Subject matter of patent families
The collection of patent documents directed to vaccine adjuvants claim adjuvants in a variety of formats. To say that claims come in two flavors - product claims and method claims - belies the breadth of actual claims. Product claims to adjuvant compositions, vaccines containing adjuvant compositions, adjuvants in combination with specific antigens can range from relatively broad scope to narrow scope. Similarly, method claims, such as to methods of producing adjuvants or to methods of stimulating an immune response, display a range of scope. In this section, a few examples from granted patents and patent applications will serve to illustrate this point.
Product claims that recite adjuvant compositions
The following three examples begin with a claim to monophophoryl lipid A (MLA) in a formulation. This claim is quite broad given the long history, and advanced state, of adjuvant technology. In fact, the importance of this patent claim, and claims of related patents, has been stated as a primary reason for GlaxoSmithKline's acquisition of Corixa. The claim of Wyeth is also directed to MLA, but more specifically states the structure of MLA as well as precise range of amounts of other additives. Moreover, it's narrowed by the requirement that the composition is lyophilized. The final example claims saponin of a defined chemical structure. Remember that in general, the narrower the claim is drafted, the easier it is to avoid infringement.
EP 1194166 B (Corixa) An aqueous immunostimulatory adjuvant composition comprising an attenuated lipid A derivative, which is monophosphoryl lipid A or 3-O-deacylated monophosphoryl lipid A, one or more non-immunostimulatory surfactants, and glycerol.
EP 1096954 B (Wyeth) A lyophilized composition comprising 3-O-desacyl-4'-monophosphoryl lipid A in an amount up to 5% by weight, greater than 70% by weight of sugar and 0 to 30% by weight of an added amine based surfactant.
AU 764052 B (Kitasato Inst.) A saponic compound when used as an adjuvant, said compound having a presenegenin skeleton substituted at position 28 with a sugar residue substituted with a trimethoxycinnamate residue, where the substituted sugar residue essentially comprises an apiose residue as its substituent when the substituted sugar residue is tetra-substituted.
Product claims that recite adjuvants in combination with antigen
This category of patents mostly have claims that recite a specific adjuvant in combination with a limited group of antigens. This type of claim most likely comes about because of prior art (e.g., publications) that render a claim to the adjuvant alone unpatentable or because of other patentability requirements. While many patent applications contain claims to a specified adjuvant in combination with any antigen, claims of this type are infrequent in granted patents that don't also claim the adjuvant alone.
The first example is from a granted European patent and illustrates a claim to a specific adjuvant (QS-21 or MLA) along with glycoproteins from respiratory synctial virus. Supposing that 3-deacylated MLA or QS-21 are patented as well by another entity, then Wyeth would need a license to use the adjuvant. The second example is a claim from a patent application that attempted to claim an LFA-3 adjuvant in combination with any antigen.
EP 0 705 109 B (Wyeth) A vaccine formulation comprising (a) a respiratory syncytial viral (RSV) protein selected from the group consisting of (i) RSV glycoprotein G, (ii) RSV glycoprotein F, (iii) a chimeric polypeptide comprising at least one immunogenic fragment from both RSV glycoproteins F and G, and (iv) combinations thereof, and (b) an adjuvant selected from the group consisting of QS-21, 3-deacylated monophosphoryl lipid A and combinations thereof, in a physiologically acceptable vehicle.
WO 91/11194 A (Biogen) A vaccine comprising (1) an immunogenic component and (2) an adjuvant component, wherein the adjuvant comprises LFA-3 or a fragment thereof capable of binding to CD2.
Method claims for preparing adjuvant
Another type of claim directed to adjuvants is methods for preparing or making the adjuvant. Overall, this type of claim would not keep someone else from using the adjuvant or from making the adjuvant by a different method. Claims like these would be pursued mainly if it's the only type of protection available for the adjuvant, or the options to prepare the adjuvant are limited, or the method has a particular advantage like yield or efficacy, or it's another piece of protection used to build a wall around the subject matter.
US 4877612 (F Berger) A process for preparing an immunological adjuvant that when administered to animals increases the immune response to antigens, and that is substantially free from mycolic acids, mycolic acid esters, and lipopolysaccharides, which comprises suspending Amycolata bacteria cells in aqueous saline solution; extracting the cells with an inert organic solvent in which the immunological adjuvant is soluble or dispersible; separating the organic solvent solution from the bacteria cells and the aqueous saline solution; and recovering immunological adjuvant.
Method claims for producing an immune response
This type of claim represents a way to protect use of the adjuvant. In the second example, the claim was obtained in addition to claims reciting the vaccine composition. Composition claims are generally deemed more valuable to the patent owner because they are easier to enforce. Methods of "treating" are considered less advantageous because of difficulties in identifying and pursuing the infringer(s), the exception in the United States to infringement on the part of medical doctors, the prohibition on this type of claim in some countries.
US 6017537 (Sanofi-Aventis) A method of enhancing the immune response of a host to an antigen of interest, comprising the steps of administering to the host a suboptimal amount of the antigen of interest and an immunogenicity-enhancing amount of an N-formyl methionyl peptide adjuvant, wherein the antigen of interest and the N-formyl methionyl peptide adjuvant are not co-immobilized on the surface of liposomes.
US 6780421 B1(Sanofi-Aventis) A method of inducing an immune response in a mammal, comprising administering a vaccine composition comprising at least one antigen and an adjuvanting amount of 3-.beta.-(N-(N'-N-'-dimethylaminoethane)carbamoyl) cholesterol to a mammal.
The information contained in this page was believed to be correct at the time it was collated. New patents and patent applications, altered status of patents, and case law may have resulted in changes in the landscape. CAMBIA makes no warranty that it is correct or up to date at this time and accepts no liability for any use that might be made of it. Corrections or updates to the information are welcome. Please send an email to info@bios.net.
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