Yesterday, the U.S. Supreme Court heard oral argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., No. 24-889, a case that could reshape the landscape of pharmaceutical patent enforcement and generic drug competition. The case concerns the scope of induced infringement liability under 35 U.S.C. § 271(b) in the context of “skinny labels” — the mechanism by which generic drug manufacturers may carve out patented indications from their FDA-approved labeling and enter the market for unpatented uses under Section viii of the Hatch-Waxman Act. A decision is expected by the end of the Supreme Court’s current term in June 2026. As we discussed in our earlier blog post on The Patent Playbook, this case squarely implicates the enforceability of method-of-use patents for later-developed drug indications, and the viability of the Section viii pathway for generic drug manufacturers.
Supreme Court Takes Up Hikma v. Amarin: Induced Infringement and Skinny Labels in the Crosshairs
The Supreme Court’s decision to review Hikma Pharmaceuticals USA Inc. v. Amarin Pharma Inc. places renewed attention on a familiar but unsettled issue in pharmaceutical patent law: how the induced infringement doctrine applies when a generic drug launches with a concededly “skinny” label, but engages in broader marketing and communications outside the FDA-approved label.
Although the case arises under the Hatch-Waxman Act, it squarely implicates the scope and enforceability of method-of-use patents, particularly for later-developed indications that often represent substantial additional investment by brand-name manufacturers.
Sonos, Inc. v. Google LLC: CAFC Leaves Expanded Role for Prosecution Laches in Limbo
The practice of serially filing continuation applications through a patent’s lifetime has come under increased pressure in recent years from newly implemented continuing application fees to expanded case law on non-statutory obviousness-type double patenting. A somewhat new interpretations of the doctrine of prosecution laches emerging from Sonos, Inc. v. Google
Novo Nordisk v. Mylan: Method of Treatment Claims Must Be Aligned with Label
Method-of-treatment (“MoT”) claims can be powerful tools for pharmaceutical companies seeking to extend market exclusivity for their products after the original composition-of-matter patents expire. However, the District of Delaware’s recent decision in Novo Nordisk v. Mylan is another reminder that the scope of method of treatment claims must be aligned with an FDA approved drug label.
Beyond the Deal: How are Expiring Patents Fueling M&A in the Life Sciences Industry?
Expiring patents can be a catalyst for M&A in the life sciences industry as pharmaceutical and biotechnology companies seek to maintain revenue streams and competitive advantages. In this edition of Beyond the Deal, our lawyers assess the evolving landscape, share insights on the impacts of strategic deals and explain how
Troubling Trend of “Self” Revocation In the CRISPR Space Continues in Europe
Less than two months after CVC made the surprising move to revoke two of its seminal European CRISPR patents, Sigma-Aldrich has done it too. While the facts that led to Sigma’s “self” revocation may be different than CVC’s, this en vogue trend of avoiding final decisions is troubling because it
To Be Or Not To Be: Self-Revocation of Seminal European Patents Creates New Uncertainty In CRISPR IP Space
There is no shortage of surprises and twists in the decade-long fight over the control of dominant IP in the CRISPR space. The newest one is the self-revocation of two seminal CRISPR patents in Europe by the team led by two Nobel Laureates Emmanuelle Charpentier and Jennifer Doudna (aka “CVC”).
The Broad Impact of Edwards v. Meril on the Safe Harbor Provision
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. § 271(e)(1). The Federal Circuit’s ruling, and the subsequent denial of Edwards’s petition for rehearing en banc, underscores
Duty of Candor Continues Before the PTAB or Does it?
In an unprecedented PTAB decision involving Spectrum Solutions LLC and Longhorn Vaccines & Diagnostics, the Board found all five challenged patents invalid and imposed sanction against patent owner Longhorn for failure to meet the duty of candor and fair dealing. The board determined that Longhorn selectively disclosed testing results to
The Supreme Court Kept the Door Open to Genus Claims
The U.S. Supreme Court on May 18, 2023 delivered its decision on the scope of the patent enablement requirement, set forth in 35 U.S.C. § 112, in the antibody dispute Amgen, Inc. v. Sanofi. While the parties obtained finality, many in the pharmaceutical and biotechnology industries received the opinion under a cloud of uncertainty and concern for exclusivity rights broad enough to both protect clinical candidates and deter competitors. While the patent bar may remain apprehensive, the Supreme Court kept the door open to genus claims. The impact of the decision may not be as far-reaching as feared.