A patent is a counterintuitive thing. It is a negative right, in that it permits its owner to stop others from practicing the patented invention. More precisely, a patent gives its owner the legal right to stop others from making, using, selling, offering for sale, or importing the patented invention.
What it does not do is grant its owner an affirmative right to actually practice the patented invention. As the examples in this chapter show, a patent acts as a stop sign, not as a green light to practice one’s own invention. It is this concept that makes a patent counterintuitive, in that many outside the legal profession would expect it to reward an inventor with an exclusive right to practice her own invention. This often-expected affirmative right simply doesn’t exist. The counterintuitive concept of a patent as a negative right is vital to understanding patent law. For this reason, its meaning cannot be overstated.
A patent is territorial. It cannot generally be enforced outside the country in which it was issued. A U.S. patent, for example, can be used to stop another from making, using, offering to sell, or selling a patented invention in the United States and from importing the invention into the United States. Yet it cannot usually be used to stop another from practicing the claimed invention in, say, China. The reach of a Chinese patent, meanwhile, is analogously limited to China.
The patent is also a form of quid pro quo between an inventor and the government. It is a powerful, public, and often extremely valuable right that the government grants to reward innovation and promote science. In exchange for this exclusive right, the patent holder must benefit the public by placing the invention in the public domain. That is, the patent holder must disclose the invention in the patent in sufficient detail and with sufficient candor that the public can understand the invention and, once the patent expires, practice it.
A patent is a complex technical document, a hybrid of sorts. It is analogous to a fusion between a grant proposal and a real estate deed. Like a grant proposal, it is highly technical. Like a real estate deed, it precisely demarcates enforceable boundaries.
A patent has many parts. It has a title and a brief section describing the field of invention to orient the reader. As needed, it has figures to help the reader understand the invention. These figures can illustrate anything, such as nucleic acid and amino acid sequences, plasmid maps, diagnostic devices, and synthetic chemical processes. There is also a section describing the background of the invention. This section sets the stage for the invention by disclosing the scientific backdrop against which the invention came into being. Ideally, it describes the problem that the invention solves.
A patent includes several sections describing the invention. These include a short abstract, a summary of the invention, and a detailed description of the invention. Typically, the detailed description includes a robust discussion of experiments leading to or validating the invention. It sometimes contains prophetic experiments that can be—but have not yet been—done to further demonstrate the invention’s operability and advantages. The detailed description also includes key definitions and other explanatory language permitting the reader to understand the invention’s advantages.
Finally, and most importantly, a patent has claims. The claims are what give shape to the patent’s negative right, in that they define the invention that the patent holder can stop another from practicing.
Simply put, claims are the business end of a patent. Patent claims—their properties, scope, and function—are at the heart of patent law and are therefore the focus of much of section I.
A claim is a single-sentence description of an invention. A patent contains at least one claim and typically many. A patent’s claims set forth the patent’s scope; that is, the metes and bounds of what the patent covers. A claim having a broad scope encompasses more than one having a narrow scope, although broad and narrow are relative terms in this context.
In industry and academia alike, there is often talk of one patent or another “on” an entire technology that “locks down” a new platform or that “secures” rights to a broad swath of the scientific realm. Such talk, whether a boast in a press release or a fearful utterance by a prospective competitor, is seldom more than hyperbole. A patented invention is that which the claims define—no more and no less.
Each claim in a U.S. patent is the product of extended negotiation between the patent applicant and the U.S. Patent and Trademark Office (Patent Office). This negotiation mirrors that between two parties to a contract and ideally results in a document with a scope agreeable to both sides. It is an integral part of patent prosecution; that is, the exchange between the patent applicant and the Patent Office required to obtain a patent. In essence, the patent applicant (ideally represented by counsel) presents to the Patent Office claims that, among other things, define the invention in the broadest possible way. In examining the claims for compliance with requirements for patentability, the Patent Office, through a scientifically trained examiner, typically rejects some or all of the claims as not patentable for one or more reasons. In response, the applicant typically presents more narrowly drafted claims to the examiner, who again reviews them for patentability. This cycle of give and take continues until—hopefully—the claims presented are both patentable according to the examiner and commercially meaningful to the patent applicant. Chapter 5 covers patent prosecution in more detail.
