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The impact of gene patents on fostering innovation is a highly debated topic. Several compelling arguments have been put forward to support the notion that gene patents will promote innovation and banning gene patents will hamper current and future investments that may affect the development of future patient care products ((1). Further, the long-term effects of gene patents in innovation and research have been considered as myths (2). On the contrary, we believe granting patent rights to any naturally occurring biomolecules, such as genes, proteins or metabolites or nucleic acids (like miRNA), that are relevant to biomedical applications may hamper future innovations in developing cost-effective patient care products and services.

Gene patents are discoveries, not inventions – patenting discoveries may hamper scientific innovations

It is a well known fact that genes, proteins and other biomolecules present in humans or any other living organisms are naturally occurring and cannot be patented. The question is, whether naturally occurring genes or recombinant genes isolated from natural environment can be considered as a patentable invention? Several scientific aspects, excluding legal interpretations that will not be discussed in this blog, need to be considered to answer this question. The foremost argument is isolation and functional characterization of a gene is a discovery, it is not an invention. If discoveries are considered as patentable inventions, not only scientific discoveries are at stake but also it will hamper scientific knowledge based innovations that may lead to the development of innovative and low-cost patient care products, which are certainly required for reducing health care costs. Moreover, discovery based patents are vulnerable to costly legal battles that will slow down R&D innovations and deeply destroy entrepreneurial initiatives by start-ups, which are the core thriving force behind transforming scientific discoveries into patient care innovations.

Genes can be isolated and cloned using well-known technologies and such genes cannot be considered as inventions. However, a new method developed for isolating or cloning a gene may be considered as an invention. Likewise, identification of the function of a gene or a gene mutation associated with the incidence of a disease is a discovery, it cannot be considered as an invention. The obvious reason is the function of an isolated gene or the association of gene mutation/s with a particular disease is a natural occurring phenomenon that was not invented by researchers, rather it was discovered using known or inventive methods or technologies. Furthermore, isolating and cloning a natural gene in a vector or other formats do not mean that the inventor will automatically get all the rights on the use of a gene that is naturally present in humans or other living organisms. In other words, if a scientist has used inventive methods to isolate or clone a naturally occurring gene, the patent privileges should be limited to the process or the recombinant product, not extended to naturally occurring gene that is not patentable. Likewise, discovery of a compound present in a plant species is not an invention, however, development of a novel process for isolating this compound or a method of using this isolated compound for treating human or animal diseases can be an invention since it is not a naturally known phenomenon. Often, such examples have been cited to justify the validity of gene patents.

It is also important to note that isolated genes are of no use unless the clinical or diagnostic or therapeutic associations or roles of these genes have been discovered. The association of genes, gene mutations and biomarkers with diseases can be dependent on several factors such as ethnicity, geographical location, environmental factors, food habits etc. Granting patent rights to an inventor who has discovered a disease specific mutation in a gene for all possible known and undiscovered mutations in that gene cannot be scientifically justified. Such practices may result in hampering future discoveries since incentives from these discoveries are automatically transferred to a third party through their broad patent claims. Gene patents should not be granted for claims with broader applications without scientifically validated experimental evidences, which are very critical for any scientific inventions. Besides, patents do not follow basic scientific principles and this offer ample opportunities for inventors to claim any hypothetical or impracticable applications of patented genes, without even considering the scientific merits of their discoveries or inventions. Consequently, this may lead to unrealistic patent claims on clinical and commercial potentials of scientific discoveries that may not have any direct impact on improving patient care. If we continue with the practice of patenting discoveries, it will not only delay or prevent genuine applications of basic scientific discoveries but also challenge the fundamental ethical principles and values of scientific research.

genepatents

Fig.1: Possible impact of patentable and non-patentable discoveries in patient care innovations

Gene patents may hamper innovations in drug discovery and clinical diagnostics

Over expression or down regulation of genes can be associated with diseases and these genes can be used as therapeutic drug targets for the prevention or treatment of diseases. Likewise, over expression or down regulation of genes can be used as biomarkers for the diagnosis of diseases. Association of genes with a disease is a natural phenomenon and identification of such association is a discovery rather than an invention. The real use of disease specific genes will be the discovery of new drugs targeting genes or gene products that may lead to the development of novel drugs or new treatment methods. If a disease specific gene patent has a claim like “diseases can be treated by inhibiting the gene or gene products using drugs molecules such as, but not limited to, small molecules, proteins, oligonucleotides, antisense nucleic acids, miRNAs, antibodies, aptamers, peptides”, that could lead to a real problem. Such claims may block or decelerate promising research and development (R&D) activities related to a patented gene and destroy creativity in entrepreneurial scientist cum innovators, who could transform current limitations in clinical patient care into high potential enterprises that deliver innovative patient care products through creating large number of innovation driven jobs. In gene patents, genes and gene sequences as well as further downstream applications of genes can be patented without providing any supporting scientific experimental evidences. This is one of the most scientifically disputable aspects of gene patents, which may contain dubious and impracticable claims on the utility of genes. Gene patents can also slow-down or cripple innovations in promising next generation patient care strategies such as personalized medicine. Therefore, gene patents can be a real road block to innovations in drug discovery research, which may have long-term positive impact on inventing new therapeutic drugs or treatment methods, faster bench to clinics timeline, reducing mortality and morbidity from diseases, reducing health care costs and creating high growth entrepreneurial startups (Fig.1).

