Posts Tagged: "pharmaceuticals"

The U.S. government filed its brief in opposition yesterday to Janssen Pharmaceuticals and Bristol Myers Squibb Company’s (BMS) petition for writ of certiorari challenging the government’s Medicare Drug Price Negotiation Program. A split U.S. Court of Appeals for the Third Circuit decision  in September 2025 affirmed a grant of summary judgment to the government that the imposition of the Program via the Inflation Reduction Act (IRA) does not violate the companies’ constitutional rights.

As policymakers consider the future of American healthcare, it is imperative to recognize the potential dangers of adopting foreign price controls for life-saving medications. These price controls, which are referred to as foreign “reference pricing,” would tie the price of medicines in the United States to prices set by foreign governments that are paid in other countries with vastly different healthcare systems. While this approach may initially sound appealing, the reality is that foreign reference pricing imports the failed models of other countries rather than rewarding innovation or recognizing the true value of breakthrough therapies. It pegs prices here to bureaucratic decisions made abroad and threatens to undermine the very engine of medical innovation that has made the United States a global leader in life sciences and benefited millions of patients.

We recently wrote an introductory overview of navigating the Common Law Research Exemption and the Hatch-Waxman Safe Harbor and an exploration of the application of the Common Law Research Exemption. Here, we take a closer look at the Hatch-Waxman safe harbor under 35 U.S.C. § 271(e)(1), particularly through treatment by the courts over the past decade.

Over the last several years the pharmaceutical industry has come under increased pressure. While many often say the pharmaceutical industry has the most powerful lobby, the truth is many politicians have grown increasingly frustrated with what they characterize as high drug prices; or at least much higher than in virtually every other country around the world. This has led to patents being blamed, with billboards and buses in Washington, DC, wrapped with slogans like “patents kill”.

Yesterday, the Federal Trade Commission (FTC) sent a series of seven warning letters to several pharmaceutical companies renewing the agency’s challenge to dozens of patent listings in the U.S. Food & Drug Administration’s (FDA) Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the Orange Book. The FTC’s redoubled effort to improve consumer access to generic drugs by removing patent listings from the FDA’s list of approved New Drug Applications (NDAs), which continues under the FTC’s new Republican leadership, targets inhaler and drug delivery device patents without addressing decades of calls from the pharmaceutical industry seeking clarity on the guidelines for listing device patents in the Orange Book.

In a previous article, we analyzed the contours of the common law experimental use exemption. Now, we will explore the application of the exemption to common research activities, including those at universities and research institutions, in cases spanning recent decades. These cases illustrate the narrow confines of the experimental use exemption and its limited applicability in scenarios involving activities with direct or indirect commercial or business-related objectives. As a result, researchers should tread carefully and not count on the exemption to shield them from liability for patent infringement.   

On Sunday, May 11, President Donald Trump announced on Truth Social that he would sign an Executive Order today aimed at lowering prescription drug prices. The order refocuses the drug pricing debate, which often is centered around patents, on “equalizing” pricing among developed nations.    In his social media post, Trump blamed pharmaceutical companies for chalking up the high price of drugs in the United States to research and development costs. “It was always difficult to explain and very embarrassing because, in fact, there was no correct or rightful answer,” Trump wrote. He also implied that Democrats have resisted efforts to lower prices due to campaign contributions from the industry and said the Order signed today will reduce drug prices “almost immediately, by 30% to 80%” via a “most favored nations” policy that will mandate U.S. citizens pay the same price as the nation paying the lowest price.

In a precedential decision issued May 6, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) reversed in part and vacated in part a Delaware district court’s injunction that blocked Avadel CNS Pharmaceuticals from conducting clinical research and seeking regulatory approval for expanded uses of its once-nightly narcolepsy drug, Lumryz. The Federal Circuit ruled that the injunction unlawfully covered conduct protected by the Hatch-Waxman Act’s “safe harbor” provision, 35 U.S.C. § 271(e)(1), which exempts pre-approval research and regulatory activities from infringement liability.

In recent years, the pharmaceutical industry has undergone significant changes in the focus of its innovation, research and development efforts. Historically, oncology and immunology were the primary targets for pharmaceutical companies, with most resources and capital allocated to developing new technologies in these areas.

This week our conversation is with Patrick Kilbride, who is a public policy expert with significant expertise at the intersection between market economics, innovation and intellectual property. At the beginning of our conversation Kilbride explains that “one of the most remarkable things about the American economy is that what we have done historically does seem to be so unique.” He then pointed to five distinguishing features, which we spend the rest of our conversation discussing. According to Kilbride, what makes the U.S. unique is that the American economic approach enables risk taking and failure, fosters competition and ensures goods and services can cross state lines, provides property rights, is based on the rule of law, and establishes markets.

Pharmacy benefit managers, or simply PBMs, are often owned by either the pharmacies themselves or sometimes by insurers, which creates a lot of self-dealing to say the least. These PBMs are middlemen who receive 50% of the value of the drug, significantly raising drug prices. This has nothing to do with IP whatsoever.

The U.S. Court of Appeals for the Federal Circuit (CAFC) issued a precedential decision today reversing a district court’s grant of Hikma Pharmaceuticals’ motion to dismiss Amarin Pharma, Inc.’s complaint against it for induced infringement. Amarin claimed Hikma induced infringement of its “icosapent ethyl” product, an ethyl ester of an omega-3 fatty acid commonly found in fish oils, marketed as Vascepa. U.S. District Court for the Western District of Texas Judge Alan Albright was sitting by designation on the CAFC panel.

In what has to be the unkindest cut of all, those expected to benefit from the proposed misuse of march-in rights so the government can impose drug price controls say they don’t support it either. The proponents promoting this hot house theory have seen it denounced by those who created the Bayh-Dole Act as being unauthorized under their law and seen evidence they can’t refute that it would have little impact on drug prices but would devastate small business entrepreneurs in all fields of federally supported research and development. And now they’ve lost the generic drug industry.

The U.S. Senate Committee on Health, Education Labor & Pensions held a hearing today on why the United States pays “by Far, the Highest Prices in the World for Prescription Drugs.” Patents came up throughout the hearing as one barrier to lowering prescription drug prices, while pharmaceutical industry representatives underscored the cost of bringing innovative and life-saving drugs to market and the superior access Americans have to such drugs compared with other countries.