Stevioside associated with inhibited artherosclerosis in obese, insulin-resistant mice.
According  to a study published online in the International Journal of Obesity, "stevioside treatment was associated with increased adiponectin and insulin sensitivity and improved antioxidant defense in both the adipose tissue and the vascular wall, leading to inhibition of atherosclerotic plaque development and inducing plaque stabilization." After treating "14 mice...with 10 mg/kg stevioside and 20 with placebo for 12 weeks," researchers found that "stevioside treatment...lowered levels of glucose and insulin, improved adipose tissue maturation, and increased glucose transport, insulin signaling and antioxidant defense in white visceral adipose tissue, compared with placebo," and "reduced plaque volume in the aortic arch. 

"Shire Plc's Replagal [agalsidase alfa] provided 'substantial and sustained' benefits to patients with a rare condition called" Fabry disease "after five years taking the enzyme replacement therapy, according to" data collected on 181 multinational patients. In fact, the "drug improved all areas studied, including heart mass and function, kidney function, pain, and quality of life," investigators noted in their paper in The Lancet. However, "advanced complications of Fabry disease do not appear to be fully reversible with treatment and that future studies [should] examine whether early initiation of treatment can improve long-term outcomes more than was evident in the current study."  

Specific drug combination may be more effective in patient with high HIV viral load.
"In patients with a high HIV viral load at the start of initial therapy, regimens based on tenofovir/emtricitabine (Truvada) were more effective than those based on abacavir/lamivudine (Epzicom)," Brigham and Women's Hospital researchers found after evaluating 1,858 patients. "Current guidelines for initial HIV therapy suggest a regimen based on two nucleoside reverse transcriptase inhibitors (NRTIs) and either a protease inhibitor or a non-nucleoside reverse transcriptase inhibitor."  

While such combinations are "potent," it has "not been clear if they differ in antiviral activity, tolerability, and safety." The new "surprise finding," however, "suggests that physicians should be aware of the difference when prescribing initial treatment for patients with a high level of HIV-1 RNA in their blood," according to the paper in the New England Journal of Medicine.  

Roche says experimental diabetes drug works better than Januvia.
In a clinical trial, Roche Holding AG's experimental diabetes treatment, taspoglutide, worked better than Merck & Co. Inc.'s Januvia [sitagliptin]. In a phase III trial for treatment of type 2 diabetes, the drug met its primary endpoints. Researchers found that the drug lowered blood-glucose levels more than Januvia, and showed superior HbA1c reduction compared to placebo.   

Pharmaxis says Bronchitol improved lung function in patients with cystic fibrosis.
Drugmaker Pharmaxis Ltd. said "its Bronchitol [mannitol] drug improved patients' lung function" in "a study of 170 patients with cystic fibrosis." Researchers found that patients "who switched to the drug after taking a placebo for six months improved by 10.3 percent." 
 

FDA rejects approval of Merck's cladribine to treat Multiple Sclerosis.
Merck KGaA announced that the FDA rejected approval of its cladribine drug to treat multiple sclerosis. The company sought approval of cladribine as a potential short-course treatment for the condition, but the agency said Merck's application is not adequately complete. Merck intends "to request a meeting with the FDA" to discuss the agency's "concerns with its application for approval," according to a spokesperson. 

Also at http://www.pharm-education.com/2010/01/clinical-research-updates-on-new-drugs.html

Disclaimer – This information is presented for knowledge purpose only and should not be interpreted as medical advise.

In the past 12 months, two significant decisions (one in Canada, the other in the United States) have the potential to dramatically recalibrate the scope of patent protection for so-called "business methods" (and possibly "software inventions" as well). These cases may herald a backward swing of the patent law pendulum towards less protection for business methods. 

In Canada, the Canadian Patent Appeal Board rejected a patent application of Amazon.com Inc. for its novel "one-click" online product ordering system. In the US, the Court of Appeals for the Federal Circuit in the Bilski case has narrowed extensively the ambit of patent protection in a decision involving a commodities-hedging system. 

The Bilski decision is under appeal to the US Supreme Court, and the Amazon decision is also being appealed to the Federal Court of Canada. This is welcome, because each decision is unsatisfactory. But the importance of their ultimate respective determinations cannot be underestimated. Therefore it is worth taking stock, even at this interim stage, of the issues presented by them — and of what exactly is at stake in what will be their final judicial resolutions. 

