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Biotechnology inventions relate to new and nonobvious compositions of matter and/or new and nonobvious methods of making or using novel or known compositions of matter (see "What can be patented?").

The following issued claims exemplify the numerous ways in which patent protection relating to a protein may be obtained (erythropoietin is a protein, essential in red blood cell formation, that had previously been isolated from human urine):

U.S. Patent No. 5,621,080
1. An isolated erythropoietin glycoprotein having the in vivo biological activity of causing bone marrow cells to increase production of reticulocytes and red blood cells, wherein said erythropoietin glycoprotein comprises the mature erythropoietin amino acid sequence of FIG. 6 and has glycosylation which differs from that of human urinary erythropoietin.

U.S. Patent No. 6,048,971
1. A secretable mutant human erythropoietin protein having an amino acid residue which differs from the amino acid residue present in the corresponding position in wild type human erythropoietin, the amino acid residue of said wild type erythropoietin selected from the group consisting of: amino acid residue 103, amino acid residue 104, and amino acid residue 108.

U.S. Patent No. 5,955,422
1. A pharmaceutical composition comprising a therapeutically effective amount of human erythropoietin and a pharmaceutically acceptable diluent, adjuvant or carrier, wherein said erythropoietin is purified from mammalian cells grown in culture.

U.S. Patent No. 4,703,008
1. A purified and isolated DNA sequence encoding erythropoietin, said DNA sequence selected from the group consisting of: a. the DNA sequences set out in FIGS. 5 and 6 or their complementary strands; and b. DNA sequences which hybridize under stringent conditions to the DNA sequences defined in (a). & 4. A prokaryotic or eukaryotic host cell transformed or transfected with a DNA sequence according to claim [1] in a manner allowing the host cell to express erythropoietin.

U.S. Patent No. 5,618, 698
1. A process for the preparation of an in vivo biologically active erythropoietin product comprising the steps of:

1. growing, under suitable nutrient conditions, host cells transformed or transfected with an isolated DNA sequence selected from the group consisting of (1) the DNA sequences set out in FIGS. 5 and 6, (2) the protein coding sequences set out in FIGS. 5 and 6, and (3) DNA sequences which hybridize under stringent conditions to the DNA sequences defined in (1) and (2) or their complementary strands; and
2. isolating said erythropoietin product therefrom.

U.S. Patent No. 5,641,670
1. A homologously recombinant cell having incorporated therein a new transcription unit, wherein the new transcription unit comprises an exogenous regulatory sequence, an exogenous exon and a splice-donor site, operatively linked to the second exon of an endogenous gene, wherein the homologously recombinant cell comprises said exogenous exon in addition to exons present in said endogenous gene.

10. The homologously recombinant cell of claim [1] wherein the endogenous gene encodes a protein selected from the group consisting of erythropoietin, calcitonin, growth hormone, insulin, insulinotropin, insulin-like growth factors, parathyroid hormone, beta-interferon, gamma-interferon, nerve growth factors, FSH-beta, TGF-beta, tumor necrosis factor, glucagon, bone growth factor-2, bone growth factor-7, TSH-beta, interleukin 1, interleukin 2, interleukin 3, interleukin 6, interleukin 11, interleukin 12, CSF-granulocyte, CSF-macrophage, CSF-granulocyte/macrophage, immunoglobulins, catalytic antibodies, protein kinase C, glucocerebrosidase, superoxide dismutase, tissue plasminogen activator, urokinase, antithrombin III, DNAse, alpha-galactosidase, tyrosine hydroxylase, blood clotting factor V, blood clotting factor VII, blood clotting factor VIII, blood clotting factor IX, blood clotting factor X, blood clotting factor XIII, apolipoprotein E, apolipoprotein A-I, globins, low density lipoprotein receptor, IL-2 receptor, IL-2 antagonists, alpha-1 antitrypsin, immune response modifiers, and soluble CD4.

