U.S. Taxpayers Should Not Be Paying for Private Patent Infringement

For more than a year, Senator Elizabeth Warren (D-Massachusetts) and several members of Congress have urged Secretary of Health and Human Services Xavier Becerra to invoke a 100-year-old law to repeal drug patents and revoke drug patents. I have participated in campaigns asking for lower prices. , Title 28 of US Code 1498.

The strategy took a new turn in early March 2023 when the Biden administration’s Department of Justice filed a surprise “expression of interest” in a private lawsuit on behalf of “the government and its Department of Health and Human Services and the Department of Defense.” showed. The lawsuit, filed in federal court in Delaware, was initiated by Arbutus Biopharma and Genevant Sciences. These companies allege that their patents were infringed by Moderna in manufacturing that version of his COVID-19 vaccine. Curiously, the Justice Department has not attempted to intervene, instead acknowledging that the government does not have jurisdiction to determine infringement claims against Moderna arising from his 2020 Army contract to purchase Moderna’s vaccine. It simply decided to “notify” the trial judge. Liability Under Section 1498.

dangerous meaning

The Justice Department declared that its “statement of interest” should resolve the applicability of Section 1498, but a federal judge was not persuaded. He said Congress enacted this law in 1910 to make the government liable to pay “reasonable compensation” to owners if they infringed patents in exercising prominent domain authority. It reminded the government to clarify one thing. Then, in 1949, Section 1498 was amended to exempt contractors who worked in the World War II effort, but to ensure that the infringement was “for the government’s sake” and not “with government permission.” Only if you have given your consent.

Importantly, the precedent law of appeals states: [a] Funding or reimbursement for the program in general, or for all or part of its costs, is too far from making the government a beneficiary of the program for the purposes underlying § 1498. ” Larson vs. USA (Cl. Ct. 1992). therefore, Arbutus A federal judge ruled that while the government may have paid for the Moderna vaccine, it was manufactured “for use” for the benefit of private citizens, not “for the government,” so Section 1498 More importantly, he recognized the dangerous implications of the Justice Department’s position. It states that “all government-funded products are used to advance policy goals articulated by the U.S. government, such as intravenous needles to fight HIV or cancer drugs to fight wars.” It means ‘may mean’. It relates to cancer and is subject to the defenses of §1498(a). ”

Notably, the government also denied that Moderna was involved in patent infringement. Instead, we want an Article 1 court, many of whose judges are former federal lawyers, to make that decision, even if the amount could be in the billions. bottom.

The timing of the Justice Department’s Statement of Interest is also interesting. Within a week, Moderna made his $400 million “catch-up” payment to the National Institutes of Health to obtain the rights to use a chemical technology that Moderna vehemently contested as unpatentable. . Moderna offers no explanation for the previous reversal of positions.

just the beginning

The DOJ’s recent private infringement lawsuit marks the final step in the administration’s attempt to abuse Section 1498(a) to advance a policy agenda that undermines patent property rights, particularly in the pharmaceutical industry. No attempt. But every American industry whose business is centered around patents should be concerned. Continued vigilance is needed to prevent attempts to extend the scope of Section 1498(a) far beyond what Congress intended and pass on the costs to U.S. taxpayers.

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Copyright: Stuart Miles