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Biogen fends off Mylan’s challenge Dimethyl Fumarate, Proprietary molecule of Biogen with brand name as TECFIDERA available as delayed release capsule with two strength 120mg & 240mg. USFDA has approved the New Drug Application (NDA 204063) provides for the use of Tecfidera (dimethyl fumarate) delayed-release capsules, 120 mg and 240 mg, for the treatment of patients with relapsing forms of multiple sclerosis. OB Listed Patents: US7619001 (Expiring Jun 20, 2020) covers Method for treating Multiple Sclerosis using pharmaceutical preparations with an excipient or at least one carrier using fumarates. The fumarates are limited to dimethyl fumarate (DMF), monomethyl fumarate (MMF), or their combination. US8399514 (Expiring Feb 07, 2028) directed to methods of treating patients needing treatment for Multiple Sclerosis (MS). The heart of the treatment, and a requirement of every claim is administering about 480 milligrams (mg) per day of certain fumarates. Id. The fumarates are limi...

The  MINISTRY OF COMMERCE AND INDUSTRY (Department of Industrial Policy and Promotion) has published  Draft Patent (Amendment) Rules, 2018 (Draft Rules) Patents Act 1970  for objections and suggestions on the 4th December, 2018. (01 month for objections and suggestions) The key focus of these rules are mainly amended with respect to  international applications, patent opposition  and a few  form related extensions . The Central Government proposes to make these amendments in exercise of the powers conferred by section 159 of the Patents Act, 1970 and also change the  Controller’s role  in case of opposition proceedings. The amendment can divide in mainly two parts: 1. Amendments to Rules 2. Amendments to Schedules (Including forms) Given below are the key highlights of actual sections of Patents Act and the respective changes made to them are highlighted or in bold: 1. Amendments to Rules Sr. No. Before ...

·   Recently, The U.S. Patent and Trademark Office  announced  a propose change to the standard for construing both unexpired and amended patent claims in The Patent Trial and Appeal Board (The PTAB) proceedings under the America Invents Act (“AIA”).  ·   The change would replace the current Broadest Reasonable Interpretation (“BRI”) standard with the standard articulated in  Phillips v. AWH Corp . (415 F.3d 1303, Fed. Cir. 2005).   ·   This change would harmonize the claim construction standard applied in Inter Partes Review (IPR), Post-Grant Review (PGR), and Covered Business Method (CBM) patent proceedings before the Patent Trial and Appeal Board (PTAB) with the one used by federal district courts and the International Trade Commission (ITC).   ·   The proposed amendment would also allow the PTAB to consider any prior claim construction determination concerning a term of the involved claim in a c...

Work Flow balance is still a (?) for IPO because amended policies and rules give a  magnetic attraction  to start-ups and beneficiaries for better participate in the flow of IPO but this may be a hurdle also when the path has reduced to 60% in ratio with coming flow and ongoing and delivered flow. First, let us give credit where it is  due.  The DIPP and IPO finally managed to conduct large-scale recruitment process of patent office examiners without any major scandal that in itself is an achievement. The increased recruitment has no doubt helped clear some of the backlogs and speed up the examination process of application. Although from what appears, the quality of the examinations remains a concern. CASE 1:  A procured information  ( Refer RTI IPO 2012)  application filed in 2012 reveals that: 1.      there were a total of 835 pending pre-grant patent oppositions 2.      along with 135,874 pendi...

Did you know that “patent” and “exclusivity” are two of the most commonly searched terms on the FDA website?  Generics account for more than 80% of prescription drugs in the US, and that number continues to grow. With approaching patent expirations of several top-selling prescription brand-name drugs, sponsors of innovator drug products and generic manufacturers need to know the ins and outs of patents and exclusivity. Let's find out the basics difference between patents & exclusivity. Patents: A patent is a property right issued by the respective patent office to an inventor “to exclude others from making, using, offering for sale, or selling the invention throughout the respective territory or importing the invention into the respective territory” for a limited time, in exchange for public disclosure of the invention when the patent is granted.  Generally, the term of a new patent is 20 years from the date on which the application for the patent was filed in any...

Dear All, Today if you get to see the  Google Doodle  it shows the deep tribute to Dr. Asima Chatterjee by creating an interesting sculptured as: Fig Source: Forbes Let’s find out why Dr. Asima Chatterjee is still in memory on her 100’s Birthday.. Many of us aware with  Bengal Chemicals & Pharmaceuticals Ltd  the  first Indian  Company to manufacture quality Chemicals, Drugs, Pharmaceuticals and Home Products, employing  indigenous technology , skill and raw materials. It was the time when  Patent and other intellectual properties  were governed by  Patents and Designs Act 1911  and ambiguities and deficiencies in that Act which were fully exploited by the foreign owned pharmaceutical companies called Trans National Corporations (TNCs). Unichem  for  tolbutamide (Sulphonamide Derivative)  had been successfully sued in Bombay High Court by   Hoe...

Malaysia Issues Compulsory License for Gilead’s Sofosbuvir Despite Licence A much cheaper version of a groundbreaking hepatitis C medicine is now accessible for the hundreds of thousands of hepatitis C patients in Malaysia, as it decided to grant a compulsory licence to sofosbuvir.. The decision comes right after the Gilead Sciences decided to expand its voluntary licensing scheme to Ukraine, Belarus, Malaysia, Thailand and Philippines & announce on professional platform as follows: According to the Malaysian AIDS Council  it is 500,000 people or 2.5 per cent of the general population are estimated to be living with hepatitis C in Malaysia & the cost of the full hepatitis C treatment comes to RM 300,000 per patient (US$71,300), leading to very few patients benefitting from it. Since Sofosbuvir is patented, a government-use licence is needed to waive the monopoly right and enable the sale of generic drugs. Thus, the government decision is the key to opening the...