Andrew Williams

Andrew Williams

McDonnell Boehnen Hulbert & Berghoff LLP

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Supreme Court to Review BPCIA -- Amgen v. Sandoz Petitions for Writs of Certiorari Granted

On Friday, the Supreme Court granted both petitions for writs of certiorari and consolidated the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals. Sandoz had petitioned the Court on February 16, 2016...more

1/17/2017 - Amgen Biosimilars BPCIA Patent Litigation Petition for Writ of Certiorari Sandoz Sandoz v Amgen SCOTUS

Phigenix, Inc. v. ImmunoGen, Inc. (Fed. Cir. 2016)

Can any petitioner appeal a Board's final written decision from an inter partes review or post grant review proceeding? Contrary to the language of 35 U.S.C. § 141(c) which permits any party "who is dissatisfied with" the...more

1/10/2017 - Inter Partes Review (IPR) Proceeding Patent Litigation Patent Trial and Appeal Board Patents Pharmaceutical Industry Spokeo v Robins Standing

Patent Trolls Beware! -- Supreme Court to Review Patent Venue Statute

In the past few years, the Supreme Court has been single-handedly tackling the so-called Patent Troll problem. Sure, in that time, the President and Congress have made Patent Trolls a focus of their agendas, and have...more

12/15/2016 - Certiorari Patent Infringement Patent Litigation Patent Trolls Patent-Eligible Subject Matter Patents

Supreme Court Preview -- Life Technologies Corp. v. Promega Corp.

On Tuesday, December 6, the Supreme Court will hear oral arguments regarding the interpretation of 35 U.S.C. § 271(f)(1), with the pertinent section highlighted...more

12/6/2016 - Life Technologies v Promega Patent Infringement Patent Litigation Patents

IPR Update -- Is Reviewability of Time-Bar Institution Decisions Headed En Banc?

"It appears to me that en banc consideration is warranted." -- Judge Taranto (concurring in Click-To-Call Technologies, LP v. Oracle Corp.). "I write separately, however, to note that I believe the Supreme Court's...more

12/5/2016 - Cuozzo Speed Technologies v Lee Inter Partes Review (IPR) Proceeding Patent Trial and Appeal Board Patents Popular

Biotechnology Innovation Organization's Amicus Brief for In re Aqua Products, Inc.

On Friday, December 9, 2016, the Federal Circuit will hear oral arguments en banc in the In re Aqua Products, Inc. case to consider two questions related to the PTAB's treatment of Motions to Amend in IPR proceedings. ...more

11/16/2016 - America Invents Act Amicus Briefs Biotechnology Inter Partes Review (IPR) Proceeding Patent Litigation Patent Ownership Patent Trial and Appeal Board Patents

In re NuVasive, Inc. (Fed. Cir. 2016)

The Federal Circuit remanded a final written decision of the Patent Trial and Appeal Board ("PTAB" or "Board") because the Board invalidated certain claims in a patent without providing adequate notice or opportunity to the...more

11/11/2016 - Inter Partes Review (IPR) Proceeding Patent Litigation Patent Trial and Appeal Board Patents Prior Art

PTAB Update -- Patent Office Proposes Rule Amendment to Recognize Patent Agent-Client Privilege

When Congress created the post-issuance proceedings before the Patent Trial and Appeal Board as part of the Leahy-Smith America Invents Act ("AIA"), it did so with the recognition that they would be adjudicatory in nature. ...more

10/27/2016 - America Invents Act Attorney-Client Privilege Patent Agent Privilege Patent Trial and Appeal Board Patents Popular USPTO

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

10/20/2016 - Biosimilars Biotechnology Celltrion FDA Obviousness Patent Expiration Patent Infringement Patent Invalidity Patents Pfizer Pharmaceutical Industry

FDA Approves Amjevita -- Amgen's HUMIRA® Biosimilar

On September 23, 2016, the FDA approved Amgen's application to market Amjevita (adalimumab-atto), a biosimilar to AbbVie's HUMIRA (adalimumab) fully human anti-TNF-a antibody. This marks the fourth biosimilar approved by the...more

9/26/2016 - Amgen Biosimilars BPCIA FDA Patents

AbbVie v. Amgen: The Litigation Phase for a HUMIRA® Biosimilar Begins

To date, Amgen has been the reference product sponsor for many biosimilar applications. Correspondingly, Amgen has been the Plaintiff in many of the litigations that have been based on the provisions of the Biosimilar Price...more

8/10/2016 - AbbVie Amgen Biosimilars BPCIA Commercial Marketing FDA Inter Partes Review (IPR) Proceeding Patent Dance Patent Infringement Patent Portfolios Patents Popular Sandoz v Amgen

Amgen Inc. v. Apotex Inc. (Fed. Cir. 2016)

Last year, the Federal Circuit described the Biologics Price Competition and Innovation Act ("BPCIA") as "a riddle wrapped in a mystery inside of an enigma" in the Amgen v. Sandoz case. Nevertheless, one of the provisions of...more

7/12/2016 - aBLA Amgen Apotex Appeals Biosimilars BPCIA Commercial Marketing FDA Notice Requirements Patent Dance Patent Infringement Patent Litigation Pharmaceutical Patents Preliminary Injunctions Sandoz v Amgen

