this rapidly developing field.

Our experience with biologics includes:

  • Monoclonal antibodies
  • Recombinant human coagulation factors
  • Recombinant insulin
  • Recombinant growth hormone
  • Related diagnostic and research tools

Our knowledge and understanding of the legal and regulatory issues, science, market economics and business strategies that drive the biologics industry inform our advice to clients as they confront the legal challenges that arise when they develop and bring new products to market.

The Biologics Price Competition and Innovation Act of 2009 provides a statutory basis for FDA approval of biosimilar and interchangeable biologic products, as well as a detailed scheme for patent litigation over those follow-on products.

As science advances and patents on small molecule drugs expire, the pharmaceutical industry has looked increasingly towards biologics with a focus on biosimilars. Applications for approval of biosimilar products, some of which will be subject to challenge under dozens of patents, will inevitably provoke litigation under the new act.

Members of our team have been in-house counsel at biotech companies. Recognizing the importance of patent issues, they can put them in the context of real business situations and are fully equipped to resolve biosimilars patent litigation.

Thought leaders in the field, we regularly publish articles in academic and industry journals, and speak frequently at public conferences on such current issues as Biologics Act litigation strategies.

An Exceptional Team

Our team is composed of talented, seasoned trial lawyers. They are patent attorneys with strong science and technology backgrounds, who know how to translate complex patent concepts for a judge or jury. From pre-trial proceedings to developing pleadings and arguments as we prepare for trial, they maintain a clear focus on supporting our closing arguments.

When settlement is appropriate, our antitrust and corporate practitioners work with our core team to craft sound settlement agreements. We have successfully litigated cases in the most important jurisdictions for Hatch-Waxman litigation, including district courts in Delaware, New Jersey, New York, and California; and appellate cases before the Federal Circuit.

  • Experience

    Our experience in Paragraph IV litigation, coupled with a keen interest in our clients’ businesses, a creative and current understanding of the patent litigation landscape, a willing experience-based ability to take cases to trial when appropriate, and a clear understanding of the risks and rewards of settlement, equips our team with the resources to address our clients’ needs and achieve their goals.

    Over the years, our team of attorneys has successfully represented clients in litigation involving azithromycin, bupropion, cardizem beta blockers, cefaclor, docetaxel, escitalopram, epinephrine, eszopiclone (Lunesta®), esomeprazole (Nexium®), lanthanum carbonate (Fosrenol®), fenofi brate, gabapentin, levonorgestrel and ethinyl estradiol (Seasonale®, Seasonique® and Loseasonique®), lopinavir/ritonavir (Kaletra®), loratadine, malathion, memantine (Namenda®), metaxalone, metformin HCl (Fortamet®), mirtazapine, norethindrone acetate and ethinyl estradiol (Femcon Fe® and Loestrin®24 Fe), omeprazole (Prilosec®), oxaliplatin, quetiapine, quinapril, ramipril, and several other products.

    Some of these cases have set legal precedents in Paragraph IV litigation. We are also experienced in litigating cases related to medical devices, including, heart stents and computer based systems for detecting cancerous and precancerous conditions.

  • Awards & Honors

    • Chambers USA
      • Intellectual Property, Illinois (2018-2021)
    • The Legal 500 U.S. – Practice Groups Recommended
      • Patents: Litigation (2021)
    • LMG Life Sciences – Hatch-Waxman Impact Case of the Year (2020)
    • Managing Intellectual Property - IP Stars in Illinois, Patent Contentious (2016-2021)
    • IAM Patent 1000: The World’s Leading Patent Professionals (2017, 2019-2021)
    • BTI – Industry Power Rankings Clientopia, Pharmaceuticals  (2016-2017)
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Clients Rely on Aly and Patel as Strategic Advisers to Bring Generic Drugs to Market

Intellectual Property Practice Group Co-Leaders Imron Aly and Sailesh Patel were featured in Leading Lawyers Magazine—2018 Business Edition for their successful track record in challenging giant pharmaceutical companies to bring generic drugs to the marketplace. MORE

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Aly Featured Discussing BPCIA Litigation Key Trend

Hatch-Waxman and Biosimilars Practice Group Leader Imron Aly explained the key trend that has emerged from litigation regarding the Biologics Price Competition and Innovation Act (BPCIA). MORE