Andrew Williams

Andrew Williams

McDonnell Boehnen Hulbert & Berghoff LLP

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Gotta Dance? Apparently Not -- A Biosimilar Update

United States District Judge Seeborg of the Northern District of California denied Amgen's motion for a preliminary injunction today in the Amgen v. Sandoz case, thereby paving the way for the marketing of the first...more

3/20/2015 - Biosimilars BPCIA Patent Litigation Patents Pharmaceutical Manufacturers Sandoz v Amgen

Enzo Biochem Inc. v. Applera Corp. (Fed. Cir. 2015)

When can a district court's factual findings related to the extrinsic evidence in a claim construction determination not be given deference by the Federal Circuit? At least one situation is when the findings do not...more

3/18/2015 - Claim Construction Patent Litigation Patents Pharmaceutical Patents

The First Biosimilar Application Has Been Approved -- But What About the Patent Issues?

As we reported earlier this week, the U.S. Food and Drug Administration ("FDA") approved the first biosimilar application -- an application by Sandoz to market a biosimilar version of Amgen's NEUPOGEN® (filgrastrim) biologic...more

3/13/2015 - Biosimilars BPCIA FDA Patents Pharmaceutical Pharmaceutical Manufacturers Popular Sandoz

STRONG Patents Act of 2015 -- An Alternative Patent Reform Bill

Yesterday, Sen. Christopher Coons (D-DE), Sen. Richard Durbin (D-IL), and Sen. Mazie Hirono (D-HI) introduced the "Support Technology and Research for Our Nation's Growth (STRONG) Patents Act of 2015." What is unique about...more

3/5/2015 - Inter Partes Review Proceedings Non-Practicing Entities Patent Reform Patent Trial and Appeal Board Patent Trolls Patents Post-Grant Review Proposed Legislation

MBHB Snippets: Review of Developments in Intellectual Property Law: Winter 2015 - Vol. 13, Issue 1

In This Issue: - Tips for Developing a Cost-Effective Foreign Patent Strategy - Supreme Court Holds that Trademark Tacking Should be Decided by a Jury in Hana Financial, Inc. v. Hana Bank - Amending...more

3/5/2015 - Computer-Related Inventions Expert Testimony Foreign Patent Applications Hana Financial v Hana Bank Patent Cooperation Treaty Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents SCOTUS Tacking Trademarks

Amending Claims Before the PTAB: What Have We Learned From the Board?

When Congress enacted the America Invents Acts in 2011, they created three new mechanisms to challenge issued claims at the Patent Office – Covered Business Method patent review, Post-Grant Review, and Inter Partes Review...more

3/2/2015 - America Invents Act Covered Business Method Proceedings Inter Partes Review Proceedings Patent Trial and Appeal Board Patents Post-Grant Review

PTAB Update -- Biopharmaceutical Edition

Earlier this week, the Patent Trial and Appeal Board ("PTAB" or "Board") handed down what is thought to be the first set of inter partes review ("IPR") Final Written Decisions ("FWDs") in the biopharmaceutical industry. And...more

2/27/2015 - Biologics Biopharmaceutical Drug Manufacturers Genzyme Hatch-Waxman Inter Partes Review Proceedings Obviousness Patent Trial and Appeal Board Patents Pharmaceutical Pharmaceutical Manufacturers Prescription Drugs

Federal Circuit Sides with Patent Office in First IPR Final Written Decision Review

On February 4, the Federal Circuit affirmed the Patent Trial and Appeal Board’s (“PTAB” or “Board”) first inter partes review (“IPR”) Final Written Decision. In fact, In re Cuozzo Speed Technologies, LLC. was the first appeal...more

2/6/2015 - Cuozzo Speed Technologies Inter Partes Review Proceedings Patent Trial and Appeal Board Patents Prior Art

In re Cuozzo Speed Technologies, LLC (Fed. Cir. 2015)

Federal Circuit Sides with Patent Office in First IPR Final Written Decision Review - Earlier today, the Federal Circuit decided the first appeal from the Patent Trial and Appeal Board ("PTAB" or "Board") related to an...more

2/5/2015 - Appeals Inter Partes Review Proceedings Patent Trial and Appeal Board Patents

Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. -- "Evidentiary Underpinnings" of Claim Construction: Supreme Court Holds Findings...

In a 7-2 decision authored by Justice Breyer, the Supreme Court held yesterday that an "appellate court must apply a 'clear error,' not de novo, standard of review" to the evidentiary underpinnings of a district court's claim...more

1/21/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. – U.S. Supreme Court Requires Trial Court’s Findings of Fact in Claim Construction...

In a 7-2 decision authored by Justice Breyer, the U.S. Supreme Court held yesterday that an “appellate court must apply a ‘clear error,’ not de novo, standard of review” to the evidentiary underpinnings of a district court’s...more

1/21/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

Teva Pharmaceuticals USA, Inc. v. Sandoz Inc. (2015) - Is Deference in Claim Construction Review a Good Thing for the Patent...