Importance of Patents
Before going into the two decisions, just a reminder of why patents are so incredibly important: in essence, it is because they afford the strongest form of intellectual property (IP) protection. While copyrights and trade secrets are useful as far as they go, they actually do not go that far because they protect only against copying. For example, independent creation is always a full defence to a copyright or trade secret claim. 

By contrast, independent creation (subject to some nitty-gritty nuances) is generally not a defence in a patent claim. That is, you can never successfully be sued under copyright/ trade secret law for ripping off someone else's software if you never had access to it; but you certainly can be sued for infringing a third party's patent even if you know nothing about it. Therefore, for the duration of the patent (roughly 20 years), the patent holder can assert an effective monopoly on the invention it covers (and presumably charge monopoly profits on its sale or licensing for such time period). Patents, in a word, are incredibly valuable IP assets. 

Hurdles to Patenting
Not surprisingly, given their significant value, the government agency that issues patents — in Canada, the Canadian Patent Office (CPO) — does not hand them out willy-nilly, but only very carefully and selectively, applying the patentability criteria with rigour and discipline. By contrast, copyright arises automatically, as does trade secret protection so long as you take appropriate steps to keep secret your proprietary information. 

In general terms, the invention for which you desire to be issued a patent must be new and inventive. In terms of novelty, essentially this means that no one, anywhere in the world, can have disclosed or used something similar to what you want patented. And even if you satisfy this requirement, then your invention must not be obvious — it has to embody some degree of inventive spark that an average technical person in your space would not have come up with (in short, there has to be some creative ingenuity buttressing your invention). 

In addition, your invention must come within one of the categories of patentable subject matter permitted by the Patent Act; namely, it has to be a "new and useful art, process, machine, manufacture or composition of matter." It was this latter requirement that was found to be missing in the Amazon case. 

Amazon's One-Click Invention
To understand the genius behind Amazon's "One-Click" online ordering invention, you have to cast back your mind to the mid-1990s, and the infancy of business-to-consumer e-commerce. Unlike today (when Amazon is a leading online retailer — or "e-tailer"), back then, Amazon was one of many struggling new online businesses, each trying to set themselves apart from the others in a new, crowded and difficult marketplace. 

One particular difficulty was that more than 60 per cent of online prospective consumers who started to order products from websites never completed the purchase because they found the "shopping cart/checkout line" process cumbersome, frustrating and time-consuming. Finding something to buy online was easy, particularly given the cookie technology that most e-tailers used (by sending your computer a cookie — a bit of software code — when you first visited their site, the next time you came back to the site, the cookie would allow the e-tailer to "recognize you" so that ads tailored to your own preferences — based on what you looked at last time — would be served up to you). It seems like magic — "My, how fortuitous that all of these ads showcase books that are of interest to me! It's as though they know me!" But it's not magic, of course; it's just simple cookie technology at work. 

While the new e-consumer was wowed by the personalization features of e-tailers' websites, they were underwhelmed by the check-out buying process. Each time the "shopping cart" was ready to be pushed through the online cash register process, multiple screens confronted the customer with information to complete, instructions to follow, and precious time to waste (usually typing in the same information they had given on their previous visits). As noted above, the statistics showed that well over half the people who started this check-out process never completed it. 

To address this real, practical problem, the clever folks at Amazon.com invented, developed, perfected and deployed on their own website their so-called "One-Click" product-ordering system. Essentially, when you wanted to purchase something from their site the second and subsequent time, you could do so by merely clicking the "One-Click" button (this would populate your order with the same information you used the last time you ordered something, thereby getting you through the check-out process in a fraction of the time). In essence, if you used Amazon, you only had to endure the check-out hassle once; after that the Amazon computer remembered who you are (courtesy of the cookie they put on your computer that first visit) and, by using your previously provided check-out data, could give you a much more satisfying online purchasing experience. 

Amazon's US One-Click Patent

Amazon obtained a US patent for the One-Click invention. In the fall/Christmas season of 1999, it used this patent to great effect when, on the strength of it, Amazon successfully obtained an injunction against Barnes and Noble, preventing them from using a similar one-click check-out system on the B&N website (at the time B&N was a key rival of Amazon).

In this injunction case, B&N argued that the Amazon patent should be found invalid given all the other online ordering systems that B&N brought to the court's attention (that B&N argued proved that Amazon's system was neither novel nor inventive). The court considered each of these examples of prior art, but concluded that none actually implemented a "one-click" type functionally.

