Andrew Williams

Andrew Williams

McDonnell Boehnen Hulbert & Berghoff LLP

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Final "Ministerial" Rule Amendments for Practice Before the PTAB

On May 19, 2015, the U.S. Patent and Trademark Office published its first "Final Rules" package of amendments to the Rule of Practice before the Patent Trial and Appeal Board ("PTAB"). Keeping with Director Lee's...more

5/21/2015 - America Invents Act Patent Applications Patent Trial and Appeal Board Patents USPTO

Classen Immunotherapies, Inc. v. Elan Pharmaceuticals, Inc. (Fed. Cir. 2015)

The Hatch Waxman statute created a safe-harbor provision, found at 35 U.S.C. § 271(e)(1), that allows ANDA filers and others to practice patented inventions without fear of infringement liability, provided the acts are...more

5/15/2015 - ANDA Classen Immunotherapies Elan Pharmaceuticals FDA Hatch-Waxman Patent Infringement Patents Pharmaceutical Patents Safe Harbors

Amgen v. Sandoz Update -- Amgen's Continuing Efforts to Obtain Preliminary Injunction

Amgen is once again seeking a preliminary injunction in the Amgen v. Sandoz case, this time at the Federal Circuit while that Court resolves the issues on appeal from the District Court. Sandoz has only agreed to stay off...more

4/29/2015 - Biosimilars BPCIA Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Popular Preliminary Injunctions Sandoz v Amgen

Amgen v. Sandoz Update -- BIO Files an Amicus Brief at the Federal Circuit

On March 19, 2015, U.S. District Judge Seeborg of the Northern District of California denied a motion for a preliminary injunction filed by Amgen to prevent the imminent launch by Sandoz of a biosimilar version of NEUPOGEN®...more

4/22/2015 - Appeals Biosimilars BPCIA Hatch-Waxman Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz v Amgen

Amgen Receives No Help from the FDA -- A Biosimilar Update

Near the end of last month, the U.S. Food and Drug Administration ("FDA") denied a citizen petition filed by Amgen in which it requested that action be taken to ensure that biosimilar applicants comply with the disclosure and...more

4/16/2015 - Amgen ANDA Biosimilars BPCIA FDA Hatch-Waxman Orange Book Pharmaceutical Pharmaceutical Manufacturers Sandoz v Amgen

Apotex Inc. v. Daiichi Sankyo, Inc. (Fed. Cir. 2015)

Can a Federal district court ever have subject-matter jurisdiction to hear a declaratory judgment action of non-infringement for a disclaimed patent? Of course, the Federal Circuit explained this week in the Apotex Inc. v....more

4/4/2015 - ANDA Apotex Declaratory Judgments Federal Jurisdiction Generic Drugs Hatch-Waxman Intellectual Property Litigation Jurisdiction Medicare Modernization Act Mylan Pharmaceuticals Noninfringement Patent Infringement Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Subject Matter Jurisdiction

USPTO Director Announces "Quick-Fix" and Anticipated Changes to PTAB Practice

On Friday, March 27, U.S. Patent and Trademark Office Director Michelle Lee issued a statement on the PTO Blog indicating several "quick-fix" and proposed rule changes. The "quick-fix" rules package will apply to all newly...more

4/1/2015 - America Invents Act Patent Trial and Appeal Board Proposed Standards USPTO

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

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