In clinical diagnostics arena, gene or similar biomarker patents may have different consequences. Identification of genes or biomolecules associated with diseases is only a primary step towards the development of clinical diagnostics assays. The most critical aspect is to develop and optimize highly sensitive, robust, reliable and cost-effective assays or methods for the detection of specific genes or biomolecules in patients for the accurate diagnosis of diseases. Undoubtedly, innovations are essential for the development of reliable and robust diagnostics assays, which are very critical for developing efficient clinical diagnostics products. Disease specific genes or biomarkers offer incredible opportunities for innovations through the development of 1) new diagnostic or companion diagnostic tools and methods, 2) methods for the prevention of diseases though early detection methods (diagnostic imaging, nanoparticle based diagnosis etc.), 3) new biomedical and analytical devices and instruments, 4) diagnostic assays to identify patient’s response to a particular drug, 5) methods for optimizing personalized drug treatment regimen (drug dose, drug treatment schedule etc), 6) methods for monitoring the efficacy of treatment (disease stage, tumor progression, tumor recurrence etc), 7) methods for predicting life-threatening side effects of therapeutic drugs and 8) novel theranostics (diagnostics therapy) approaches. The above-mentioned patentable high-value innovations can attract investments that can create sustainable entrepreneurial establishments and scientific jobs, which may be significantly higher that gene patents alone can offer. Conversely, granting patent rights to naturally occurring genes or biomarkers may obstruct health care related technological, scientific and clinical innovations that are very critical for developing life-saving patient care products.

Recombinant genes may not have any direct clinical or commercial value in patient care

Genes can be isolated and cloned using standard recombinant DNA methods, and these recombinant gene and gene products (proteins) can be used for studying structure-function analysis, which can be utilized for identifying drugs and developing diagnostic assays using known or inventive methods. The cloned gene may be considered as non-natural and may be patentable. However, recombinant genes may not have any direct clinical or commercial value whatsoever in patient care (exceptions are gene based innovations such as use of recombinant gene in gene therapy or recombinant gene based vaccines and biopharmaceuticals or cell therapy using cells expressing recombinant gene or similar specialized therapeutic/diagnostics technologies). The reasons are 1) any drugs that are invented will be targeted towards the natural gene present in humans, not the cloned gene, and 2) disease specific mutation/s in cloned gene has no value in diagnosing a disease, instead diagnosis must be performed through the detection of specific mutation/s in patients or patient derived samples using known or inventive methods. Granting patent rights to all possible use and applications of natural genes or gene variants based on the fact that recombinant gene is non-natural is not scientifically and ethically justifiable.

The general conception that banning gene patents will prevent innovations or investments may not be true, rather it will encourage innovations in critical areas where clinical health care inventions are required. These inventions may lead to the development of innovative cost-effective therapeutic drugs and clinical diagnostic tools that will reduce patient care costs. Granting patent rights to naturally occurring biomolecules such as genes, proteins or metabolites may hold back these innovations. It is unfortunate that if gene patents are treated as an easy source of return of investment (ROI) with less effort, without even taking into consideration the scientific, social and moral responsibilities of discoveries, which are more often publicly funded. It may be true that isolated genes may be unknown to us earlier; therefore, can it be considered as an invention? The answer will be no, because genes were already been present in humans and we could not isolate these genes due to the lack of suitable methods or technologies. Evidently, scientific and technological innovations in molecular cloning, sequencing, PCR, bioinformatics, biochemical methods etc., have created innovative ways to identify genes and assign functions, without these inventions genes would have been a still unknown factor. Thus, gene patents are not true inventions; rather these are discoveries made possible through other technological and scientific inventions. Most importantly, unprecedented innovations are warranted to establish the usefulness of genes for the invention of novel therapeutic drugs and clinical diagnostic assays that may provide clinical and economical benefits to patients. Unfortunately, gene patents and the complex legal interpretations of simple scientific principles surrounding gene patents may slow down or hamper future innovations in patient care, specifically the development of cost-effective novel diagnostic and therapeutic products that enable physicians to provide best possible care for their patients. Moreover, gene patents may lead to innovation bottlenecks that favor fewer inventions, restricted entrepreneurial initiatives, limited job growth, and non-competitive monopoly (Fig. 1).

