 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current pharmaceutical and clinical research updates, patent news, views and data. Lilly sued Novopharm for infringement under Canadian Patent No. 2,041,113, a selection patent for the compound olanzapine (sold under the brand name Zyprexa), owned by Lilly. Olanzapine is used to treat schizophrenia. Novopharm argued that the ’113 Patent is invalid. A Federal Court judge (the trial judge) agreed with Novopharm and dismissed Lilly’s action. The Federal Court of Appeal reversed. On appeal, the question raised by the parties was: Do the conditions for a valid selection patent constitute an independent basis upon which to attack the validity of a patent? Lilly already obtained Canadian Patent No. 1,075,687, a genus patent described by the court as covering “approximately 15 trillion compounds predicted to be useful in the treatment of mild anxiety and certain kinds of psychotic conditions, such as schizophrenia and acute mania. The ’687 Patent expired 15 years ago. The ’687 Patent encompassed, but did not disclose, olanzapine. The trial judge concluded that olanzapine fell within the “most preferred” compounds. The ’687 Patent specifically disclosed flumezapine, ethyl flumezapine and ethyl olanzapine.Further research was conducted on some of the ’687 Patent’s compounds, one of which was olanzapine. In 1989, clinical trials began with patients. Lilly decided to file the ’113 Patent, which characterizes olanzapine as a selection from the class of the ’687 Patent. The patent for olanzapine was filed in Canada on April 24, 1991 and the ’113 Patent issued July 14, 1998. In the reasons for judgment, the trial judge identified the ’113 Patent’s stated advantages over both the ’687 Patent and other antipsychotic drugs, including lower incidence of liver enzyme elevations compared to flumezapine; lower CPK levels than flumezapine; lower ESP liability than flumezapine; and no increase in cholesterol compared to ethyl olanzapine. The trial judge reasoned that if these advantages amounted to a substantial advantage secured by the drug (or a substantial disadvantage avoided in comparison with the genus patent), if they were known or predicted at the time of filing, and if they were adequately disclosed, the ’113 Patent would be a valid selection patent. The trial judge concluded that there was insufficient evidence of the advantages identified by the ’113 Patent. Specifically, the trial judge determined: the stated advantages were not substantial and peculiar; a person skilled in the art (POSITA) would not be able to appreciate any inventive difference between the ’687 Patent and the ’113 Patent; the test for sound prediction was not met; Lilly had very little idea about what olanzapine’s effect was likely to be; and the ’113 Patent did not meet the requirements for adequate disclosure. Although not restricted to chemical patents, selection patents more commonly arise in that context. Simply stated, the originating (or genus) patent typically refers, in general terms, to a group of products or processes from all of which a particular result (or results) may be obtained or predicted. If a property, quality or use in relation to one or more members of the genus is subsequently discovered, that discovery may be an invention giving rise to a valid selection patent. As explained in Pfizer and Sanofi, selection patents exist to encourage researchers to further use their inventive skills so as to discover new advantages for compounds within the known class. A selection patent can be claimed for a selection from a class of thousands or for a selection of one out of two. In Sanofi, the characteristics of a valid selection patent are described as follows:
- There must be a substantial advantage to be secured or disadvantage to be avoided by the use of the selected members;
- The whole of the selected members (subject to “a few exceptions here and there”) possess the advantage in question;
- The selection must be in respect of a quality of a special character peculiar to the selected group. If further research revealed a small number of unselected compounds possessing the same advantage, that would not invalidate the selection patent. However, if research showed that a larger number of unselected compounds possessed the same advantage, the quality of the compound claimed in the selection patent would not be of a special character.
Lilly argued that the trial judge erred by creating an “illegitimate amalgam by merging the doctrine of sound prediction of utility with obviousness and sufficiency and in the process required Lilly to provide proof of the inventive step (i.e. the advantages) in the disclosure.” In Lilly’s view, the “selection” issue goes to the question of obviousness and is properly addressed as part of that inquiry. The Federal Court of Appeal felt likewise: In my view, a challenge directed to a determination that the conditions for a selection patent have not been met does not constitute an independent basis upon which to attack the validity of a patent. Rather, the conditions for a valid selection patent serve to characterize the patent and accordingly inform the analysis for the grounds of validity set out in the Act – novelty, obviousness, sufficiency and utility. In short, a selection patent is vulnerable to attack on any of the grounds set out in the Act. Notably, the Act contains no reference to invalid selection. On consideration, I think it would be unwise to endeavour to state in definite language all the conditions on which a selection patent must depend; for after all a selection patent does not in its nature differ from any other patent and is open to attack on the usual grounds of want of subject-matter, want of utility, want of novelty and so forth. Application to this Case:I have concluded earlier that a determination that the conditions for a selection patent have not been met does not constitute an independent basis upon which to attack a patent’s validity. A selection patent is the same as any other patent. Its validity is vulnerable to attack on any of the grounds set out in the Act. It necessarily follows that the trial judge erred in determining the validity of the ’113 Patent on the basis that he did. That is not to say, however, that his analysis is not relevant to the issue of utility, or other grounds of validity. Related posts:
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- http://decisions.fct-cf.gc.ca/en/2009/2009fc1018/2009fc1018.html
- http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/07/eli-lilly-canada-v-novopharm-ltd.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.Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 The litigation between Pfizer and Apotex over Apotex's ANDA for a generic version of Lipitor (atorvastatin calcium) presents the fairly typical scenario of a later ANDA filer (Apotex) trying to trigger the 180-day exclusivity of the first filer (in this case, Ranbaxy).