This was an important patent victory for Amazon, and forced B&N to redesign its check-out system for that critical 1999 Christmas e-commerce season. (It should be noted that subsequent litigation ensued, and the parties ultimately settled their dispute in 2002). 

Amazon's Canadian Patent Application

Amazon filed for a Canadian patent for the One-Click invention, but so far has been unsuccessful in having it issued. The initial review was undertaken by an Examiner at the CPO. In Amazon's case, the Examiner concluded that the One-Click idea was not inventive, and moreover that it did not constitute patentable subject matter. 

Amazon appealed to the Canadian Patent Appeal Board and the Commissioner of Patents (collectively, the "Board"). Interestingly, on the issue of inventiveness, the appeal was successful. There was one particular book on the subject of online e-commerce that pre-dated the patent application, and the Examiner held that various references in this book anticipated what Amazon had developed in its One-Click invention. 

The Board carefully reviewed the book, and concluded otherwise. While use of cookies to enhance the e-consumer experience was at that time obvious, the Board found that Amazon's single-action ordering system was not obvious: the Board concluded that a skilled technician would not have directly and without difficulty conceived of the One-Click system. 

Canadian Subject Matter

On the other hand, in what cannot be termed anything but a surprising decision, the Board concluded that a patent should not be issued to Amazon for the One-Click invention because it did not constitute patentable subject matter. In essence, the Board stated unequivocally that in its view, a pure business method that has no "technological effect" is not patentable in Canada. 

This is startling for several reasons. First, the current CPO Manual of Patent Office Practice expressly states that business methods are not automatically excluded from patentability by jurisprudence or statute. In its decision, the Board considered and rejected that statement in the Manual. Therefore, for the Board to take such a hard and unnuanced view of business methods is disappointing (more recently, a proposed amendment to the Manual would bring it in line with the Amazon decision, also denying patentability to business methods). 

The second surprising aspect of the Amazon decision is that the Board found that the term "art" and "process" in the Patent Act are confined to acts performed by "some physical agent upon some physical object and producing in such object some change of character or condition." That is, the Board believes that all categories of invention in the Patent Act are physical in nature; they involve tangible object or instruments. The decision also seems to ignore the prevalence of computers and processing systems in today's environment in assessing the "technological effect" issue. 

Describing this conclusion in another way, the Board stipulates that the common characteristics of the five categories of invention is that they are "technological" in nature. And the Amazon One-Click invention does not qualify because it is only a retailing concept and some rules for ordering items. (As the Board stated, "Single-action ordering without checkout ... involves streamlining the rules for practice for shopping, that is, it relates to a business decision with business implications. There is nothing technical about this aspect of the claimed invention."). 

The authorities relied upon by the Board for its conclusion on patentable subject matter are strange, particularly in terms of its use of American authorities. For example, it cites the dissent in a Canadian Supreme Court decision that refers to the State Street Bank case, which did not involve a physical system! And the Board cites the Bilski decision, which as we shall see in the next TLQ, actually takes a much more nuanced view of business method patents. (After reviewing Bilski, we will also draw some conclusions about the practical — and strategic — impact of these two cases). 

Also at http://pharmaceutical-patents.blogspot.com/2010/01/canada-patent-pendulum.html 

Disclaimer : The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

UK's NICE says bevacizumab is not cost-effective, should not be prescribed.
The UK's National Institute for Health and Clinical Excellence reported that Roche Holding AG's Avastin (bevacizumab) should not be prescribed for bowel cancer patients under the National Health Service because it is too costly. NICE added in its preliminary ruling that Avastin in combination with oxaliplatin should not be paid for by NHS because it is not cost-effective. The recommendation follows Roche's offer to subsidize treatment following discussions with the UK Department of Health.  

NICE's formula to determine the cost-effectiveness of drugs "looks at quality of life and overall cost effectiveness," but its maximum limit "has not changed in ten years despite inflation." A number of "patient groups and experts voiced their dismay" regarding the decision, and the Daily Mail adds that NICE, "which has been accused of spending more on spin than on evaluating drugs, has often been criticized for banning drugs from NHS use as too expensive."  

Judge dismisses Fosamax case.
The Wall Street Journal reported that a federal judge dismissed a case over allegations that Merck & Co.'s osteoporosis drug Fosamax caused osteonecrosis in a 74-year-old woman. Bessie Flemings claimed that she developed the severe jaw condition from taking the drug and that Merck did not adequately warn of the risk of osteonecrosis.  

