Archives: Intellectual Property

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Federal Circuit Holds Patentee Cannot Use Retroactive Statutory Disclaimer to Avoid Patent Marking Statute, But Leaves Open a Key Question About the Statute’s Application

Last week, in its opinion in Rembrandt Wireless Technologies, LP v. Samsung Electronics Co., Ltd., the Federal Circuit resolved one question about patent marking under 35 U.S.C. § 287 but left another open—whether the marking statute applies on a claim-by-claim or patent-by-patent basis. The case stemmed from a jury verdict in the Eastern District of … Continue Reading

District Court Dismisses State Law Unfair Competition Claim as Preempted by Federal Copyright and Patent Law

The Northern District of Texas recently held that federal copyright and patent laws preempted a state law unfair competition claim involving rival medical device companies.  The decision reflects that a preemption analysis does not consider whether the facts support actual protection by copyright or patent law.  Rather, the copyright preemption analysis looks to, among other … Continue Reading

Federal Circuit Rules Device Patent Claims Not Limited by Specification Description, Not Invalid for Lack of Written Description

Earlier this month in ScriptPro LLC v. Innovation Associates, Inc., the Federal Circuit overturned a district court’s grant of summary judgment based on a lack of written description under 35 U.S.C. § 112. The device patent at issue, ScriptPro’s U.S. Patent No. 6,910,601 (“the’601 patent”), “is directed to a ‘collating unit’ used with a control … Continue Reading

District Court Opinion Provides Guidance for Extensions of Medical Device Patents Containing Method Claims

Last month, the Eastern District of Virginia held that a patent covering a medical device may not be eligible for an extension unless the patent “claim[s] the use of the particular product that underwent FDA review.”  The case serves as an important reminder that, for purposes of securing a patent term extension, applicants claiming methods … Continue Reading

Upcoming Webinar: Trends in Pharmaceutical and Medical Device Patent Litigation (February 11, 2015)

As part of Covington’s ongoing Life Sciences Essentials webinar series we will be presenting a program on pharmaceutical and medical device patent litigation trends on February 11, 2015 (12:30-2:00 p.m. EST). Panelists and topics include: Shara Aranoff – Current trends in Section 337 patent litigation at the ITC, including the evolving domestic industry requirement and the … Continue Reading

Myriad’s Fight Continues: Federal Circuit Finds Composition and Method Claims Ineligible under 35 U.S.C. §101

On December 17, 2014, the Federal Circuit released its decision in the matter of In re: BRCA1- and BRCA2-Based Hereditary Cancer Test Patent Litigation (“In re: BRCA1/2”).  Myriad asserted a set of patent claims that were not part of the Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics (“Myriad”).  The BRCA1/2 … Continue Reading

Recent Trends in Medical Device Patent Litigation at the ITC — Part 1

Over the past 20 years, the number of patent infringement disputes filed annually at the U.S. International Trade Commission (ITC) has more than tripled.  Although typically associated with smartphones and semiconductor chips, the ITC has also seen quite a few disputes involving medical devices.  Important trends are emerging in medical device patent litigation at the … Continue Reading

Supreme Court Agrees To Hear Two Additional Patent Cases

On Friday, the Supreme Court granted certiorari in two patent appeals from the Federal Circuit, Limelight Networks, Inc. v. Akamai Technologies, No. 12-786 and Nautilus, Inc. v. Biosig Instruments, Inc., No. 13-369.  Both cases have potential implications for medical device patent litigation. The first case, Akamai, involves the scope of liability for induced infringement under … Continue Reading

Federal Circuit Clarifies Standard For Litigants Seeking Attorneys’ Fees Under 35 U.S.C. § 285

Fee shifting has become a hot topic in patent litigation.  All patent holders, including holders of medical device patents, should take notice of these developments as they may influence decisions regarding whether to enforce a patent against a potential defendant. In Kilopass Tech., Inc. v. Sidense Corp., the Federal Circuit, in an opinion written by … Continue Reading

NIH Once Again Rejects Call To Exercise March-In Rights

Last month, the National Institutes for Health once again rejected a petition requesting that the agency exercise its “march-in rights” under the Bayh-Dole Act for patents owned and used to manufacture an HIV drug, Norvir®.  The petition was the second to concern this product, and the fifth, of which we are aware, asking NIH to … Continue Reading

