On Nov. 19, 2020, Federal Circuit affirmed judgment of infringement & damages against Glaxo. Plaintiff (Vectura Ltd) filed suit in 2016 against defendant (Glaxo) for alleged infringement of US 8,303,991 patent. The ’991 patent concerns the production of “composite active particles” for use in pulmonary administration, such as in dry-powder inhalers. The composite active particles described in the patent consist of additive material (magnesium stearate) that is adhered to particles of active ingredient. The additive particles promote the dispersion and delivery of the active ingredie ..read more

It's time to say goodbye to 2020 & also this blog. As most of the you are aware that "Pharma IP Circle" has moved to new address & this current address would no longer serve. Looking forward to 2021 with new learning & experience. Here is our new address: https://www.pharmaipcircle.com/ Wish all the readers very hopeful, healthy & happy new year 2021. Image source: https://i.ytimg.com/vi/atLLOMcK830/maxresdefault.jpg ..read more

  On Dec. 21, 2020, Federal Circuit affirmed district court’s summary judgment that found infringement under Doctrine of Equivalents (DoE). Eli Lilly owns US 7,772,209 patent which relates to “a method of administering an antifolate to a mammal in need thereof, comprising administering an effective amount of said antifolate in combination with a methylmalonic acid lowering agent”. Independent claims covers administration of pemetrexed disodium (antifolate) with folic acid & methylmalonic acid lowering agent (vitamin B12). This patent is listed in Orange Book for the product ALIMTA ..read more

Dear Readers, Happy to share that "Pharma IP Circle" blog has moved from blogger to full fledged secure website. Please subscribe to the new blog so that you can get the litigation updates. I would be discontinuing this blog from January 01, 2021 & will share update on only new blog thereafter. You can "subscribe" by putting your name & mail id mentioned on the home page. Here is the new address:? https://www.pharmaipcircle.com Thanks for your support. Looking forward to much more in 2021. Happy learning to all!? Regards, Mahendra Gunjal ..read more

  On Dec. 18, 2020, Federal Circuit affirmed (Rule 36 judgment) Delaware court in Uceris® litigation. Previously, Plaintiffs Bausch Health Americas, Inc., Salix Pharmaceuticals Ltd., and Cosmo Technologies Limited (collectively, "Plaintiffs") filed complaint asserting that Defendants Actavis Laboratories FL., Inc., Actavis Pharma, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries Ltd. (collectively, "Defendants") infringed and continue to infringe U.S. Patent Nos. 10,052,286, 10,064,878, 10,105,374, 10,143,698, 10,154,964, and 10,172,799 by filing ANDA for budesonid ..read more

  On Dec. 16, 2020, Federal Circuit affirmed (Rule 36 judgment) PTAB finding method of use patent invalid as obvious.You can find the IPR details reported “"here"” on this blog ..read more

  IPR decision: Dec. 08, 2020 AIA Review # Filing Date Institution Date Petitioner Patent Respondent Status IPR2020-01045 06/10/2020 09/01/2020 Teva 7,326,708 Merck Terminated-Settled Note: Mylan already filed IPR on US’708 patent on 10/30/2019 and PTAB instituted IPR on 05/12/2020. DRL & Sun also filed IPRs (IPR2020-01060 & IPR2020-01072) which were instituted on 09/01/2020. US 7,326,708 (Merck & Co.; Exp: 05/24/2027 with PED): 1. A dihydrogenphosphate salt of 4-oxo-4-[3-(trifluoromethyl)-5,6-dihydro[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-yl ..read more

  On Dec. 04, 2020, UK High Court found second medical use patent valid & infringed by Mylan. Neurim holds EP 1,441,702 patent, which is related to use of melatonin in improving the restorative quality of sleep, in a patient suffering from primary insomnia.  Mylan/Generics UK plans to bring generic version of drug in the market. The issues before court concerned the invalidity of patent as Mylan admitted infringement if patent is found valid. Mylan asserted that claims of patent are invalid under lack of novelty, lack of inventive step & insufficiency. Claims 1 and 4 were of ..read more

  On Nov. 30, 2020, Delaware court on remand found Quillivant XR® patents valid & infringed by ANDA filer in a Hatch-Waxman suit. Plaintiff (Tris Pharma) filed suit against defendant (Actavis) for alleged infringement of U.S. Patent Nos. 8,465,765; 8,563,033; 8,778,390; 8,956,649 and 9,040,083. Actavis challenged the validity based on obviousness and obviousness-type double patenting. After a five-day bench trial, the original judge (now retired) found all the asserted claims to be invalid for obviousness under 3 5 U.S. C. § 103. Tris appealed. The Federal Circuit vacated the judgment ..read more

  On Nov. 30, 2020, Delaware court found composition patent covering combination invalid as obvious & not infringing. Background of the case: Plaintiffs (Horizon) owns NDA for DUEXIS® (ibuprofen and famotidine) tablets, 800 mg / 26.6 mg. It is indicated for the relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease the risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications. Defendant (Alkem) submitted ANDA on March 31, 2018 seeking USFDA approval to market generic version. Horizon sued Alkem in distr ..read more