Interferon For Treatment of Melanoma

Objective

Primary objective of the study was to perform a prior art search on usage of interferon for the treatment of melanoma.

To achieve our objective we performed following steps:

• Created a multi level taxonomy to categorize the patents using interferon for melanoma treatment

• Marked out relevant IPC, ECLA, US classes and Japanese F-term available for technology in question.

• Identified and clubbed relevant keywords with classes to extract relevant patents.

• Checked for patents in US, EP, PCT, JP, Great Britain, and German patent records

• Performed MPI-INPADOC search which cover bibliographic data for 71 countries and legal status for 42 countries

• Analyzed the patents and prepared an IPmap covering relevant patents for client usage.

Overview

Interferon

Interferon Source

Interferons (IFNs) are natural cell-signaling proteins produced by the cells of the immune system of most vertebrates in response to challenges such as viruses, parasites and tumor cells. They belong to the large class of glycoproteins known as cytokines and are produced by a wide variety of cells in response to the presence of double-stranded RNA, a key indicator of viral infection. Source

Interferons assist the immune response by inhibiting viral replication within host cells, activating natural killer cells and macrophages, increasing antigen presentation to T lymphocytes, and increasing the resistance of host cells to viral infection. There are 3 known classes of interferons; type I, type II and type III. All classes are very important in fighting viral infections. Recent studies have shown that Interferon can also help stop the growth and spread of cancer cells. Source

Melanoma

Melanoma is the most serious type of skin cancer. It begins in skin cells called melanocytes. Melanocytes are the cells that make melanin, which gives skin its color. Melanin also protects the deeper layers of the skin from the sun's harmful ultraviolet (UV) rays.When people spend time in the sunlight, the melanocytes make more melanin and cause the skin to tan. This also happens when skin is exposed to other forms of ultraviolet light (such as in a tanning booth). If the skin receives too much ultraviolet light, the melanocytes may begin to grow abnormally and become cancerous. This condition is called melanoma.People with melanoma who have one or more positive lymph nodes are at a high risk to have their melanoma recur. It is believed that 70 to 80% of these individuals will have their melanoma come back within the next three to five years. Source

Interferon for treatment of melanoma

Over the past several decades, the incidence of melanoma has increased at a faster rate than that of any other solid tumor. In the 1930s, the lifetime risk for a person living in the U.S. to develop melanoma was 1 in 1,500. Currently, that risk is 1 in 74, and for 2003 it was estimated that 51,400 cases of invasive melanoma would be diagnosed. While efforts to improve early diagnosis through education have resulted in the increased detection of early-stage melanoma, many patients still present with high-risk primary melanomas.

A beacon of hope in the treatment of melanoma has long been the observation that melanoma is susceptible to attack by the host’s immune system. This has resulted in the testing of a remarkably broad spectrum of immunotherapies, including the use of nonspecific immunostimulants, various approaches to vaccine therapies, and cytokine therapy. Many of these approaches failed to demonstrate a significant clinical impact, and the practitioner had been left with few options in treating high-risk melanoma patients with adjuvant therapy. One exception to this, however, has been the use of adjuvant interferon alpha (IFN-{alpha})

While the precise mechanism of action remains poorly understood, there are multiple antitumor effects of IFN-{alpha}. These include a direct antiproliferative effect, the enhancement of natural killer cell activity, and the upregulation of tumor antigens and/or HLA class I and class II antigens. Initial phase II clinical studies with IFN-{alpha} in metastatic melanoma showed response rates in the 10%–20% range [4, 5]. These response rates, while encouraging, were not significant enough to lead to its widespread use in the treatment of metastatic melanoma. Source

Taxonomy

Taxonomy

Class codes identified for searches

• Relevant IPC classes

IPC
Sr. No.	Class Code	Class definition	Class coverage
1	A61K003819	Medicinal preparations containing peptides - Cytokines; Lymphokines; Interferons	Broad
2	A61K003821	Medicinal preparations containing peptides Interferon	Specific
3	C07K001452	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof - Cytokines; Lymphokines; Interferons	Broad
4	C07K014555	Peptides having more than 20 amino acids - Interferon	Specific
5	C07K001456	Peptides having more than 20 amino acids - IFN-alpha	Specific
6	C07K014565	Peptides having more than 20 amino acids - IFN-beta	Specific
7	C07K001457	Peptides having more than 20 amino acids - IFN-gamma	Specific
8	A61P003500	Therapeutic activity of chemical compounds or medicinal preparations -antineoplastic agents	Broad

• Relevant ECLA classes

ECLA
Sr. No.	Class Code	Class definition	Class coverage
1	A61K003819	Medicinal preparations containing peptides - Cytokines; Lymphokines; Interferons	Broad
2	A61K003821	Medicinal preparations containing Interferon	Specific
3	A61K38/21A	Medicinal preparations containing IFN-alpha	Specific
4	A61K38/21B	Medicinal preparations containing IFN-beta	Specific
5	A61K38/21C	Medicinal preparations containing IFN-gamma	Specific
6	C07K001452	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof - Cytokines; Lymphokines; Interferons	Broad
7	C07K014555	Peptides having more than 20 amino acids - Interferon	Specific
8	C07K001456	Peptides having more than 20 amino acids - IFN-alpha	Specific
9	C07K014565	Peptides having more than 20 amino acids - IFN-beta	Specific
10	C07K001457	Peptides having more than 20 amino acids - IFN-gamma	Specific
11	C07K014715G	Receptors; Cell surface antigens; Cell surface determinants - for interferons -	Specific