Pfizer and Ranbaxy settled their Lipitor ANDA litigation in 2008, agreeing that Ranbaxy would not market its generic version of Lipitor until November 30, 2011. Later ANDA filers like Apotex, therefore, must wait until at least mid-2012 to launch their own generic Lipitor--unless one of them triggers Ranbaxy's exclusivity earlier. In order to do so, the later filer must obtain a final decision of non-infringement or invalidity of the Lipitor patents. But this isn't easy to do if the patent owner doesn't sue the later filer: the later filer must obtain a declaratory judgment, which requires establishing declaratory judgment jurisdiction. In this case, Pfizer listed six patents in the Orange Book for Lipitor. Apotex filed a Paragraph III certification on U.S. Patent No.4,681,893 (expiring March 2010) and Paragraph IV certifications on the other five. Pfizer sued Apotex on only two of the five challenged patents. In its Answer, Apotex filed declaratory judgment counterclaims of non-infringement and invalidity of all five challenged patents, as it must have in order to trigger Ranbaxy's exclusivity. Pfizer then filed a motion to dismiss Apotex's counterclaims with respect to the three patents that Pfizer did not assert against Apotex (the "Unasserted Patents"), on the grounds that they did not present a "case" or "controversy" as required by Article III of the Constitution. In an Opinion and Order filed June 30, the district court denied Pfizer's motion, allowing Apotex's declaratory judgment counterclaims--and its attempt to trigger Ranbaxy's exclusivity--to proceed. In its motion to dismiss, Pfizer argued that Apotex lacked standing to assert its counterclaims. To establish standing, a plaintiff must demonstrate (1) an injury-in-fact, (2) that is fairly traceable to the defendant's conduct, and (3) that can be redressed by the court. Apotex alleged two injuries-in-fact: first, by not suing on the Unasserted Patents while reserving the right to do so in the future, Pfizer created uncertainty as to Apotex's legal rights under its ANDA; second, by refusing to litigate all of its patents and settling its litigation with Ranbaxy, Pfizer erected a barrier to FDA approval of Apotex's product, thereby barring Apotex from entering the market. Pfizer countered that Apotex's alleged injuries were "not sufficiently imminent in light of Apotex's Paragraph III certification to the '893 patent, which prevents the FDA from approving Apotex's ANDA until the '893 patent expires." Siding with Apotex, the court found that the facts of this case were more like those in Teva v. Novartis (where the Federal Circuit held that the "threat of litigation" on unasserted patents and the "legal undertainty" caused when a patent holder sues an ANDA filer on some but not all of Orange Book-listed patents create a justiciable controversy) and Caraco v. Forest (where the Federal Circuit held that blocking a generic drug company from selling a non-infringing product presents a justiciable controversy) than in Janssen v. Apotex (in which the Federal Circuit found no justiciable controversy because Apotex had stipulated to infringement and validity of one of the Orange Book-listed patents). On July 14, Pfizer filed a motion for reconsideration of the district court's June 30 decision. In addition, today Pfizer filed a second motion to dismiss, arguing that the circumstances have changed in two important ways since the court's June 30 decision: first, "in light of the Court's decision Pfizer has now given Apotex a covenant not to sue on the Formulation Patents (two of the three Unasserted Patents) and thus there is no possibility of a future lawsuit on these patents"; and second, "also in light of the Court's decision, Pfizer has brought a counter-counterclaim against Apotex on (the third Unasserted Patent, U.S. Patent No. 5,969,156), which expires, including pediatric exclusivity, in January 2017, after the expiration of the Formulation Patents and after the November 30, 2011 date that Ranbaxy may enter the market under its settlement with Pfizer." According to Pfizer, "the earlier-expiring Formulation Patents and the Ranbaxy settlement with its November 30, 2011 license date cannot prevent Apotex from overcoming Ranbaxy's 180-day exclusivity rights unless and until Apotex prevails on the '156 patent." Thus, Pfizer argues that any alleged injury to Apotex is "based solely on the possibility that the '156 patent is not infringed or is invalid" and "such a speculative injury is 'conjectural' and 'hypothetical', and does not rise the level of 'concrete and actual or imminent'," as required to be justiciable. Of course, the longer the case lasts, the less likely Apotex is to obtain the declaratory judgment that it seeks, get the judgment affirmed by the Federal Circuit, and trigger Ranbaxy's exclusivity. Pfizer might simply run out the clock. http://www.istockanalyst.com/article/viewarticle/articleid/4335245http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/07/apotex-vs-pfizer-in-lipitor-patent.htmlDisclaimer- 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. Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.
