C&EN’s article on Dr. Du Bois’s synthesis of (-)-Batrachotoxin caught my Eye. I once took care of a few poison dart frogs for a friend while he was travelling. Feeding them fruit flies was actually fun. Naturally I checked to see what patents have issued.
Check out: “Batrachotoxin analogues, compositions, uses, and preparation thereof”
US 9090627 B2
The Patent Trial and Appeal Board upheld US Patent 8,642,012 “Methods of Treatment Using AmmoniaScavenging Drugs” owned by Horizon Therapeutics LLC, which claims methods for treating a patient having a urea cycle disorder using a phenylacetic acid (PAA) prodrug [Glycerol phenylbutyrate (Ravicti®)]. Par Pharmaceutical Inc. and Lupin Ltd. had challenged the claims on obviousness grounds.
Claim 1. A method of treating a patient having a urea cycle disorder comprising (a) determining a target urinary phenylacetyl glutamine (PAGN) output (b) calculating an effective initial dosage of phenylacetic acid (PAA) prodrug selected from glyceryl tri-[4phenylbutyrate] (HPN-100) and phenylbutyric acid (PBA) or a pharmaceutically acceptable salt of PBA, wherein the effective dosage of PAA prodrug is calculated based on a mean conversion of PAA prodrug to urinary PAGN of about 60%; and (c) administering the effective initial dosage of PAA prodrug to the patient.
The USPTO, provides an example of a patent-eligible claim for a process of hydrolyzing fat molecules into free fatty acids and glycerol without using conventional methods (at the time of invention) of steam distillation with lye or sulfuric acid. [May, 2016]
May 2016 Update: Subject Matter Eligibility Examples: Life Sciences (May 6, 2016)
The USPTO based the following “patent eligible” claim on technology from US Patent 11,766, which was upheld by the Supreme Court in Tilghman v. Proctor, 102 U.S. 707 (1881). Although the case is very old, the USPTO notes that Supreme Court has subsequently described the decision as upholding the eligibility of process claims containing a law of nature. See, e.g., Parker v. Flook, 437 U.S. 584, 590-91 and n.12 (1978); Gottschalk v. Benson, 409 U.S. 63, 70 (1972).
Claim 1. A process for obtaining free fatty acids and glycerol from fat comprising:
(a) mixing substantially equal quantities of fat and water in a closed vessel; and
(b) heating the mixture to an elevated temperature of at least 600 degrees Fahrenheit under sufficient pressure to prevent the formation of steam in the closed vessel; and maintaining the elevated temperature for at least 10 minutes.
Although the claim is founded upon a chemical principle relating to neutral fats, the claim is eligible because, it is not attempting to tie up the chemical principal so that others cannot practice it. Even if the claim were directed to a judicial exception, the claim amounts to something “significantly more” than any exception. The claim would amount to something “significantly more” because the claim recites specific unconventional steps.
Chemical & Engineering News (C&EN) published a news update about a 57% increase in patent activity over the past 5 years for fighting fungal wilt known as Panama disease. Chemical Abstracts Service searched the HCAplus database on STN with a result of 510 patents since 2010 that mention Fusarium oxysporum. C&EN notes that Azole-based fungicides continue to dominate the fight and included BASF patent application publication WO 2015/181009 as an example.
“New Weapons in the Fight against Fungal Wilt”
Chemical & Engineering News, Vol. 44, page 11, November 7, 2016.
http://cen.acs.org/articles/94/i43/New-weapons-fight-against-fungal.html
To obtain a valid patent, does an inventor need to know why his invention works? Hal Wegner reminds us in his blog that the answer is “no.”
Going back a bit to 1911, the Supreme Court in Diamond Rubber stated:
“A patentee may be baldly empirical, seeing nothing beyond his experiments and the result ***. It is certainly not necessary that [the inventor] understand or be able to state the scientific principles underlying his invention ***.”
Diamond Rubber Co. v. Consol. Rubber Tire Co., 220 U.S. 428, 435–36 (1911) (citations omitted)
If you have invented a new compound, the new compound must be “useful.” You may still be able to get a patent on it even if you haven’t nailed down its mechanism of action. You may show that is useful in an enzymatic assay. But you do not need to prove exactly how or where the molecule binds to the target enzyme.
The United States Patent and Trademark Office (USPTO) published a proposed rule for recognizing privileged communications between clients and non-attorney patent agents and forgein patent practitioners at the Patent Trial and Appeal Board (PTAB).
This new rule, however, will not affect the duty of disclosure and candor before the Office under 37 CFR 1.56.
The Office is soliciting comments from the public on this proposed rulemaking. Written comments must be received on or before December 19, 2016 to ensure consideration.
The Amphastar case is concerned with the § 271(e)(2) Hatch-Waxman “safe harbor.”
35 U.S.C. § 271(e)(1) [Hatch-Waxman Act safe harbor] states that it “shall not be an act of infringement to … use … a patented invention … solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs[.]”
Amphastar and others petitioned the Supreme Court on May 17, 2016 presenting the question: “Whether the safe harbor protects a generic drug manufacturer’s bioequivalence testing that is performed only as a condition of maintaining FDA approval and is documented in records that must be submitted to the FDA upon request.”
The Supreme Court denied Certiorari on October 3, 2016. [Order List]
Amphastar argued that the US Court of Appeals for the Federal Circuit (CAFC) interpreted the Safe Harbor provision of § 271(e)(1) too narrowly. The CAFC denied Amphastar safe harbor immunity from Momenta’s patent covering the only approved test for showing bioequivalence of Lovenox.
Amphastar Pharmaceuticals, Inc., et al. v. Momenta Pharmaceuticals, Inc., et al., No. 15-1402
—————————————
Battle of Lovenox Generics Brought to Supreme Court [Bloomberg BNA 5/20/2016]
Cert. Petition:No. 15-1402 (May 17, 2016)
Amerigen Pharmaceuticals, Ltd and Alembic Pharmaceuticals Limited are challenging the claims of U.S. Patent No. 6,858,650 as being obviousness under 35 U.S.C. § 103(a). Amerigen and Alembic each filed their own petition and seek to join in the IPR of Mylan Pharmaceuticals, Inc.et al. v. UCB Pharma GmbH, Case IPR2016-00510, which the Patent Trial and Appeal Board (PTAB) has already issued its Decision instituting Inter Partes Review (IPR) in January, 2016. The PTAB said in its decision that UCB Pharma GmbH’s patents, licensed to Pfizer for Toviaz, are likely obvious because the compounds used are too similar to Pfizer’s drug Detrol. TOVIAZ® (fesoterodine fumarate) succeeded DETROL ® (tolterodine tartrate) as the company’s branded incontinence treatment.
Patent at Issue:
U.S. Patent No. 6,858,650 (“Stable salts of novel derivatives of 3,3-diphenylpropylamines,” issued February 22, 2005).
Claim 1: Generic structure for the covered molecules: derivatives of 3,3-diphenylpropylamines
Claims 2-5: Specify the type of compatible acid, specify chirality, and specify substitutions and salt forms.
Claim 5: R-(+)-2-(3-(diisopropylamino- 1-phenylpropyl)-4-hydroxymethyl-phenyliobutyrate ester hydrogen fumarate (commonly referred to as fesoterodine fumarate).
Claims 21-24: recite methods of use.
http://www.patentdocs.org/2016/09/ptab-life-sciences-report-1.html
http://www.law360.com/articles/820997/mylan-wins-ptab-review-of-pfizer-s-toviaz-patents
I created this site on August 27, 2016. Please Join me as I build it into a resource for organic chemistry patents.
