The US Court of Appeals for the Federal Circuit Court has ruled against The Medicines Company in its Angiomax (bivalirudin) patent litigation with Hospira, Inc.
In its ruling, the Federal Circuit held that US patent numbers 7,582,727 (the 727 patent) and 7,598,343 (the 343 patent) are invalid.
On March 31, 2014, the US District Court of Delaware found that all of the asserted claims of the '727 patent and the ‘343 patent covering Angiomax were valid but not infringed by Hospira’s ANDA products. The Medicines Company appealed the District Court’s claim construction and non-infringement rulings, while Hospira appealed the validity rulings.
“We are evaluating court ruling and considering our next steps,” said Clive Meanwell, MD, PhD, chairman and chief executive officer, The Medicines Company.
“We remain committed to interventional cardiovascular medicine and will continue to support bivalirudin. We are focused on the current launch of Kengreal, our newly approved platelet inhibitor, which we anticipate will be used by many of our existing customers in cardiac catheterization laboratories. We also look forward to the release of important new data on our PCSK9 RNAi compound at the European Society of Cardiology meeting, August 31 to September 2. Meantime our launch and launch preparations for Ionsys, Orbactiv and a new formulation of Minocin for injection are also underway.”
Angiomax is indicated in patients undergoing PCI with provisional use of GPI and in patients with, or at risk of, heparin-induced thrombocytopenia and thrombosis syndrome (HIT/HITTS) undergoing PCI. In addition, Angiomax is also indicated for use as an anticoagulant in patients with unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA). Angiomax is intended for use with aspirin. Angiomax is not approved for use in patients with acute coronary syndromes (ACS) not undergoing PCI or PTCA.
In clinical trials comparing Angiomax and heparin, the most common adverse reaction for Angiomax was bleeding (28 per cent). Other common adverse reactions were headache, thrombocytopenia and fever. An unexplained fall in blood pressure or hematocrit, or any unexplained symptom, should lead to serious consideration of a hemorrhagic event and cessation of Angiomax administration. Angiomax should be used with caution in patients with disease states associated with an increased risk of bleeding.
In gamma brachytherapy, an increased risk of thrombus formation, including fatal outcomes, has been associated with the use of Angiomax. Angiomax is contraindicated in patients with active major bleeding or hypersensitivity to Angiomax or its components.
Kengreal, a synthetic, small molecule, is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.
Ionsys contains the opioid fentanyl and is a compact, needle-free, pre-programmed system that is indicated for the short-term management of acute postoperative pain in adult patients requiring opioid analgesia in the hospital. Ionsys is only for use in patients who are alert enough and have adequate cognitive ability to understand the directions for use. Ionsys not for home use and is intended for use only in patients in the hospital. Ionsys is for use after patients have been titrated to an acceptable level of analgesia using alternate opioid analgesics.
Ionsys will only be administered to patients in hospitals enrolled in the Ionsys Risk Evaluation and Mitigation Strategy (REMS) programme, the goal of which is to decrease the risk of respiratory depression resulting from accidental exposure to persons for whom it is not prescribed by ensuring it is only dispensed to patients in certified hospitals and informing health care providers of the serious risk of respiratory depression resulting from accidental exposure to fentanyl.
Orbactiv (oritavancin) for injection received FDA approval in the US in August 2014. Orbactiv is the first and only FDA-approved single-dose IV antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused or suspected to be caused by susceptible isolates of the following gram-positive microorganisms: Staphylococcus aureus (including methicillin-susceptible and methicillin–resistant isolates),Streptococcus pyogenes, Streptococcus agalactiae, Streptococcus dysgalactiae, Streptococcus anginosus group (includes S. anginosus, S. intermedius, and S. constellatus), and Enterococcus faecalis (vancomycin-susceptible isolates only).
Minocin (minocycline) for injection is indicated for the treatment of infections due to susceptible strains of designated microorganisms, including Acinetobacter species bacteria.