Pharmacapsules @ Gowlings - May 29, 2008.Edited by Jennifer Wilkie & Chantal Saunders Contents MPs Support Orphan Drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the Proposal Annual Drug Spending In Canada FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Clinical Trial Regulations FDA To Keep Closer Eye On Drug, Device Safety New Computer Tracking System Designed To Identify Dangerous Side Effects Side effects Effects of a proposed project on other parts of the firm. Emerging Nanotechnologies Raises Concerns EU Expands Antitrust Inquiry Of Drug Companies Proposed Amended Drug Regulations Not Popular With Provinces Some Canadian Biotech Companies Unhappy With Length Of FDA Approval Process New Global Initiative Of The World Heath Organization (WHO) Bisphenol A Bisphenol A is a chemical compound containing two phenol functional groups. It belongs to the phenol class of aromatic organic compounds. It is widely prepared and sold and various important polymers/plastics are made from it. Concerns Continue Recent Cases MPs Support Orphan Drug Proposal By: Andrea Flewelling Canada is now one step closer to a national orphan drug plan after the House of Commons House of Commons: see Parliament. recently voted in favour of a motion compelling the government to consider a policy to help those suffering from orphan diseases or·phan disease n. A disease that is so rare that it is not considered commercially viable to develop drugs to treat it. orphan disease and facing unequal access to medicines. Orphan diseases are commonly defined as those affecting only one in 2,000 Canadians. Orphan drugs are generally very expensive, at times costing up to $400,000 a year. The private member's motion, M-426, was passed on Wednesday May 7, 2008. This motion will require the government to: (1) examine options for defining rare medical conditions See carpal tunnel syndrome, computer vision syndrome, dry eyes and deep vein thrombosis. ; (2) consider creating a fund to improve access to treatments and (3) explore methods to encourage drug research. The motion was brought forward by Liberal MP Don Bell. This is a cause close to Mr. Bell's heart as his grandson, Dylan Hunter Dylan Hunter (born May 21, 1985 in Quebec City, Quebec) is an ice hockey player, who is a former captain of the London Knights of the OHL and currently plays for the Rochester Americans. Bell, died on July 14, 2007 at the age of 12 after suffering from pulmonary hypertension Pulmonary Hypertension Definition Pulmonary hypertension is a rare lung disorder characterized by increased pressure in the pulmonary artery. The pulmonary artery carries oxygen-poor blood from the lower chamber on the right side of the heart (right , an orphan disease, having required continual drug treatment. For more information, please see: http://www.checkbiotech.org/orphan_News_treatmentandhealth.aspx?infoId=3305 Annual Drug Spending In Canada By: Natalie Rizkalla-Kamel The Canadian Institute for Health Information The Canadian Institute for Health Information (CIHI) is an independent, not-for-profit organization in Canada, primarily funded by the provincial and federal governments of Canada. recently released its annual report entitled Drug Expenditure in Canada, 1985 to 2007. It reveals that spending on prescription and non-prescription drugs totalled $27 billion last year, compared to $25 billion in 2006. It is estimated that 84% of the total spending on drugs in 2007 was for prescription drugs prescription drug Prescription medication Pharmacology An FDA-approved drug which must, by federal law or regulation, be dispensed only pursuant to a prescription–eg, finished dose form and active ingredients subject to the provisos of the Federal Food, Drug, . It is said that the reason for this increase is due to the aging population, increased use of drug therapies and new drugs entering the market. The report also shows that drug spending varies widely from province to province due to varying provincial drug programs, disease patterns and demographics. For more information, please see: http://www.ctv.ca/servlet/ArticleNews/story/CTVNews/20080515/ drug_spending_080515/20080515?hub=Health FDA Clinical Trial Regulations By: Natalie Rizkalla-Kamel As part of the FDA's and the HHS HHS Department of Health and Human Services. Office for Human Research Protections' initiative of issuing regulations instead of guidances for clinical trials, they are working on a final rule for registering institutional review boards (IRBs). Existing FDA regulations do not take into account all the different types of organizations involved in conducting clinical trials and also