In Abbott Laboratories v. Grifols Diagnostic Solutions Inc., the U.S. District Court for the Northern District of Illinois opined as to patent-eligible subject matter in the context of a biological invention. The case presents another situation in which the law of nature and natural phenomenon judicial exceptions have come to the forefront in the analysis of patent-eligible subject matter.
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The Supreme Court of the United States recently affirmed the decision of the U.S. Court of Appeals for the Federal Circuit in Helsinn Healthcare v. Teva Pharmaceuticals, 855 F.3d 1356 (2017), which invalidated a patent-in-suit under the post-AIA on-sale bar. The question presented, answered by the Court in the affirmative, was “[w]hether, under the Leahy-Smith America Invents Act [AIA], an inventor’s sale of an invention to a third party that is obligated to keep the invention confidential qualifies as prior art for purposes of determining the patentability of the invention.”
Justice Thomas, writing for the Court, concluded that the “on sale” provision in §102(a)(1) of the AIA was a re-enactment of the “on sale” bar provision in the pre-AIA patent statute that did not alter its meaning or interpretation, despite the inclusion of the phrase “or otherwise available to the public” in post-AIA §102(a)(1). Thus, based on the Federal Circuit’s “settled precedent,” and consistent with the Supreme Court’s decision in Pfaff v. Wells Electronics, 525 U.S. 55 (1998), the Court held that “a commercial sale to a third party who is required to keep the invention confidential may place the invention ‘on sale’ under [the AIA].” Details of the ruling and some takeaways for companies entering into licenses and supply agreements are discussed below.
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Drug and biologic developers have faced increasing pressure from patients and their advocates to make investigational drugs available for compassionate use prior to approval by the Food and Drug Administration (FDA). Over the past year social media campaigns have spotlighted patients seeking early access to potentially life-saving treatments, drawing attention to the growing debate between patient advocates promoting wider access to investigational drugs, and those urging more cautious approaches. Propelled by the plight of critically ill patients desperately seeking new treatments, several states have passed laws giving patients the “Right to Try” investigational drugs or biologics. FDA has also taken steps to make its “Expanded Access” process more user-friendly, and the Agency continues to solicit input from patient groups on risk-benefit analysis and available treatments as part of its Patient-Focused Drug Development Initiative.
Companies may want to monitor regulatory and legislative developments relating to early access to investigational treatments, and to adopt formal compassionate use policies.
Continue reading “Expanding Access to Experimental Drugs”
By Vicki G. Norton, Siegfried J.W. Ruppert, and Michael Swit
In a trio of March 6, 2014 inter partes review (IPR) decisions, the Patent Trial and Appeal Board (PTAB) canceled patent claims related to next generation DNA sequencing technology, after Illumina, Inc. countered Columbia University’s patent infringement suit by successfully petitioning for IPR of claims in three of five of Columbia’s patents-in-suit.
The decisions illustrate the utility of the new IPR process before the PTAB, implemented under the America Invents Act (AIA), as a parallel venue in which patent litigation defendants can challenge the patentability of claims asserted against them in litigation, more expeditiously and less costly than in court proceedings.
Continue reading “Successful Use of Inter Partes Review to Cancel Claims Asserted in Parallel Litigation”
By Vicki G. Norton and Michael A. Swit
FDA-regulated firms — drug, device, biologic or otherwise — on both sides of the patent aisle concerned with the bounds of the “Safe Harbor” exception to patent infringement under 35 U.S.C. § 271(e)(1) can learn several key lessons from the recent decision in Isis Pharmaceuticals, Inc. v Santaris Pharma A/S Corp. (hereafter: “Isis”), particularly how to properly prove the safe harbor defense once the litigation unfolds and also when the harbor provides shelter from post-approval patent storms.
Continue reading “Court Offers Insights On When the 271(e)(1) Safe Harbor Applies to the Use of Patented Technology in Early – and Late — Drug Development”
On March 16, 2013, Virginia became the first state to enact legislation regulating a pharmacist’s substitution of an interchangeable biologic drug for a prescribed reference biologic drug. Section 54.1-3408.04 of the Code of Virginia permits pharmacists to dispense a biosimilar in place of a prescribed biological product only if that biosimilar meets the higher safety standards for “interchangeability” under the federal Biologics Price Competition and Innovation Act of 2009. Section 54.1-3408.04 raises additional hurdles for biosimilar and interchangeable biologic drug manufacturers by imposing recordkeeping and prescriber and patient notification requirements on a pharmacist dispensing an interchangeable biosimilar in the place of a prescribed biological product. In contrast, pharmacists are not subject to those burdens when substituting a therapeutically equivalent small-molecule generic drug for a prescribed branded drug. The provisions of the Act are discussed in more detail in a March 28, 2013 Duane Morris client alert (click here).
Continue reading “Virginia Enacts the First State Law Regulating Interchangeable Biosimilar Products”