Imagine That IP Law Blog

The Bayh-Dole Act, officially known as the Patent and Trademark Law Amendments Act, was enacted in 1980 as a United States federal law. Its purpose is to establish a framework for the ownership and commercialization of intellectual property that arises from research and development (R&D) activities funded by the federal government.

Prior to the enactment of the Bayh-Dole Act, the U.S. government retained ownership of inventions resulting from federally funded research. However, this approach often led to the underutilization of these inventions, as the government lacked the ... Read More ›

In Amgen v. Sanofi (Case No. No. 21–757), the U.S. Supreme Court affirmed the lower courts’ holdings that Amgen’s patent claims to antibodies were invalid. These claims were claims 19 and 29 of U.S. Patent No. 8,829,165 and claim 7 of U.S. Patent No. 8,859,741.

The ‘traditional manner’ of antibody claim was to recite the epitope to which the antibody binds plus the effect of the binding. This has been the format since at least In Re Wands (858 F.2d 731) in 1988. For example, see claims 1 and 7 of Amgen’s U.S. Patent 8,859,741:

1. An isolated monoclonal antibody that binds to ... Read More ›

In Arbutus Biopharma Corporation, FKA Protiva Biotherapeutics, Inc. V. Modernatx, Inc., FKA Moderna Therapeutics, Inc. (Fed. Cir. 2020-1183, April 11, 2023), Moderna challenged claims 1–22 of Arbutus’ U.S. Patent No. 9,404,127 (the ’127 Patent) by Inter Partes Review. The Board found all challenged claims anticipated by U.S. Patent 8,058,069 (Yaworski). The Board’s determination of anticipation relied on inherency and the disclosure of documents incorporated by reference by both Yaworski and the ’127 Patent.

The ’127 Patent was directed to compositions of ... Read More ›

Regents of the University of Minnesota v. Gilead Sciences., Inc., CAFC 2021-2168

Gilead Sciences filed a petition for Inter Partes Review (IPR) against the University of Minnesota’s U.S. patent No. 8,815,830 (the ’830 Patent). Gilead challenged claims 1-9, 11-21, and 23-28 of the ’830 Patent, and alleged that they are anticipated by U.S. pre-grant publication No. 2010/0016251 (Sofia). The Patent Trial and Appeal Board (PTAB) held that the Challenged Claims were anticipated, and the University of Minnesota appealed to the Court of Appeals for the Federal Circuit.

The ... Read More ›

Astrazeneca v. Mylan (Fed. Cir. 2021) 2021-1729

AstraZeneca AB and AstracZeneca Pharmacueticals LP (AstraZeneca) sued Mylan Pharmaceuticals Inc. and Kindeva Drug Delivery L.P. (Mylan) for infringement of every claim of each of U.S. Patent Nos. 7,759,328 (the ’328 Patent); 8,143,239 (the ’239 Patent); and 8,575,137 (the ’137 Patent). These patents are listed in the U.S. FDA “Orange Book” as the patents covering AztraZeneca’s Symbicort® pMDI and Symbicort® Turbohaler, and Mylan obtained an interest in an abbreviated new drug application (ANDA) seeking ... Read More ›

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 ›

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 ›

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 ›

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 ›

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 ›

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 ›

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 ›