Typically, a claim has three parts: a preamble, a transition, and a body.
The preamble establishes the overall category of the claimed invention. For example, a preamble might state “a device,” “a recombinant molecule,” “a cell line,” or “a therapeutic method.”
The transition is a word or a phrase of up to a few words. It follows the preamble. It also precedes the body, which includes the claim’s remaining language. The transition specifies the degree to which the body’s language—that is, the subsequent claim elements—limits the claim’s scope. There are a number of possible transition phrases. The three most common are “comprising,” “consisting essentially of,” and “consisting of.”
“Comprising X” means the invention contains at least X, and possibly more. This is the broadest transition term and is typically called an open-ended term.
EXAMPLE 1.1
Claim 1 of a patent provides “a pharmaceutical composition for treating pancreatic cancer comprising Peptide X and a pharmaceutically acceptable carrier.”
The claimed composition must contain at least Peptide X and a pharmaceutically acceptable carrier. However, because this claim uses the transition term “comprising,” the claimed composition may also contain, for example, Peptide Y. Thus, claim 1 encompasses not only (i) a composition containing Peptide X and a pharmaceutically acceptable carrier but also (ii) a composition containing Peptide X, a pharmaceutically acceptable carrier, and Peptide Y.
“Consisting essentially of X” means the invention contains X and possibly also Y, so long as Y doesn’t affect the basic and novel characteristics of X. Whether something affects the “basic and novel characteristics” of something else depends on the facts and is subject to debate. Example 1.2 illustrates the use of this transition phrase.
EXAMPLE 1.2
Claim 1 provides “a recombinant protein consisting essentially of the amino acid sequence shown in figure X, wherein the protein binds to Tumor Antigen X with an affinity of at least 1 × 10−9 M.”
Because this claim uses the transition term “consisting essentially of,” the invention would likely encompass a recombinant protein that has the sequence shown in figure X and, for example, two additional glycine residues added to the C-terminus that do not affect the protein’s binding properties. However, it would not likely encompass that protein if the two additional glycine residues lowered the protein’s binding affinity for Tumor Antigen X to 1 × 10−8 M.
“Consisting of X” means the invention contains X—and only X—without containing anything more related to the invention. This is the narrowest transition term.
EXAMPLE 1.3
Claim 1 provides “a diagnostic kit consisting of, in separate compartments, (i) a plurality of beads, each bead having operably affixed to its surface a plurality of Antibody X (AbX) specific for Antigen X (AgX), (ii) a plurality of detectable non-immobilized Antibody Y specific for the AbX/AgX complex, and (iii) a suitable reaction buffer.”
Because this claim uses the transition term “consisting of,” it would not encompass anything relating to the kit beyond what is identified in the body of the claim. So, for example, this claim would not encompass a diagnostic kit wherein compartment (ii) also includes Antibody Z specific for the AbX/AgX complex.
As shown in the preceding examples, the body of a claim states the claim’s other required features. These features are known as elements or limitations. We discuss this point further in chapter 9, which addresses patent infringement.
The importance of language in defining the scope of a claim cannot be overstated. Whether drafting claims, litigating them, or advising clients as to their scope, attorneys are acutely aware of how much a claim’s language can affect its scope, and thus its value to the patent owner. A single linguistic error, such as a misplaced comma or a poorly chosen word, can render a claim worthless.
A claim covers a technology if that technology possesses all of the claim’s elements. Chapters 2 and 9 address the coverage-related topics of claim construction and infringement, respectively.
The following three related examples show claim scope and how different transition phrases can affect it. In these examples, claims 1, 2, and 3 are identical except for their transition phrases.
EXAMPLE 1.4
Claim 1 provides “a pharmaceutical composition comprising (i) a humanized monoclonal antibody (MoAb) specific for TNFα and having the amino acid sequence shown in figure X, and (ii) a pharmaceutically acceptable carrier.”