fail to take account for electronic data issues, data standardization, electronic health records, electronic patient-reported outcomes and electronic case report forms. For more information, please see: http://www.fdanews.com/newsletter/article?issueId=11571&articleId=106581 FDA Clinical Trial Regulations By: Michael Walsh On Thursday May 22, 2008, U.S. health officials announced that the FDA will implement a proactive system designed to help identify dangers associated with prescription drugs and medical devices that are currently on the market. The new computerized "Sentinel System" will assist the FDA in monitoring existing data sources such as the U.S. government's Medicare health insurance plan. Health and Human Services Noun 1. Health and Human Services - the United States federal department that administers all federal programs dealing with health and welfare; created in 1979 Department of Health and Human Services, HHS Secretary Mike Leavitt told reporters that, "We're moving from a reactive dependence on voluntary reporting of product safety concerns to a proactive surveillance of medical products that are currently on the market." In the past, the FDA relied on mandatory reports of side effects by manufacturers and voluntary reports by physicians and patients. Under the new proposal, data will be gathered from private insurer claims, hospital records, and Medicare. The FDA expects that the large sample populations involved will allow it to rapidly identify risks that appear when products move from small clinical trials to wider use in the marketplace. More than 25 million patients receive prescription drug care under Medicare alone. It is not clear how soon the Sentinel System will be implemented. For more information, please see: http://www.msnbc.msn.com/id/24782042/ Emerging Nanotechnologies Raises Concerns By: Scott Robertson Scott Robertson may be:
A recent study reported in the scientific journal, Nature Technology, has revealed concerns over the use of nanotubes because their qualities mimic the toxic qualities of asbestos. The structure of nanotubes, which are currently available for sale, endows them with powerful physical properties, such as strength greater than that of steel, and as such, carbon nanotubes are being explored for a wide range of uses in electronics and medicine. Some potential applications involve coating the nanotubes in other substances, which could blunt any toxic effects. However, British and U.S. based scientists have reported experiments, which find that longer threads of nanotubes injected into the lining of mice stomachs provoke inflammation and lesions. Researchers have acknowledge that their findings have limitations and have called for more study into the efficacy of nanotechnology. These findings support earlier research from Japan which showed that mice injected with carbon nanotubes developed mesothelioma Mesothelioma Definition Mesothelioma is an uncommon disease that causes malignant cancer cells to form within the lining of the chest, abdomen, or around the heart. Its primary cause is believed to be exposure to asbestos. . It is unclear what causes these effects. For more information, please see: http://www.cbc.ca/technology/story/2008/05/21/tech-nanotubes-asbestos.html EU Expands Antitrust Inquiry Of Drug Companies By: Roger Tam European antitrust regulators are continuing their inquiry into industry and corporate practices in the European pharmaceutical market. The inquiry was initiated as a result of the declining number of new drugs reaching the market, as well as perceived delays in entry of generic drugs generic drug, a drug sold or prescribed under the nonproprietary name of its active ingredients or under a generally descriptive name rather than under a brand or trade name. as compared to other jurisdictions such as the U.S. The inquiry has included questioning or raiding approximately 100 companies, including some of Europe's largest pharmaceutical manufacturers, as well as various medical organizations. Investigators are also investigating whether generic companies have accepted payments from brand-name manufacturers during the course of patent litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , mirroring earlier antitrust decisions in the U.S. The competition commissioner has indicated that it is still far too early to draw preliminary conclusions from the sector query. For more information, please see: http://www.lawday.ca/newsletter.asp?ID=890&ArticleID=2 Proposed Amended Drug Regulations Not Popular With Provinces By: Jennifer Wilkie The provincial health ministries are unhappy with proposed federal regulations