Posts Tagged: "safe harbor"

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.

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.

When exploring exemptions to patent infringement, there are several key U.S. Court of Appeals for the Federal Circuit cases to be aware of. First, we will examine a number of cases that have shaped the contours of the common law experimental use exemption, which applies to all industries, and secondly, we will look at recent decisions evaluating activities under the safe harbor of 35 U.S.C. § 271(e)(1) for products requiring U.S. Food and Drug Administration (“FDA”) approval.

The International Center for Law and Economics (ICLE) released a white paper on Thursday arguing that Section 512 of Title 17 of the Copyright Act has been a failure, and it should be reevaluated and overhauled. Congress passed Section 512 as part of the Digital Millennium Copyright Act (DMCA), and authors Kristian Stout and Geoffrey Manne argue the federal courts have written out key provisions in the law. Stout and Manne write that Section 512 has succeeded in allowing online service providers (OSPs) such as social media companies to grow and thrive by providing a safe harbor provision as long as they take down infringement promptly. However, the authors argue that the law has failed to provide proper incentives and systems to prevent digital piracy

This morning, the full U.S. Senate Committee on the Judiciary convened an executive business meeting during which the committee advanced S. 673, the Journalism Competition and Preservation Act (JCPA). Though the bill was reported favorably with an amendment drawing support from the Republican members of the committee, others on the Senate Judiciary raised concerns that could presage further debate after it hits the floor of the Senate. The JCPA was first introduced into both houses of Congress last March, with Senators Amy Klobuchar (D-MN) and John Kennedy (R-LA) sponsoring the Senate version and Representatives David Cicilline (D-RI) and Ken Buck (R-NY) sponsoring the version introduced into the House of Representatives.

The U.S. District Court for the Northern District of California this week ruled that the safe harbor provision of the Digital Millennium Copyright Act (DMCA) protects Pinterest from a photographer’s claim that the platform infringed his copyrights by displaying his works alongside advertisements in the form of “promoted pins.” Harold Davis, an artist and professional photographer, claimed that Pinterest infringed 51 of his copyrighted works. In one example, Davis’ work, “Kiss from a Rose,” was displayed next to a promoted Pin for an art print called “White Tea Roses by Neicy Frey,” which Davis contended constituted unauthorized commercial use of his work.

Online shopping has become a huge part of our everyday lives. In fact, 15% of all 2020 retail sales are projected to take place online. Unfortunately, despite their convenience, e-commerce retail platforms also provide fertile ground for counterfeiters because shoppers cannot physically examine the products being sold and shoppers often cannot identify the ultimate seller.  Worse yet, online counterfeiting is not limited to fake fashion and luxury goods, but more often involves poor quality or tainted products that endanger the health and safety of the purchaser. Reported incidents of dangerous online counterfeit purchases have included children’s car seats that disintegrate in crashes, engine oils that contain dirt and water, cold medications that are simply sugar pills, and cell phone adapters that can shock or electrocute consumers. Counterfeiting is no longer a sort of comic fakery that only dupes designer bargain hunters. Rather, it has become a real problem for everyday consumers.

The United States-Mexico-Canada Agreement (USMCA) was passed by the U.S. Senate on January 16, 2020 and will be signed by President Trump today. The treaty, which renegotiates and cancels the 1994 North American Free Trade Agreement (NAFTA), is expected to dramatically affect many areas of law of its three member states. With respect to copyright law, the USMCA largely exports copyright standards from the United States. Once it is implemented, content creators and owners, Internet Service Providers (ISPs) and copyright professionals can expect the laws of Mexico and Canada to more closely resemble those of the United States with respect to liability and safe harbors for ISPs, the term of the life of a copyright, rights for sound recordings used in interactive streaming and anti-circumvention measures.

The Court of Justice of the European Union (CJEU) has ruled that host providers, such as Facebook, can be required to take down illegal content, including identical or equivalent variations, worldwide once they are made aware of it. The Court was ruling on the interpretation of the E-Commerce Directive (Directive 2000/31/EC) in a defamation case brought by an Austrian politician. (Eva Glawischnig-Piesczek v. Facebook Ireland Limited, Case C-18/18 [ECLI:EU:C:2019:821].) The politician, Eva Glawischnig-Piesczek of the Green party, asked Facebook Ireland (which operates Facebook outside of the U.S. and Canada) to delete a news clipping and associated comment, which she claimed insulted and defamed her. Following court proceedings in Austria, Facebook Ireland disabled access in Austria to the specific content published. However, the case raised the following questions: could Facebook Ireland additionally be ordered to remove posts with identical or equivalent content to that already found to be illegal, and should it disable access to the illegal content worldwide?

The U.S. Senate is slated to vote on the Stop Enabling Sex Traffickers Act (SESTA), legislation that would help prevent online sex trafficking by holding accountable the websites that knowingly facilitate such trafficking. After overwhelmingly passing the House in late February, and with 67 co-sponsors already on the Senate version, the legislation is almost certain to head to President Trump’s desk. Despite significant support from Congress, the White House, and stakeholders including the Fraternal Order of Police, U.S. Institute Against Human Trafficking, UNICEF USA, and Teens Against Trafficking, SESTA has received considerable pushback from portions of the tech community who are concerned with the changes the legislation would make to Section 230 of the Communications Decency Act (CDA)

ACTION for Trade asks Lighthizer to consider advocating for strong IP protections and robust enforcement to benefit a diverse group of industries, including digital content producers and distributors, biopharmaceutical firms and software developers… Along with strong patent policy, ACTION for Trade calls for the establishment of regulatory data protection (RDP) provisions which are consistent with U.S. law, especially where medical innovations are concerned. The letter to USTR Lighthizer notes that U.S. law recognizes a 12-year period of RDP for biologic treatments and a 5-year period of RDP for small molecule treatments. Such provisions would allow the original innovators of novel medicines to submit data on the safety and efficacy of medicines while shielding that data from others who might produce generics based on the data.

On February 1, 2018, the U.S. Court of Appeals for the Fourth Circuit issued a decision in the case, BMG Rights Management LLC v. Cox Communications, Inc. The Fourth Circuit affirmed in part the district court’s granting of summary judgment to BMG on the § 512(a) Digital Millennium Copyright Act (DMCA) safe harbor defense. Ultimately, the Fourth Circuit agreed with the district court’s decision that Cox was not entitled to the safe harbor defense, finding that Cox’s 13-strike policy for repeat infringers was effectively no policy at all, and far less than the termination policy required in order to maintain safe harbor protections.

In 2017, there were several noteworthy decisions relating to the Digital Millennium Copyright Act (DMCA). Specifically, the Ninth Circuit addressed two separate cases, one dealing with safe harbor provisions, the other on anti-circumvention. This article discusses three separate decisions including Mavrix Photographs LLC v. LiveJournal Inc., 873 F.3d 1045 (9th Cir. 2017)(on DMCA safe harbor), and Disney Enterprises, Inc. v. VidAngel, Inc., 869 F.3d 848 (9th Cir. 2017)(anti-circumvention provisions).

Understanding the Digital Millennium Copyright Act (DMCA) has become increasingly important for companies that want to protect their digital content. The DMCA was created primarily as a solution for service providers such as YouTube that host content uploaded by third parties rather than create their own original content. Service providers benefit from the DMCA because it protects them from liability in the event content uploaded to their site infringes another’s copyrights. While the DMCA addresses a number of copyright issues, the “safe harbor” provision remains one of its most important aspects.