• Relevant US classes

US class
Sr. No.	Class Code	Class definition
1	4240854	DRUG, BIO-AFFECTING AND BODY TREATING COMPOSITIONS - this subclass provides for patents which broadly claim interferon or a method of treatment of interferon where the classification of the interferon as alpha, beta or gamma interferon is impossible
2	4242811	DRUG, BIO-AFFCTING AND BODY TREATING COMPOSITIONS - Virus (e.g., interferon-inducing virus, etc.)
3	42400141	DRUG, BIO-AFFECTING AND BODY TREATING COMPOSITIONS - Attached to lymphokine, cytokine, or other secreted growth regulatory factor, differentiation factor, or intercellular mediator specific for a hematopoietic cell (e.g., interferon, interleukin, macrophage factor, colony stimulating factor, erythropoietin); derivative thereof
4	514889	DRUG, BIO-AFFECTING AND BODY TREATING COMPOSITIONS - INTERFERON INDUCER
5	530351	CHEMISTRY: NATURAL RESINS OR DERIVATIVES; PEPTIDES OR PROTEINS; LIGNINS OR REACTION PRODUCTS THEREOF - Lymphokines, e.g., interferons, interlukins, etc.
6	930142	PEPTIDE OR PROTEIN SEQUENCE - Interferon
7	4240851	LYMPHOKINE - Included in this and the indented subclasses interferon, interleukin and macrophage factors (monokines)
8	4240855	Gamma or immune: This subclass is indented under subclass 85.4. Subject matter in which the interferon is gamma or immune interferon.
9	4240856	Subject matter in which the interferon is beta or fibroblast interferon.
10	4240857	Subject matter in which the interferon is alpha or leukocyte interferon.

Intellectual property

Search strategy and concept

Date of Search: 1836 to October 26, 2009 Database used: Micropatent - Include extensive full text and MPI-Inpadoc searches

Search in Micropatent full text - English language search

Micro patent full text search allow search in fulltext of US, EP, PCT, Great Britain, and German patent records as well as the front page of JP documents. US, EP, and DE are covered at first publication and when granted.

Sr. No.	Search concept	Search Scope	Search reason	Class Code (IPC,US,ECLA)	Search query	No. of hits
1	Interferon for treating Melanoma	Title, Abstract and Claims	Specific classes of interferon AND melanoma keywords	A61K003821* OR C07K014555 OR C07K001456 OR C07K014565 OR C07K001457 OR C07K014715G OR 4240854 OR 4242811 OR 42400141 OR 514889 OR 530351 OR 930142	(Melanoma OR (Skin NEAR3 (cancer OR carcinoma OR tumor)) OR (Melanocyte* NEAR3 (cancer OR carcinoma OR tumor)))	576
2	Interferon for treating Melanoma	Title, Abstract and Claims	Broad classes of interferon AND melanoma, interferon keywords	A61K003819 OR C07K001452 OR 4240851 OR 4240855 OR 4240856 OR 4240857 OR A61P003500	(Melanoma OR (Skin NEAR3 (cancer OR carcinoma OR tumor)) OR (Melanocyte* NEAR3 (cancer OR carcinoma OR tumor)))	756
3	Final query	1 OR 2				1019 records 571 unique records

Search in Micropatent full text - Foreign language search

Micro patent full text search allow search in fulltext of US, EP, PCT, Great Britain, and German patent records as well as the front page of JP documents. US, EP, and DE are covered at first publication and when granted.

Sr. No.	Search concept	Language	Search Scope	Search reason	Class Code (IPC, ECLA)	Search query	No. of hits
1	Interferon for treating Melanoma	French	Title, Abstract and Claims	Specific classes of interferon AND melanoma’s foregin langugae keywords	A61K003821* OR C07K014555 OR C07K001456 OR C07K014565 OR C07K001457 OR C07K014715G	(mélanome or (Peau NEAR3 (Cancer or Carcinome or Tumeur)) OR (Mélanocytes Near3 (Cancer or Carcinome or Tumeur)))	184 hits
		German				(Melanom or (Haut NEAR3 (Krebs or Karzinom or Krebsgeschwür or Tumor or Geschwulst)) OR (Melanozyten Near3 (Krebs or Karzinom or Krebsgeschwür or Tumor or Geschwulst)))
2	Interferon for treating Melanoma	French	Title, Abstract and Claims	Broad classes of interferon AND melanoma’s and interferon’s foregin langugae keywords	A61K003819 OR C07K001452 OR A61P003500	(mélanome or (Peau NEAR3 (Cancer or Carcinome or Tumeur)) OR (Mélanocytes Near3 (Cancer or Carcinome or Tumeur)))	3375 hits
		German				(Melanom or (Haut NEAR3 (Krebs or Karzinom or Krebsgeschwür or Tumor or Geschwulst)) OR (Melanozyten Near3 (Krebs or Karzinom or Krebsgeschwür or Tumor or Geschwulst)))
3	Final query					1 OR 2	3422 hits (2023 unique records, 30-35 % relevant)

Search in Micropatent MPI-INPADOC - English language search

Micrpatent MPI-INPADOC search bibliographic data for 71 countries and legal status for 42. Only those patents were analyzed which have English title and/or abstract.

