PTAB Denies Joinder Where Petitioner Relied on Different Experts

A recent PTAB  order refused joinder of IPR petitions challenging the same formulation patent at issue in a previously instituted IPR proceeding despite almost complete overlap between the challenged claims and reliance on the exact same prior art.  Famy Care Ltd. v. Allergan, Inc., IPR2017-00566, Paper 12, (PTAB July 12, 2017).  The patent at issue […]

ANDA Litigants May Use “Post Art” to Support or Challenge Patent Validity

Last week, in Novartis, et al., v. West-Ward Pharmaceuticals International Limited, the District of Delaware denied Defendant’s motion in limine seeking to exclude “post art” evidence, i.e. references published after the critical date, as irrelevant and prejudicial.  In its order, the court remarked that though there are some limitations, post art can be offered for […]

Federal Circuit Clarifies Doctrine of Equivalents As Applied to Chemical Compounds

In Mylan Institutional LLC v. Aurobindo Pharma Ltd., the Federal Circuit offered some clarity to the “sparse and confusing case law” concerning the doctrine of equivalents in the chemical context.  In reviewing a preliminary injunction where the district court found a reasonable likelihood of infringement under the doctrine of equivalents, the Court suggested that the […]

Federal Circuit Purges Non-Infringement Verdict for Patented Colon Cleansing Method

This month the Federal Circuit held that Breckenridge’s proposed labeling for a generic colonoscopy prep kit would induce infringement of Braintree’s patent covering SUPREP.  Braintree Labs., Inc. v. Breckenridge Pharm., Inc., No. 16-1731 (Fed. Cir. May 5, 2017).  In doing so, the Federal Circuit clarified when proposed labeling amounts to an affirmative intent to induce […]

Invention Need Not Be Publicly Disclosed to Trigger AIA Version of On-Sale Bar

The Federal Circuit ruled yesterday that public sales of a product do not need to disclose the details of an invention to bar a patent application under post-America Invents Act (“AIA”) 35 U.S.C. § 102.  Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc. et al.  In reaching this decision, the court rejected Helsinn’s argument that […]

A Thin Gray Line: Reading Claims in Light of the Specification Versus Impermissibly Reading Limitations into the Claims

There is a fine and often ambiguous line between improperly importing limitations from the specification into the claims and interpreting claims in light of the specification.  The Federal Circuit recently drew that line in The Medicines Company v. Mylan, Inc., reversing a lower court’s judgment that Plaintiff Mylan’s proposed bivalirudin formulation would infringe U.S. Patent […]

Board Holds that Unexpected Results Overcome Claims that Were Prima Facie Obvious

In Coalition for Affordable Drugs V LLC v. Biogen MA Inc., the PTAB denied an obviousness challenge of a patent covering methods of treating multiple sclerosis using a particular dosage of known fumarate drugs.  The patent at issue—U.S. Patent No. 8,399,514—is listed in the Orange Book for Biogen’s Tecfidera® product. The claims of the ’514 […]

District of Delaware Applies IPR Estoppel Provisions to Bar Party from Pursuing New Prior Art Combinations

Although not a Hatch-Waxman case, the District of Delaware’s recent ruling in Parallel Networks Licensing, LLC. v. IBM, could have a significant impact on ANDA-filers strategic approach to IPRs.  In this case, the patentee (“Parallel”) filed a complaint in 2013 asserting that IBM infringed three patents.  The litigation proceeded in federal district court; however, in […]

Federal Circuit Confines Exception to Closed-Ended Interpretation of “Consisting of” Transition

On Friday, the Federal Circuit weighed in on the exception to the closed nature of the “consisting of” transition in patent claims, holding that the exception is more limited than perhaps previously thought.  In Shire Development, LLC v. Watson Pharmaceuticals, Inc., the Federal Circuit reversed the district court’s infringement finding, holding that a claimed Markush […]