PRABHA SRIDEVAN,CHAIRMAN - (1.) THE invention in patent application No.6117/DELNP/2007 is for a "Dosage Form Containing Oxycodone and Naloxone". The Controller held that the application does not meet the requirements of Section 2(1)(g), 3(d), 3(e), 8 and 10(4) of the Patents Act. He relied on five prior arts: D1 : WO 2003/084504 D2 : WO 2003/007802 D3 : WO 2002/092060 D4 : DE 4325465 D5 : EP -A -1604666, and refused the grant
(2.) THE learned counsel for the appellant submitted that the aim of the invention is intended to be a Dosage Form in a specific patient population who are not only suffering from pain but also experiencing side effects due to opioid pain therapy (particularly constipation) and also adverse events (particularly diarrhea) due to active agent naloxone in the dosage form. This invention lies in the dosage form capable of providing pain relief as well as an optimal balance between side effects and adverse events as described above.
(3.) THE learned counsel referred to the complete specification which refers to the embodiment examples and the optimization of naloxone and oxycodone ratio in patients suffering pain. The learned counsel also refer to the estimated improving by using oxycodone naloxone ratio versus naloxone placebo groups The estimates indicate that bowel function improvement increases as oxycodone/naloxone ratio decreases, with the estimated improvement at 2:1 approximately 50% higher than at 4:1 (p The estimates indicate that bowel function improvement increases as oxycodone/naloxone ratio decreases, with the estimated improvement at 2:1 approximately 50% higher than at :1 (p 0.05) and with a minimal improvement from the 2:1 ratio to the 1.5:1 ratio. 4. The learned counsel also refers to the complete specification: Opioid analgesics are considered to be strong agonists if they bind with high affinity to opioid receptors and induce a strong inhibition of pain reception. Substances that also bind with high affinity to opioid receptors, but that do not cause a reduction of pain reception and which thereby counteract the opioid agonists, are designated as antagonists. Depending on the binding behaviour and the induced activity, opioids can be classified as pure agonists, mixed agonists/antagonists and pure antagonists. Pure antagonists comprise, for example, naltrexone, naloxone, nalmefene, nalorphine, nalbuphine, naloxocazinen, methylnaltrexone, ketylcyclazocine, norbinaltorphimine, naltrindol, 6 -B -naltrexone (Forth W.; Henschler, D.; Rummel W.; Starke, K.: Allgemeine und Spezielle Pharmakologic und Toxikologie, 7, Auflage, 1996, Spektrum Akademischer Verlag, Heidelberg Berlin Oxford). Other attempts aim at minimizing the addictive and habituation forming potential of opioid analgesics, as well as their other side effects by the administration of antagonists which counteract the opioid analgesic. Such antagonists might be naltrexone or naloxone.;