Andrew Williams

Andrew Williams

McDonnell Boehnen Hulbert & Berghoff LLP

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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 Proceedings 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 Proceedings 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 Proceedings 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 Proceedings 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

The VENUE Act -- A Last-Ditch Attempt at Patent Reform?

It has been some time since we have heard serious discussions about patent reform legislation from Congress. Sure, the Innovation Act (H.R. 9) is still pending in the House, and the Patent Act (S. 1137) is still pending in...more

3/29/2016 - Patent Litigation Patent Reform Patent Trolls Proposed Legislation Venue

In re Queen's University at Kingston (Fed. Cir. 2016)

Are communications between a patent agent and a client privileged? Up until last week, the Federal Circuit had not addressed the subject, although there had been a split with the district courts that had considered the...more

3/17/2016 - Discovery Patent Agent Privilege Patent Infringement Patent Litigation Patents

Supreme Court Preview -- Cuozzo Speed Technologies, LLC v. Lee -- Question 2

On March 4, the Supreme Court announced that the Cuozzo Speed Technologies, LLC v. Lee appeal would be argued on April 25, 2016 (the last week of oral hearings for the October Term 2015). As we reported previously, the...more

3/10/2016 - Appeals Biotechnology Broadest Reasonable Interpretation Standard Cuozzo Speed Technologies Inter Partes Review Proceedings Judicial Review Patent Trial and Appeal Board Patents SCOTUS

The PTAB and the Federal Circuit – One Year Later

February 4, 2016, marked the one-year anniversary of the initial In re Cuozzo Speed Technologies, LLC[1] Federal Circuit decision – the first opinion stemming from the first appeal of the first final written decision of the...more

3/8/2016 - America Invents Act Appeals Broadest Reasonable Interpretation Standard Covered Business Method Proceedings Cuozzo Speed Technologies v Lee Inter Partes Review Proceedings Patent Trial and Appeal Board

Does the "Notice of Commercial Marketing" Provision in the BPCIA Stand Alone? -- Amgen v. Apotex Case Preview

According to the Federal Circuit website, the appeal from the Amgen Inc. v. Apotex Inc. case will be argued on April 4, 2016 in Courtroom 402. This case is an appeal from a decision by Judge Cohn of the Southern District of...more

3/3/2016 - aBLA Amgen Apotex Biosimilars BPCIA Commercial Marketing FDA Notice Requirements Patent Dance Patent Infringement Patents Pharmaceutical Patents Preliminary Injunctions

Trolls v. Pirates: Supreme Court Oral Argument Reviewing Enhanced Damages

Earlier today, the Supreme Court heard oral arguments in two related cases: Halo Electronics, Inc. v. Pulse Electronics, Inc. (Supreme Court docket number 14-1513) and Stryker Corp. v. Zimmer, Inc. (Supreme Court docket...more

2/24/2016 - Attorney's Fees Damages Enhanced Damages Halo v Pulse Highmark v. Allcare Octane Fitness v. ICON Patent Infringement Patents SCOTUS Stryker v Zimmer Willful Infringement

Celltrion's Proposed REMICADE® Biosimilar Recommended for Approval

On February 10, 2016, the FDA's Arthritis Advisory Committee recommended approval of biologics license application ("BLA") 125544 submitted by Celltrion, Inc. for CT-P13, a proposed biosimilar to Janssen Biotech Inc.'s...more

2/10/2016 - Amgen Apotex Biosimilars BPCIA FDA FDA Approval Injunctive Relief Janssen Pharmaceuticals Sandoz v Amgen

Cutsforth Inc. v. MotivePower, Inc.

Back in January 2002, when this author was near the beginning of his patent law career, the Federal Circuit handed down the In re Sang-Su Lee case. Among other things, this case provided patent practitioners with support for...more

2/1/2016 - Examiners Inter Partes Review Proceedings Obviousness Patent Litigation Patent Trial and Appeal Board Prior Art Remand Vacated

Redline Detection, LLC v. Star Envirotech, Inc. (Fed. Cir. 2015)

The PTAB at the Federal Circuit -- Supplemental Evidence Edition - On New Year's Eve, the Federal Circuit affirmed the PTAB's denial of a motion to submit supplemental evidence pursuant to 37 C.F.R. § 42.123(a),...more

1/21/2016 - Appeals Patent Trial and Appeal Board Patent-Eligible Subject Matter Patents Supplemental Evidence

No Per Se Ethical Violation for "Subject Matter Conflicts"

Maling v. Finnegan, Henderson, Farabow, Garrett & Dunner, LLP - In a case that was watched by the entire patent law community with some fascination, the Supreme Judicial Court of Massachusetts concluded on December 23,...more

1/13/2016 - Conflicts of Interest Dismissals Ethics Patent Prosecution Rules of Professional Conduct

PTAB Update -- PTAB Claim Amendment Practice at the Federal Circuit

In another unsurprising turn, the Federal Circuit affirmed the motion-to-amend practice adopted by the PTAB in IPR proceedings. The majority opinion in Prolitec Inc. v. Scentair Technologies, Inc., authored by Chief Judge...more

12/9/2015 - Anticipation Broadest Reasonable Interpretation Standard Burden of Proof Inter Partes Review Proceedings Motion to Amend Patent Trial and Appeal Board

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