In the recent discourse surrounding the legislative landscape of patent infringement, particularly concerning “skinny labels,” there appears to be a contentious debate on whether reform is truly necessary. The concept of “skinny labeling” allows generic drug manufacturers to produce FDA-approved drugs that only include non-patented uses, thereby avoiding patent infringement on specific patented indications
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As it stands, two seminal Federal Circuit cases have reinforced the existing legal framework, suggesting it remains both stable and balanced. For instance, in GlaxoSmithKline LLC v. Teva Pharm USA Inc., Teva faced accusations of induced infringement despite their application of a skinny label that omitted a patent-covered method of treating congestive heart failure. However, the Federal Circuit determined that the substantial evidence pointed towards induced infringement due to both labeling and marketing practices, not changing the fundamental legal approach to skinny labeling, but addressing specific factual circumstances.
The discussion extends to the case of Amarin Pharma Inc. v. Hikma Pharms. USA Inc. Hikma’s label, although relegated to a single non-patented indication, still sparked claims of infringement based on the marketing materials that potentially encouraged an infringing use. Here again, the Federal Circuit upheld its decision by considering the totality of the evidence, not just isolated aspects.
Despite these rulings, legislative efforts are underway with the introduction of the “Skinny Labels, Big Savings Act“, which seeks to establish that pursuing approval and marketing of a drug with a skinny label does not equate to patent infringement. This legislation faces skepticism, as articulated by legal experts from Orrick, who argue such measures may disrupt the existing balance and challenge the rights of patent holders.
Given the ongoing nature of this debate, it remains paramount for legal practitioners to closely monitor these developments and their potential implications. The recent Supreme Court’s request for the solicitor general’s opinion in the Hikma case further underlines the significance of this issue and its potential impact on patent litigation in the pharmaceutical field.