Sr. No.	Search concept	Search Scope	Search reason	Class search	Search query	No. of hits
1	Interferon for treating Melanoma	Title and Abstract	Specific IPC classes of interferon AND melanoma keywords	A61K03821 OR C07K014555 OR C07K01456 OR C07K014565 OR C07K01457	(Melanoma OR (Skin NEAR3 (cancer OR carcinoma OR tumor)) OR (Melanocyte* NEAR3 (cancer OR carcinoma OR tumor)))	174
2	Interferon for treating Melanoma	Title and Abstract	Broad IPC classes of interferon AND melanoma, interferon keywords	A61K03819 OR C07K01452 OR A61P03500	(IFN* OR *IFN OR interferon* OR *interferon OR huIFN) AND (Melanoma OR (Skin NEAR3 (cancer OR carcinoma OR tumor)) OR (Melanocyte* NEAR3 (cancer OR carcinoma OR tumor)))	484
3	Interferon for treating Melanoma	Title and Abstract	Specific ECLA classes of interferon AND melanoma keywords	A61K03821* OR C07K014555 OR C07K01456 OR C07K014565 OR C07K01457 OR C07K014715G	(Melanoma OR (Skin NEAR3 (cancer OR carcinoma OR tumor)) OR (Melanocyte* NEAR3 (cancer OR carcinoma OR tumor)))	102
4	Interferon for treating Melanoma	Title and Abstract	Broad ECLA classes of interferon AND melanoma, interferon keywords	A61K03819 OR C07K01452 OR A61P03500	(IFN* OR *IFN OR interferon* OR *interferon OR huIFN) AND (Melanoma OR (Skin NEAR3 (cancer OR carcinoma OR tumor)) OR (Melanocyte* NEAR3 (cancer OR carcinoma OR tumor)))	9
5	Final query				1 OR 2 OR 3 OR 4	587 hits 232 unique records

Search in Micropatent MPI-INPADOC - Foreign language search

Micrpatent MPI-INPADOC search bibliographic data for 71 countries and legal status for 42. Only those patents were analyzed which have English title and/or abstract.

Search in Japanese database

Database: IPDL (Industrial property digital library), Japan

Date of search: 1900/01/01 to 2009/10/26

Total patents: 846 (Relevancy ~10%)

• F-Terms and theme used in search

Japanese F-term search			Definition
Sr. No.	F- Term theme	4H045	Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
1	F-term	DA15	Peptide or protein characterised by function - Interferons
2	F-term	DA16	Alpha-interferons
3	F-term	DA17	Beta-interferons
4	F-term	DA18	Gamma-interferons

Sample patents

S.No.	Patent/Publication No.	Date of Publication	Assignee / Applicant	Inventor(s)	Title	Dolcera Summary
1	US7482014B2	1/27/2009	Schering Corporation	Rybak, Mary Ellen and Rose, Esther Helen	Melanoma therapy	The invention relates to a method of treating a patient having Stage IIB or Stage III melanoma which has been surgically removed. A first dose of 6.0 micrograms/kg of pegylated interferon alpha-2b once a week for eight weeks, and then administering to the patient a second dose of 3.0 or less micrograms/kg of pegylated interferon alpha-2b once a week for the remainder of a five year treatment period.
2	US5997858A	12/7/1999	Pharma Pacific Pty Ltd.	Tovey, Michael Gerard and Kaido, Thomas James	Stimulation of host defense mechanisms against tumors	A method for treating multiple myeloma, hairy cell leukemia, malignant melanoma, brain tumors etc. by administering a therapeutically effective amount of an interferon (1500 IU to about 20×106 IU for a 70 kg man per day) via oromucosal contact.
3	EP288055A1	10/26/1988	MERRELL DOW PHARMACEUTICALS INC.	Sunkara, Sai P.	Use of ODC inhibitors, dacarbazine, and interferon, in the treatment of malignant melanoma	A combinational therapy containing an ornithine decarboxylase inhibitor, Interferon and Dacarbazine for simultaneous, separate or sequential use in treating rapidly-proliferating cell-growth disease such as melanoma.
4	EP241242A1	10/14/1987	CETUS ONCOLOGY CORPORATION	Rudolph, Alfred	The use of interferon-beta and interleukin-2 for combination therapy and compositions therefor	A composition comprising of a mixture of lFN- beta and IL-2 for administration to human patients for therapeutic or prophylactic treatment of cancer such as colon cancer, melanoma, renal cell cancer, lung cancer.