General – Page 11 – Duane Morris Life Sciences Law

January 24, 2019 by Duane Morris

What Competitors Don’t Know Can Hurt You: SCOTUS Rules Secret Sales Can Trigger On-Sale Bar Under AIA

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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January 14, 2019 by Duane Morris

FDA Issues Final Guidance on Data Integrity and Compliance with Drug CGMP

Data integrity means complete, consistent and accurate recording of data. This requires an original or true copy of contemporaneously recorded data that is attributable to a specific individual and is legible and accurate. The Food and Drug Administration (FDA) considers data integrity to be critical throughout the current good manufacturing practice (CGMP) to ensure product quality and public safety. In response to an increased number of data integrity violations, which have led to warning letters, import alerts and consent decrees, the FDA published a draft guidance on Data Integrity and Compliance with CGMP on April 14, 2016. After considering comments to the draft guidance, the FDA has now issued its Final Guidance on Data Integrity and Compliance with Drug CGMP on December 12, 2018. The Final Guidance is in a Q&A format and provides detailed instructions to the industry that reflects the FDA’s current thinking on data integrity.

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January 4, 2019 by Duane Morris

DOJ Implements 2018 Granston Memo on False Claims Act

In early 2018, the U.S. Department of Justice announced a new policy encouraging prosecutors handling False Claims Act (FCA) cases to seek dismissal of qui tam complaints that threaten the government’s interests. However, it was unclear how and to what extent prosecutors would carry out that directive. Now a year later, federal prosecutors appear to be embracing the new policy—and it is already having an effect on one case involving a drug manufacturer.

The January 2018 Granston memorandum outlined the Department’s new approach to handling FCA prosecutions in “in light of the government’s limited resources.” Under the new policy, prosecutors are encouraged to move to dismiss qui tam claims as a way to “advance the government’s interests, preserve limited resources, and avoid adverse precedent.” This marked a departure from the Department’s previous policy of rarely exercising its statutory authority to dismiss such claims. To guide prosecutors, the memorandum offered a nonexhaustive list of factors as to when a motion to dismiss a qui tam claim is proper. Those factors include: (1) “curbing meritless qui tams”; (2) “preventing parasitic or opportunistic qui tam actions”; (3) “preventing interference with agency policies and programs”; (4) “controlling litigation brought on behalf of the United States”; (5) “safeguarding classified information and national security interests”; (6) “preserving government resources”; and (7) “addressing egregious procedural errors.” Overall, the memorandum instructed prosecutors to seek dismissal when the litigation does not serve the government’s interests.

Read the full Alert on the Duane Morris LLP website.

December 27, 2018 by Duane Morris

FDA Announces New UDI Compliance Deadlines via Another Guidance Document

On September 24, 2013, the Food and Drug Administration (FDA) issued a “final” rule regarding the Unique Device Identification System to adequately identify devices through distribution and use. The FDA has since issued several guidances updating implementation of the unique device identifier (UDI). On November 5, 2018, the FDA issued its latest UDI policy, “Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking,” which supersedes the direct marking deadlines mandated by an earlier guidance.

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December 18, 2018December 18, 2018 by Duane Morris

FDA Withdraws Proposed Generic Drug Labeling Rule

The U.S. Food and Drug Administration recently announced it will withdraw a proposed rule that would have required generic drug manufacturers to independently update their drug labels with new information. The proposed rule, Supplemental Applications Proposing Labeling Changes for Approved Drugs and Biological Products, would have imposed on generic drug manufacturers the same labeling-update mandates that now apply only to brand-name drug manufacturers.

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November 27, 2018 by Duane Morris

New FDA Draft Guidance on Uncertainty Considerations in Benefit-Risk Determinations for Medical Device Premarket Approvals

The Food and Drug Administration recently issued draft guidance entitled “Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions.” Comments to this draft guidance should be provided by December 5, 2018.

FDA provides authorization for marketing a device when its benefits outweigh its risks. Uncertainty surrounding these benefits and risks is a factor that FDA considers when making its determination with respect to premarket approval application (PMA) approvals, de novo classifications, 510(k) clearances, humanitarian device exemption (HDE) approvals and investigational device exemption approvals. As it has in previous guidances, FDA attempts to provide “a flexible, patient-centric, benefit-risk approach” that is “tailored to the type and intended use of the device and the type of decision” required. For example, PMA and de novo requests require a demonstration of reasonable assurance of safety and effectiveness. However, HDE applications inherently have a greater uncertainty surrounding the benefit-risk profile as Congress provided that these applications need not show a reasonable assurance of effectiveness as the patient population is generally very small.

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November 20, 2018November 20, 2018 by Duane Morris

FDA Publishes Redraft of 510(k) Third Party Review Program

Section 523 of the Federal Food, Drug, and Cosmetic (FD&C) Act codifies the 510(k) Third Party Review Program (3P Review Program), which authorizes certain qualified third parties (3P Review Organizations) to conduct the initial review of premarket notification submissions for certain low-to-moderate risk medical devices. The 3P Review Program has been in existence since 1996, and the Food and Drug Administration (FDA) has modified aspects of the 3P Review Program from time to time to comply with changes in the statutory framework. The FDA Reauthorization Act of 2017 (FDARA), which was signed into law on August 18, 2017, amended Section 523. In response, the FDA has now published a draft guidance, titled “510(k) Third Party Review Program Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations,” which modifies the 3P Review Program guidance. Comments and suggestions are due by December 13, 2018. When finalized, this guidance will supersede FDA’s guidance documents from 2001 and 2004.

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November 9, 2018 by Duane Morris

CDER’s New MAPP on Risk-Based Site Selection Model for Routine Inspections

The Food and Drug Administration’s Center for Drug Evaluation and Research (CDER) published a new Manual of Policies and Procedures (MAPP) for the Site Selection Model (SSM) used to prioritize manufacturing sites for routine current good manufacturing practice inspections. As in the past, FDA will use a risk-based approach to inspections of both domestic and foreign drug establishments in order to promote parity in inspectional coverage (i.e., equal frequency for sites with equivalent risk regardless of geography or product type) and effective and efficient use of FDA’s resources.

We invite you to read the full text of this Duane Morris Alert on the firm website.

November 5, 2018 by Duane Morris

Five Good Habits of University Researchers Launching Spinouts

By Sandra G. Stoneman and Matthew C. Mousley

Photo of attorney Sandra Stoneman — Sandra G. Stoneman

Photo of attorney Matthew Mousley — Matthew C. Mousley

If you are a university researcher interested in launching a startup based on an invention developed in your lab, below is a list of some key guidelines to keep in mind as you start your company: Continue reading “Five Good Habits of University Researchers Launching Spinouts”

October 25, 2018 by Duane Morris

SUPPORT Act Expands Sunshine Act Disclosure Requirements, Covered Recipients

On October 24, 2018, President Donald Trump signed the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment for Patients and Communities Act (SUPPORT Act), a combination of a number of previously passed House and Senate bills related to addressing the opioid crisis. One of the provisions of this lengthy bipartisan package of bills includes an expansion of the disclosure requirements initially imposed by the Physician Payments Sunshine Act.

Read the full text of this Alert on the Duane Morris LLP website.