Sheppard Mullin

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Review – U.S. Patent and Trademark Office Subject Matter Eligibility Guidelines

On March 4, 2014 the USPTO issued new patent subject matter eligibility guidelines in an attempt to provide examiners and patent practitioners with some guidance on which claims improperly encompass laws of nature, natural principles, natural phenomena, or products of nature in the wake of the U.S. Supreme Court ruling in Association for Molecular Pathology … Continue Reading

The $330-Million Dollar Question

The question every false claims defendant must face is whether to pursue litigation or simply concede and settle.  While many shy away from litigation, opting for an expensive but certain resolution, for Johnson & Johnson and its subsidiary Janssen Pharmaceuticals, Inc., the decision to pursue their day in court has saved J&J over $330 million.… Continue Reading

Cybersecurity: FDA Risks for Medical Devices

On Thursday, June 13, 2013, the U.S. Food and Drug Administration (“FDA”) released a draft guidance on measures to help ensure the cybersecurity of medical devices. The draft guidance, titled “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices,” proposes cybersecurity features that should be incorporated into wireless, Internet- and network-connected medical devices … Continue Reading

Supreme Court Hears Arguments on “Pay for Delay” Agreements

On March 25, 2012, the Supreme Court heard oral argument on the legality of “reverse payment” or “pay for delay” agreements between brand-name and generic drug manufacturers. Reverse payment agreements settle patent infringement actions brought by a brand-name drug manufacturer against a potential generic competitor under the Hatch-Waxman Act. In contrast to typical settlements of … Continue Reading

The Impact of Cloud Computing on FDA’s Regulation of Medical Products

The following blog article is drawn from the upcoming book Cloud Computing Deskbook, which is set to be released by Thomson Reuters West next summer. Cloud Computing Deskbook covers the legal and regulatory aspects of cloud computing, including those related to regulation by U.S. Food and Drug Administration. Please contact the author with any questions related to FDA … Continue Reading

FTC Proposes Amendments to the Premerger Notification Rules to Expand the Reportability of Transfers of Exclusive Patent Rights in the Pharmaceutical Industry

On August 13, 2012, the Federal Trade Commission (“FTC”) proposed amendments to the Premerger Notification Rules issued under the Hart Scott Rodino Antitrust Improvements Act of 1976 (the “HSR Act”). The proposed amendments would expand when a transfer of exclusive rights to a patent in the pharmaceutical industry is potentially reportable under the HSR Act.… Continue Reading

CLS Bank: The patent eligibility of computerized trading platforms for exchanging obligations

By Barry Wilson and Martin Bader On July 9, 2012, a three judge panel of the Federal Circuit in CLS Bank International v. Alice Corporation (Appeal No. 2011-1301) ("CLS Bank"), decided a case of patent eligibility under 35 U.S.C. § 101. In a split decision, the panel reversed the district court’s finding that three Alice Corporation … Continue Reading

Supreme Court Holds That a Law of Nature Applied Using Known and Obvious Steps Is Not Patent Eligible

By Kevin Capps On March 20, 2012, the Supreme Court issued its much-anticipated decision in Mayo Collaborative Services, DBA Mayo Medical Laboratories, et al. v. Prometheus Laboratories, Inc., with potentially far-reaching ramifications for pharmaceutical and biotechnology companies, particularly those developing diagnostic methods and assays.… Continue Reading

Mandatory Debarment for FCPA Violations? A Bad Idea Whose Time Should Never Come

By Mike Emmick In the fervor of the U.S.’s current anti-foreign-corruption efforts, a particularly misguided proposal has occasionally reared its ugly head: Requiring “mandatory debarment” for any company that violates the Foreign Corrupt Practices Act (“FCPA”). On the merits, such a proposal is completely wrong-headed. Debarment is a severe, forward-looking administrative remedy – the corporate … Continue Reading

The Uncomfortable Resurgence of the Responsible Corporate Officer Doctrine

By Mike Emmick and Joseph Barton Corporate executives in the health care and environmental industries are rapidly coming to appreciate the implications of the responsible corporate officer doctrine, a recently-revitalized weapon in U.S. Department of Justice’s battle against corporate crime. This doctrine is a peculiar exception to the usual requirements for a criminal prosecution. Ordinarily, … Continue Reading

New California Commission Contract Rules – It is Not Too Early To Get Ready!

By Jennifer Redmond, Morgan Forsey, and Bram Hanono  Employers with sales teams in California need to get ready. California has a new commission contract law, AB 1396, which takes effect January 1, 2013. Under AB 1396, which amends California Labor Code section 2751, employers who pay commissions to their employees are required to enter into … Continue Reading

The FCPA in 2011: Five Answers and a Looming Question

The Department of Justice has been warning the Life Sciences industries – pharmaceutical and medical device companies – of its intent to focus "on the application of the Foreign Corrupt Practices Act" ("FCPA") on the pharmaceutical and related industries. (Lanny Breuer, Assistant U.S. Attorney for the Criminal Division, November 12, 2009). The FCPA prohibits, among … Continue Reading

Court of International Trade Ruling Provides Tariff Relief for Cell Culture Bioreactors

By Curt Dombek and Mark Jensen A recent ruling from the U.S. Court of International Trade has the potential to reduce customs duties significantly for some biotechnology companies. In Applikon Biotechnology Inc. v. United States, 07-364 (Ct. Int’l Trade Dec. 12, 2011), the court changed the tariff classification of Cell Culture Bioreactors from heading 8419, … Continue Reading

FDA Announces Proposals for Biosimilars User Fees and Performance Review Goals

By Peter Reichertz FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) … Continue Reading

Safe-Harbor Provision of Hatch-Waxman Act Does Not Protect Post-Approval Research Activities

By Gray Buccigross The Federal Circuit issued its opinion in Classen Immunotherapies, Inc. v. Biogen Idec, 2011 U.S. App. Lexis 18126, on August 31, 2011. As part of that decision it held that the safe-harbor provision of the Hatch-Waxman Act is limited to activities reasonably related to obtaining pre-marketing FDA approval of generic counterparts, and … Continue Reading

Rights to Compensation for use of Biospecimens: OHRP and FDA Clarify that Waivers of Rights in Informed Consents are not “Exculpatory”

By Peter S. Reichertz In a Federal Register notice of September 7, 2011,[1] the Office of Human Research Protection (“OHRP”) and the Food and Drug Administration have clarified that a waiver by an individual in an informed consent to compensation for use of his/her biospecimens is not “exculpatory”, and permissible, if worded properly. This Guidance – … Continue Reading

Institute of Medicine Report: Dead on Arrival

By Seth A. Mailhot On Friday, July 29, 2011, the Institute of Medicine of the National Academies (IOM) released its long awaited report on the premarket clearance process under section 510(k) of the Federal Food Drug and Cosmetic Act.[1] The premarket clearance submission, commonly known as a 510(k), allows manufacturers to market a medical device … Continue Reading
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