Royalty Report: Drugs, Therapeutic, Chemicals – Collection: 172754

Polyethylene glycol (PEG) is a polyether compound with many applications from industrial manufacturing to medicine

Licensor Patents

. U.S Patent No. 5,468,478, entitled 'Conjugates of Superoxide Dismutase Coupled to High Molecular Weight Polyalkylene Glycols, issued November 21,   1995.

. U.S Patent No. 5,283,317, entitled 'Intermediates for Conjugation of Polypeptides With High Molecular Weight Polyalkylene Glycols, issued February 1, 1994.

. U.S Patent No. 5,080,891, entitled 'Conjugates of Superoxide Dismutase Coupled to High Molecular Weight Polyalkylene Glycols, issued January 14,   1992.

. U.S Patent No. 5,006,333, entitled 'Conjugates of Superoxide Dismutase   Coupled to High Molecular Weight Polyalkylene Glycols, issued April 9, 1991.

.  U.S. Patent No. 5,468,478, entitled 'Conjugates of Superoxide Dismutase
   Coupled to High Molecular Weight Polyalkylene Glycols, issued November 21,
   1995;

.  U.S. Patent No. 5,283,317, entitled 'Intermediates for Conjugation of
   Polypeptides With High Molecular Weight Polyalkylene Glycols, issued February
   1, 1994;

.  U.S. Patent No. 5,080,891, entitled 'Conjugates of Superoxide Dismutase
   Coupled to High Molecular Weight Polyalkylene Glycols, issued January 14,
   1992;

.  U.S. Patent No. 5,006,333, entitled 'Conjugates of Superoxide Dismutase
   Coupled to High Molecular Weight Polyalkylene Glycols, issued April 9, 1991.

Licensor shall grant a sole license, with the right to grant sublicenses, under those rights Licensor has to the Enzon Patents, solely to develop, make, have made, use, import, offer for sale and sell in the territory that version of the Product that uses Reagent to covalently bond to the active molecule in Licensees-001 Product and has a branched backbone structure with two (2) arms and a molecular weight of 40K daltons.

Licensor shall grant, for the sole purpose of, and with respect to and only with respect to, the manufacture, use, sale, offer for sale, and importation in the territory of that version of the Product that uses Reagent to covalently bond to the active molecule in Licensees-001 and has a branched backbone structure with two (2) arms and a molecular weight of 40K daltons, a non-exclusive license under those rights Licensor has to patents or patent applications ( other than the Enzon Patents) owned or controlled by Enzon or the Enzon affiliates; and all patent claims owned or controlled by Enzon or the Enzon affiliates that are not within the Enzon Patents;  issue from any patent application filed after January 7, 2002; and claim the composition, manufacture, or use of that version of the Product that uses Reagent to covalently bond to the active molecule in Licensees-001 and has a branched backbone structure with two (2} arms and a molecular weight of 40K daltons.

For the Manufacture and Supply of the Reagent Exclusivity, Licensor will manufacture and supply one hundred percent (100%) of Licensees, its affiliates and sublicensees purchase requirements of the Reagent for the manufacturing of the Product.  Licensee, its affiliates and sublicensees will purchase the Reagent exclusively from Licensor for the manufacture of the Product.

The license granted excludes patent claims owned or controlled by Enzon or the Enzon affiliates that claim the composition of matter of an un-pegylated active molecule, methods of making an un-pegylated active molecule, or methods of using an un-pegylated active molecule (other than a claim to a method of pegylating an unpegylated active molecule), even if such active molecule is contained in or is part of the Product.

PEG shall mean poly (ethylene glycol).  Pegylation / Pegylated, shall mean covalent chemical bonding of polyethylene glycol.

Product shall mean a product produced by linking Licensees-001 to the Reagent.  Licensees-001 is a vascular endothelial growth factor antagonist.

Reagent shall mean N-Hydroxysuccinimide ester of bis-<Methoxypoly(ethylene glycol} MW 20.0000}-modified lysine (mPEG2NHS 40K}.

Technology relates to the pegylation of Macugen that occurs by linking a reagent supplied by Licensor to the active pharmaceutical ingredient.

Licensor shall grant to Licensee, until the last-to-expire valid patent claim of Enzon Patents, a sole license (with the right to grant sublicenses) under those rights Licensor has to the Enzon Patents, solely to develop, make, have made, use, import, offer for sale and sell in the territory that version of the Product that incorporates Reagent as covalently bonded to the Therapeutic Agent and has a branched backbone structure with two (2) arms and a molecular weight of 40K daltons. Such license shall be subject to the retained rights of Enzon and the Enzon affiliates to practice all the inventions described and claimed in the Enzon Patents for the conduct of research and development (such purposes not including in connection with human clinical trials) of pharmaceutical products that it is developing either itself, with its affiliate, or in conjunction with a third party.

