Royalty Report: Drugs, Cancer, Disease – Collection: 204382

License Grant

The Licensor and the Licensee wish to resolve the dispute regarding Licensees Commercially Reasonable Efforts to Develop the controlled release formulation of anagrelide by making certain amendments to the License Agreement.  Anagrelide is a treatment for thrombocythemia – the overproduction of blood platelets.

License Property

Essential thrombocythemia (ET) is a rare chronic blood condition characterised by the overproduction of platelets by megakaryocytes in the bone marrow.  Essential thrombocythemia (ET) is one of a related group of blood cancers known as “myeloproliferative neoplasms” (MPNs) in which cells in the bone marrow that produce the blood cells develop and function abnormally. … ET does not generally shorten life expectancy.

The Licensor is a biotechnology company, developing and commercializing drugs and devices for the control of hyperplasia associated with vascular procedures and control of cardiovascular risk factors.

Field of Use

The Licensee designs and develops active ingredient anagrelide, GALE-401 (Anagrelide CR) used for treatment of Essential Thrombocythemia.

License Grant

Licensor hereby grants to Licensee and its Affiliates an exclusive license, with the right to sublicense, under the Licensor Technology to make, have made, use, sell, offer for sale, import, and export Products in the Field in the Territory.

License Property

Licensor has developed and owns or controls certain intellectual property rights with respect to a controlled release formulation of anagrelide.

Licensor Patents means (a) those Patents set forth hereto (the Initial Licensor Patents); (b) any other Patents owned, licensed, or controlled by Licensor or any Affiliate thereof, or subject to an obligation of assignment to Licensor or any Affiliate thereof, Covering or relating to any portion of the Technology; (c) any additions, divisionals, continuations, continuations-in-part, conversion, supplemental examinations, extensions, term restorations, registrations, re-instatements, amendments, reissuances, corrections, substitutions, re-examinations, registrations, revalidations, supplementary protection certificates, renewals, and foreign counterparts of the Initial Licensor Patents or the Patents described in (b) above, and any other Patents owned, controlled, or licensed by Licensor claiming priority to any of the foregoing or any of the Patents referenced in clause (a) or (b) above; and (d) all patents issuing from any of the Patents mentioned in clause (a), (b), or (c) above and any foreign counterparts of any such Patents, and which shall include, in any case, patents surviving post grant review and inter partes review.

US patent 6,585,995  Methods and compositions for treating platelet-related disorders
US Patent Application 20130022671

Product means a product that is Covered by one or more Licensor Patents in any country in which such product or any part thereof is made, used, or sold.

Licensor Technology means the Licensor Know-How and the Licensor Patents.

Patent(s) means any granted or issued patents and pending patent applications, together with all additions, divisionals, continuations, continuations-in-part, substitutions, reissues, re-examinations, supplemental examinations, patents reviewed under post grant review or inter partes review, extensions, registrations, patent term extensions, revalidations, supplementary protection certificates, and renewals of any of the foregoing, and all foreign applications and patents corresponding to or claiming priority from any of the foregoing.

Field of Use

GALE-401 contains the active ingredient anagrelide, an FDA-approved product, which has been in use since the late 1990s for the treatment of essential thrombocythemia (ET).

Essential thrombocythemia (ET) is a rare chronic blood cancer (myeloproliferative neoplasm) characterised by the overproduction of platelets (thrombocytes) by megakaryocytes in the bone marrow.

Cardiovascular Field means the direct prevention, treatment, diagnosis of myocardial infarction, strokes and peripheral arterial disease in humans or other animals. For sake of clarity the Cardiovascular Field will not include the prevention, treatment or diagnosis of conditions that may ultimately lead to a decrease in the risk of thrombotic events, such as Myeloproliferative Disorders and other hematological indications.

License Grant

The license agreement has the Primary Licensor granting an exclusive worldwide license to the Primary Licensee.  Royalties associated with this license are marked confidential and not available other than a stated range. In the termination clause, royalty rate information is available for the cross license. The Primary Licensee is now the Licensor and shall be deemed without any further action to have granted to Licensee (was Primary Licensor) a non-exclusive, worldwide, royalty-bearing license (including the right to grant sublicenses), under the know-how and patents controlled by Licensor (formerly Licensee) on the effective date of termination solely covering inventions (1) conceived and reduced to practice by Licensor (formerly Licensee) solely in connection with the Development of the Product and (2) necessary to make, use and sell Product, for use by Licensee as reasonably necessary to develop, have developed, make, have made, use, have used, offer for sale, sell, have sold, import and have imported the Products.   This grant clause becomes effective if the original license is terminated and the clause is a commitment that the Primary Licensor (now Licensee) pay royalties to the Primary Licensee (now Licensor).

License Property

Licensee (formerly Licensor) has developed and owns or controls certain intellectual property rights with respect to a controlled release formulation of anagrelide, among other things, and owns or controls certain know-how, technology, documentation, data, and other materials relating thereto.

The license cites the following as relevant: US patent 6,585,995 B1; US Patent Application 20130022671; Issued UK Patent GB 2462022B; Issued UK Patent GB 2460915B; PCT/US2009/003632 (Publication No. WO 2010/005480)

US patent 6,585,995 B1
US Patent Application 20130022671
Issued UK Patent GB 2462022B
Issued UK Patent GB 2460915B
PCT/US2009/003632 (Publication No. WO 2010/005480) and related regional and national applications

Field of Use

The Cardiovascular Field means the direct prevention, treatment, diagnosis of myocardial infarction, strokes and peripheral arterial disease in humans or other animals. For sake of clarity the Cardiovascular Field will not include the prevention, treatment or diagnosis of conditions that may ultimately lead to a decrease in the risk of thrombotic events, such as Myeloproliferative Disorders and other hematological indications.

Myeloproliferative disorders is the name for a group of conditions that cause blood cells, platelets, white blood cells, and red blood cells, to grow abnormally in the bone marrow.

License Grant

This exclusive license agreement with Licensee is to commercialize fostamatinib in all indications, including chronic ITP, AIHA, and IgAN, in Europe and Turkey.  Licensee will receive exclusive rights to fostamatinib in human diseases, including chronic immune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), and IgA nephropathy (IgAN).

License Property

Fostamatinib refers to fostamatinib disodium hexahydrate which is an oral spleen tyrosine kinase (SYK) inhibitor, for the treatment of adult patients with chronic ITP who have had an insufficient response to a previous treatment (product called TAVALISSE®)

The Licensor is a biotechnology company dedicated to discovering, developing and providing novel small molecule drugs that significantly improve the lives of patients with immune and hematologic disorders, cancer and rare diseases. The pioneering research focuses on signaling pathways that are critical to disease mechanisms.

Field of Use

Fostamatinib is a medication for the treatment of chronic immune thrombocytopenia.

Adult chronic immune thrombocytopenic purpura (chronic ITP) is an autoimmune disorder in which patients produce antiplatelet autoantibodies and specialized white blood cells that destroy their blood platelets and, in some cases, damage their megakaryocytes (the cells that produce platelets in the bone marrow), causing a decrease in platelet production. This results in a low blood platelet count (thrombocytopenia) that may produce bruising or excessive bleeding.