On Patents, Patients and the Public Interest

By Michael Young

Earlier this month, a U.S. District Court in Delaware issued an injunction to bar sales of a minimally invasive Medtronic replacement heart valve that putatively infringed on competitor’s Edwards Lifesciences valve system patent.  After this ruling was issued, Medtronic filed an emergency motion requesting stay and expedited appeal of this injunction, contending that that “if the injunction were permitted to go into effect, treatable patients [with aortic annuli larger than 25mm for whom Edwards’ valve is not suited] may unnecessarily die in the name of already expired patent rights. Put simply, the calamity to public health that would result from the injunction is premised on a legally improper extension of patent rights” (Medtronic v. Edwards, 08-CV-0091, 2014).  Shortly thereafter, The Federal Court Circuit of Appeals agreed to postpone the injunction and to expedite Medtronic’s appeal.

While still unraveling, this case offers unique insights into the important yet often overlooked dialectic between patient safety and patent rights.

To what extent can courts take into account the public interest when adjudicating patent disputes and in considering injunctions?  More fundamentally, how should courts go about determining “where the public interest lies” in such cases [1]?

Related questions were brought to light in the context of patenting DNA and potential harms to society that might accrue by virtue of slowed scientific progress and less affordable access to potentially life-saving diagnostics and treatments predicated on patented gene products.  These considerations, many argued, outweigh any good attained by allowing genetic information to be patented.

Since the lives of patients can hinge, directly or indirectly, on particular court decisions or patent policies, the relative paucity of guidelines on how public health concerns should factor into these legal constructs is surprising.

These issues bring to mind Dov Fox’s recent work on interest creep, a phenomenon which he describes as the “uncritical  expansion of underspecified interests…to capture multiple, distinct sources of government concern. By shielding such concerns from critical judicial appraisal, interest creep erodes the  adjudicative duty to provide litigants, lawmakers, and lower courts with clear  reasons for its decisions. Worse, interest creep generates incorrect legal outcomes when the discrete concerns that go by the name of a sweeping state interest cannot do the doctrinal work for which that shibboleth is enlisted. Only by disentangling the constellation of concerns that its reliance papers over will decisionmakers be able to assess the force with which those more particular concerns apply within diverse and dynamic contexts.”

While the recent decision of the Federal Court Circuit of Appeals to postpone the injunction barring sales of Medtronic’s valve reflects positively on the ability of the Court to consider patient safety in adjudicating intellectual property disputes, it highlights a great need for (a) more proactive safeguards to protect patient safety; (b) procedures to regularly elicit impartial medical perspectives on proposed injunctions that may bear on the health of patients; and (c) further consideration of what kinds of advancements in public interest may justifiably trump countervailing corporate interests.

Meaningful reforms to protect specified public interests and to explicitly encapsulate the needs of patients can profoundly enhance our patent system.  By bringing the goals of patent law and public health into closer alignment, the place of both within the evolving fabric of society can be enriched and strengthened.

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[1] Opinion of the Supreme Court in Nken v. Holder: “…The party requesting a stay bears the burden of showing that the circumstances justify an exercise of that discretion. See, e.g., Clinton v. Jones, 520 U.S. 681, 708, 117 S.Ct. 1636, 137 L.Ed.2d 945 (1997)Landis v. North American Co., 299 U.S. 248, 255, 57 S.Ct. 163, 81 L.Ed. 153 (1936). The fact that the issuance of a stay is left to the court’s discretion “does not mean that no legal standard governs that discretion …. `[A] motion to [a court’s] discretion is a motion, not to its inclination, but to its judgment; and its judgment is to be guided by sound legal principles.'” Martin v. Franklin Capital Corp., 546 U.S. 132, 139, 126 S.Ct. 704, 163 L.Ed.2d 547 (2005) (quoting United States v. Burr, 25 F.Cas. 30, 35 (No. 14,692d) (CC Va. 1807) (Marshall, C.J.)). As noted earlier, those legal principles have been distilled into consideration of four factors: “(1) whether the stay applicant has made a strong showing that he is likely to succeed on the merits; (2) whether the applicant will be irreparably injured absent a stay; (3) whether issuance of the stay will substantially injure the other parties interested in the proceeding; and (4) where the public interest lies.” Hilton, supra, at 776107 S.Ct. 2113. There is substantial overlap between these and the factors governing preliminary injunctions, see Winter v. Natural Resources Defense Council, Inc., 555 U.S. ___, ___, 129 S.Ct. 365, 376-77, 172 L.Ed.2d 249 (2008); not because the two are one and the same, but because similar concerns arise whenever a court order may allow or disallow anticipated action before the legality of that action has been conclusively determined.”

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