which reaffirm re·af·firm tr.v. re·af·firmed, re·af·firm·ing, re·af·firms To affirm or assert again. re transitional provisions enacted in 2006. A decision last year however had the effect of reading down this legislation thus generic manufacturers were effectively able to argue that they can ignore certain patents on the patent register. The legislation introduced at the end of April, was for the stated intention of restoring the certainty and the intention of Parliament in requiring these patents to be addressed. Provinces complain that this may mean that certain products will not become genericized as quickly as it would if the Court's decision continued to apply with consequentially higher prices for drugs to be paid for by the provinces. While the B.C. Health Minister had written to Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. requesting additional time to make submissions and complaining about the abbreviated time that had been provided, a communications officer at Industry Canada Industry Canada is the department of the Government of Canada with responsibility for regional economic development, investment, and innovation/research and development. The department employs 6104 FTEs across Canada. indicated that "a longer consultation period was not warranted since the regulatory proposal merely reaffirms a policy measure dating from 2006 that was the subject of extensive consultations at the time.". For more information, please see: http://www.reportonbusiness.com/servlet/story/LAC.20080527.GENERICS27/TPStory/?query Some Canadian Biotech Companies Unhappy With Length Of FDA Approval Process By: Jennifer Wilkie Canadian biotech companies amongst other countries' companies are reported recently to have been indicating their unhappiness with the speed with which the FDA is approving new drugs. In particular, certain Canadian companies This is a list of companies from Canada.
Directory: A B C D E F G H I J K L M N O P Q R S T U V W X Y Z Current Companies have been delayed an entry to U.S. markets for months due to delays in obtaining approvals. Such delays effect stock prices and business dealings relating to relating to relate prep → concernant relating to relate prep → bezüglich +gen, mit Bezug auf +acc anticipated approval time frames. The FDA has indicated that a shrinking staff and dwindling dwin·dle v. dwin·dled, dwin·dling, dwin·dles v.intr. To become gradually less until little remains. v.tr. To cause to dwindle. See Synonyms at decrease. funds have resulted in hold-ups in approving new products. For more information, please see: http://www.reuters.com/article/rbssHealthcareNews/idUSN2250269220080526 New Global Initiative Of The World Health Organization (WHO) By: Jennifer Wilkie Recently, delegates at the annual Assembly of the WHO have backed a new initiative which aims to promote new approaches to pharmaceutical R&D and enhance access to medicines around the world. The 61st Assembly, which reportedly had a record 2,704 delegates from 190 nations attending have approved a global strategy aimed to provide a framework for enhancing essential R&D especially with relevance to diseases impacting on developing countries, also focussing on the major current threats to health such as cancer and heart disease and making R&D finances in developing countries sustainable. The strategy also calls for a finalization of a plan to provide drug makers with greater incentives in such areas of research and making advances affordable and accessible in developing countries. For more information, please see: http://www.who.int/mediacentre/events/2008/wha61/issues_paper1/en/index.html http://www.pharmatimes.com/WorldNews/article.aspx?id=13565&src=EWorldNews Bisphenol A Concerns Continue By: Jennifer Wilkie In a recent article it is reported that not only baby bottles and water bottles are cause for concern with bisphenol A but also canned foods canned food food sterilized by heat in a closed, durable container such as tin and aluminum cans, flexible aluminum foil and thermoplastic containers including squeeze tubes. Technically, the processes used are highly efficient and used universally. . According to according to prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. recent testing conducted for various news agencies, the amounts of bisphenol A have been found in higher amounts than even those amounts for the bottles previously looked at. Health Canada has indicated that none of the amounts tested exceed the regulatory limits and that Health Canada is not concerned about these levels for older children and adults saying that the risk is negligible. However, the fact that