Worldwide Patent Term Extension Provisions -
Mechanisms to recover patent term lost during regulatory approval are available in many countries throughout the world. The August 2017 issue of Sterne Kessler’s Global Patent...more
Biosimilar uptake in Japan has been a bit mixed, but according to experts the volume shares of biosimilars suggests it could be a key market in years to come. The Pharmaceuticals and Medical Devices Agency (PMDA), which is...more
Europe has led the way globally with respect to biosimilar medicines since 2005. In that year, the European Medicines Agency (EMA) issued regulatory guidelines for the development and assessment of biosimilars....more
Biosimilars Around the World -
Last month’s Supreme Court ruling in Sandoz v. Amgen brought greater certainty to both biosimilar applicants and originators in the United States. The July 2017 issue of Sterne Kessler’s...more
Challenging the validity of a patent through the courts of Europe and the United States can be a time-consuming and expensive process. Oppositions at the European Patent Office (EPO) and US post-grant cancellation...more
6/21/2017
/ Administrative Procedure ,
Administrative Proceedings ,
Amended Complaints ,
EU ,
European Patent Office ,
Expert Witness ,
Inter Partes Review (IPR) Proceeding ,
International Trade Commission (ITC) ,
Patent Prosecution ,
Patent Prosecution Highway ,
Patents ,
Post-Grant Review ,
USPTO
Revocation Proceedings Around the World -
Mechanisms to challenge the validity of granted patents are available in many countries throughout the world. The June 2017 issue of Sterne Kessler’s Global Patent Prosecution...more
In Sandoz Inc. v. Amgen Inc., the Supreme Court brought greater certainty to two key issues relating to the “patent dance” under the Biologics Price Competition and Innovation Act (BPCIA). First, the Court held that where a...more
6/13/2017
/ Amgen ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
SCOTUS ,
State Law Claims ,
Unfair Competition
Please see full map and corresponding legend regarding grace period around the world. ...more
Albania -
6 months -
Novelty/Inventive Step in Limited Circumstances -
Disclosure not to be taken into account in determining patentability if it occurred within six months before the filing date (priority date) when...more
Public Disclosure Grace Periods Around the World -
Public disclosure prior to a patent application filing can present a significant hurdle to patentability in most countries because of absolute novelty requirements....more
As patent filing and grant numbers have skyrocketed in China, so has the attractiveness to settle patent infringement suits there. The opening of a series of specialized intellectual property courts, especially the courthouse...more
China is in the midst of a tremendous patent boom. Worldwide, total patent application filings were up 7.8% in 2015, with China accounting for 84% of the total growth[1]. In 2015, the State Intellectual Property Office of the...more
5/17/2017
/ Animal Patents ,
China ,
Diagnostic Method ,
Filing Requirements ,
Life Sciences ,
Patent Applications ,
Patent Cooperation Treaty ,
Patent Fees ,
Patent Prosecution ,
Patent-Eligible Subject Matter ,
Patents ,
Pharmaceutical Patents ,
Request for Examination ,
SIPO ,
Stem cells
With the implementation of Revisions to the Chinese Patent Examination Guidelines on April 1, 2017, the April 2017 issue of Sterne Kessler's Global Patent Prosecution Newsletter includes information and practical tips for...more
It should come as no surprise that the home of the Bundesautobahn has multiple mechanisms to speed up patent prosecution. And since the average pendency of a European application is approximately four years[i], patentees will...more
The March 2017 inaugural issue of Sterne Kessler's Global Patent Prosecution Newsletter includes information and practical tips for accelerated examination strategies in the United States, Europe, and Asia.
...more
The Federal Circuit on Tuesday ruled that the 180-day notice of commercial marketing provision of the Biologics Price Competition and Innovation Act (BPCIA) is a requirement for all biosimilar applicants regardless of whether...more
7/8/2016
/ Amgen ,
Apotex ,
Appeals ,
Biologics ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Licensing Rules ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions
On November 17, 2015, the FDA finalized a guidance document, that was first issued as a draft in March 2013, regarding formal meetings between the FDA and biosimilars applicants. Because meetings with biosimilars applicants...more
On August 6, 2015, Amgen sued Apotex in the US District Court for the Southern District of Florida for patent infringement related to Apotex’s pegfilgrastim product, which is purported to be biosimilar to Neulasta®. What is...more
On July 2, 2015, the Court of Appeals for the Federal Circuit held that a patent owner’s use of a contract manufacturer (CMO) to prepare validation batches of a drug formulation for submission to FDA created an invalidating...more
On April 14, 2015 the Biotechnology Industry Organization (BIO) filed an amicus curiae brief with the Court of Appeals for the Federal Circuit1 in support of remand or reversal of the Amgen v. Sandoz lower court’s ruling that...more
In parallel with the district court case where Amgen is asserting that Sandoz has not complied with the BPCIA because they have not provided Amgen with a copy of their biosimilar application, in October 2014 Amgen filed a...more
On March 19, 2015, Judge Seeborg of the United States District Court for the Northern District of California denied Amgen Inc.’s motion for a preliminary injunction in the Amgen v. Sandoz case, thereby removing one more...more
3/23/2015
/ Amgen ,
Biologics ,
BPCIA ,
Commercial Marketing ,
Conversion ,
Dismissals ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Preemption ,
Preliminary Injunctions ,
Sandoz ,
Sandoz v Amgen ,
Unfair Competition
On Friday, December 5, the U.S. Court of Appeals for the Federal Circuit rendered its decision in Sandoz v. Amgen, No. 2014-1693, a case with major implications for the emerging U.S. biosimilars industry. The decision...more
Sandoz announced yesterday that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics...more
On March 4, 2014, the USPTO issued a Guidance memorandum for examination of subject matter eligibility under 35 U.S.C. § 101 in view of AMP v. Myriad (2013) and Mayo v. Prometheus (2012). Under the new guidelines, the...more