Senator Leahy is the Latest to Pressure NIH to Exercise Bayh-Dole March-In Rights

An issue device manufacturers may not always fully consider when developing products from government-funded research is the Bayh-Dole Act’s authorization for a federal funding agency (for drugs and devices, often the National Institutes of Health) to “march-in” to the intellectual property rights of the inventor.  Although, to date, the NIH has refused to exercise its … Continue Reading

Federal Circuit Decides Appeals on Patent Liability Issues Are Possible Before Willfulness And Damages Trials

A recent decision by the Federal Circuit could impact litigation strategy in patent infringement cases.  In Robert Bosch, LLC v. Pylon Manufacturing Corp., the Federal Circuit decided en banc that, under 28 U.S.C. § 1292(c)(2), it has jurisdiction over an appeal on liability issues (i.e. patent infringement and patent validity) before the district court tries … Continue Reading

Supreme Court Issues Decision on Gene Patenting in Myriad Case

Kurt Calia and Allison Kerndt also contributed to this post. The Supreme Court released its decision in Association for Molecular Pathology et al. v. Myriad Genetics, Inc. et al. (Appeal No. 12-398) earlier today.  The question presented was whether human genes are patent eligible.  In a unanimous decision, the Supreme Court held that naturally occurring … Continue Reading

Federal Circuit Declines to Hold On Summary Judgment That Third-Party Clinical Trial Was Invalidating Public Use

In Dey, L.P. v. Sunovion Pharms., Inc., the Federal Circuit provided guidance for determining whether the use of a formulation during a clinical trial constitutes a “public use” sufficient to invalidate a patent claiming the formulation. Appeal No. 2012-1428 (Fed. Cir. May 20, 2013). The parties, Dey and Sunovion, are competitors that both own patents … Continue Reading

Challenging Issues Confronting Companion Diagnostics Transactions — Part 2

This is the second entry in our series on Challenging Issues Confronting Companion Diagnostics Transactions. The first entry is available here. Financial Structures in Companion Diagnostics Transactions Pharmaceutical companies and companion diagnostics companies traditionally have very distinct business models, which can pose a challenge when it comes to aligning on the financial components of a development … Continue Reading

Challenging Issues Confronting Companion Diagnostics Transactions – Part 1

Overview The market for companion diagnostics has been growing steadily for a number of years, with some sources estimating that global companion diagnostics market will reach $19.3 billion by 2023.  There are a handful of companies that are major players in both the pharmaceutical and companion diagnostics spaces, as well as a number of smaller … Continue Reading

Federal Circuit to Consider Claim Construction Review Standard En Banc

On March 15, 2013, the Federal Circuit agreed to consider en banc whether claim construction decisions made by district courts should be given deference on appeal.  The Federal Circuit’s standard for review of claim construction decisions, as stated in Cybor Corp. v. FAS Techs., is “as a purely legal question, we review claim construction de … Continue Reading

Medical Device Patent Litigation at the ITC

The International Trade Commission (“ITC”) has become an increasingly popular forum for litigating patent infringement disputes, including for medical device companies.  In fact, over the past few months alone, at least three separate complaints involving medical device companies have been filed at the ITC.  Given the nature of the ITC, this raises the stakes for … Continue Reading

Leahy-Smith America Invents Act: “First-Inventor-to-File” Takes Effect on March 16, 2013

The America Invents Act (AIA) has made numerous changes to U.S. patent law.  Pub. L. No. 112-29, 125 Stat. 284 (2011).  Some changes took effect immediately upon the law’s signing on September 16, 2011, while others, including various new post-grant proceedings, took effect on September 16, 2012.  Perhaps the most profound change brought about by … Continue Reading

Recent Trends in Medical Device Patent Litigation

The medical device industry has seen a rise in the number of cases filed by patent holders in recent years.  A study of patent litigation trends, the 2012 Patent Litigation Study published by Pricewaterhouse Coopers LLP, contains some interesting observations regarding trends in patent litigation, including cases involving medical devices.  For example: Number of cases.  … Continue Reading