The judge ruled that "experts for Bessie Flemings...can't establish that Fosamax caused her osteonecrosis," and as a result, "her failure-to-warn claim is insufficient as a matter of law," An attorney for Merck noted that "Flemings did not present any reliable evidence supporting her claim," adding that "Flemings had medical problems that cause people to develop jaw problems regardless of whether they were taking Fosamax." The company, "as of Sept. 30, faced about 953 Fosamax cases, including suits with multiple patients.". 

Pfizer ordered to pay $103 million in punitive damages in hormone drug cases. On the front page of its Business Day section, the New York Times reported that, "Pfizer has been ordered to pay a total of $103 million in punitive damages to two women who were found to have breast cancer after they used" the hormone drugs Premarin and Prempro. Pfizer units Pharmacia and Wyeth "marketed the drugs as a standard, long-term hormone treatment for menopausal women, until medical evidence emerged indicating that such therapy raised women's risk of breast cancer." Now, a jury has "reached a $28 million judgment" in a case Monday, "while a judge unsealed a month-old $75 million judgment in the other case."  

Lawyers for the plaintiff Monday noted, "This is just the tip of the iceberg as Wyeth faces lawsuits from more than 10,000 additional women who also claim that Wyeth's drugs gave them breast cancer," But, a Pfizer spokesman said that "of the 34 trial-set cases to date, there have been only four plaintiffs' verdicts that have not been set aside."  

Also at http://www.qa-expert.com/2010/01/drug-regulatory-updates.html  

Disclaimer : The information presented here is for information purpose only and should not be interpreted as medical advise.

Sanofi fails to win preliminary NICE backing for its Multaq heart drug.
Sanofi-Aventis SA failed to win the preliminary backing of the UK's health-cost panel for its Multaq [dronedarone] heart medicine after a committee said the medicine isn't more beneficial than standard therapies." The UK's "National Institute for Health and Clinical Excellence's [NICE] independent appraisal committee found that the drug doesn't work as well and costs more than medicines already on the market, NICE said today in an emailed statement and added that "NICE will make a final recommendation on whether the UK's National Health Service should pay for the medicine after a consultation period that ends on Jan. 28 2010.  

MedImmune responds to FDA inquiry regarding motavizumab.
 AstraZeneca PLC, the London pharmaceutical that owns MedImmune, said the local subsidiary has filed its formal responses to the Food and Drug Administration's questions about motavizumab, an enhanced version of MedImmune's blockbuster drug Synagis." According to the Business Journal, the drug, which treats respiratory syncytial virus disease in infants, "has hit its share of delays to market." 

Combination therapy with mirtazapine may be more effective than fluoxetine alone.
According to a study published online Dec. 15 in the American Journal of Psychiatry, "mirtazapine used in combination with fluoxetine, venlafaxine, or bupropion is more effective and as well tolerated in treating major depressive disorder (MDD) as fluoxetine alone." After treating "a total of 105 patients meeting Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, criteria for MDD," researchers found that "patients treated with these combinations had mean differences of 4.5 to 4.8 points on the Hamilton Depression Rating Scale (HAM-D) by day 42, compared with those treated with monotherapy."  

FDA says Aridol cannot be approved in present form.
Pharmaxis, Ltd. reported that it has received a so-called complete response letter from the US Food and Drug Administration saying the application for its lung-function test Aridol [mannitol dry powder for inhalation] couldn't be approved in the present form." The agency "cited deficiencies at three manufacturing and testing subcontractors, a labeling issue, and post-marketing requirements, Pharmaxis said in a statement." The company plans to "address the issues and seek approval as soon as possible," Pharmaxis CEO Alan Robertson said. Aridol, which is already "approved for sale in Australia, major European countries, and Korea," is "a lung function test designed to help doctors diagnose and manage asthma by detecting active airway inflammation through measuring airway hyper-responsiveness."  

Monoclonal antibody may be promising in Ewing's sarcoma.
A monoclonal antibody that targets an insulin-like growth-factor receptor (IGF-1R) was well tolerated and demonstrated antitumor activity in refractory Ewing's sarcoma," according to research appearing online in Lancet Oncology. In a study of "29 patients with advanced sarcomas treated with figitumumab," researchers assessed "tumor response...every six to eight weeks by CT, MRI, or both." The study showed that "two patients...had confirmed responses," and eight "had disease stabilization." Researchers found "no cardiac toxicity," and "no substantial change in cardiac valve function or left ventricular ejection fraction," which they said "was noteworthy...because IGF-1R is expressed on cardiac myocytes, and three-quarters of the patients had previously received potentially cardiotoxic anthracyclines."  

