Andrew Williams

Andrew Williams

McDonnell Boehnen Hulbert & Berghoff LLP

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PTAB Finally Proposes Rule Amendments: The More Things Change . . .

More than a year ago, then-Deputy Director Michelle K. Lee posted on the Director's Forum Blog that the USPTO was seeking feedback on PTAB trial proceedings established by the Leahy-Smith America Invents Act ("AIA"). The...more

8/20/2015 - America Invents Act Broadest Reasonable Interpretation Standard Claim Construction Duty of Candor Inter Partes Review Proceedings Ministerial Function Patent Owner Preliminary Response Patent Trial and Appeal Board Patents Pleadings Policies and Procedures USPTO

Microsoft Corporation v. Proxyconn, Inc. (Fed. Cir. 2015)

Earlier this week, we noted that parties wishing to challenge IPR Final Written Decisions from the PTAB on appeal to the Federal Circuit would face an uphill challenge. However, even if that challenge is extremely difficult,...more

8/6/2015 - Broadest Reasonable Interpretation Standard Claim Construction Inter Partes Review Proceedings Microsoft Motion to Amend Patent Infringement Patent Invalidity Patent Litigation Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Petition For Rehearing Prior Art

Trustees of Columbia University v. Illumina, Inc. (Fed Cir. 2015)

One of the first IPR petitions ever filed, IPR2012-0006, was related to biotechnology -- specifically DNA sequencing. Illumina, Inc. filed that petition, and two others, IPR2012-00007 and IPR2013-00011, against patents owned...more

8/4/2015 - DNA Inter Partes Review Proceedings Obviousness Patent Infringement Patent Litigation Patent Trial and Appeal Board Patents Prior Art

"Don't Stop the Dance"[*] -- The Dissents-in-Part from Amgen v. Sandoz

As we have been reporting this week, the Federal Circuit handed down its decision in Amgen Inc. v. Sandoz Inc. -- a case of first impression relating to the Biologics Price Competition and Innovation Act ("BPCIA") for...more

7/24/2015 - aBLA Amgen Biosimilars BPCIA Drug Manufacturers FDA FDA Approval Notice Requirements Patent Applications Patent Infringement Patent Litigation Patents Pharmaceutical Manufacturers Pharmaceutical Patents Preliminary Injunctions Prescription Drugs Sandoz Sandoz v Amgen

Should the Federal Circuit Be Reviewing Any Part of the Decision to Institute? -- The Versata Dissent-in-part

As we reported earlier, the Federal Circuit recently affirmed the PTAB's Final Written Decision in the Versata Development Group v. SAP America, Inc. case -- the first appeal under the covered business method ("CBM") patent...more

7/17/2015 - America Invents Act Appeals Covered Business Method Patents Covered Business Method Proceedings Cuozzo Speed Technologies Patent Infringement Patent Invalidity Patent Litigation Patent Trial and Appeal Board Patents Post-Grant Review

Federal Circuit Tackles Claim Construction Review under New Standard

The More Things Change (Lighting Ballast Control LLC v. Philips Electronics North America), the More They Stay the Same (Teva Pharmaceuticals USA, Inc. v. Sandoz Inc.) - On June 18, 2015, the Federal Circuit handed down...more

6/26/2015 - Claim Construction Nautilus Inc. v. Biosig Instruments Patent Litigation Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Prescription Drugs Sandoz SCOTUS Teva Pharmaceuticals Teva v Sandoz

Amgen v. Sandoz -- Federal Circuit Oral Argument

The Federal Circuit heard oral arguments in the Amgen v. Sandoz case on Wednesday, June 3, 2015. The three judges on the panel were Judge Newman, Judge Lourie, and Judge Chen. This case is on appeal from the U.S. District...more

6/8/2015 - Amgen Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz Sandoz v Amgen

BIO International Convention 2015 Preview - BIO and Biosimilars

The 2015 BIO International Convention begins in two weeks in Philadelphia. For the past few years, we have provided a series of previews with the goal of making the large amount of information and opportunities available at...more

6/3/2015 - Amgen Biologics Biologics Price Competition and Innovation Act of 2009 Biosimilars Biotechnology Patents Pharmaceutical Pharmaceutical Manufacturers Pharmaceutical Patents Sandoz Sandoz v Amgen

Koepsell and Noonan on Gene Patenting

In 2009, the first edition of Dr. David Koepsell's book "Who Owns You: The Corporate Gold Rush to Patent Your Genes" was published. With the second edition of his text about to be published, Dr. Koepsell allowed Patent Docs...more

5/29/2015 - BRCA DNA Gene Patenting Myriad Myriad-Mayo Patent-Eligible Subject Matter Patents

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

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