News & Analysis as of

An Inflectra Update -- Pfizer Announces Launch of REMICADE® Biosimilar

On April 5, 2016, the FDA approved Celltrion's application to market a biosimilar to Janssen Biotech Inc.'s REMICADE® (infliximab) anti-TNF-a antibody (see "FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar"). ...more

PTAB Upholds Lialda Patent Over Kyle Bass IPR Challenge

The USPTO Patent Trial and Appeal Board (PTAB) has issued a final written decision upholding Shire’s Lialda® patent over the Inter Partes Review (IPR) challenge brought by Kyle Bass and his Coalition for Affordable Drugs. The...more

Purported Public Interest Group Challenges Drug Patent in Qui Tam Action

The intersection of patent law, drug regulations, creative lawyering, and commerce (if not outright greed) has once again arisen in a qui tam suit brought under 31 U.S.C. §§ 3729–3733 (alleging fraud against the U.S....more

Practical Implications from the Federal Circuit’s Rare en Banc Reversal in Apple v. Samsung

In a precedential opinion issued en banc on Friday, October 7, 2016, the Federal Circuit overturned a panel decision, affirming and reinstating the district court’s judgment and the jury’s verdict. The majority opinion...more

Smartphone Patent War: En Banc Federal Circuit Rebukes Earlier Panel Decision and Reinstates Jury Verdicts for Apple against...

In its October 7 en banc decision in Apple v. Samsung, the US Court of Appeals for the Federal Circuit, without benefit of en banc briefing, issued an unusual opinion overturning a panel decision for the purpose of...more

Accused Infringer Puts the Screws on Patentee

We wrote recently about a summary judgment decision in which Judge Indira Talwani found certain asserted claims of two patents on a type of breakable screw to be obvious in light of the prior art. This ruling came even though...more

Internal Fight Over Role of Appellate Court Reveals Substantial Difference of Opinion over Substantial Evidence at Federal Circuit

In Apple, Inc., v. Samsung Electronics Co., Inc., [2015-1171, 2015-1195, 2015-1994] (October 7, 2016), the en banc Federal Circuit completely undid the panel decision with respect to three patents, with the three original...more

PTAB Denies Institution of IPR Based on Petitioner’s Failure to Rebut Strong Evidence of Objective Indicia of Non-Obviousness

Petitioners Praxair Distribution, Inc. and NOxBOX Limited filed petitions requesting inter partes review (IPR) of the claims of four related patents owned by Mallinckrodt Hospital Products IP Ltd. (“Mallinckrodt”). The claims...more

Judge Grants Gilead Motion To Invalidate Remicade Patent For Obviousness-Type Double Patenting

The FDA approved Inflectra–Celltrion’s biosimilar version of Janssen’s Remicade® (infliximab) product–in April 2016, but according to Pfizer’s press release it’s commercial launch still “depend[s] on a number of factors”...more

Federal Circuit Rules the Patent Trial and Appeal Board Can Consider New Evidence During AIA Review Trial

On September 26, 2016, the U.S. Court of Appeals for the Federal Circuit declined to review in a unanimous en banc decision a panel Federal Circuit decision affirming that the Patent Trial and Appeal Board (the “Board”) at...more

Final Judgment Prescribed For Antibody Patent After Double Patenting Decision

We previously wrote about Judge Wolf’s decision to invalidate Janssen Biotech, Inc.’s (“Janssen”) biopharmaceutical patent (U.S. Patent No. 6,284,471 (the “’471 Patent”)), based on the doctrine of obviousness-type double...more

Federal Circuit Review | September 2016

Claims Directed to Monitoring and Analyzing Data Held to Be Invalid under § 101 - In Electric Power Group, LLC v. Alstom S.A., Appeal No. 2015-1778, the Federal Circuit upheld the district court’s grant of summary...more

Generalized Common Sense Allegations Cannot Be Used to Supply Important Missing Claim Limitation

Addressing the use of common sense for an obviousness analysis, the US Court of Appeals for the Federal Circuit held that conclusory statements about common sense cannot be used to supply missing claim limitations that play a...more

The Halo Effect: Original Halo Case Remanded to District Court to Consider New Test for Enhanced Damages

Earlier in 2016, the Supreme Court of the United States issued its landmark decision in Halo Electronics v. Pulse Electronics and Stryker v. Zimmer, modifying the US Court of Appeals for the Federal Circuit’s previous...more

It was Error Not to Consider Secondary Considerations, But They Wouldn’t Have Made a Difference

In ClassCo, Inc. v. Apple, Inc., [2015-1853] (September 22, 2016), the Federal Circuit affirmed a PTAB decision affirming an Examiner’s rejection of claims to a call-screening system that verbally announces a caller’s...more

PTAB Life Sciences Report - September 2016 #2

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Medtronic Xomed, Inc. v. Neurovision Medical Products, Inc. - PTAB Petition: ...more

Janssen v. Celltrion (Infliximab): District Court Enters Partial Final Judgment in Favor of Celltrion

As we previously reported, after the district court found that all the asserted claims of the ’471 patent were invalid for obviousness-type double patenting, Celltrion moved for entry of final judgment on that patent under...more

Double Patenting Decision Delivers Bitter Pill To Antibody Patent

In a recent decision on obviousness-type double patenting, Judge Wolf shortened the shelf life of a dispute between Janssen Biotech, Inc. (“Janssen”) and Celltrion Healthcare Co. Inc. (“Celltrion”), relating to a...more

Preliminary Injunction Granted Due to Weakened Invalidity Defense in Light of Inter Partes Review Decision

A judge in the Northern District of California has enjoined a group of defendants from selling a laboratory DNA sequencing machine. The plaintiff first asserted the patent against one defendant in litigation in the District...more

Four Years of IPRs: Lessons from Proceedings for the Cabilly II Patent

It has been four years since the first inter partes review proceedings were filed in the United States. The first IPR petition, filed on September 16, 2012 (the first day IPRs became available), made it all the way to the...more

Federal Circuit Reverses PTAB’s Conclusion that Claims Challenged in Reexamination Would Have Been Obvious

Federal Circuit Reverses PTAB’s Conclusion that Claims Challenged in Reexamination Would Have Been Obvious - On August 31, 2016, the Federal Circuit issued a non-precedential opinion reversing a judgment by the Patent...more

Federal Circuit: Go whole-hog on validity below if you want to contest an independent determination of invalidity on appeal

Think you’ve won on validity at the U.S. Patent and Trademark Office’s Patent Trial and Appeal Board (PTAB) and your claims are safe on appeal? “Not so fast,” says the Federal Circuit in Software Rights Archive, LLC v....more

News from Abroad: Canada's Federal Court Questions No File Wrapper Estoppel on Claim Construction

The Supreme Court of Canada in Free World Trust v Électro Santé Inc, 2000 SCC 66 rejected the use of extrinsic documents such as file wrappers (patent prosecution histories) for claim construction, on the basis that allowing...more

PTAB Life Sciences Report - September 2016

About the PTAB Life Sciences Report: Each week we will report on recent developments at the PTAB involving life sciences patents. Amerigen Pharmaceuticals Limited v. UCB Pharma GmbH - PTAB Petition: IPR2016-01665;...more

Federal Circuit Holds PTAB Unreasonable in Denying Motion to Amend

In Veritas Technologies LLC v. Veeam Software Corp., Appeal No. 2015-1894 (Fed. Cir. Aug. 30, 2016), the Federal Circuit affirmed the PTAB’s conclusion of obviousness but vacated its denial of a conditional motion to amend...more

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