Patients with MDD taking paroxetine may undergo greater personality change. According to a study published in the Dec. issue of the Archives of General Psychiatry, "patients with major depressive disorder (MDD) taking paroxetine underwent greater personality change than those taking placebo, including a significant reduction in neuroticism and a marked increase in extraversion, even after controlling for depression improvement." Researchers arrived at that conclusion after randomizing "240 MDD patients aged 18 to 70 years to receive paroxetine (n = 120), placebo (n = 60), or cognitive therapy (n = 60)," then following them for a year. Notably, paroxetine "appears to have a positive effect on personality that is separate and distinct from its antidepressant effects."  

Also at http://www.pharm-education.com/2010/01/drug-clinical-research-updates_18.html 

Disclaimer : The information presented here is for knowledge purpose only and should not be interpreted as medical advise.

Researchers increasingly targeting cellular environments in cancer research. NewYork Times reports that "more and more researchers are studying tumors in their cellular environments," a "major shift in thinking about why cancer occurs and how to stop it." The approach is rooted in the idea "that cancer cells cannot turn into a lethal tumor without the cooperation of other cells nearby," which implies that "cancer might be kept under control by preventing healthy cells around it from crumbling." Drugmakers are also "investigating the way some skin, ovarian, colon, and brain cancers signal surrounding cells to promote cancer growth." Dr. Barnett Kramer, associate director for disease prevention at the National Institutes of Health, noted, however, that such ideas are not new, pointing to a 1962 study in The Lancet that suggested "cancer may be a disorder of cellular organization."  

Compugen confirms development of cancer treatment target.

Israeli drug developer Compugen Ltd. said that it has discovered a potential cancer treatment target using its RNA sequence technology." The company claims to have validated CGEN-671, which "can be used to better tailor treatments to target a wide range of cancers." According to Compugen's research, CGEN-671 "is expressed in more than 75 percent of colorectal and breast cancers, and 50 percent in lung cancers."

Teva seeks approval for copy of Amgen's Neupogen.
Teva Pharmaceutical "has tired of waiting for the U.S. government to establish a pathway for approval of generic versions of biologic drugs," and has instead decided to seek approval "for its copy of Amgen's Neupogen under the normal branded-drug process." Teva has recently submitted a Biologic License Application "for XM02, its copycat of Neupogen - a drug that stimulates the production of a type of white blood cells in cancer patients." However, "it doesn't mention having tested XM02 in acute myeloid leukemia or severe chronic neutropenia," and is "likely settling for fewer patients in exchange for a more restrictive label." 


Synta Pharmaceuticals begins mid-stage trial of treatment for gastrointestinal stromal tumors.
Synta Pharmaceuticals Corp. Reported that it has started a mid-stage trial of a cancer drug candidate as a treatment for cancers of the digestive tract." The drugmaker will examine STA-9090 in patients with gastrointestinal stromal tumors "who have not responded to treatment with two other cancer drugs, Novartis AG's Gleevec [imatinib] and Pfizer Inc.'s Sutent [sunitinib]." The drug works by inhibiting a protein, Hsp90, which "activates other proteins that cancer cells need to grow.

Gefitinib may improve survival among lung cancer patients with EGFR mutations.
According to research appearing online Dec. 21 in Lancet Oncology, "Asian patients with lung cancer and epidermal growth-factor receptor (EGFR) mutations respond well to initial treatment with gefitinib." In a study of 177 patients, researchers found that "gefitinib conferred superior progression-free survival time vs. standard treatment with platinum-based combination chemotherapy." The study also showed that "the objective response rate in patients with measurable disease was significantly higher among patients receiving gefitinib," and "the disease control rate was also higher."

Findings may help researchers understand how cordycepin inhibits cancer cell growth.
According to findings published in the Journal of Biological Chemistry, "scientists have discovered how a promising cancer drug, first discovered in a wild mushroom, works." Researchers found that the drug cordycepin "inhibits the uncontrolled growth and division of the cells" at low doses by interfering "with the production of mRNA, the molecule that gives instructions on how to assemble a protein." Meanwhile, "at high doses it stops cells from sticking together, which also inhibits growth." The results may help investigators determine which cancers may be treated with cordycepin.

Also at http://www.pharm-education.com/2010/01/cancer-drugs-clinical-research-updates.html

Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise. 

