Much of the
Life Science blogosphere has focused on the Supreme Court’s decision in Mayo
v. Prometheus lately. The decision
has jolted the biotech industry through a unanimous ruling that threw out two
medical-testing patents and has questioned the very concept of what a law of
nature is when it comes to medical testing. The case involved a group of drugs used to
treat diseases such as Crohn's and ulcerative colitis. For patients taking
thiopurine drugs for such immune system diseases, physicians must adjust the
dose to make sure the drug works while side effects are avoided. The Prometheus
patent described connecting the level of certain chemicals in the blood to the
thiopurine dosage to balance between too high or too low dosage. This led justice
Breyer to conclude that the Prometheus patents recited laws of nature, which
has sparked a big discussion. Personalized medicine and
companion diagnostics are examples of areas that are heavily affected by this
and given the fact that thousands of patents for diagnostic tests have been
issued in the past two decades - the court ruling could have dramatic effects
on the biotech industry. One of the most cited examples is of course Myriad
Genetics’ test for breast-cancer risk using information about the BRCA1 and
BRCA2 genes. To follow the debate I recommend visiting Patent Baristas,
Patently BIOtech or Holman’s Biotech IP Blog.
On the
pharma/biotech side of the industry there is also activity in the IP-realm. Due
to the commotion around Prometheus, IP analysis around pharma/bio seems to have
been in the background lately. Therefore, this month, Intangitopia is providing
you with an overview of IP lawsuits, settlements and infringements in the pharma/biotech
space covering Jan-June 2012:
As can be
seen in the diagram above, most of the activity has been in the disease groups:
1) nervous system diseases, 2) nutritional and metabolic diseases, and 3) respiratory
tract diseases. Below are summaries of the top IP news in media within these disease groups.
Nervous System Diseases
| Indication | Companies | Products | Top news description |
| Pain | Merck & Co Inc | Vioxx | Merck Resolves Vioxx Litigation in Canada |
| Opioid Abuse/Pain | BioDelivery Sciences International (BDSI), Endo Pharmaceuticals | BEMA Buprenorphine | BioDelivery Sciences Receives Patent Allowance Triggering $15 Million Milestone Payment from Endo Pharmaceuticals |
| Pain | Zalicus Inc. | Hydromorphone hydrochloride | Settlement confirmed in litigation between Zalicus and Mallinckrodt and Watson Laboratories Inc |
| Parkinson's Disease | Orion Corporation | Stalevo | Orion sues Mylan to enforce its U.S. patents covering the proprietary drug Stalevo |
| Post-Herpetic Neuralgia | Watson Pharmaceuticals Inc, Endo Health Solutions Inc, Impax Laboratories, Inc. | Lidocaine, Lidoderm | Watson Announces Lidoderm Patent Challenge Settlement |
| Relapsing Remitting Multiple Sclerosis | Genmab A/S | -- | Genmab Announces Patent Settlement Agreement for Ofatumumab |
| Sleep Disorders | Mylan Inc, Teva Pharmaceutical Industries Ltd | Modafinil, Nuvigil | Mylan Settles Provigil Litigation With Teva |
Nutritional and metabolic diseases
| Indication | Companies | Products | Top news description |
| Diabetes Mellitus | Lupin Pharmaceuticals Inc | Metformin hydrochloride | Lupin announces settlement with Santarus and Depomed for Glumetza Patent Litigation |
| Hypertriglyceridemia | Pronova BioPharma ASA, GlaxoSmithKline plc | Omacor | US District Court Rules in Pronova BioPharma's Favour on Lovaza Patents |
| Non-Insulin-Dependent Diabetes Mellitus | Novo Nordisk Inc, Sun Pharmaceutical Industries Ltd., Depomed Inc, Santarus Inc, Mylan Inc | Victoza, Glumetza, Pioglitazone hydrochloride, Metformin hydrochloride | Depomed files patent infringement lawsuit against Watson |
Respiratory tract diseases
| Indication | Companies | Products | Top news description |
| Allergic Rhinitis | Merck & Co Inc | Nasonex | U.S. District Court Rules Against Merck in Nasonex Patent Lawsuit |
| Asthma | Mylan Inc | Levalbuterol hydrochloride | Mylan Announces Settlement Agreement in Litigation Relating to its Generic Xopenex |
| Chronic Obstructive Pulmonary Disease | Mylan Inc | -- | Mylan Announces Settlement Agreement in Patent Infringement Litigation Relating to Sunovion's Brovana Product |
| Infant Respiratory Distress Syndrome | Cornerstone Therapeutics Inc | Curosurf | Court Orders Dismissal of Curosurf Case |
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