Tag Archives: intellectual property

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

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

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

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

CFDA Issues Proposed Regulations on Medical Devices

On March 20, 2013, the China Food and Drug Administration (CFDA) released for public comment two proposed regulations on medical devices.  The comment period for the proposed regulations ended on March 31, 2013. The first proposed regulation — titled Special Review and Approval Process for Innovative Medical Devices (Interim) (draft) — provides for special review … 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

Federal Circuit Holds That Testing in Animals is Sufficient to Satisfy Enablement Requirement

In Edwards Lifesciences AG v. CoreValve, Inc., the Federal Circuit recently confirmed that in vivo testing is not required to satisfy the enablement requirement when experimentation on humans would be inappropriate.  699 F.3d 1305, 1309 (Fed. Cir. 2012). In this case, the patentee asserted U.S. Patent No. 5,411,552 (“the ’552 patent”), directed to a prosthetic … Continue Reading