Human Genome Sciences seeks FDA approval for hepatitis C drug.
Human Genome Sciences, Inc. reported that it has filed for marketing approval of its hepatitis C drug Zalbin [albinterferon alfa-2b]." Human Genome "did not say when it expected a response to its biologics license application," but did say that "its partner Novartis AG will file for European Union approval before the end of 2009." The company plans "to market the drug under the name Joulferon" outside of the US.

FDA delays decision on drug to treat hospital-acquired pneumonia.
Theravance, Inc. said that the Food and Drug Administration delayed a decision on whether to approve its infection drug Vitabiv [telavancin] as treatment for hospital-acquired pneumonia." The FDA "asked for more data and analysis on patients who participated in clinical trials of Vitabiv," according to the company. The agency also "wants more information about deaths in Theravance's clinical trials, comparing patients on Vitabiv to those on other treatments, as well as details on why Theravance combined data for two trials.

NHS decides not to make sorafenib, bevacizumab available.
In the United Kingdom, the National Health Service (NHS) has decided not to make two more cancer drugs available because of cost." According to the National Institute for Health and Clinical Excellence, the use of "sorafenib (Nexavar) for liver cancer and...bevacizumab (Avastin) for metastatic colorectal cancer" is "not cost-effective." But, the decision on bevacizumab "is preliminary, and the manufacturer, Roche, has said that it will continue to work with NICE on making the drug available." The moves "have sparked headlines about cancer patients being denied life-prolonging drugs" as well as criticism from some oncologists. Karol Sikora, MD, medical director of Cancer Patterns UK, noted that "the British decision about sorafenib puts it 'hopelessly out of step with the rest of Europe,' because every other country within the European Union makes the drug available."

FDA delays decision on Exalgo.
The Boston Business Journal reported that the FDA "has advised Cambridge-based CombinatoRx Inc. and Canada-based Neuromed Pharmaceuticals Inc. that it will put off making a decision on whether to approve the companies' pain drug target," called Exalgo (hydromorphone HCl), "for three months." The agency said the companies "may need to submit additional data," and that "it will now complete its review by Feb. 22, 2010."

Also at http://www.qa-expert.com/2010/01/pharma-regulatory-updates.html

Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise. 

On June 4, 2009, in Merck Frosst Canada Inc. v. Apotex, Inc., the Federal Court of Appeal released an important decision limiting the range of damages available in actions under section 8 of the Patented Medicines (Notice of Compliance) Regulations. In particular, the Court of Appeal confirmed that section 8 damages do not include either an accounting of the innovator's profits or any damages for loss of market share that extends beyond the period for which the generic company's approval was actually delayed.

Background The Regulations The Regulations are intended to provide innovators with protection from early generic entry in light of Canada's scheme to allow early working of patented drugs by generic pharmaceutical companies ("second persons") for the purpose of seeking regulatory approval. Under the Regulations, a drug company that files an abbreviated new drug submission (ANDS) with the Minister of Health for approval of a generic version of an innovative drug must serve a notice of allegation for each relevant patent listed by the innovator on the Patent Register. If a generic company makes an allegation of invalidity or non-infringement in respect of any patent, the patentee may apply to the Federal Court for an order prohibiting the Minister of Health from approving the ANDS on the ground that it would result in the infringement of a valid patent. The Regulations provide that the filing of such proceeding automatically stays the Minister's approval of the ANDS for the duration of the proceeding, up to a period of 24 months.

Triggering an automatic stay is not risk-free for patentees. Section 8 of the Regulations provides that a generic company may bring an action against the patentee to receive compensation for "any loss suffered" by virtue of a delay in receiving its approval. The period of delay is defined to be the period beginning on the date on which the ANDS would have been approved by the Minister "in the absence of these Regulations," and ending on the date of the withdrawal, discontinuance, dismissal or reversal of the proceeding brought under the Regulations. Subsection 8(4) states that the court may make such order for relief "by way of damages or profits" as the circumstances require.

Apotex's Section 8 Claim Against Merck Frosst In Merck Frosst, Apotex brought an action in damages under section 8, following the Federal Court's dismissal of Merck Frosst's application for a prohibition order in respect of Apotex's proposed alendronate drug product. Merck Frosst defended Apotex's damages action on a variety of grounds, including the argument that Apotex could not claim an accounting of profits or damages for any permanent loss of market share (allegedly caused by the delay attributable to Merck's failed proceeding).