food makers may start reformulating cans without this chemical, they have indicated they are committed to working with the industry to investigate possible safe replacements for these cans containing epoxy epoxy Any of a class of thermosetting polymers, polyethers built up from monomers with an ether group that takes the form of a three-membered epoxide ring. The familiar two-part epoxy adhesives consist of a resin with epoxide rings at the ends of its molecules and a curing based linings. For more information, please see: http://www.theglobeandmail.com/servlet/story/RTGAM.20080528.wcans29/BNStory/ Front/home Recent Cases By: Beverley Moore Apotex v. Sanofi-Aventis; Appeal of Motion of to Strike; Infringement Proceeding; May 13, 2008; ramipril The Court of Appeal upheld the order of trial judge striking portions of the counterclaim A claim by a defendant opposing the claim of the plaintiff and seeking some relief from the plaintiff for the defendant. A counterclaim contains assertions that the defendant could have made by starting a lawsuit if the plaintiff had not already begun the action. relating to improper conduct. However, the Court of Appeal found that the reasons of the trial judge were unsupportable. The Court of Appeal struck the improper conduct pleading as there was no relationship between the alleged improper conduct and the equitable relief sought by the parties. The Court also considered and approved of the Trial Division's reasoning in staying part of the counterclaim that was duplicative. The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2008/2008fca175/2008fca175.html Abbott Laboratories Abbott Laboratories (NYSE: ABT) is a diversified pharmaceuticals and health care company. It has over 65,000 employees and operates in 130 countries. The corporate headquarters are in Abbott Park, Illinois, a neighborhood of North Chicago, Illinois. v. Canada (Minister of Health); Mandamus mandamus (măndā`məs) [Lat.,=we order], in law, writ directing the performance of ministerial acts. A ministerial act is one that a person or body is obliged by law to perform under given circumstances; e.g. Proceeding; May 20, 2008; lansoprazole The Court of Appeal upheld the decision of the trial judge refusing to grant an order prohibiting the Minister from issuing a NOC (Network Operations Center) A central or regional location for monitoring a large network. Also called a "network management center" (NMC), "service management center" (SMC) or "network control center" (NCC), a NOC may be used to manage a large enterprise network, to a generic company without requiring them to address two patents on the Patent Register. The Court held that this decision would not preclude Abbott from challenging such a decision in the future should the Minister issue the NOC. However, the Federal Court will not grant an order that simply requires the Minister to do what the NOC Regulations require. Furthermore, granting the order requested by Abbott would not be fair to any other generic manufacturers who filed an ANDS prior to the listing of the two patents at issue on Patent Register, as they would not have an opportunity to be heard. The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2008/2008fca186/2008fca186.html Nycomed v. Sandoz; motion under s. 6(5)(b) of the NOC Regulations; April 28, 2008; pantoprazole The Court dismissed a motion by the generic manufacturer to dismiss the proceeding on the basis of abuse of process. The Court found that there had been no final determination as to the eligibility of listing of one of the patents at issue. Furthermore, the Court held that there had been no previous decisions on the issue of whether there were any claims to the medicine itself or the use of the medicine in the patent. The Court also refused to grant the motion to dismiss the non-infringement allegations on the basis of abuse of process. The Court found that Sandoz had failed to meet its burden of establishing by evidence or cogent COGENT - COmpiler and GENeralized Translator argument that there could be no evidence whatsoever on the merits on the merits adj. referring to a judgment, decision or ruling of a court based upon the facts presented in evidence and the law applied to that evidence. A judge decides a case "on the merits" when he/she bases the decision on the fundamental issues and considers from which infringement could be found. The Court awarded costs to Nycomed at the high end of Column V of the Tariff forthwith Immediately; promptly; without delay; directly; within a reasonable time under the circumstances of the case. forthwith adv. a term found in contracts, court orders, and