As we reported yesterday, the Supreme Court held in a 7-2 decision authored by Justice Breyer that an "appellate court must apply a 'clear error,' not de novo, standard of review" to the evidentiary underpinnings of a...more

1/21/2015 - Claim Construction Clear Error Standard De Novo Standard of Review Federal Rules of Civil Procedure Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents SCOTUS Teva v Sandoz

PTAB Update -- No Institution of CBM Patent Review for Jazz's Orange-Book Listed Patents

On January 13, 2015, the Patent Trial and Appeal Board ("PTAB" or "Board") denied institution of four covered business method ("CBM") patent review petitions filed by Par Pharmaceutical, Inc. ("Par"), Roxane Laboratories,...more

1/16/2015 - Covered Business Method Proceedings Inter Partes Review Proceedings Par Pharmaceutical Patent Trial and Appeal Board Patents Pharmaceutical Patents Roxane Laboratories

"No Clinically Meaningful Differences": The First Accepted Biosimilar Application Has Been Recommend for FDA Approval

Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug....more

1/15/2015 - Amgen Biosimilars BPCI FDA Patent Litigation Patents Sandoz

PTAB Update -- The Board Grants Its Second Motion to Amend (At Least in Part)

For only the second time, the Patent Trial and Appeals Board ("PTAB" or "Board") granted a motion to amend claims. However, even though these two current motions were only granted-in-part, the fact that some claim amendments...more

1/9/2015 - Inter Partes Review Proceedings Motion to Amend Patent Trial and Appeal Board Patents

Hatch-Waxman Watch: Personal Jurisdiction Edition

Is the ability to obtain personal jurisdiction against an ANDA filer for a Hatch-Waxman-type litigation going to become exceedingly more difficult? In the past, jurisdiction against such a defendant was often predicated on...more

12/31/2014 - ANDA AstraZeneca DaimlerChrysler v Bauman Hatch-Waxman Mylan Pharmaceuticals Patents Personal Jurisdiction Pharmaceutical Manufacturers Pharmaceutical Patents Popular

More Misinformation Regarding the Patent System and Non-Practicing Entities

The press has been all too eager to decry the so-called "broken" U.S. patent system and the alleged "scourge" of non-practicing entities (NPEs). However, few if any articles attempt to provide an even-handed analysis of...more

12/19/2014 - CLS Bank v Alice Corp Covered Business Method Patents Nautilus Inc. v. Biosig Instruments Non-Practicing Entities Obviousness Octane Fitness v. ICON Patent Litigation Patent Reform Patent Trial and Appeal Board Patent Trolls Patents SCOTUS Software

PTAB Update -- Hatch-Waxman-Watch Edition

The pharmaceutical industry has been closing watching the proceedings at the Patent Trial and Appeal Board ("PTAB" or "Board") to see if inter partes review ("IPR") will be a viable option for generic drug companies seeking...more

12/12/2014 - Drug Manufacturers Generic Drugs Hatch-Waxman Inter Partes Review Proceedings Patent Trial and Appeal Board Patents Pharmaceutical Prescription Drugs

Sandoz Inc. v. Amgen Inc. (Fed. Cir. 2014)

Last year, Sandoz filed a declaratory judgment action against Amgen and Roche related to its etanercept biosimilar drug product, which it developed to compete with Amgen's Enbrel® TNF inhibitor. Specifically, Enbrel® is a...more

12/10/2014 - Amgen Biosimilars Declaratory Judgments Drug Manufacturers Hoffman LaRoche Patent Infringement Patent Litigation Patents Prescription Drugs Sandoz Subject Matter Jurisdiction

PTAB Update -- Amending Claims in an IPR Proceedings

Just what does it take to amend your claims during an IPR proceeding before the PTAB? Of course, the America Invents Act ("AIA") specifically provides that Patent Owners may file one motion to amend the claims. AIA, §...more

12/5/2014 - America Invents Act Inter Partes Review Proceedings Motion to Amend New Guidance Obviousness Patent Trial and Appeal Board Patents Prior Art

Versata Software, Inc. v. Callidus Software, Inc. (Fed. Cir. 2014)

The Federal Circuit made it clear earlier today that district courts should freely grant stays in view of Covered Business Method ("CBM") patent reviews instituted by the Patent Trial and Appeal Board ("PTAB"). In Versata...more

11/21/2014 - America Invents Act Covered Business Method Proceedings Interlocutory Appeals Motion To Stay Patent Infringement Patents Software Software Developers

Antares Pharma, Inc. v. Medac Pharma Inc. (Fed. Cir. 2014)

When can a sufficient disclosure for patentability purposes nevertheless fail to adequately "describe" the claims of a patent? According to the Federal Circuit in a case issued this week, when the claims are added in a...more

11/19/2014 - Patent Litigation Patents Pharmaceutical Patents Written Descriptions

In re Cuozzo Speed Technologies LLC Federal Circuit Argument -- The Patent Office Asks to Have Its Cake and Eat It Too

Last week, the Federal Circuit heard the first oral argument for the first appeal of an inter partes review ("IPR") final written decision for the first IPR ever filed (IPR2012-00001). ...more

11/11/2014 - Administrative Authority Appeals Inter Partes Review Proceedings Oral Argument Patents USPTO

Patent Litigation Reform -- Will the Outcome of the Mid-Term Elections Matter, and Is Reform Still Necessary?

Unless you have been hiding under a rock, you are probably aware that mid-term elections are next Tuesday. And the issue on every voter's mind is obviously patent litigation reform. In all seriousness, even though the...more

10/31/2014 - Legislative Agendas Patent Litigation Patent Reform Patent Trolls Patents

PTAB Update -- Is "Broadest Reasonable Interpretation" the Appropriate Standard?

One of the more controversial rules concerning PTAB trials promulgated by the USPTO in the wake of the America Invents Act was the adoption of the "broadest reasonable interpretation" ("BRI") claim construction standard for...more

10/28/2014 - America Invents Act Claim Construction Motion to Amend Patent Trial and Appeal Board Patents USPTO

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