In October 2008, the Federal Court held that section 8 does not enable second persons to claim an innovator's profits. They could claim damages for any permanent loss of market share caused during the period set out in section 8, as a result of the innovator's unsuccessful proceeding under the Regulations. That decision also dismissed several administrative and constitutional arguments as to why section 8 should not be enforced by the federal courts.

The Federal Court of Appeal Limits the Damages Available Under Section 8 The Federal Court of Appeal affirmed the Federal Court's finding that section 8 does not authorize a generic company to claim an accounting of profits from the innovator for any delay allegedly caused by an unsuccessful proceeding under the Regulations. While disgorgement of profits is a remedy available to a patentee under the Patent Act, the Court of Appeal emphasized that a delayed generic company is not in the same position as a patentee. The Court of Appeal held that the use of the terms "damages or profits" in section 8 should be interpreted to mean "damages or lost profits" because the purpose of this provision is to compensate generics for any delay: "a measure which compels a first person to place the second person in the position in which it would have been, if the operation of the stay had not been triggered, fits well within the contemplated balance" (para. 90). The Court of Appeal also affirmed the Federal Court's decision on the administrative and constitutional arguments, permitting the section 8 claim to go forward.

The Federal Court of Appeal reversed the Federal Court on the issue whether a second person may claim for any ongoing loss of market share. Relying on the wording of section 8, which defines the specific period of time for which damages are available, the Court of Appeal held that an innovator is not liable for any long-term losses caused by a failed proceeding under the Regulations. Although an innovator may be liable for lost sales during the defined period, Apotex's market share claim was barred to the extent that its alleged disadvantage (i.e., its late market entry) would result in lost sales after the period defined in section 8.

Also at http://pharmaceutical-patents.blogspot.com/2010/01/canadas-federal-court-of-appeal-limits.html

Disclaimer : This information is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.  

Statin use not associated with risk of developing advanced AMD. “Statin use is not associated with risk of developing advanced, age-related macular degeneration (AMD)," according to a study published in the Dec. issue of Ophthalmology. In a study of 744 patients, researchers from the University of Pennsylvania found that "among patients who had bilateral large drusen, use of the cholesterol-lowering medications was not associated with a higher or lower risk of progressing to advanced disease." The investigators theorized, however, that "a protective effect may have been obscured because patients who are taking statins for cardiovascular disease are also at high risk for developing AMD."

FDA approves Kalbitor for hereditary angioedema. Biotherapeutic drug company Dyax Corp. said Tuesday it received Food and Drug Administration approval to market Kalbitor [ecallantide] for treatment of the genetic disorder hereditary angioedema in patients 16 years and up. In patients with "the rare disorder," fluids accumulate "outside the blood vessels, which causes swelling in extremities, the intestinal tract, or airway."  

The company said it entered a three-year deal with AmerisourceBergen Corp., a drug wholesaler, to set up an exclusive distribution network and call-center services for the drug. The FDA denied approval of the drug in March, seeking more safety data.

FDA approves OTC version of Zegerid. Merck & Co. and Santarus Inc. Reported that the Food and Drug Administration approved Merck's over-the-counter version of the Santarus prescription heartburn drug Zegerid [omeprazole and sodium bicarbonate]." For its part, Santarus "stands to receive a $20 million milestone must pay royalties on net sales of the over-the-counter drug to the University of Missouri.

FDA requests more research on Ampligen to treat CFS. Hemispherx Biopharma Inc. said the FDA "requested more research on its experimental treatment Ampligen." The company said two clinical studies "submitted with a new drug application for Ampligen, designed to treat chronic fatigue syndrome, weren't sufficient to prove the drug's efficacy" to the FDA, which also "requested at least one more study to show the drug works and to confirm its safety." The FDA also requested that Hemispherx resolve inspection issues at some of its manufacturing facilities that produce Ampligen.

Aspirin therapy may raise recurrent peptic ulcer bleeding risk, lower mortality rates. Continuous low-dose aspirin therapy may increase the risk for recurrent peptic ulcer bleeding, but potentially lowers mortality rates, according to a paper in the Annals of Internal Medicine. Researchers in Hong Kong explained that "aspirin has been increasingly used as a treatment of cardiovascular and cerebrovascular diseases," but "it causes a two- to three-fold increase in the risk for dose-related peptic ulcer bleeding." Hence, the need for the current study in which, as expected, investigators observed that the "main endpoint of recurrent ulcer bleeding within 30 days occurred in 10.3% in the aspirin group and 5.4% in the placebo group." Still, "compared with patients who received placebo, patients who received aspirin had lower all-cause mortality rates."  