U.S. Patent No. 6,048,524
1. A method of expressing erythropoietin in a mammal, comprising the steps of:

1. obtaining a source of primary cells from a mammal;
2. transfecting primary cells obtained in (a) with a DNA construct comprising exogenous DNA encoding erythropoietin and additional DNA sequences sufficient for expression of the exogenous DNA in the primary cells, thereby producing transfected primary cells which express the exogenous DNA encoding erythropoietin;
3. culturing a transfected primary cell produced in (b), which expresses the exogenous DNA encoding erythropoietin, under conditions appropriate for propagating the transfected primary cell which expresses the exogenous DNA encoding erythropoietin, thereby producing a clonal cell strain of transfected secondary cells from the transfected primary cell;
4. culturing the clonal cell strain of transfected secondary cells produced in (c) under conditions appropriate for and sufficient time for the clonal cell strain of transfected secondary cells to undergo a sufficient number of doublings to provide a sufficient number of transfected secondary cells to produce erythropoietin; and
5. introducing transfected secondary cells produced in (d) into a mammal of the same species as the mammal from which the primary cells were obtained in sufficient number to express erythropoietin in the mammal.

U.S. Patent No. 4,397,840
1. A method for the preparation of an erythropoietin product having no inhibitory effect against erythropoiesis which comprises the steps of:

1. adsorbing a crude erythropoietin product obtained from the urine of healthy human on to a weakly basic anion exchanger from a neutral or weakly acidic aqueous solution in the presence of an inorganic neutral salt in a concentration in the range from 0.1 to 0.2 mole per liter, and
2. eluting the thus adsorbed erythropoietin product with an aqueous eluant solution containing an inorganic neutral salt in a concentration in the range from 0.5 to 0.7 moles per liter.

U.S. Patent No. 4,667,016
1. A process for the efficient recovery of erythropoietin from a fluid, said process comprising the following steps in sequence: subjecting the fluid to ion exchange chromatographic separation at about pH 7.0, thereby to selectively bind erythropoietin in said sample to a cationic resin; stabilizing materials bound to said resin against degradation by acid activated proteases; selectively eluting bound contaminant materials having a pKa greater than that of erythropoietin by treatment with aqueous acid at a pH of from about 4.0 to 6.0; and selectively eluting erythropoietin by treatment with an aqueous salt at a pH of about 7.0; and isolating erythropoietin-containing eluent fractions.

U.S. Patent No. 6,001,800
1. A method for preparing spray dried recombinant human erythropoietin (rhEPO), comprising:

1. providing an aqueous solution of rhEPO having a concentration within the range of about 20 mg/ml to about 100 mg/ml;
2. atomizing said solution into a spray;
3. drying said spray with hot drying air in order to evaporate the water from the spray to form a dried rhEPO; and
4. separating dried rhEPO from the drying air to provide biologically active spray dried rhEPO.

U.S. Patent No. 5,629,175
1. A method for producing a mammalian peptide which comprises: growing tobacco plant cells containing an integrated sequence comprising, a first expression cassette having the direction of transcription (1) a transcriptional and translational initiation region functional in said plant cells, (2) a structural gene coding for said mammalian peptide, and (3) a termination region, whereby said structural gene is expressed to produce said mammalian peptide.

U.S. Patent No. 5,780,709
A method to increase water stress resistance or tolerance in a monocot plant, comprising: introducing into cells of a monocot plant an expression cassette comprising a preselected DNA segment comprising an mtlD gene, operably linked to a promoter function in the monocot plant cells to yield transformed monocot plant cells; and b) regenerating a differentiated fertile plant from said transformed cells, where in the mtlD gene is expressed in the cells of the plant so as to render the transformed monocot plant substantially tolerant or resistant to reduction in water availability that inhibits the growth of an untransformed monocot plant.

As exemplified above, it is likely that patents directed to related compositions of matter and/or distinct methods corresponding to these compositions will issue to multiple parties. In situations where party A has been granted a patent directed to composition X and party B has been granted a patent having claims directed to a new use of composition X, party A may preclude others (including party B) from making, using or selling compound X, whereas party B may preclude others (including party A) from using composition X according to B's patented use.

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