Amgen v. Sandoz Update -- Supreme Court Seeks Views of United States

In other Supreme Court news from Monday, June 20, 2016, the Court invited the Solicitor General to file briefs in the Sandoz v. Amgen (No. 15-1039) and Amgen v. Sandoz (No. 15-1195) appeals to express the views of the United...more

6/22/2016 - Amicus Briefs Biologics Biosimilars BPCIA Commercial Marketing Cross-Complaints Declaratory Relief FDA Approval Injunctive Relief IP License Notice Requirements Patents Petition for Writ of Certiorari Popular Sandoz v Amgen SCOTUS Solicitor General

Cuozzo Speed Technologies, LLC v. Lee (2016) -- Question 2 -- PTAB Shenanigans and Reviewability

The saga of the first-filed IPR petition (IPR2012-00001) came to a close today when the Supreme Court decided the Cuozzo Speed Technologies, LLC v. Lee case. We have been following this case ever since the PTAB issued its...more

6/21/2016 - Appeals Arbitrary and Capricious Covered Business Method Proceedings Cuozzo Speed Technologies v Lee Due Process Inter Partes Review (IPR) Proceeding Judicial Review Patent Trial and Appeal Board SCOTUS Statutory Authority USPTO

Supreme Court Rules District Courts to Have More Discretion in Finding Willful Patent Infringement by Malicious Pirates

On June 13, 2016, the Supreme Court ruled unanimously, in an opinion by Chief Justice Roberts, that an award of enhanced damages pursuant to 35 U.S.C. § 284 should be within the sound discretion of a district court, albeit...more

6/14/2016 - 35 U.S.C. § 284 Abuse of Discretion Appeals Enhanced Damages Halo v Pulse Highmark Octane Fitness v. ICON Patent Infringement Patents SCOTUS Standard of Proof Standard of Review Stryker v Zimmer Totality of Circumstances Test Willful Infringement

BIO International Convention 2016 Preview

U.S. Patent Practice – the PTAB, Federal Courts, and Patent Eligibility - The 2016 BIO International Convention has already begun in San Francisco, but most of the sessions and forums get underway beginning on Tuesday,...more

6/7/2016 - Biotechnology BPCIA Claim Construction Inter Partes Review (IPR) Proceeding Inventions Patent Infringement Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents

Standing Alone – The Current Status of the BPCIA’s Notice of Commercial Marketing

In March 2015, the FDA approved the first biosimilar application, which was for a follow-on biologic drug of Amgen’s reference product NEUPOGEN® (filgrastim). Yet, before the applicant, Sandoz, could launch its biosimilar...more

6/3/2016 - aBLA Amgen Apotex Appeals Biosimilars BPCIA Commercial Marketing Declaratory Judgments FDA Generic Drugs Patent Dance Patent Infringement Patent Litigation Patents Pharmaceutical Patents Preliminary Injunctions Sandoz Sandoz v Amgen

BIO International Convention 2016 Preview

BIO and Biosimilars - The 2016 BIO International Convention begins next week in San Francisco. This convention has become an important destination for all organizations working in the biotechnology space, but the large...more

6/2/2016 - Biologics Price Competition and Innovation Act of 2009 Biosimilars Biotechnology Patents Pharmaceutical Industry Pharmaceutical Patents Sandoz Technical Conference

Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd. (Fed. Cir. 2016)

Have you ever mixed up the obviousness determinations of "motivation to combine" and "reasonable expectation of success"? If so, you are apparently not alone -- the Federal Circuit recently faulted the Patent Trial and...more

5/24/2016 - Inter Partes Review (IPR) Proceeding Obviousness Patent Infringement Patent Trial and Appeal Board Patents Prior Art

In re TC Heartland (Fed. Cir. 2016)

"You Can Arrange the Menu, the Venue, the Seating" The above slightly-modified quote is from a lyric sung by Thomas Jefferson in the Tony-award nominated musical "Hamilton" (with apologies to Lin Manual Miranda) -- the...more

5/7/2016 - Cause of Action Accrual Kraft Patent Infringement Patent Trolls Patents Personal Jurisdiction Venue

Of Patent Trolls and Hot Dog Stands -- The Supreme Court Oral Argument in Cuozzo Speed Technologies, LLC v. Lee

Earlier today, the Supreme Court heard oral arguments in the Cuozzo Speed Technologies, LLC v. Lee appeal (Supreme Court docket number 15-466). The Court was considering two issues related to the recently implemented IPR...more

4/26/2016 - Broadest Reasonable Interpretation Standard Cuozzo Speed Technologies v Lee Inter Partes Review (IPR) Proceeding Patent Owner Preliminary Response Patent Trial and Appeal Board Post-Grant Review SCOTUS

An Inflectra Update: Janssen Requests an Expedited Trial

As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. On Tuesday, April 12,...more

4/15/2016 - Biosimilars Doctrine of Equivalents FDA Janssen Pharmaceuticals Pharmaceutical Patents

FDA Approves Inflectra - Celltrion's REMICADE® Biosimilar

Earlier today, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. This marks only the second...more

4/6/2016 - Biosimilars BPCIA FDA Pharmaceutical Industry Pharmaceutical Patents Sandoz v Amgen

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