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.htmlDisclaimer – This information is presented for knowledge purpose only and should not be interpreted as medical advise.
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.htmlDisclaimer : 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.htmlDisclaimer : 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-
- PCL Constructors Inc., Edmonton, AB
- EllisDon Corporation, London, ON
- Cisco Canada, Toronto, ON
- Bennett Jones LLP, Calgary, AB
- CIMA+ Partner in Excellence, Laval, QC
- WestJet , Calgary, AB
- JTI-Macdonald Corp., Mississauga, ON
- BC Biomedical Laboratories Ltd., Surrey, BC
- Farm Credit Canada, Regina, SK
- Edward Jones, Mississauga, ON
- Wellington West Holdings Inc., Winnipeg, MB
- Stikeman Elliott LLP, Montreal, QC/Toronto, ON
- Aecon Group Inc., Toronto, ON
- Marriott Hotels of Canada Ltd., Mississauga, ON
- GlaxoSmithKline Inc., Mississauga, ON
- Chubb Insurance Company of Canada, Toronto, ON
- McDonald's Restaurants of Canada Limited, Toronto, ON
- The Co-operators, Guelph, ON
- Flight Centre Canada, Vancouver, BC
- Delta Hotels and Resorts, Toronto, ON
- LoyaltyOne Inc., Toronto, ON
- G&K Services Canada Inc., Mississauga, ON
- OMERS Administration Corporation, Toronto, ON
- Scotiabank Group, Toronto, ON
- AstraZeneca Canada Inc., Mississauga, ON
- TD Bank Financial Group, Toronto, ON
- Conexus, Regina, SK
- Earl's Restaurants Ltd., North Vancouver, BC
- Novartis Pharmaceuticals Canada Inc., Dorval, QC
- Starwood Hotels & Resorts Worldwide Inc. (Canada), Toronto, ON
- Ivanhoe Cambridge Inc., Montreal, QC
- Co-operators Life Insurance Company, Regina, SK
- Graham Group Ltd., Calgary, AB
- Bentall LP, Toronto, ON
- Canadian Western Bank, Edmonton, AB
- ATB Financial, Edmonton, AB
- Ericsson Canada Inc., Town of Mount Royal, QC
- Keg Restaurants Ltd., Toronto, ON
- Federal Express Canada Ltd., Mississauga, ON
- Coast Capital Savings Credit Union, Surrey, BC
- Nova Scotia Community College, Dartmouth, NS
- Envision Financial, Langley, BC
- Meyers Norris Penny, Calgary, AB
- Ceridian Canada Ltd., Markham, ON
- Cintas Canada Limited, Mississauga, ON
- British Columbia Automobile Association, Burnaby, BC
- Clark Builders, Edmonton, AB
- Procter & Gamble, Inc., Toronto, ON
- 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.htmlDisclaimer : This information is for knowledge puspose only. Specialist advise should be sought for your specific circumstances.
In a decision dated August 12, 2009, the Federal Court clarified the disclosure requirements in patent drafting. This case is important to patent owners as it makes clear that misinformation, lack of information or insufficient information to support the invention can be fatal to a patent's validity. In Ratiopharm Inc. v Pfizer Limited 2009 FC 711, the Federal Court found a patent that contained inaccurate information invalid on the basis of obviousness, lack of utility, insufficiency, invalid selection and Section 53(1) of the Patent Act (which provides that a patent is void when there were material misstatements willfully made in the patent for the purpose of misleading).
The case in question involved a claim to the besylate salt of the pharmaceutical ingredient amlodipine. The patent promised that the besylate salt had certain advantages over other salts that were "unexpected" and that it had a "unique" combination of properties that made it "outstandingly" suitable for pharmaceutical preparation of amlodipine. (para. 108) Such superlatives can often be found in patents, particularly in improvement patents, however, those superlatives are often accepted at face value or side-stepped as, in effect, puffery.
In the present case, the court looked closely at the disclosure and data in the patent in light of evidence presented at the trial. The Court considered whether the superlatives were justified and found that, contrary to the representations in the patent, the unique or outstanding properties of the besylate salt were shared with other salts as well. The patent omitted data that would have shown similar properties in other salts. The court noted that the superlative words such as "unique and outstanding" were not words used by the inventors respecting the besylate salt but were words that had been selected by the patent department who had drafted the patent.
As amlodipine and its pharmaceutically acceptable salts had been claimed previously, the Court considered whether the claim to amlodipine besylate qualified as a selection patent. The Court concluded it did not merit such status as "adjectives and adverbs without solid foundation cannot create a 'selection patent' where none in fact exists". (para.179) Neither the patent itself, nor the evidence demonstrated the besylate salt to be sufficiently superior to the other salts to qualify.
The Court also conducted a utility analysis based on the promise that amlodipine besylate was superior to other salts. It accepted the evidence at trial that the besylate salt did not deliver the superior performance promised by the patent. The court went on to say that an inventor has a duty to act uberrima fides, to give all information known to him that will enable the invention to be carried out to its best effect as contemplated by him. On the evidence at trial, the promised utility of the invention was not fulfilled.
The court further analyzed the patent under sufficiency, in accordance with Patent Act requirements to correctly and fully describe the invention and its operation or use as contemplated by the inventor. It noted that courts in the past had focused on whether the patent itself provided sufficient information to enable a person skilled in the art to make use of the invention as contemplated by the inventor. On the evidence, the court accepted that what the inventor contemplated, and what the patent disclosed, were not one and the same. It noted that other courts, when assessing the sufficiency of the disclosure in the absence of other evidence, had to assume that the words of a specification coincided with what the inventor contemplated. In this case, the evidence showed that the specification of the patent did not disclose the invention, as contemplated by the inventors. The patent was found invalid as failing to correctly and fully describe the invention as required by the Patent Act.
The court also analyzed the patent under Section 53.1 of the Patent Act, which indicates that a patent will be void if the patentee willfully provides in the specification more or less than is necessary, so as to mislead a person skilled in the art. The court found a breach of Section 53 in that the patentee, Pfizer, (i) omitted to mention the stability of another salt and stated that the salt was unsuitable for tablet formulation, when it was in fact suitable, (ii) omitted test data demonstrating the suitability of other salts and (iii) added a statement that none of the salts had been found to be satisfactory, when in fact that was not the case. The court concluded there were misstatements that served to enhance the alleged uniqueness and outstanding characteristics of the besylate salt and that these misstatements and the selection of superlative descriptive words were the work of patent draftsmanship and not of the inventors. The court also concluded that proper disclosure was essential in a patent and that intent to mislead could be inferred. The court found sufficient intent to make such misleading statements based on the evidence.
Counsel who are drafting or supervising the drafting of patent applications are well advised to carefully consider the disclosure requirements set out in this case. The Court quoted the inventor who stated that "a patent has to be clear, honest and right" with approval. (para. 55) The patent specification must describe the invention made by the inventor, not a super version of that invention. The patent drafter cannot choose patent data in support of the invention that omits relative data that might detract from a promise of uniqueness or special attributes. Careless patent drafting or inflating an invention so as to increase its patentability, risks not only a finding of invalidity for insufficient or inadequate disclosure but also a finding of fraud by the patentee itself. The conclusion to be drawn from this case is that care must be taken by those drafting a patent. The patent specification and claims must correctly and fully describe the invention rather than a wished-for invention. Disclosure in support of the invention should be full and frank and not selective and incomplete.
Also at http://pharmaceutical-patents.blogspot.com/2010/01/canadian-patent-disclosure-requirements.html
Disclaimer : This information is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.