U.S. International Trade Commission Finds Patent Violation and Issues Orders
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The U.S. International Trade Commission (ITC) has concluded an investigation, finding a violation of Section 337 of the Tariff Act of 1930. This decision relates to certain photodynamic therapy systems and related products. The investigation was filed by Sun Pharmaceutical Industries, Inc.
The ITC has issued a Limited Exclusion Order (LEO). This means that unlicensed entry of the infringing products—such as specialized therapy systems and pharmaceutical products—is prohibited. These products are made by, or on behalf of, four companies: Biofrontera Inc. and three companies located in Germany, namely Biofrontera Pharma GmbH, Biofrontera Bioscience GmbH, and Biofrontera AG.
The Commission began looking into the complaint on August 1, 2024. This was after Sun Pharmaceutical Industries claimed that these four companies were importing and selling products in a way that infringed on their patents. The patents involved are U.S. Patent Nos. 11,446,512 and 11,697,028.
The ITC’s decision included the issuance of Cease and Desist Orders against each of the companies. This requires that the companies stop violating the patent rights. The Commission determined that a bond of zero percent is set for any infringing products brought in during the Presidential review phase.
The investigation and decision offer resolution to allegations of patent infringement in the U.S. This aims to protect domestic industries from unfair competition and patent violations.
The findings affirmed the construction of certain technical patent terms, such as “nested hinges,” and ruled that the claims are not obvious, therefore are valid. The investigation has been concluded, and the orders have been issued with modification to address different aspects of the investigation.
The ITC also considered public interest factors and concluded that these do not prevent the issuance of the orders. The Commission vote for this determination took place on May 6, 2026.
These steps ensure that patent rights are respected, and they set forth the importance of protecting U.S. industries and encouraging innovation within the legal system.
For more information, you can visit the ITC’s website or view the records of this investigation online.
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