Canada Approves Seasonal Flu Nasal Vaccine. Health Canada for the first time "granted approval for a nasal vaccine FluMist, designed to protect against seasonal flu." The nasal vaccine which is marketed by AstraZeneca Canada, is attractive to many who have a fear of needles. Another benefit of the nasal vaccine is that research finds it is "more effective in children age 2 to 17 than the traditional injectable flu vaccine." Extended Stroke Treatment Window Appears To Be A Safe Option For Saving Lives. Extending the time window to treat stroke patients with the clot-dissolving drug tPA from three hours to up to 4.5 hours after the onset of stroke doesn't result in any significant delays in treatment and appears to be a safe option for saving lives," according to a new paper in The Lancet Neurology. The "three-hour post-stroke time limit was set because of fears that use of the clot-dissolving drug beyond that period might cause dangerous bleeding or other complications," but after the "publication of two landmark studies, the American Heart Association, the American Stroke Association and the European Stroke Association revised their guidelines in October 2008 to recommend that tPA be used up to 4.5 hours after the onset of an ischemic stroke." Still, "experts have been worried." So, researchers at the Karolinska Institute "analyzed data from 23,942 patients with ischemic stroke who were included in SITS-ISTR [the Safe Implementation of Treatment in Stroke-International Stroke Thrombolysis Registry] between December 2002 and February 2010," and reported that "although the rate of symptomatic hemorrhage and death was higher among those treated beyond three hours -- and the rate of functional independence was lower -- the benefits of treatment in that window outweighed the risks," the researchers explained. In fact, "safety and functional outcomes are less favorable after three hours, but the wider time window now offers an opportunity for treatment of those patients who cannot be treated earlier." FDA Adds Boxed Warning To Plavix.
FDA "is adding its strongest warning to the label for Plavix [clopidogrel bisulfate], cautioning that some patients do not respond to the blockbuster blood thinner." The "warning indicates that the drug is dangerous only in the sense that it doesn't work in" certain "patients and thus may leave them unprotected against heart attacks and strokes." Specifically, some patients have a difference in a liver enzyme known as CYP2C19, which helps to convert Plavix to a form that the body can use, Notably, FDA officials said CYP2C19 tests typically cost less than $500. Robert Temple, deputy director for clinical science at the FDA's Center for Drug Evaluation and Research, said, "What there hasn't been is a clear test of whether you can take people who are poor metabolizers, double their dose and do just as well. Reovirus May Hold Promise As Nontoxic Prostate Cancer Treatment. The respiratory, enteric, orphan virus, or 'reovirus' is widespread," but those who are exposed to it tend to "suffer, at most, mild flu-like respiratory symptoms or diarrhea." More interestingly, the "reovirus has 'oncolytic' potential," as there "is already some evidence of its effect against lymphoid, ovarian, breast, pancreatic, and high grade glioma brain cancers." With that in mind, researchers in Canada "recruited six men with early-stage prostate cancer that had not yet started to spread. Each was given a single injection of the virus into their tumor, guided by ultrasound." After three weeks, "patients had their prostate glands removed as part of their normal treatment." Investigators were then able to see that the virus "triggered the cancer cells' self-destruct program. All around the injection site, the reovirus -- a product from Oncolytics Biotech Inc. called Reolysin -- made cancer cells go away" without harming normal cells. The only flaw was that "the virus did not spread throughout the prostate," meaning "cancer cells not in the immediate area of the injection were spared.Research Team Finds Q Fever Demands 18 Months Or More Of Treatment.
