Canada Proposes Introducing Patent File Wrapper Estoppel
Bill C-86, the Budget Implementation Act is an 884 page omnibus bill recently introduced in Parliament. Among a myriad of other items, the... Read More
The New NAFTA: Trademark and Industrial Design Changes Under the United States-Mexico-Canada Agreement
Mexico, the United States and Canada have agreed on the text of a new trade agreement, known as the United States-Mexico-Canada Agreement... Read More
The New NAFTA: Copyright Changes Under the United States-Mexico-Canada Agreement
Mexico, the United States and Canada have agreed on the text of a new trade agreement, known as the United States-Mexico-Canada Agreement... Read More
The New NAFTA: Patent Changes Under the United States-Mexico-Canada Agreement
Mexico, the United States and Canada have agreed on the text of a new trade agreement, known as the United States-Mexico-Canada Agreement... Read More
Apotex Seeks Rehearing of NEXIUM Patent Validity Following Supreme Court’s Decision
On August 29, 2017 Apotex filed a motion with the Supreme Court of Canada, requesting a rehearing of the appeal and an... Read More
Supreme Court of Canada To Hear AstraZeneca’s Esomeprazole Appeal
On March 10, 2016, the Supreme Court of Canada granted AstraZeneca’s application for leave to appeal the decision of the Federal Court... Read More
Competition Bureau Launches Public Consultation on IP Enforcement Guidelines
The Competition Bureau has released draft and updated Intellectual Property Enforcement Guidelines for public consultation, and is seeking comments and feedback by... Read More
Government publishes proposed amendments to patent listing requirements for combination drug products
On May 2, 2015, the federal government published proposed amendments to the Patented Medicines (Notice of Compliance) Regulations. As we previously blogged... Read More
Apotex Challenges Minister’s Refusal To Approve Apo-rasagiline
Apotex is seeking judicial review of a decision to decline to issue a Notice of Compliance (“NOC”) to Apotex for its Apo-rasagiline... Read More
Overrun by nettles: Government to prune the PM(NOC) Regulations
Industry Canada has announced its intention to amend the Patented Medicines (Notice of Compliance) Regulations. These proposed changes focus on the issue... Read More
US CAFC squelches patent for cloned sheep
The Court of Appeals for the Federal Circuit Court recently upheld the USPTO’s rejection of patent claims directed to cloned farm animals... Read More
Would a biologic by any other (nonproprietary) name smell as sweet?
One of the many contentious issues in the evolving U.S. biosimilar regulatory landscape regards whether 351(k) biosimilar products will have the same... Read More
FDA approves Teva’s tbo-filgrastim for severe neutropenia
On August 29, 2012, the U.S. FDA approved Sicor Biotech’s BLA for tbo-filgrastim (XMO2 filgrastim), to reduce the time certain patient receiving... Read More
Celltrion announces Korean approval of biosimilar monoclonal antibody
On July 23, 2012, Celltrion announced the approval by the Korean Food and Drug Administration of REMSIMA, its biosimilar anti-TNFα monoclonal antibody.... Read More
Supplementary Protection Certificates for new uses – ECJ clarifies “first authorization of the product”
On July 19, 20120 the European Court of Justice (ECJ) rendered it decision in Case C-130/11 dealing with the availability of Supplementary... Read More
Genentech and U Penn settle HERCEPTIN patent suit
On June 8, 2012, Genentech’s lawsuit seeking a declaration that US Patent No. 6,733,752 was invalid and not-infringed by Genentech’s trastuzumab product... Read More
Merck Serono partners with Dr. Reddy’s on cancer biosimilars
On June 6, 2012, Germany’s Merck Serono, a division of Merck, announced a partnership with India’s Dr. Reddy’s Laboratories Inc. to develop... Read More
On your mark, get set, go! Biosimilar litigation takes off in Canada
On May 18, 2012, Amgen Canada Inc. and Amgen Inc. (“Amgen”) commenced a proceeding (Court File No. T-989-12) under the Patented Medicines... Read More
FDA’s biosimilar stakeholder submission roundup – Part IV
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
FDA’s biosimilar stakeholder submission roundup – Part III
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
FDA’s biosimilar stakeholder submission roundup – Part II
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
FDA’s biosimilar stakeholder submission roundup – Part I
In March 2010, the Biologics Price Competition and Innovation Act of 2009 (BPCIA) became law and established a legal pathway for the... Read More
PM(NOC) guidance document updated to address cross-referenced drug submissions
On April 2, 2012, Health Canada issued an updated guidance document on the Patented Medicines (Notice of Compliance) Regulations. In particular, section... Read More
EMA publishes new procedural advice document for biosimilar applicants
The European Medicines Agency (EMA) has published a new document providing procedural advice for users of the centralised procedure for biosimilar product... Read More
AstraZeneca and Amgen team up to develop five human monoclonal antibodies
AstraZeneca and Amgen have announced an agreement to jointly develop a portfolio of Amgen’s clinical stage human monoclonal antibodies. The antibodies subject... Read More