The Cross-Border Biotech Blog

Biotechnology, Health and Business in Canada, the United States and Worldwide

Category Archives: Guest Blogger

Mixed Reaction to U.S. Patent Reform

Guest post by Andrew Franklin, a colleague in the Pharmaceuticals and Life Sciences practice at Norton Rose.

With the passage of the America Invents Act of 2011, the United States’ patent system will change from a “first-to-invent” system to a “first-to-file” system for granting patents. Under the new system, patents will be granted to the first person to submit an application to the U.S. Patent and Trademark Office (“USPTO”) as opposed to the first person who first  invented the subject matter of the invention. This is the most significant change to US patent law since 1952.

While this legal reform aligns the US patent law with the rest of the world, it has been met with mixed reaction. Read more of this post

Canadian Drug Pricing and Reimbursement Conference Report

Earlier this week, the Canadian Institute held its 5th annual Drug Pricing and Reimbursement Conference in Toronto. The conference highlighted a number of key issues including market access for pharmaceutical companies, Federal and Provincial regulatory and reimbursement policies, and global trends that may affect Canada’s pharmaceutical landscape. Attendees included both innovative and generic drug manufacturers, public and private payers, policy makers and lawyers.  One recurring theme at the meeting was a focus on patients as the target/end-users of the regulatory and pricing initiatives being discussed.

Of particular interest was the Patented Medicine Prices Review Board’s (“PMPRB”) session, one year after the new guidelines were released. Michelle Boudreau, Executive Director of the PMPRB, gave an update in light of the impact of the guidelines and touched on the future directions of the board. She focused on the issue of transparency in drug pricing including access to public information and open hearings for the PMPRB. In terms of moving forward, she commented on the Board’s new direction in trying to become more aligned with our international counterparts. In the coming months, the PMPRB’s transparency initiative will be exemplified through ongoing monitoring and evaluation, and increased public information made available on their web site. A consolidated version of the guidelines was promised to be available on the website by the end of June. A pdf of the presentation is available here.

Special thanks to the Canadian Institute for the conference pass and to Norton Rose summer student Karen Sie for this report.

Monday Biotech Deal Review: June 6, 2011

Welcome to your Monday Biotech Deal Review for June 6, 2011.  This week’s deal review is brought to you by Norton Rose OR LLP summer student Steven Zuccarelli who, before entering law school at Osgoode Hall Law School, obtained his B.Sc and M.Sc at McMaster University in Biochemistry and Health Sciences, respectively, where he was involved in researching peptide vaccine models.  Steven will be assisting over the summer months with the Monday Deal Review, and it’s great to have him aboard. 

Aside from some interesting commercial deals, as well as CardioComm’s related-party announcement of a $788k asset purchase, things were fairly slow last week.  Read on to learn more. 

Read more of this post

Canada’s First Subsequent Entry Biologic!

Guest post from Jill Daley, part of our all-star life sciences team at Ogilvy:

Today, Sandoz Canada announced that Health Canada has granted it a market authorization for Omnitrope™.

This announcement marks the approval of the first subsequent entry biologic (SEB, also known as a “follow-on biologic” (FOB) in the U.S. or a “biosimilar” in the EU) of a previously approved recombinant biotechnology drug by Health Canada.

Omnitrope™ has received similar treatment in the United States and in Europe where it has been approved as a “follow-on protein” and a “biosimilar”  respectively.

Interestingly, today’s announcement came less than one month following Health Canada’s issuance of the Draft Guidance for Sponsors: Information and Submission Requirements for Subsequent Entry Biologics.  The Ogilvy Renault bulletin analyzing the draft guidance is here.

The draft guidance is open to consultation until May 26, 2009. Interested stakeholders are invited to submit written coments via email (BGTD_PPD_DPP@HC-SC.GC.CA), mail or fax (613-952-5364).

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100th Post – State of the Blog

5 contributors, 46 days since launch, 100 posts, 544 tags, 3300 hits.* 

Thanks for stopping by!  Leave a comment; take the poll: 

* Hits as in page-views.  Don’t assume stuff just because we’re in Canada.

How *Not* to Cut Back

Hat tip to Paul Carenza

In difficult economic times, managing cash flow is key to survival. However, a recent case serves as a reminder that corporate directors in Canada are exposed to personal liability for the corporation’s unremitted source deductions for income tax, EI and CPP, as well as GST collected, unless the director has exercised appropriate due diligence to ensure the corporation respects its obligations.  (We’ll stipulate that EI and CPP are more relevant in the Biotech context than income tax and GST, which require … well, income and sales; but still…)

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New MOPOP Chapter 17 re Biotechnology

From Inaugural Guest Blogger Brian Gray, setting a high bar:

On January 14 CIPO issued the revised version of chapter 17 of its Manual of Patent Operating Procedures (MOPOP) re biotechnology (pdf). Obviously a lot of work has gone into this. Interestingly enough, while the previous chapter 17 (pdf) dealt mainly with the formalities of filing sequence listings and other technical issues relating to biotechnology, this chapter attacks the more meaty issues of subject matter, utility, sufficiency and novelty as they relate to biotechnology, matters that had previously been and still are covered by chapter 12, a chapter that is still waiting for revision and is probably hung up on policy issues relating to business method patents and other abstract methods and elsewhere in MOPOP.

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