Researchers based in France have outlined treatment for Q fever, and "the findings have relevance because of the current -- and unusual -- outbreak of Q fever in the Netherlands, where 3,483 cases have been diagnosed since 2007 and six people have died." Dr. Didier Raoult, of the University of the Mediterranean and colleagues, published results of their study of 104 patients in the journal Lancet Infectious Diseases. The team said that "at least" 18 months of treatment are necessary to "cure an infection of the heart lining or valves resulting from Q fever, and an additional six months will most likely be required if the patient has a prosthetic valve." Read more at-http://www.latimes.com/news/health/la-heb-q-fever-20100714,0,2951263.story http://www.theglobeandmail.com/life/health/nasal-vaccine-against-flu-gets-green-light-in-canada/article1640399/ http://consumer.healthday.com/Article.asp?AID=641489 http://www.medpagetoday.com/Cardiology/Strokes/21395 http://www.pharm-education.com/2010/07/extended-stroke-treatment-window.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.Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10 Do you have questions for the author?
 FDA Approves Three-In-One Blood Pressure Drug.
"Daiichi Sankyo Inc. stated that regulators have approved the sale of its three-in-one high blood pressure drug Tribenzor [hydrochlorothiazide, amlodipine, olmesartan medoxomil]." The drug product is intended "to treat patients whose blood pressure is not controlled on angiotensin receptor blockers, calcium channel blockers, or diuretics." The FDA issued several warnings regarding the use of the drug, including that "pregnant patients should not take the new combination drug," and "those who become pregnant while on the polypill should discontinue therapy immediately." The drug also "may increase the risk of angina and myocardial infarction once calcium channel blocker therapy has started or after a dose increase, particularly in patients with severe obstructive coronary artery disease." The most common adverse reactions seen in clinical trials of the combo drug were dizziness, peripheral edema, headache, fatigue, nasopharyngitis, muscle spasms, nausea, upper-respiratory-tract infection, diarrhea, urinary-tract infection, and joint swelling."
New "Smart Bomb" invented to target cancer cells.A team of researchers from Australia and India are hard at work developing a new "smart bomb" to target tumors. The investigators are developing an antibody that binds to cancer stem cells, delivering a lipid particle containing an anti-cancer therapy coupled with RNAi gene silencing tech. "While current treatments kill the bulk of the cancer cell, the cancer root escapes the therapy and can regenerate into a new cancer mass," says Wei Duan, an associate professor at Deakin University, who is collaborating with colleagues in India on the project. "The aim of our research is to develop a smart bomb that can penetrate the cell and release the drugs within the cells, rather than from the outside, and kills the whole tumor, root and all."Indian Institute of Science in Bangalore, Barwon Health's Andrew Love Cancer Centre and ChemGenex Pharmaceuticals are all collaborating on the program, which has been funded in part by the Indian and Australian governments. And the scientists say the delivery technology isn't restricted to the cancer field. The same approach could also work for Alzheimer's, heart disease and diabetes."This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects," says Duan. The molecular drug delivery system would use a technique known as RNA interference, or gene silencing, which enables control over the genes inside cells.First, the scientists are developing a chemical antibody that will bind specifically to cancer cells. This "guided missile" will have a purpose-built lipid particle - carrying an anti-cancer drug as well as anti-cancer genes - as its payload. Combined, they create a treatment that will actively seek and penetrate the cells in a tumour, killing those vital for a cancer to spread. The working of the ‘smart bomb’: According to the scientists, the mechanism is aimed at killing the root of the cells that play a vital role in generating the lethal cells in body. The process involves a molecular drug delivery system which will pick out the active cells of the cancer before they can develop into a full blown lethal disease. Researchers are designing a chemical antibody that will bind the cancer cells, which together with the technique known as 'RNA interference', or gene silencing, will penetrate and destroys mutated cells that cause the occurrence and reoccurrence of cancer. Dr Duan stated, "Our precision-guided cancer therapy will afford reduced side-effects, decreased toxicity to normal cells. We will probably still be using existing drugs but the way we use them will be much more specific."We're not saying we will have a cure cancer in 10 years but at least these people will live longer and importantly enjoy a higher quality of life."The researchers are optimistic that the clinical trials of the treatment will soon be on the way.Dr Duan said there was also potential to use the same technique to tackle neurodegenerative diseases such as Alzheimer's disease, heart disease and diabetes.The project is a collaboration with the Indian Institute of Science in Bangalore, Barwon Health's Andrew Love Cancer Centre and ChemGenex Pharmaceuticals.It has received $400,000 funding over three years from the federal government's Australia-India Strategic Research Fund, with reciprocal support from the Indian government. "This system would also be very human compatible and human degradable meaning it would not be toxic to other cells in the body and would cause very limited side-effects, that professes to slash the grim but inevitable effects of conventional treatment such as hair loss, vomiting, and irritated mucous membrane."The success of this project will bring us a step forward in significantly improving the survival rate and quality of life of cancer patients."AIDS Vaginal Gel Considered Promising, But More Work Remains.
