Petitioners in Inter Partes Review proceedings have looked beyond typical patent and scientific literature to find a “printed publication” that might invalidate a patent. This has given the USPTO Patent Trial and Appeal Board...more
In Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC, the Federal Circuit affirmed decisions of the Patent Trial and Appeal Board (PTAB) that invalidated seven Orange Book-listed patents for Xyrem®. The main issue on...more
In Endo Pharmaceuticals Solutions, Inc. v. Custopharm Inc., the Federal Circuit affirmed the district court’s finding that two patents listed in the Orange Book for Aveed® had not been shown to be obvious. Although prior art...more
7/26/2018
/ CAFC ,
Inherency ,
Intellectual Property Protection ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Public Use ,
Section 103
Practitioners with an international patent practice generally view the U.S. written description requirement as more liberal than similar requirements in other jurisdictions, especially the European Patent Office. That said,...more
In Impax Laboratories Inc. v. Lannett Holdings Inc., the Federal Circuit upheld the district court decision finding that defendants had failed to establish obviousness of AstraZeneca’s Zomig patents (directed to intranasal...more
Did you know there are patents on ice cream, ice pops, and other frozen confections? A search of the USPTO patent database identified 1452 granted patents with the term “ice cream” in at least one claim. What better way to...more
On June 7, 2018, the USPTO issued a memorandum to the Examining Corps providing patent eligibility examination guidance based on the recent Federal Circuit decision in Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals....more
As we noted in this article on PTAB Trial Insights, Senator Hatch (R-UT) has introduced the Hatch-Waxman Integrity Act, which is intended to restore the brand-generic balance many say has been skewed by Inter Partes Review...more
6/19/2018
/ Abbreviated New Drug Application (ANDA) ,
Biosimilars ,
BPCIA ,
FDA Approval ,
Generic Drugs ,
Hatch-Waxman ,
Inter Partes Review (IPR) Proceeding ,
Orange Book ,
Patent Applications ,
Patent Litigation ,
Patent Trial and Appeal Board ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Post-Grant Review
In Droplets, Inc. v. E*Trade Bank, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that Droplet’s patent was not entitled to the priority date of a provisional application because...more
In Praxair Distrib., Inc. v. Mallinckrodt Hospital Prods. IP Ltd., the Federal Circuit found that the printed matter doctrine applies equally to physically embodied information and mental steps, and can be invoked in the...more
5/29/2018
/ Claim Limitations ,
Evidence ,
Patent Invalidity ,
Patent Trial and Appeal Board ,
Patent-Eligible Subject Matter ,
Patents ,
Personalized Medicine ,
Pharmaceutical Patents ,
Printed Matter Doctrine ,
Prior Art ,
Section 101 ,
Section 102 ,
Section 103
Several important changes to Bayh-Dole Act implementing regulations took effect on May 14, 2018, that will apply to funding agreements executed after that date and may apply to existing funding agreements modified after that...more
In Sumitomo Dainippon Pharma Co. V. Emcure Pharm. Ltd., the Federal Circuit affirmed the district court’s decision that construed a chemical structure as reading on the lurasidone enantiomer that is the active ingredient of...more
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Next, we considered how the Fanapt® label was...more
5/8/2018
/ Abbreviated New Drug Application (ANDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Section 101 ,
Subject Matter Jurisdiction
Our first article on Vanda Pharmaceuticals, Inc. v. Aventisub, LLC focused on the Federal Circuit’s decision upholding the subject matter eligibility of the personalized method of treatment claims under 35 USC § 101. Here, we...more
5/1/2018
/ Abbreviated New Drug Application (ANDA) ,
Induced Infringement ,
Method Claims ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Patients ,
Pharmaceutical Industry ,
Physicians ,
Product Labels ,
Section 101
As announced in a Federal Register Notice dated April 20, 2018, the USPTO has issued a new memorandum to the Examining Corps providing supplemental patent eligibility examination guidance under Berkheimer, a Federal Circuit...more
In Vanda Pharmaceuticals Inc. v. West-Ward Pharmaceuticals Int’l Ltd., a divided panel of the Federal Circuit upheld Vanda’s personalized method of treatment claims relating to its Fanapt® (iloperidone) product against a...more
In a non-precedential decision issued in In re Bhagat, the Federal Circuit affirmed the decision of the USPTO Patent Trial and Appeal Board (PTAB) that claims directed to certain lipid compositions were ineligible for...more
In the non-precedential decision issued in Exergen Corp. v. Kaz USA, Inc., Judge Moore considered the time and money it took to develop the invention at issue when deciding that the claims satisfy the patent eligibility...more
The USPTO issued a two page memorandum to the Patent Examining Corps noting that some of the USPTO’s written description guidance pertaining to antibody claims is “outdated.” The memo specifically notes withdrawal of the...more
In Novartis v. Lee (Fed. Cir. 2014), the Federal Circuit agreed with the USPTO that “time spent in a continued examination” does not count towards the three years the USPTO is allotted to examine a patent before if it must...more
We’ve written previously about ex parte decisions of the Patent Trial and Appeal Board (PTAB) affirming patent eligibility rejections that seem to be inconsistent with the USPTO’s Subject Matter Eligibility Guidance....more
In Genzyme Corp. v. Dr. Reddy’s Labs. Ltd., the Federal Circuit affirmed the district court decision upholding Genzyme’s Orange Book listed patent for the cancer drug Mozobil® against an obviousness challenge, because the...more
A few weeks ago I joined Kathleen Fonda, Ph.D., J.D., Senior Legal Advisor in the USPTO’s Office of Patent Legal Administration, and Gary Ganzi, J.D., Senior Counsel and Head of Intellectual Property for Evoqua Water...more
Although non-precedential, the Federal Circuit decision in Aptalis Pharmatech, Inc. v. Apotex Inc. is worth a read to see how the court “tiptoes” the “fine line between reading a claim in light of the specification, and...more
A new USPTO fee schedule took effect on January 16, 2018, which usually means that all fees must be paid at the new (higher) rate. However, thanks to revisions to 35 USC § 151 effected by the Patent Law Treaties...more