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Category Archives: Patents

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Supreme Court of Canada to Hear Landmark Pharmaceutical Section 8 Damages Case

Posted in Intellectual Property, Patents

On October 30, 2014, the Supreme Court of Canada granted leave to Sanofi-Aventis’ (“Sanofi”) application for leave to appeal a decision of the Federal Court of Appeal (2014 FCA 68). By granting leave to Sanofi, the Supreme Court will now consider for the first time the correct interpretation of, and the correct legal framework applicable to quantifying section 8 damages under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).

The PM(NOC) Regulations strike a balance between the interests of innovative pharmaceutical companies and generic manufacturers, by requiring generic manufacturers to address innovators’ patents before receiving … Continue Reading

Canada and the EU Successfully Conclude CETA: What It Means to the Pharmaceutical Industry

Posted in Intellectual Property, Patents

On September 26, 2014, Prime Minister Harper announced that Canada and the European Union have successfully concluded negotiations on a new trade agreement, the Comprehensive Economic and Trade Agreement (CETA) that was five years in the making, and publicly released the consolidated text of the agreement.

CETA is deeper in substance and broader in scope than any other such agreement in Canadian history, significantly affecting all economic areas, including the pharmaceutical sector.

The CETA chapter on intellectual property is of particular interest to the pharmaceutical industry, because it will introduce into Canada for the first time:

SAGD Patents and Applications in Canada

Posted in Intellectual Property, Patents

INTRODUCTION

In 1979, Dr. Robert Butler and his research team filed a Canadian patent application for the oil recovery technology known as Steam Assisted Gravity Drainage (“SAGD”).  Over thirty years later, SAGD technology has become a formative oil-recovery process, with over two hundred patent applications filed in Canada relating to SAGD technology.

SAGD operations have increased primarily due to its potential to enhance bitumen recovery.[1]  Patent applications have been filed in respect of many aspects of SAGD technology, including the orientation of the wells, the composition of the wells themselves, and the infrastructure that is required to … Continue Reading

B.C. Supreme Court Breathes Life Into New Breed of Potential Pharma-Related Class Action Whereby Innovator Profits Are At Risk

Posted in Intellectual Property, Patents

In Canada, innovator drug companies can protect their market exclusivity from generic copycats by asserting patents against the generic manufacturer in litigation under the PM(NOC) Regulations. Until now, the consequences of losing PM(NOC) litigation was the potential payment of damages to the generic whose market access was delayed by the litigation. These so-called “section 8 damages” are limited to the actual loss suffered by the generic during that specific period of delay. Public policy is such that the profits earned by the innovator during that period cannot, however, be disgorged pursuant to section 8 of the PM(NOC) Regulations.… Continue Reading

Canada Patent Litigation: Federal Court Rules “Enhanced Disclosure” Requirement for Sound Prediction Applies Only To “New Use” Patents

Posted in Intellectual Property, Patents

On July 2, 2014, Mr. Justice Rennie of the Federal Court released his judgment and reasons in Astrazeneca Canada Inc v. Apotex Inc., 2014 FC 638 dismissing AstraZeneca’s action for infringement and granting Apotex’s counterclaim for a declaration that Canadian Patent 2,139,653 (the “‘653 Patent”) is invalid. This patent relates to AstraZeneca’s successful drug NEXIUM® (esomeprazole).

Justice Rennie found the invention of the ‘653 Patent was novel and non-obvious, but nevertheless invalidated the patent for promising an improved therapeutic profile which was not soundly predicted.

While Justice Rennie canvassed a number of legal issues, his … Continue Reading

Federal Court Dismisses Notion that Patents Should be Given Only One Interpretation for All Purposes

Posted in Intellectual Property, Patents

Summary

In a pair of simultaneously released decisions on June 13, 2014, Justice O’Reilly allowed Allergan’s applications (the “Applications”) prohibiting the Minister of Health from issuing NOCs to Cobalt (now “Actavis”) (2014 FC 566) and Apotex (2014 FC 567) to market their generic versions of LUMIGAN RC® until the expiry of Canadian Patent 2,585,691 (the “‘691 Patent”) in 2026.

Allergan was represented by Andrew Reddon, Steven Mason, Steven Tanner and Sanjaya Mendis of McCarthy Tétrault LLP.