"The best AIDS-prevention news in years was released...last week at a world conference on the disease: a vaginal gel, called a microbicide, that can be used without a man knowing it, gave women a 39 percent chance of avoiding infection with the deadly virus." The Times adds, "After more than a dozen microbicide failures," these findings were "a huge relief." Dr. Anthony S. Fauci, director of the NIH's NIAID, said, "There's a certain feeling of ease and pleasure for me as a scientist that any way you slice the data, it's statistically significant." Still, researchers must address many questions before the treatment can be submitted for regulatory approval. http://www.pharm-education.com/2010/07/new-smart-bomb-tech-used-to-target.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. Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D, a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data.
Large Drugmakers Placing New Emphasis On Targeted Cancer Treatments.
Increasingly, large pharmaceutical companies are restructuring their business models so that they can collaborate with small biotech firms to develop medications which target small groups, rather than large populations. This move is influenced in part by a new emphasis on personalized medicine and the need for targeted therapies. For instance, Pfizer has partnered with Abbott Molecular to develop a treatment called crizotinib, which would only benefit four percent of lung cancer patients. Meanwhile, AstraZeneca is seeking FDA approval so that its drug Iressa [gefitinib] can be used to treat EGFR-positive lung cancer patients.
http://www.ft.com/cms/s/2/72803d54-9046-11df-ad26-00144feab49a,dwp_uuid=e8477cc4-c820-11db-b0dc-000b5df10621.html Experts Warn Absence Of Clinical Trials For Biosimilar Drugs Could Hurt Safety, Effectiveness.
Medical experts warned that the absence of mandatory clinical trials for biosimilar drugs could compromise their safety and effectiveness." That provision was "designed to get biosimilars – and the cost savings that accompany them – to the marketplace more quickly" by allowing FDA to base its approval, "in part, on the safety and efficacy record of the original breakthrough drug." The provision, however, is "vague," according to critics, and "leaves FDA with a great deal of leeway to okay those drugs – including the flexibility to decide whether clinical trials are necessary at all." The "difference in manufacturing processes" between companies "can alter the drugs 'in ways that technology can't detect.'" http://thehill.com/blogs/healthwatch/health-reform-implementation/109647-experts-concerned-about-lack-of-clinical-trials-for-biosimilar-drugsNumber Of HIV-Positive Patients Receiving Antiretroviral Drugs Increased By More Than A Quarter In 2009.
The number of HIV-positive people receiving antiretroviral drugs for their infections jumped by more than a quarter in 2009, growing from four million to 5.2 million, the World Health Organization disclosed at the International AIDS Conference in Vienna." The organization's Dr. Hiroki Nakatani said, "This is the largest increase in people accessing treatment in a single year." But "unfortunately, that still leaves 10 million who need therapy." http://www.latimes.com/news/health/boostershots/la-heb-aids-treatment-20100719,0,3111390.story Bosentan May Not Improve Exercise Capacity In Patients With Systemic Sclerosis.
"Treatment with the endothelin receptor antagonist bosentan (Tracleer) failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found." James R. Seibold, MD, of the University of Connecticut in Farmington, and colleagues said that after one year of treatment, "there was a nonsignificant mean change in the six-minute walk test in the bosentan-treated patients (−12 meters) compared with the change in the placebo group (9 meters)." In addition, the study found bosentan "had no effect on time to death or worsening pulmonary function test scores."
http://www.medpagetoday.com/Rheumatology/GeneralRheumatology/21082Clinical Trials To Continue For Potential Hemophilia Drug.
"Biogen Idec Inc. and Swedish Orphan Biovitrum stated they will continue clinical testing of a potential hemophilia drug based on promising results from an early trial." The companies "are testing a form of a protein called factor VIII," which "is involved in the formation of blood clots, and people with hemophilia A have little or none of it." Biogen and Biovitrum also "said that in an early study on 16 patients, their drug was safe and had 'a prolonged half-life' compared an older drug, Advate."
http://www.businessweek.com/ap/financialnews/D9GRJQP00.htm Vaccine May Help Shrink The Most Deadly Cancers.
"An injection to help kill off the most deadly cancers...has been created by scientists" in the UK. The "Middlesex University vaccine capitalizes on the finding that some of the most vicious tumors produce a hormone normally only found in pregnancy," that is, human chorionic gonadotropin. In fact, "a form of hCG is...made by around half of bladder and pancreatic cancers," and "some breast, bowel, ovarian, and cervical tumors also pump it out." The vaccine, however, "which is being developed in conjunction with US firm Celldex Therapeutics, revs up the immune system, directing it to destroy hCG." This "shrinks tumors -- and, crucially, stops them from spreading, or metastasizing." http://www.dailymail.co.uk/health/article-1293927/Jab-halt-deadly-forms-cancer.html http://www.pharm-education.com/2010/07/vaccine-may-help-shrink-most-deadly.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. Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 EU Approves Chewable Form Of Lipitor For Children. The European Union has approved a new chewable form of cholesterol blockbuster Lipitor for children 10 and up with high levels of bad cholesterol and triglycerides...Pfizer said Tuesday.This "approval includes children whose high blood fats are due to...familial hypercholesterolemia.http://www.google.com/hostednews/ap/article/ALeqM5j7lgaYrKYwRcQCtKT0Y2jSQstyNQD9GPLL480Doctors Identify Two Therapies That May Slow Progress Of Diabetic Retinopathy.
The Los Angeles Times blog reported that, according to data published June 29 in the New England Journal of Medicine and presented at the American Diabetes Association meeting, "doctors said they have identified two therapies that may slow the progress of" diabetic retinopathy. After examining data on a subset of 2,856 people from the ACCORD study, researchers found that "people with type 2 diabetes who adhere to intensive blood sugar control, compared with standard blood sugar control, have reduced progression of retinopathy. In addition, patients treated with a combination of a cholesterol-lowering statin and fibrate drugs also had a lower rate of progression compared with patients taking statins alone." http://latimesblogs.latimes.com/booster_shots/2010/06/diabetes-retinopathy-glucose-control.html http://content.nejm.org/cgi/content/full/NEJMoa1001288 http://www.nhlbi.nih.gov/health/prof/heart/other/accord/index.htm Weight-Loss Supplement Contains Potentially Dangerous, Undeclared Drug Ingredients, FDA Warns. MedPage Today reported, "The FDA warned customers about several potentially dangerous and undeclared drug ingredients in Que She, a pill sold as an herbal weight-loss supplement." Specifically, the "supplement contains fenfluramine, a stimulant drug withdrawn from the market because it may cause serious heart valve damage; propranolol, a prescription beta-blocker that may be hazardous to patients with bronchial asthma or certain heart conditions; sibutramine, a controlled, prescription weight-loss drug that studies have shown may increase heart attack and stroke risk; and ephedrine, a stimulant that is sold over-the-counter for temporary asthma relief but may have adverse cardiovascular effects.http://www.medpagetoday.com/ProductAlert/OTC/21087Two Studies Suggest Diabetes Drug Avandia Increases Risk Of Heart Problems.
ABC World News reported, "Two major studies have found the medicine called Avandia [rosiglitazone] could create a significant new risk of heart attack and other serious problems." The CBS Evening News reported, "FDA experts meet in two weeks to decide whether or not to pull Avandia off the market." NBC Nightly News reported, however, that the drug's maker, GlaxoSmithKline, "said today the drug is effective and safe." The Washington Post reported that one study, "involving more than 35,500 people, found that Avandia significantly raises the chances of a heart attack." A separate study "of more than 227,500 Medicare patients -- the largest such study to date -- found that the drug boosts the risk for strokes, heart failure, and death." The Los Angeles Times reported that the first study "found Avandia raised the risk of heart attacks by 28% to 39% as compared with other diabetes medications. The study was published online in the Archives of Internal Medicine." Bloomberg News quoted "I think we've got more than enough evidence to say this drug should not be used." USA Today reported that in the second study, published in the Journal of the American Medical Association, "scientists from the Center for Drug Evaluation and Research at the Food and Drug Administration evaluated data from 227,571 Medicare beneficiaries taking either Avandia or Actos [pioglitazone hydrochloride]." The investigators found "no differences in the risk for heart attack between the two drugs, but the study found that compared with Actos, Avandia was associated with a 25% increased risk of heart failure, a 27% increased risk of stroke and a 14% increased risk of death." The Boston Globe quoted the study's coauthor Dr. David Graham, the FDA's associate director for science and medicine, as saying, "Look at our study, and then ask yourself, 'Why would you want to take Avandia?'" The New York Times reported that "the studies were made public in hopes of influencing an expert panel to offer advice to the Food and Drug Administration about whether Avandia should be removed from the market." According to Dr. Joshua M. Sharfstein, the FDA's principal deputy commissioner, the studies "will be part of the discussion that FDA has as we consider the important question of Avandia's safety." The AP reports that "at the FDA's request, Glaxo began a big study last year comparing heart and stroke risks in patients on Avandia or Actos, made by Japan's Takeda Pharmaceuticals. It aims to enroll thousands of patients, but an editorial in JAMA about the Medicare study says it would be unethical to let the study continue." The NPR blog reported that "Glaxo, for its part, defended the medicine, saying in a statement that randomized clinical trials have shown 'Avandia does not increase the overall risk of heart attack, stroke or death.'" http://www.washingtonpost.com/wp-dyn/content/article/2010/06/28/AR2010062802089.html?hpid=moreheadlines http://www.latimes.com/news/science/la-sci-diabetes-avandia-20100629,0,6076476.story?track=rss http://archinte.ama-assn.org/cgi/content/abstract/2010.207v1?maxtoshow=&hits=10&RESULTFORMAT=&fulltext=Avandia&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT http://www.bloomberg.com/news/2010-06-28/glaxo-diabetes-drug-avandia-harms-patients-should-be-pulled-doctors-say.html http://www.usatoday.com/news/health/2010-06-28-Avandiaheartrisks-diabetes_N.htm http://jama.ama-assn.org/cgi/content/full/jama.2010.920 http://www.boston.com/business/healthcare/articles/2010/06/29/new_studies_add_to_avandia_concerns/ http://www.nytimes.com/2010/06/29/health/research/29drug.html?_r=1&ref=health http://www.forbes.com/feeds/ap/2010/06/28/business-health-care-us-med-diabetes-drugs_7726225.html http://jama.ama-assn.org/cgi/content/full/jama.2010.954 http://www.npr.org/blogs/health/2010/06/28/128161946/diabetes-avandia-heart-risks http://www.medpagetoday.com/MeetingCoverage/ADA/20933 http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/ http://online.wsj.com/article/SB10001424052748703964104575334570859778764.html?mod=googlenews_wsj http://www.washingtontimes.com/news/2010/jun/28/study-finds-diabetes-drug-risky-health/ http://www.reuters.com/article/idUSN2826887120100628 http://www.google.com/hostednews/afp/article/ALeqM5gk-BsMFSQxxxAoQBhSkWMTivx9fA http://consumer.healthday.com/Article.asp?AID=640571 http://diabetes.webmd.com/news/20100628/new-study-avandia-riskier-than-actos http://www.pharm-education.com/2010/07/eu-approves-chewable-form-of-lipitor.htmlDisclaimer- 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.
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations, pharmaceutical patents and quality-by-design. Shruti brings to you some highlights from current pharmaceutical and clinical research news, views and data.
Blessing of ‘Business Patents’ in US will affect you.The US Supreme Court recently issued its long-awaited decision in the case of Bilski v Kappos which is considered to be one of the most anticipated patent decisions of recent time.The case involved a patent application for a method of hedging risk in commodities trading. The application was rejected in the first instance by the patent examiner as the invention was a business method which did not relate to any specific apparatus. It was therefore considered to be an abstract idea which is not patentable under US law. The case was then appealed all the way to the Supreme Court. The main issue for the Supreme Court was whether a patent could be issued for an invention which was a business method. The Court rejected the lower court's ruling that the patent was invalid because it didn't meet the "machine or information" test, meaning that a process must be associated with a machine or must physically transform a product to qualify for a patent. It found that whilst the test was a useful tool, it was too narrow and should not form the sole test as it excluded all business methods. The focus should instead be on whether a claim is "directed to an abstract idea". The Court's OpinionThe Court's opinion was written by Justice Kennedy and joined by Chief Justice Roberts and Justices Scalia (in part), Thomas, and Alito... More at http://www.pharmaceuticalpatentsandintellectualproperty.com/2010/07/us-supreme-court-hedges-its-bets-on.htm What this means to you?Holders of existing business method patents can breathe a sigh of relief. By not foreclosing the patent-eligibility of all business methods and rejecting the exclusivity of the machine-or-transformation test, the Supreme Court has given existing business method patents new life. Going forward, the Patent Office must now consider how to adapt. The machine-or-transformation test remains important, and processes that meet this test are likely to be deemed patentable, provided other statutory criteria (e.g., for novelty and non-obviousness) are satisfied. However, the machine-or-transformation test is not the exclusive test for patent-eligibility, and some business methods that do not meet this test could be patent-eligible, if not too abstract. While abstract ideas, laws of nature, and mathematical formulae are not patent-eligible, as noted by the Supreme Court, "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Indeed, the inventors in Bilski have themselves promised to go back to the Patent Office seeking the allowance of revised claims. The Federal Circuit will likely revisit the scope of patent eligibility very soon, as the Supreme Court vacated and remanded two cases (Classen Immunotherapies Inc. v. Biogen Idec and Mayo Collaborative Services v. Prometheus Laboratories) in light of Bilski. References 1. For additional details concerning the Bilski case, please link to our recent circular: http://www.ogilvyrenault.com/en/resourceCentre_10445.htm2. Bilski et al. v. Kappos, US Sup. Ct., Slip Opinion No. 08-964 (28 June 2010)3. Indeed, in Bilski the Court affirmed the rejection of claims drawn very broadly toward the protection of methods of hedging risks in commodities markets. The rejected claims, however, were so broad that they could have been infringed by individuals passing cash among amongst themselves in a living room.4. In Re Bilski et al., US Court of Appeals for the Federal Circuit, Slip Opinion No. 2007-1130, at 21 and note 23.5. See Respondent's Memorandum of Fact and Law in Amazon.com, Inc. v. Attorney General, Fed. Court file T-1476-09, at 27. CIPO's reliance on Bilski has itself been questioned.6. Fed. Court file T-1476-09.7. http://www.mondaq.com/article.asp?articleid=104790&email_access=onhttp://www.mondaq.com/article.asp?articleid=104790&email_access=on8. http://www.mondaq.com/unitedstates/article.asp?articleid=104664&email_access=on9. http://www.mondaq.com/unitedstates/article.asp?articleid=104818&email_access=on A free white paper is available on request. Contact@Innoworksltd.com 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. Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.Translates innovative concepts to PROFITS.YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Do you have questions for the author?