Lead investigator Dr. Joseph JY Sung was also quick to point out that "the possibility that the difference in all-cause mortality is merely [due to] chance cannot be excluded. Along those lines, Dr. Dominick Angiolillo, of the University of Florida, maintains that "the mortality differences seen by Sung, et al., 'need to be taken with a grain of salt,'" considering it "is a secondary end point." The "other thing to keep in mind is that the study outcomes were evaluated out to eight weeks, and we do know that with bleeding, there can be potential clinical implications even long-term, beyond the eight weeks." Nevertheless, "cardiologists and gastroenterologists should be aware that there is a likelihood of increasing risk of cardiovascular death if aspirin is withheld for a prolonged period."  

Disclaimer : This information is for knowledge purpose only and should not be interpreted as medical advise.

The list goes as-

1.  PCL Constructors Inc., Edmonton, AB
2.  EllisDon Corporation, London, ON
3.  Cisco Canada, Toronto, ON
4.  Bennett Jones LLP, Calgary, AB
5.  CIMA+ Partner in Excellence, Laval, QC
6.  WestJet , Calgary, AB
7.  JTI-Macdonald Corp.,  Mississauga, ON
8.  BC Biomedical Laboratories Ltd., Surrey, BC
9.  Farm Credit Canada, Regina, SK
10.  Edward Jones, Mississauga, ON
11.  Wellington West Holdings Inc., Winnipeg, MB
12.  Stikeman Elliott LLP, Montreal, QC/Toronto, ON
13.  Aecon Group Inc., Toronto, ON
14.  Marriott Hotels of Canada Ltd., Mississauga, ON
15.  GlaxoSmithKline Inc., Mississauga, ON
16.  Chubb Insurance Company of Canada, Toronto, ON
17.  McDonald's Restaurants of Canada Limited, Toronto, ON
18.  The Co-operators, Guelph, ON
19.  Flight Centre Canada, Vancouver, BC
20.  Delta Hotels and Resorts, Toronto, ON
21.  LoyaltyOne Inc., Toronto, ON
22.  G&K Services Canada Inc., Mississauga, ON
23.  OMERS Administration Corporation, Toronto, ON
24.  Scotiabank Group, Toronto, ON
25.  AstraZeneca Canada Inc.,  Mississauga, ON
26.  TD Bank Financial Group, Toronto, ON
27.  Conexus, Regina, SK
28.  Earl's Restaurants Ltd., North Vancouver, BC
29.  Novartis Pharmaceuticals Canada Inc., Dorval, QC
30.  Starwood Hotels & Resorts Worldwide Inc. (Canada), Toronto, ON
31.  Ivanhoe Cambridge Inc., Montreal, QC
32.  Co-operators Life Insurance Company, Regina, SK
33.  Graham Group Ltd., Calgary, AB
34.  Bentall LP, Toronto, ON
35.  Canadian Western Bank, Edmonton, AB
36.  ATB Financial, Edmonton, AB
37.  Ericsson Canada Inc., Town of Mount Royal, QC
38.  Keg Restaurants Ltd., Toronto, ON
39.  Federal Express Canada Ltd., Mississauga, ON
40.  Coast Capital Savings Credit Union, Surrey, BC
41.  Nova Scotia Community College, Dartmouth, NS
42.  Envision Financial, Langley, BC
43.  Meyers Norris Penny, Calgary, AB
44.  Ceridian Canada Ltd., Markham, ON
45.  Cintas Canada Limited, Mississauga, ON
46.  British Columbia Automobile Association, Burnaby, BC
47.  Clark Builders, Edmonton, AB
48.  Procter & Gamble, Inc., Toronto, ON
49.  Nexen Inc., Calgary, AB

Novotel Canada, Mississauga, ON

The 2010 list of Best Employers in Canada includes 25 organizations from Ontario, nine from Alberta, six from British Columbia, four from Quebec, three from Saskatchewan, one from Manitoba, one from Nova Scotia and one headquartered jointly in Ontario and Quebec. Eight organizations have never appeared on the Best Employers in Canada list before.For more information visit, http://www.pharm-education.com/2010/01/who-are-50-best-employers-in-canada.html

Disclaimer : This information is for knowledge puspose only. Specialist advise should be sought for your specific circumstances.