Background

Allergan originally marketed a 0.03% bimatoprost (“Bp”) containing formulation for treating glaucoma called LUMIGAN, … Continue Reading

PM(NOC) Proceedings: Apotex defeats Bayer’s Canadian patent on oral contraceptive YAZ

Posted in Intellectual Property, Patents

On June 4, 2014 Justice Roger Hughes of the Federal Court released his public reasons for dismissing Bayer’s prohibition application against Apotex in respect of its generic YAZ tablets on the basis that Apotex’s non-infringement allegation was justified. His confidential judgment was issued on May 7, 2014 and Apotex received its NOC the very next day. The term of Bayer’s patent was not set to expire until August 31, 2020. For the full written decision see: Bayer Inc. et al. v. Apotex Inc. et al. 2014 FC 436.

Although not determinative, this decision addresses the somewhat contentious issue of … Continue Reading

Your Patent Has Been Infringed: Enforcement of Oil and Gas Patents in Canada

Posted in Intellectual Property, Patents

Introduction

Patent disputes are on the rise.  101 patent infringement actions were filed in in the Federal Court in 2013 as compared with 48 patent infringement cases in 2012.  As we explained previously, part of that increase is due to an increase in oil and gas patent litigation.  This raises the question; what do you do when you discover that your patent has been infringed?

Prosecuting Infringers

On April 23, we met with in-house counsel and other industry leaders at our new Calgary office to discuss the eleven steps that a patent holder in the oil and gas sector … Continue Reading

Patent Law Historical Observations: Oil and Gas

Posted in Intellectual Property, Patents

We recently posted an article reviewing the year past in oil and gas patent litigation.  We analyzed new Federal Court cases and issued decisions and provided commentary on future implications.  You can read that article here.

This article continues that analysis by looking backwards in time; specifically to oil and gas patent litigation for the years 2009-2012.  What conclusions can be drawn if we look at a 5-year window of time?

The short answer is that 2013 was as busy a year for oil and gas patent litigation as the previous four years combined.

For the 2009-2012 timeframe there … Continue Reading

McCarthy Tétrault receives four Benchmark Canada awards

Posted in Awards and Recognitions, Intellectual Property, Patents

McCarthy Tétrault is delighted to announce that Euromoney Legal Media Group’s Benchmark Canada named partners Andrew Reddon and Steven Mason as Canada’s Intellectual Property Litigators of the Year – Patents. The award is in recognition of Mr. Reddon and Mr. Mason’s exceptional knowledge of patents and superior trial skills. The pair’s recent successes include their representation of AbbVie in its patent infringement case against Janssen related to AbbVie’s Canadian patent on anti-IL-12 antibodies. This was Canada’s first antibody engineering trial, and the action was the first in Canada dealing with the scope of protection for the new class of … Continue Reading

Patent Law Year in Review: Oil and Gas (2013)

Posted in Intellectual Property, Patents

In 2013 the Federal Court experienced a surge in patent infringement actions. Whereas 48 patent infringement actions were filed in 2012, that number rose to 101 in 2013.[1] Part of that increase came about because of growth in the oil and gas patent infringement sector. Put simply, oil and gas companies were more aggressive at enforcing their patent rights in 2013.

This blog is a review of oil and gas patent litigation in the year 2013. Specifically, we review each of the decided Federal Court cases released during the past calendar year, and provide an overview of the newly … Continue Reading

A Massive House-Cleaning: Canadian Government Tables Five New IP Treaties

Posted in Intellectual Property, Patents, Trade-marks

On January 28, 2014, the Government of Canada signalled its intent to transform  its intellectual property regimes by tabling five intellectual property law treaties in Parliament. If implemented into domestic law, these treaties would harmonize Canada’s trade-mark, patent and industrial design legislation with its major trading partners. Following a 21-sitting-day waiting period, the Government will be able to introduce legislation to implement these treaties. Such legislation will transform important aspects of the trade-marks practice in Canada, and will lead to significant changes in the industrial designs field as well.

