Patent Baristas

Some readers have asked why there is a pediatric exclusivity add-on for FDA approvals. These exclusivity extensions are provided under the Food and Drug Administration Modernization Act of 1997, section 505A of the Federal Food, Drug and Cosmetic Act (21 U.S.C. § 355(a)), which permits certain new drug applications to obtain an additional six months […]

The CAFC finally shot down Pfizer’s Norvasc® patent after it filed suit against Apotex alleging infringement stemming from Apotex’s filing an Abbreviated New Drug Application (“ANDA”) seeking approval to commercially sell amlodipine besylate tablets before the expiration of the term of U.S. Patent No. 4,879,303. Pfizer, Inc. v. Apotex, Inc. (f/k/a Torpharm) (2006-1261; Decided March […]

Earlier, the USPTO published an Official Gazette notice in November of 1996 providing a partial waiver of the requirements for restriction and for unity of invention determinations. The 1996 Notice permitted examination of a reasonable number (reasonable being normally up to ten, independent and distinct molecules). Now, in their quest to reduce patent application pendency […]

I have been tagged by Colin Samuels of the Infamy or Praise blog to continue a meme-tag that has been circulating about.   Actually, I was tagged a bit ago but am just catching up on some loose ends. OK, in the interest of collegiality, here are five things you probably didn’t know about me: I  have a […]

Harvard Drug Group has filed an antitrust class action suit against Purdue Pharma alleging an unlawful scheme to maintain its monopoly in the U.S. for its brand name prescription drug OxyContin CR, the notorious opioid analgesic prescribed to treat moderate to severe pain.  OxyContin CR (oxycodone hydrochloride) is a controlled release formulation.  (Harvard Drug Group […]

In 2004, Tercica, a licensee under a Genentech patent for a growth hormone, filed suit against Insmed in the U.K. alleging infringement of EP patent No. 571,417, or the ‘417 patent. The ‘417 patent has claims directed to particular uses of a combination of IGFBP-3 and IGF-1. In the complaint, Tercica asked the court for an […]

On March 8, a Senate committee will hold initial hearings on legislation that would establish a process for the U.S. Food and Drug Administration to approve biogenerics (generic versions of biologic drugs known as biosimilars). On average, the FDA approves one new generic version of a conventional (small molecule-type) drug per day but it lacks […]

The European site Rated-Patent Exchange (RPE) takes a new approach from the regular patent auction sites in they claim that the power of public patent databases is leveraged. The system allows a so-called Seeker to anonymously request a patent asset from a Holder. Therefore, a Seeker does not need to wait until a patent incidentally […]