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
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.
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.
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.
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…)
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.
The views expressed here are solely the authors’ and should not be attributed to any of their firms or clients. The material and information provided on this website are for general information only and should not be relied on as legal or business advice or as a legal opinion. The authors make no claims, promises or guarantees about the accuracy, completeness, currency, or adequacy of any information linked or referred to or contained on this blog. No person should act or refrain from acting in reliance on any information found on this blog without first obtaining appropriate professional advice from a consultant or from a lawyer duly licensed to practise law in the relevant province, state, territory or country. These materials do not create a solicitor-client relationship between you and any author. Please note that the authors will not provide free legal, financial or other advice. Please don’t send us any confidential information or questions by email or otherwise because any information sent to us cannot be considered to be privileged or confidential.
Note that by accessing, commenting on or linking to the blog, you (like us) are subject to the WordPress Terms of Service. Most images are from Wikimedia Commons or from governments, others link back to commercial sources. If you want us to remove an image, just let us know.