statutes, meaning as soon as it can be reasonably done. and in any event of the cause as it was successful in opposing the motion and at least two of the grounds raised were ill-considered, ill-founded and should not have been raised. These grounds unnecessarily wasted the Court's time and the efforts of Nycomed to proceed with the merits of the case. The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2008/2008fc541/2008fc541.html Ranbaxy Laboratories Ranbaxy Laboratories Limited is an Indian company incorporated in 1961. It is India's largest pharmaceutical company. It exports its products to 125 countries with ground operations in 46 and manufacturing facilities in seven countries. Limited v. Pfizer Canada; Motion to Intervene; April 15, 2008; atorvastatin atorvastatin /ator·va·stat·in/ (ah-tor?vah-stat´in) an antihyperlipidemic agent that acts by inhibiting cholesterol synthesis, used as the calcium salt in the treatment of hypercholesterolemia and other forms of dyslipidemia. The Trial Division had issued an order of prohibition on one patent and denied prohibition on another patent. Both parties appealed. Apotex then brought the within motion for leave to intervene in that appeal. The Court of Appeal dismissed Apotex' motion. Apotex wanted to intervene on the basis that it disagreed with the Trial Judge's application of the Saccharin saccharin (săk`ərĭn), C7H5NSO3, white, crystalline, aromatic compound. It was discovered accidentally by I. Remsen and C. Fahlberg in 1879. Pure saccharin tastes several hundred times as sweet as sugar. doctrine in Canada. Apotex' argument was that Ranbaxy's position on the appeal was extremely narrow and would not adequately represent its own position in another proceeding where the issue of the Saccharin doctrine was also an issue. The Court held that it was far from clear that a decision in this case between two parties unrelated to Apotex would finally resolve the issue in an infringement action between Apotex and another party. The Court of Appeal upheld its previous decision that it is inappropriate to rely on NOC proceedings as setting binding precedent In law, a binding precedent (also mandatory precedent or binding authority) is a precedent which must be followed by all lower courts under common law legal systems. in controversial or uncertain questions in patent law. Furthermore, by allowing Apotex to intervene, the Court would need to allow the other party to the infringement proceeding to intervene as well. This would undoubtedly complicate and delay the appeal. Furthermore, Apotex had known about the decision under appeal for several months yet waited until the eve of its trial to bring the motion to intervene. The full text of the decision can be found at: http://decisions.fca-caf.gc.ca/en/2008/2008fca138/2008fca138.html GlaxoSmithKline v. Pharmascience; 55.2 Proceeding on Merits; May 9, 2008; valacyclovir The Federal Court refused the prohibit application at issue in this case. The Court upheld the validity of the patent on the basis of obviousness and anticipation. However, the Court held that GSK GSK GlaxoSmithKline plc (pharmaceutical company) GSK Glycogen Synthase Kinase GSK Gruppentraining Sozialer Kompetenzen (Germany) GSK Greenland Shark (FAO fish species code) had not met the burden of establishing that its patent was a valid selection in terms of utility as neither the patent nor the evidence of the expert witnesses was sufficient to establish an advantage of the selected compound over the genus from which it was chosen. Specifically, the Court found that the fact that patent showed testing of the selected compound against the three compounds from the genus of millions was not enough to show whether that "same advantage would exist vis---vis a few, some, many, most or all of the other compounds claimed" by the previous patent. It was necessary to have a sound prediction establishing the special advantage. The full text of the decision can be found at: http://decisions.fct-cf.gc.ca/en/2008/2008fc593/2008fc593.html 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. Gowling Lafleur Henderson LLP LLP - Lower Layer Protocol Suite 1600, 1 First Canadian Place First Canadian Place is a skyscraper in Toronto, Ontario, Canada. At 298 metres, or 978 feet (355 metres with antenna included), it is Canada's tallest skyscraper and the eleventh tallest building in North America. 100 King Street West Toronto Ontario M5X 1G5 CANADA E-mail: info@gowlings.com Click Here for related articles (c) Mondaq Ltd, 2008 - Tel. +44 (0)20 8544 8300 - http://www.mondaq.com |
|
||||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion