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Contents
Abandonment of Patent Applications Patent Troll Tracker 2008 Election and Future of Drug Industry Chantix Causes Suicidal Behavior New Inhaler for Kids Anti-depressants are Useless for Some Humira Xynthia Avastatin India Considers Overriding Cancer Drug Patents "It should also be borne in mind that no property is so uncertain as "patent rights"; no property more speculative in character or held by a more precarious tenure. An applicant who goes into the patent office with claims expanded to correspond with his unbounded faith in the invention, may emerge therefrom with a shriveled parchment which protects only that which any ingenious infringer can evade. Even this may be taken from him by the courts. Indeed, it is only after a patentee has passed successfully the ordeal of judicial interpretation that he can speak with any real certainty as to the scope and character of his invention. Especially is this true of patents on spring-tooth harrows." E. Bement & Sons v. La Dow (C.C.) 66 Fed. 185 (Circuit Ct. N.Y. 1895). Abandonment of Patent Applications USPTO Rules: 37 C.F.R. 1.137: (a) Unavoidable. If the delay in reply by applicant or patent owner was unavoidable, a petition may be filed pursuant to this paragraph to revive an abandoned application, a reexamination prosecution terminated under §§ 1.550(d) or 1.957(b) or limited under § 1.957(c), or a lapsed patent. A grantable petition pursuant to this paragraph must be accompanied by: (1) The reply required to the outstanding Office action or notice, unless previously filed; (2) The petition fee as set forth in § 1.17(l); (3) A showing to the satisfaction of the Director that the entire delay in filing the required reply from the due date for the reply until the filing of a grantable petition pursuant to this paragraph was unavoidable; and (4) Any terminal disclaimer (and fee as set forth in § 1.20(d)) required pursuant to paragraph (d) of this section. (b) Unintentional. If the delay in reply by applicant or patent owner was unintentional, a petition may be filed pursuant to this paragraph to revive an abandoned application, a reexamination prosecution terminated under §§ 1.550(d) or 1.957(b) or limited under § 1.957(c), or a lapsed patent. A grantable petition pursuant to this paragraph must be accompanied by: (1) The reply required to the outstanding Office action or notice, unless previously filed; (2) The petition fee as set forth in § 1.17(m); (3) A statement that the entire delay in filing the required reply from the due date for the reply until the filing of a grantable petition pursuant to this paragraph was unintentional. The Director may require additional information where there is a question whether the delay was unintentional; and (4) Any terminal disclaimer (and fee as set forth in § 1.20(d)) required pursuant to paragraph (d) of this section. http://www.uspto.gov/web/offices/pac/mpep/documents/appxr_1_137.htm Statutory Provisions Unintentional Abandonment: 35 USC 41(7) REVIVAL FEES. - On filing each petition for the revival of an unintentionally abandoned application for a patent, for the unintentionally delayed payment of the fee for issuing each patent, or for an unintentionally delayed response by the patent owner in any reexamination proceeding, $1,500, unless the petition is filed under section 133 or 151 of this title, in which case the fee shall be $500. http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_41.htm 35 USC 122(a)2(B):(iii) An applicant who has made a request under clause (i) but who subsequently files, in a foreign country or under a multilateral international agreement specified in clause (i), an application directed to the invention disclosed in the application filed in the Patent and Trademark Office, shall notify the Director of such filing not later than 45 days after the date of the filing of such foreign or international application. A failure of the applicant to provide such notice within the prescribed period shall result in the application being regarded as abandoned, unless it is shown to the satisfaction of the Director that the delay in submitting the notice was unintentional. http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_122.htm Unavoidable Abandonment: 35 USC 133: Time for prosecuting application. Upon failure of the applicant to prosecute the application within six months after any action therein, of which notice has been given or mailed to the applicant, or within such shorter time, not less than thirty days, as fixed by the Director in such action, the application shall be regarded as abandoned by the parties thereto, unless it be shown to the satisfaction of the Director that such delay was unavoidable. http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_133.htm 35 USC 151: If it appears that applicant is entitled to a patent under the law, a written notice of allowance of the application shall be given or mailed to the applicant. The notice shall specify a sum, constituting the issue fee or a portion thereof, which shall be paid within three months thereafter. Upon payment of this sum the patent shall issue, but if payment is not timely made, the application shall be regarded as abandoned. Any remaining balance of the issue fee shall be paid within three months from the sending of a notice thereof, and, if not paid, the patent shall lapse at the termination of this three-month period. In calculating the amount of a remaining balance, charges for a page or less may be disregarded. If any payment required by this section is not timely made, but is submitted with the fee for delayed payment and the delay in payment is shown to have been unavoidable, it may be accepted by the Director as though no abandonment or lapse had ever occurred. http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_151.htm 35 USC 371(d) The requirement with respect to the national fee referred to in subsection (c)(1), the translation referred to in subsection (c)(2), and the oath or declaration referred to in subsection (c)(4) of this section shall be complied with by the date of the commencement of the national stage or by such later time as may be fixed by the Director. The copy of the international application referred to in subsection (c)(2) shall be submitted by the date of the commencement of the national stage. Failure to comply with these requirements shall be regarded as abandonment of the application by the parties thereof, unless it be shown to the satisfaction of the Director that such failure to comply was unavoidable. The payment of a surcharge may be required as a condition of accepting the national fee referred to in subsection (c)(1) or the oath or declaration referred to in subsection (c)(4) of this section if these requirements are not met by the date of the commencement of the national stage. The requirements of subsection (c)(3) of this section shall be complied with by the date of the commencement of the national stage, and failure to do so shall be regarded as a cancellation of the amendments to the claims in the international application made under article 19 of the treaty. The requirement of subsection (c)(5) shall be complied with at such time as may be fixed by the Director and failure to do so shall be regarded as cancellation of the amendments made under article 34 (2)(b) of the treaty. http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_371.htm Unintentional or Unavoidable Abandonment 35 USC 111(4), FAILURE TO SUBMIT: Upon failure to submit the fee and oath within such prescribed period, the application shall be regarded as abandoned, unless it is shown to the satisfaction of the Director that the delay in submitting the fee and oath was unavoidable or unintentional. The filing date of an application shall be the date on which the specification and any required drawing are received in the Patent and Trademark Office. http://www.uspto.gov/web/offices/pac/mpep/documents/appxl_35_U_S_C_111.htm Caselaw: Lumenyte v. Cable Lite (Fed. Cir. 1996) Morganroth v. Quigg (Fed. Cir. 1989) New York Univ. v. Autodesk, Inc., 2007 U.S. Dist. LEXIS 50832 (SDNY 2007) Field Hybrids v. Toyota (D.Minn 2005). Case to Watch: Aristocrat Technologies v. IGT (pending before the CAFC). http://www.patentlyo.com/patent/2008/02/asdf.html Patent Troll Tracker Cisco IP Director Rick Frenkel is the Patent Troll Tracker. Cisco, Microsoft and Intel have been arguing for the "patent reform", while pharmaceutical companies and individual inventors have been arguing against the so-called reform. 2008 Election and Future of Drug Industry The winner of the 2008 election will be faced with making key decisions on a number of issues important to drug developers. Barack Obama supports: Reimportation of drugs Greater generic drug use by Medicare, Medicade, ect Establishing a government institute for comparative research between drugs. Allowing the government to purchase prescription drugs in bulk to reduce costs. Universal healthcare Embryonic stem cell (ESC) research Hilary Clintion supports: Doubling NCI and NHC funding Increaseing the number of patients involved in cancer clinical trials. A pathway for biogenerics Lower prescription drug costs and universal health care Giving Medicare the power to negotiate prescription drug prices Stricter control of drug advertising ESC research John McCain supports: A pathway to approve biogenerics An increase use of generic drugs Reimportation of drugs Allowing the government to negotiate lower prices for prescription drugs for the Medicare Part D program ESC research http://www.fool.com/investing/general/2008/02/05/drugmakers-and-the-election.aspx Chantix Causes Suicidal Behavior Government regulators said the connection between Pfizer's anti-smoking drug Chantix and serious psychiatric problems is "increasingly likely." The Food and Drug Administration said it has received reports of 37 suicides and more than 400 of suicidal behavior in connection with the drug. In November, the agency began investigating reports of depression, agitation and suicidal behavior among patients taking the popular twice-daily pill. The agency's announcement comes two weeks after Pfizer added stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out. Pfizer suggested that since nicotine withdrawal alone can cause mood swings and agitation, it may be impossible to determine if Chantix aggravates those behaviors. But FDA said it found evidence of Chantix patients who experienced psychiatric problems even though they were still smoking. GlaxoSmithKline makes Zyban, the only other non-nicotine, anti-smoking drug for sale in the U.S. Part of the antidepressant drug class, Zyban includes warnings about increased suicidal behavior. New Inhaler for Kids The Food and Drug Administration approved Asmanex Twisthaler, a once-daily inhaled corticosteroid treatment. The dosage approved for children aged 4 to 11 is 110 micrograms, half the dose for adults. The inhaler is activated when patients put the end in their mouths and take a breath. In a small study, the drug reduced day and nighttime symptoms of asthma and significantly reduced emergency medical visits, missing school and other such interruptions to daily life compared to a placebo inhaler, The Associated Press reports. Possible side effects include slowing of a child's growth rate, yeast infections of the mouth, and a higher risk of glaucoma and cataracts, as well as milder side effects such as headaches, sore throat, respiratory infection, upset stomach and muscle, bone and back pain, the AP says. Anti-depressants are Useless for Some As the number of prescriptions for anti-depressants hit a record high in England in 2006, a University of Hull team concluded that the drugs helped only a small group of the most severely depressed. But the makers of Prozac and Seroxat, two of the commonest anti-depressants, said they disagreed with the findings, claiming that the study looked at only a "small subset of the total data available". And Eli Lilly, which makes Prozac, said that "extensive scientific and medical experience has demonstrated it is an effective anti-depressant". The study focused on drugs in the class known as Selective Serotonin Reuptake Inhibitors (SSRIs), which work by increasing levels of the mood controlling chemical serotonin in the brain. These included fluoxetine (Prozac), venlafaxine (Efexor) and paroxetine (Seroxat). Humira Abbott announced it has received U.S. Food and Drug Administration (FDA) approval to market HUMIRA(R) (adalimumab) as a treatment to reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients four years of age and older. In the U.S., JIA is commonly referred to as juvenile rheumatoid arthritis (JRA) In addition to its approval for polyarticular JIA, HUMIRA is also approved by the FDA for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural joint damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression of structural damage and improving physical function in patients with psoriatic arthritis. HUMIRA is also indicated for reducing signs and symptoms in patients with active ankylosing spondylitis. HUMIRA is indicated for reducing the signs and symptoms and inducing and maintaining clinical remission in adults with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy and reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab. HUMIRA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HUMIRA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. HUMIRA resembles antibodies normally found in the body. It works by blocking tumor necrosis factor alpha (TNF-.), an inflammatory protein that, when produced in excess, plays a key role in the inflammatory responses of some autoimmune diseases. To date, HUMIRA has been approved in 72 countries and more than 250,000 patients worldwide are currently being treated with HUMIRA. Clinical trials are currently under way evaluating the potential of HUMIRA in other immune-mediated diseases. Xynthia Wyeth Pharmaceuticals, a division of Wyeth, announced that it has received approval from the U.S. Food and Drug Administration for XYNTHA(TM) (Antihemophilic Factor [Recombinant], Plasma/Albumin-Free), a recombinant factor VIII product, for patients with hemophilia A for both the control and prevention of bleeding episodes and surgical prophylaxis. XYNTHA (pronounced "ZIN-tha") is manufactured using a completely albumin-free process and state- of-the-art nanofiltration purification technology. In addition, XYNTHA is the only recombinant factor VIII product to utilize an entirely synthetic (non- human and non-animal based) purification process in its manufacture. Until now, the purification process for all recombinant factor VIII products used monoclonal antibodies derived from mouse cell lines. In the manufacture of XYNTHA, the mouse monoclonal antibody is replaced with a synthetic peptide ligand, which was invented by Wyeth scientists. Hemophilia A is a rare, inherited blood-clotting disorder. People with hemophilia A are deficient in a key protein, factor VIII, which is vital in the clotting mechanism to prevent bleeding. Hemophilia A can be characterized by spontaneous hemorrhages or prolonged bleeding, typically into joints and soft tissue. Most patients with hemophilia A are dependent on factor VIII replacement therapy. Avastatin Avastin, a Genentech drug received federal approval to treat breast cancer, a surprise decision that could represent a shift in standards for assessing the effectiveness of cancer medicines. Going against the recommendation of its advisory panel, the Food and Drug Administration judged the effectiveness of Avastin based on measurements of tumor growth, not patient survival. The ruling prompted a mixed reaction from both doctors and advocates for breast-cancer patients. First approved in the U.S. to treat colon cancer in 2004, Avastin was the first drug to fight cancer by blocking nutrients from reaching tumors. Avastin was Genentech's best-selling product last year with revenue of $2.3 billion. Through a partnership with Genentech, Swiss drug maker Roche markets the drug in Europe, where it had previously been approved as a breast-cancer treatment. India Considers Overriding Cancer Drug Patents Entering the bullpen once again, India is taking up the issue of how to balance patent protection with patient need, with the country's patent office reportedly set to consider this week whether to override patents on cancer drugs made by Pfizer Inc. and Roche AG and to allow a generics maker to ship copycat versions to Nepal for distribution. Source: The primary sources cited above, BBC News, New York Times (NYT), Washington Post (WP), Mercury News, Bayarea.com, Chicago Tribune, USA Today, Intellihealthnews, Deccan Chronicle (DC), the Hindu, Hindustan Times, Times of India, AP, Reuters, AFP, Biospace etc. Notice: The content of the articles is intended to provide general information. Specialist advice should be sought about your specific circumstances. |
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