 Dr.Shruti Bhat, Star formulator and Ace leader within pharmaceutical R&D. Shruti is a specialist with hiTech formulations and quality-by-design. Shruti brings to you some highlights from current pharma and clinical research news, views and data. The U.S. Food and Drug Administration yesterday announced it has approved the Implantable Miniature Telescope (IMT) to improve vision in some patients with end-stage age-related macular degeneration (AMD). Surgically implanted in one eye, the IMT is a small telescope that replaces the natural lens and provides an image that has been magnified more than two times. AMD, a condition that mainly affects older people, damages the center of the retina (macula) and results in a loss of vision in the center of the visual field. About 8 million people in the United States have AMD and nearly 2 million of them already have significant vision loss, according to the National Eye Institute. AMD can make it difficult or impossible to recognize faces or perform daily tasks such as reading or watching television."This innovation has the potential to provide many people with an improved quality of life," said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. The IMT is available in two models: one that provides 2.2 times magnification and another 2.7 times magnification. The IMT is designed to magnify and project images onto a healthy portion of the retina. The IMT is intended to be implanted in only one eye; the non-implanted eye is used for peripheral vision.The IMT is used in patients ages 75 years and older with stable severe to profound vision impairment (when vision impairment has not changed over time) caused by blind spots (bilateral central scotoma) associated with end-stage AMD. These patients also have evidence of a visually significant cataract. Patients agree to undergo training with an external telescope with a low vision specialist prior to implantation to determine whether adequate improvement in vision with the external telescope can be obtained and to verify if the patient has adequate peripheral vision in the eye that would not be implanted. Patients also agree to participate in a post-operative visual training program. In a 219-patient, multi-center clinical study of the IMT, 90 percent of patients achieved at least a 2-line gain in either their distance or best-corrected visual acuity, and 75 percent of patients improved their level of vision from severe or profound impairment to moderate impairment. Because the IMT is a large device, implantation can lead to extensive loss of corneal endothelial cells (ECD), the layer of cells essential for maintaining the clarity of the cornea, and chronic endothelial cell loss. The chronic rate of endothelial cell loss is about 5 percent per year. Significant losses in ECD may lead to corneal edema, corneal decompensation, and the need for corneal transplant. In the study, 10 eyes had unresolved corneal edema, with five resulting in corneal transplants. The calculated five-year risk for unresolved corneal edema, corneal decompensation, and corneal transplant are 9.2 percent, 6.8 percent and 4.1 percent, respectively. To ensure that the risks of IMT implantation are sufficiently and consistently communicated to patients, the FDA and the manufacturer created detailed labeling, including an Acceptance of Risk and Informed Decision Agreement, which patients must complete prior to IMT implantation. The agreement provides a guide for patients and their physicians to discuss the risks associated with IMT implantation. Patients should be given adequate time to review all of the information regarding the IMT. As a condition of FDA approval, the manufacturer, VisionCare Ophthalmic Technologies Inc. of Saratoga, Calif., must conduct two post-approval studies. In one study, VisionCare must continue follow-up on the subjects from its long-term follow-up cohort for an additional two years. Another study of 770 newly enrolled subjects will include an evaluation of the endothelial cell density and related adverse events for five years after implantation. http://www.pharm-education.com/2010/07/fda-approves-first-implantable.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.
Http://www.drshrutibhat.comExpert at leading Pharmaceutical R&D.
Translates innovative concepts to PROFITS.
YouTube Channel : Http://www.youtube.com/user/ShrutiBhat10Introducing ! A new blog- Http://www.PharmaceuticalCareerDevelopment.blogspot.com which contains articles on motivation, career counselling and coaching, job search strategies, personal branding etc. especially for pharma professionals.
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