Some key points and concerns about the treaties include the … Continue Reading

New Jersey District Court dismisses proposed antitrust class action over LAMICTAL patent settlement

Posted in Intellectual Property, Patents

On January 24, 2014, the District Court released its reconsideration opinion again dismissing a previously-dismissed proposed antitrust class action against GSK and Teva under the “rule of reason” test set down in the 2012 U.S. Supreme Court’s Actavis decision.

In doing so, the Court made some important statements about Actavis:

  1. It does not allow scrutiny of all patent settlements with anticompetitive potential.
  2. It requires scrutiny only of patent settlements that contain “reverse payments”.
  3. A “reverse payment” must include the exchange of money.

GSK and Teva had settled patent litigation over LAMICTAL (lamotrigine) tablets, which are used to treat epilepsy … Continue Reading

Do you need to examine inventors located in Canada as a part of your patent lawsuit?

Posted in Intellectual Property, Patents

Almost invariably, defendants in a patent lawsuit seek to examine the inventors of the patent or patents in issue.  But, what do you do if an inventor resides in Canada?  Generally, non-Canadian courts are not able to assert personal jurisdiction over Canadians and, therefore, cannot compel them to give evidence under oath for the purposes of a lawsuit.  If a Canadian witness does not willingly provide evidence, commission evidence may be sought via the enforcement of what are called “letters of request”.  Essentially, these represent a foreign court’s request that a Canadian court order someone to appear and be examined … Continue Reading

Patent Litigation in Canada: A U.S. Attorney’s guide to the Canadian Litigation Process

Posted in Intellectual Property, Patents

Canada and the United States are close neighbors. About 300,000 people cross the border each day, and bilateral trade amounts to about $1.6 billion in goods daily.  It is not surprising that patent, and other intellectual property disputes, often involve some element of cross-border litigation.  The Canadian litigation experience is relatively similar to the American experience.  There are, however, some important differences that U.S. attorneys involved in such litigation should be aware of.

  1. Like in the United States, Canada has federal and provincial/state courts. Both can decide patent cases.
  2. Litigation process and procedure is dictated by the rules of civil
  3. Continue Reading

Eli Lilly seeks arbitration with Canada over IP-related NAFTA Obligations

Posted in Intellectual Property, Patents

This is the latest chapter in the story involving Canada’s judge-made “promise of the patent” doctrine, which is sometimes referred to as the “promise doctrine” or “promise of the patent”. The promise doctrine essentially states that in order to constitute a useful (and therefore patentable) invention, an invention must not only be useful for some purpose, but it must also make good on any promise of utility found in the disclosure of the patent.

On September 12, 2013, Eli Lilly filed a $500 million claim against the Government of Canada over “invalidated patents”, alleging that Canada has “violated its obligations … Continue Reading

Ontario Court of Appeal upholds summary judgment dismissing Apotex’s claim for unjust enrichment and disgorgement of profits

Posted in Intellectual Property, Patents

On September 12, 2013, a panel of three judges of the Ontario Court of Appeal unanimously upheld the decision of the Ontario Superior Court earlier this year to grant partial summary judgment to Abbott and Takeda, denying Apotex’s claim for disgorgement of profits on the basis of unjust enrichment.

The case involved a claim for damages arising from Abbott’s invocation of the Patented Medicines (Notice of Compliance) Regulations, relating to its drug Prevacid®. The PM(NOC) proceedings were ultimately discontinued by Abbott following a settlement agreement between the parties, and Apotex thereafter brought an action in the Ontario Superior Court for … Continue Reading

Sanofi’s Canadian Patent on Plavix Valid and Infringed by Apotex

Posted in Intellectual Property, Patents

On July 24, 2013 the Federal Court of Appeal released its decision reversing the trial court’s ruling that Sanofi’s patent covering Plavix is invalid.  For the full written decision see: Apotex Inc. v. Sanofi-Aventis, 2013 FCA 187.

In its decision, the Court of Appeal provides clarification on invalidity in light of the so-called promise of the patent.  Not all patents contain a promise.  For there to be a promise, it must be both explicit and specific.  The Court of Appeal also reiterates the requirement that for an invention to be obvious, it must be self-evident that what is obvious … Continue Reading

Four Tips from Merck’s $180M Patent Damages Win Against Apotex

Posted in Intellectual Property, Patents

It is said that the wheels of justice turn slowly, but grind exceedingly fine.  That phrase could certainly apply to Merck’s recent win over Apotex in a damages trial for patent infringement in Canada, in a case that started in 1997.