Licensor shall grant to Licensee, for the sole purpose of, and with respect to and only with respect to, the manufacture, use, sale, offer for sale, and importation in the territory of that version of the Product that uses Reagent to covalently bond to the Active Molecule in the Therapeutic Agent and has a branched backbone structure with two (2) arms and a molecular weight of 40K daltons, a non-exclusive license under those rights Licensor has

US Patent 5,932,462 – Multiarmed, monofunctional, polymer for coupling to molecules and surfaces

Product shall mean Licensee’s lead compound known as of the Effective Date as El0030, the structure of which is set forth in the agreement and which is, a product produced by linking the Therapeutic Agent to the Reagent by means of Pegylation.

EI0030 is a pegylated aptamer containing 32 monomeric units (32-mer) arranged as a linear sequence of three oligonucleotide segments connected by non-nucleotide hexaethylene glycol spacers. The aptamer terminates in a hexylamino linker to which two 20-kilodalton monomethoxy polyethylene glycol units are covalently attached via the two amino groups on a lysine residue.

Reagent shall mean N-Hydroxysuccinimide ester of bis-(Methoxypoly(ethylene glycol) MW 20,0000)-modified lysine (mPEG2NHS 40K).

Peglation, with correlative meanings “Pegylated” or to “Pegylate”, means covalent chemical bonding of any poly (ethylene glycol) reagent (including the Reagent and including covalent chemical bonding through linking groups) with or to another material or materials. Such materials include, without limitation, proteins, peptides, oligonucleotides, other biomolecules, small molecules, therapeutic agents (including the Therapeutic Agent), diagnostic agents, imaging agents and detectable labels. Additional materials that may be Pegylated include without limitation, polymers, liposomes, films, chemical separation and purification surfaces, solid supports, metal/metal oxide surfaces and other surfaces such as, by way of example but not limitation, those on implanted devices, and equipment, where a poly (ethylene glycol) reagent (including the Reagent) is covalently chemically bonded to one or more reactive molecules on the surface of such device or equipment. “PEGYLATION” shall include the synthesis, derivatization, characterization, and modification of PEG for such purposes, together with the synthesis, derivatization, characterization, and modification of the raw materials and intermediates for the manufacture of poly (ethylene glycol) reagents (including the Reagent) or products (including the PRODUCT) incorporating such poly (ethylene glycol) reagent by means of covalent chemical bonding, and all methods of making and using each and all of the foregoing.

Enzon Patents shall mean (a) all patent applications owned or controlled by Enzon or affiliates that were affiliates of Enzon as of January 7, 2002 (Enzon affiliates) that pertain to Pegylation and that claim the composition, manufacture, or use of the product that (i) have issued on or before January 7, 2002, or (ii) issue from any patent application included in claue (a) of this definition. The Enzon Patents include those listed but not limited.
US Patent 5,643,575 – Non-antigenic branched polymer conjugates

Fovista® is an anti-PDGF agent administered in combination with anti-vascular endothelial growth factor (anti-VEGF) therapy for the treatment of neovascular age-related macular degeneration (or wet AMD).

The Licensor PEG Patent Rights means those patents and patent applications directed to the conjugation of interleukin-2 to a water soluble polymer selected from polyethylene glycol homopolymers or polyoxyethylated polyols.

The Licensed Licensee IL-2 Product means any product, including hybrids, conjugates and formulations, containing, by molecular combination or admixture, Roche IL-2 as the only interleukin-2 ingredient, the manufacture, use or sale thereof.

The Licensed Licensee PEG IL-2 Product means any product, including hybrids, conjugates and formulations, containing, by molecular combination or admixture, licensee IL-2 as the only interleukin-2 ingredient, the manufacture, use or sale thereof.

Licensor grants exclusive licenses, exclusive even to Licensor, under the Licensor Patent Rights the Existing Know-How and the Licensor Development Know-How, to use and sell Agreement Product in the Territory, with the right to sublicense Licensees Affiliates or third parties and to make and have made Agreement Product, with the right to sublicense Licensees affiliates.

The patent(s) and products relate to anti-virals.

Intron A belongs to a group of drugs called interferons. This medication works by stopping viruses from dividing and by triggering our immune system to kill invading pathogens or tumors.

Intron A is a prescription medication used to treat chronic hepatitis B, chronic hepatitis C, certain type of genital warts, hairy cell leukemia, malignant melanoma, AIDS-related Kaposi's sarcoma, and follicular lymphoma.