• Posts by Douglas J. Bucklin, Ph.D.
    Senior Attorney

    Doug is a science minded patent attorney and represents clients in the pharmaceutical, life science, agriculture, and chemistry industries. He has substantial experience in domestic and foreign patent prosecution ...

$1.1 Billion Dollars Washed Down the Written Description Drain

Juno Therapeutics v. Kite Pharma

Kite Pharma appealed a final judgement that (1) claims 3, 5, 9, and 11 of U.S. Patent No. 7,446,190 (the ’190 Patent) are not invalid for lack of written description or enablement, (2) the ’190 patent’s certificate of correction is not invalid, and (3) Juno Therapeutics, Inc., and Sloan Kettering Institute for Cancer Research (collectively, Juno) were entitled to $1,200,322,551.50 in damages. Let that sink in. $1,200,322,551.50 in damages.

The ’190 Patent related to CAR T-cell Therapy. T-cells are part of your immune system, and have ... Read More ›

Safe Harbors Can be Breached — Skinny Labeling, Drugs, and Patent Infringement

GlaxoSmithKline v. TEVA
Fed. Cir

Patent and U.S. Food and Drug Administration practices are complex. But these two fields were further complicated by meshing them together in a design intended to both (1) reward drug innovators but then (2) insure that cheaper, generic versions of drugs hit the market quickly after the innovator patents expired. One aspect of this tangled net of highly specialized legal fields was brought to light in the recent case GlaxoSmithKline v. Teva, 2018-1976, 2018-2023 (Fed. Cir., August 15, 2021). This post covers only a small, but still complicated ... Read More ›

Posted in: Patents

Royalties Over Lupus Treatment Terminated by Patent Disclaimer 

GLAXO GROUP LIMITED and HUMAN GENOME SCIENCES, INC. v. DRIT LP (Delaware Supreme Court, March 3, 2021, N16C-07-218).

Sophisticated parties will be held to the agreements they negotiate, and the implied covenant of good faith will not negate an unrestricted contractual right.

Background
Lupus, or systemic lupus erythematosus, is an autoimmune disease in which a person’s own immune system turns on it and destroys healthy tissue. Patients suffering from Lupus have “intense B-cell activation.” That is, their immune systems are overcharged, and one type of immune cell, the ... Read More ›

Posted in: Patents

Remdesivir Versus Designated Survivor: Life Imitating Art

Fiction and reality collide. The Netflix series Designated Survivor included a story line about a viral outbreak in Louisiana; a devastating pandemic was looming. Fictional president Tom Kirkman learns that the fictional cancer drug Extasis, being developed by fictional Pharm. Co. Benevax, showed promise to defeat the virus. Fictional CEO Carlton Mackie and the fictional President had a heated exchange in the oval office where Carlton Mackie ineptly tried to explain the economics of drug development. The fictional President chewed him out, and then used a political strategy to ... Read More ›

Posted in: Patents

Pharma Formulations – Patentability and Obviousness

In Valeant Pharmaceuticals International, Inc. v. Mylan Pharmaceuticals, Inc., the Federal Circuit reversed the District Court of New Jersey’s grant of summary judgement in favor of Valeant that claim 8 of U.S. Patent 8,552,025 (the ‘025 patent)  owned by Valeant.

The message is clear for pharmaceutical formulation patents. To establish a prima facie cases of obviousness, compounds having similar structure and function can be used as the basis for establishing similar properties.Read More ›

Posted in: Patents

In Arthrex, Inc. v. Smith & Nephew, Inc., Arthrocare Corp., No. 2019-2140 (Fed. Cir. October 31, 2019), the Federal Circuit raised Patent Owners’ hopes that inter partes review (IPR) of patents could potentially be constitutionally defective, based on how Patent Trial and Appeal Board (PTAB) judges are appointed. But the court then dashed those hopes by curing the constitutional defect in the statute controlling Administrative Patent Judge (APJ) appointment. For those accused of patent infringement, breathe easy; IPRs survive and can be used to minimize the threat of patents.Read More ›

Posted in: IP Litigation

OSI Pharmaceuticals, LLC (OSI) discovered and patented a method of treating non-small cell lung cancer (NSCLC). See US Patent No. 6,900,221. The method comprises administering a therapeutically effective amount of erlotinib to an NSCLC patient. Apotex Inc. (Apotex) challenged OSI’s patent by filing a petition for Inter Partes Review (IPR) at the United States Patent and Trademark Office (USPTO). Three references were produced during the IPR, as follows:

(1) The reference “Schnur” disclosed erlotinib along with 104 other different compounds, as potent inhibitors of a ... Read More ›

Posted in: Patents

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