The liability decision finding Apotex guilty of infringement was released in December 2010.  To view the Lexpert write-up of the liability decision click here.  It took another two years before we arrived at the damages trial.  It commenced on April 8, 2013 in Toronto.  On July 16, 2013, the public damages judgment was released.  Merck was awarded damages … Continue Reading

5 Things Every Retailer Should Consider When Threatened with Patent Infringement: 5-Item Checklist

Posted in Intellectual Property, Patents

Introduction

In recent years major Canadian retailers have been named as defendants in patent infringement lawsuits, including Wal-Mart (T-1841-11), Costco (T-1841-11), Canadian Tire (T-1002-12) and Home Depot (T-1112-13).  The common thread linking these and other cases is that the plaintiff is asserting patent rights against a retailer that sells, but does not manufacture, allegedly infringing products in its stores.

Indemnity agreements between retailers and manufacturers who supply product are common.  However, such agreements may not provide retailers with sufficient protection.  Plaintiffs will often pursue retailers because they are more likely to satisfy a judgment than manufacturers.  Sometimes, plaintiffs do not … Continue Reading

U.K. Court Sufficiently Satisfied that Janssen’s Alzheimer’s Patent is Insufficient

Posted in Intellectual Property, Patents

On June 25, 2013, the England and Wales High Court rendered its decision in Eli Lilly & Company v. Janssen Alzheimer Immunotherapy, [2013] EWHC 1737.  This ruling demonstrates the danger in drafting patents to include only broad claims without subordinate, narrow claims, which are more likely to survive a validity challenge like the one Eli Lilly Company (“Lilly”) successfully raised in this case.  That is not to say broad claims should be eliminated altogether.  However, as this ruling demonstrates, in drafting a patent it is extremely important to include a series of narrow claims that are well-supported … Continue Reading

Update: Supreme Court of Canada Amends Controversial Aspect of VIAGRA® Judgment

Posted in Intellectual Property, Patents, Regulatory Compliance

As discussed in the November 9, 2012 post, Supreme Court Invalidates Pfizer’s Blockbuster VIAGRA® Patent, the Supreme Court of Canada struck down Pfizer’s blockbuster VIAGRA® patent (the “‘446 Patent”) on the basis of insufficient disclosure: see Teva Canada Ltd. v. Pfizer Canada Inc., 2012 SCC 60.

In a curious twist, the SCC declared the ‘446 Patent “void”, despite the case being brought under the Patented Medicines (Notice of Compliance) Regulations (“PM(NOC) Regulations”).  However, on June 4, 2013, the SCC granted Pfizer’s rare Rule 76/81 Motion, varying this controversial aspect of its … Continue Reading

PM(NOC) Proceedings: Cobalt Defeats Bayer’s Canadian Patent on Oral Contraceptive YASMIN

Posted in Patents

On May 29, 2013 Justice O’Reilly of the Federal Court dismissed Bayer PM Notice of Compliance (NOC) proceeding against Cobalt.  The issue before the Court was whether Cobalt’s proposed generic product would infringe a single claim (claim 13) in a Canadian Bayer patent to drospirenone, an active ingredient in Bayer’s YASMIN contraceptive. The Court determined that Cobalt’s non-infringement allegation was justified.  For the full written decision see: Bayer Inc. v. Cobalt Pharmaceuticals Company 2013 FC 573.… Continue Reading

Pfizer Liable to Apotex for Section 8 Damages: Amount to be Determined

Posted in Intellectual Property, Patents, Regulatory Compliance

In a judgment pronounced on May 10, 2013, Justice O’Reilly of the Federal Court of Canada, granted Apotex’s claim against Pfizer for section 8 damages under Canada’s Patented Medicines (Notice of Compliance) Regulations, SOR/93-133.  The sole issue before the Court was whether Apotex had a valid claim to damages.  The amount is to be determined in a subsequent proceeding.  For the full written decision see: Apotex v. Pfizer Canada Inc., 2013 FC 493.

The section 8 claim arises out of a failed prohibition proceeding.  In early 2000, Apotex sought approval for its generic version of ZITHROMAX (azithromycin), … Continue Reading