Link to the original blog: Sciclips Blog .

Note: This scientific blog is a contribution from Sciclips Consultancy team.

References
References are hyperlinked to respective abstracts or full articles. Please click the reference numbers to the citation details

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Comprehensive cancer biomarker database with companion diagnostics pathway

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We have launched an open access stem cell therapy database that contains comprehensive information on the therapeutic applications of stem cells for more than 300 diseases or disorders. The data was extracted from patents, patent applications and clinical trials. Highlights of the key invention and protocols/methods used for validating the therapeutic applications of various stem cell types are also included in this database. Link to the database: http://www.sciclips.com/sciclips/stem-cell-therapeutics-database-main.do

Related tools:

1. Stem Cell Protocols
2. Therapeutic and Experimental Drugs Database
3. Comprehensive cancer biomarker database with companion diagnostics pathway

Related blogs:

1. Cell Based Reporter Assays vs. Animal Studies in Drug Discovery- Potential Limitations, Risks and Liabilities
2. Cell based reporter assays: misleading approach in drug discovery?
3. Cancer Theranostics – Potential Applications of Cancer Biomarker Database
4. Are stem cells ready as a next generation drug discovery tool?

Innovation Fostering innovation through scientific intelligence

Sciclips consultancy service team is comprised of highly qualified and experienced scientists who have several years of research experience in academic and industrial laboratories. We offer following custom services at competitive price:

Scientific and technical areas covered: Drug discovery, Stem cells, Genomics, Proteomics, Biomarkers, Clinical diagnostics, Companion diagnostics, Molecular diagnostics, Personalized medicine (theranostics), Plant and agricultural biotechnology

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4. Technology development: Identification of potential development opportunities in drug discovery assay development, cell based assay development, recombinant protein expression (in vitro and in vivo) and mass spectrometry/proteomics reagents and tools; Product development strategy.
5. Diagnostics and Theranostics technology developmen
t: Diagnostic assay development; Diagnostic target identification (molecular or protein or miRNA or metabolomic biomarkers); Prognostic and drug efficacy biomarkers; Theranostics tools, biomarkers and therapeutic drug targets; Identification of emerging technologies and methods.
6. Custom database development
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Highlights of recent stem cell patents issued on Sept.20, 2011 (US patents) and patent applications published on Sept.15, 2011 (US and WO (PCT)).

1. Stem cell matrix dressing for rapid repairing or healing of skin damage
2. Prohibitin as a biomarker for identifying undifferentiated pluripotent stem cells
3. Recombinant laminin-10 for enhancing self-renewal of pluripotent human stem cells
4. Stem cells for treating hemorrhagic shock
5. Method for the enrichent of cardiac stem cells
6. Marker for determining the susceptibility of a cancer patient to an osteoblastic response in mesenchymal stem cells
7. Stem cell mobilization for the treatment of damaged myocardium
8. Method of inducing the differentiation of germline stem cells
9. Stem cells derived from monocytes for treating tissue damage
10. Method for differentiating retinal stem cells into neural retinal cells
11. Stem cell therapy to build a bypass tract in the heart
12. Dermal papilla tissues having hair follicle inducting ability from stem cells
13. Adipose stem cell culture derived supernatant for the treatment of neural death
14. Treating radiation damage using genetically modified mesenchymal stem cells
15. Anti-apoptotic protein STC-1 expressing stem cells for the treatment of prostate cancer
16. Treating leukemia using PTH/PTHrP receptor antagonists that increase the normal hematopoietic stem cells
17. Method for isolating breast cancer stem cells
18. Enhanced proliferation and differentiation of stem cells using polyanion cocktail
19. SDF-1 mediated enhanced proliferation and survival of mesenchymal precursor cells
20. Method for inducing differentiation from retinal progenitor cells into retinal cells
21. Stem cells for treating brain or spinal cord injury
22. Stem cell binding peptide containing implantable devices for tissue repair

Details:

1. Method for the isolation of insulin-producing cells from differentiated stem cells
2. A method of transplanting haematopoietic precursor cells
3. Radiation injury treatment using human placental stem cells
4. Combination of pressure treatment and stem cells for stimulating cartilage formation
5. A method for extracting mesenchymal stem cells from human or animal embryo
6. A universal method for inducing neural differentiation of stem cells
8. Tissue repair/regeneration through mobilization of a bone marrow derived stem cells
9. Compounds for inhibiting leukemia stem cells
Details:


Highlights of the drug discovery patent applications (US) published on August 25, 2011:

1. Tetrazole compounds as uric acid transporter 1 (URAT1) inhibitors for the treatment of gout
2. Modified lecithin-cholesterol acyltransferase (LCAT) for the treatment of atherosclerosis
3. SPINK1 as a clinical target for prostate cancer
4. Serine threonine kinase inhibitors for treating hormone-refractory prostate cancer
5. Cyclic depsipeptide from chromobacterium for treating chronic obstructive pulmonary disease (COPD) or asthma
6. Novel P2X3 receptor antagonists for the treatment of pain
7. Composite hydroxide of a hydrotalcite and an aluminum hydroxide for the treatment of gastric ulcer
8. Novel herbal composition for the treatment of male sexual dysfunction
9. RNA aptamers as selective inhibitors of emergence of the selected miRNAs
10. Multiple myeloma SET domain-containing protein (MMSET) as a drug target for the treatment of cancer
11. Vitamin D3 lactam derivatives for the treatment of Paget’s disease
12. Calcium leakage inhibitory peptides derived from ryanodine receptor for the treatment of heart failure
13. Combination of a nitric oxide-cobalamin complex and cobalamin drug conjugate for the treatment of cancer
14. A1 adenosine receptor as a therapeutic drug target for the treatment of hearing loss
15. Thrombomodulin variants for the treatment of acute kidney injury
16. Inhibitors of VEGF-Axxx binding to VEGFR-2 for the treatment of age-related macular degeneration
17. Nanoparticle based oral formulations of chemotherapeutic agent
18. 4-O-methylhonokiol for the treatment of Alzheimer’s disease
19. Novel tetrahydronaphthalene compounds as potent calcium channel blockers
20. A novel combination therapy approach to breast cancer treatment
21. N1 -benzo[1,3]dioxol-5-ylmethyl-N2-substituted biguanide derivative for the treatment of diabetes
22. Homoisoflavanone for the treatment of inflammatory diseases or allergic diseases
23. Herbal based dual cyclooxygenase and lipoxygenase inhibitors for the treatment of skin diseases
24. Combination of DNA methyltransferase inhibitor and sapacitabine for the treatment of cancer
25. Oral composition of taxane for the treatment of cancer
26. Adenine nucleotide translocator 2 (ANT2) gene as a breast cancer stem cell drug target
27. Adenine nucleotide translocator 2 gene targeted siRNA or shRNA for the treatment of breast cancer
28. Combination therapy with niacin and 3-hydroxy-3-methylglutaryl-coenzyme A reductase inhibitor for the treatment of atherosclerosis
29. Myeloperoxidase (MPO) inhibitors for the treatment of multiple system atrophy and Huntington’s disease
30. Combination of P70S6 kinase inhibitor and EGFR inhibitor for the treatment of non-small cell lung cancer
31. c-Src inhibitors for the treatment of sudden cardiac death
32. Annelated pyrrolidin sulfonamides with oxadiazolone headgroup as PPARdelta or PPARdelta and PPARalpha agonists
33. Combination therapy using pitavastatin for preventing rupture of a lipid rich plaque in an atherosclerotic lesion
34. Pyrimidine derivatives, as gamma secretase modulators, for the treatment of Alzheimer’s disease
35. Novel 4-(indazolyl)-1,4-dihydropyridine derivatives as protein tyrosine kinase inhibitors
36. Combination therapy for chronic obstructive pulmonary disease and asthma
37. Quinolin-4-one and 4-oxodihydrocinnoline derivatives PARP inhibitors
38. Smad7 specific inhibitors for the treatment of CNS diseases
39. Substituted bicyclic amines as antagonists of the somatostatin receptor subtype 5 (SSTR5)
40. Combination of anti-epileptic drug and a psychostimulant for the treatment of psychiatric disorders
41. Immunotherapy for the treatment of Multiple Sclerosis
42. Wntl-Lmxla signaling pathway as a drug target for treating Parkinson’s disease
43. TGF-beta1 as a drug target for treatment of corneal fibrosis and corneal

Details:


Comprehensive Cancer Bomarker Database

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Bioprotocol database (open access)

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Therapeutic drug target database (open access)

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Stem cell researchers database

A comprehensive database for stem cell researchers, Stem cell research reagents, Stem cell patents, Stem cell grants, Stem cell clinical trials, Stem cell statistics, Stem cell news and Stem cell open innovation ideas. Please visit http://www.sciclips.com/

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Protein display/Protein engineering/Directed evolution protocols online

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Cell culture video protocols, Cytotoxicity assay video protocols, Stem cell video protocols, Molecular biology video protocols http://www.sciclips.com/sciclips/video-protocols.do

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Bioprotocols online (open access)

Combination therapy database (open access)

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Bioinformatics databases (open access)

HTS assay protocols online (open access)