Product A is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) Ringer’s solution (a pharmaceutically acceptable carrier). Claim 1 encompasses Product A, since this product contains all of the claim’s elements.
Product B is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, (ii) Ringer’s solution, and (iii) methotrexate. Since claim 1 employs the transition phrase “comprising,” it encompasses Product B even though this product contains methotrexate, and even though methotrexate is not recited in the claim.
Product C is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) Ringer’s solution, wherein the humanized MoAb has a PEG moiety affixed to it at position X. The result here parallels that seen with Product B. That is, since claim 1 employs the transition phrase “comprising,” it encompasses Product C even though this product contains a PEG moiety not recited in the claim.
EXAMPLE 1.5
Claim 2 provides “a pharmaceutical composition consisting essentially of (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) a pharmaceutically acceptable carrier.”
Product A is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) Ringer’s solution. Claim 2 encompasses Product A, since this product contains all of the claim’s elements. Product A does not contain any additional features, rendering moot the question of whether such features affect the composition’s basic and novel characteristics.
Product B is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, (ii) Ringer’s solution, and (iii) methotrexate.
Since claim 2 employs the transition phrase “consisting essentially of,” whether it encompasses Product B hinges on whether the presence of methotrexate affects the composition’s basic and novel characteristics. For example, assume that Product B is effective for treating Crohn’s disease but not rheumatoid arthritis. Assume, also, that Product A (which contains only the elements of claim 2 and no more) is effective for treating rheumatoid arthritis but not Crohn’s disease. In this scenario, claim 2 would likely not encompass Product B, since it contains an additional feature (i.e., methotrexate) that arguably affects the claimed composition’s basic and novel characteristics (e.g., the ability to treat rheumatoid arthritis).
Product C is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) Ringer’s solution, wherein the humanized MoAb has a PEG moiety affixed to it at position X.
The same reasoning used with Product B applies to Product C. That is, whether claim 2 encompasses Product C hinges on whether the PEG moiety affects the composition’s basic and novel characteristics. Assume that, per the scenario given for Product B, Product C behaves therapeutically like Product B, in that Product C is effective for treating Crohn’s disease but not rheumatoid arthritis. In that case, claim 2 would likely not encompass Product C, since the PEG moiety arguably affects the claimed composition’s basic and novel characteristic (e.g., efficacy against rheumatoid arthritis).
EXAMPLE 1.6
Claim 3 provides “a pharmaceutical composition consisting of (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) a pharmaceutically acceptable carrier.”
Product A is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) Ringer’s solution. Claim 3 encompasses Product A, since this product contains all of the claim’s elements and nothing more.
Product B is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in Figure X, (ii) Ringer’s solution, and (iii) methotrexate. Since claim 3 employs the transition phrase “consisting of,” it does not encompass Product B. This is because Product B contains methotrexate, which is not recited in the claim.
Product C is a recombinant antibody formulation containing (i) a humanized MoAb specific for TNFα and having the amino acid sequence shown in figure X, and (ii) Ringer’s solution, wherein the humanized MoAb has a PEG moiety affixed to it at position X. Like Product B, Product C falls outside claim 3’s scope, since this product contains a PEG moiety not recited in the claim.
Again, a patent is a negative right to stop another from practicing the claimed invention. It is not an affirmative right for the patent holder to practice the claimed invention. This is because a third party may, in turn, have a blocking patent; that is, a patent claiming steps or components required to practice the invention in question. The following example illustrates this point.
FIGURE 1.1 This Venn diagram illustrates the concept of claim scope. In examples 1.4–1.6, the scope of claim 3 is a subset of claim 2’s, and the scope of claim 2, in turn, is a subset of claim 1’s. It follows that claim 1 encompasses more subject matter than does claim 2 and that claim 2 encompasses more subject matter than does claim 3. So, for example, claim 1 encompasses Products A, B, and C, whereas claim 3 encompasses Product A but not Products B and C.
EXAMPLE 1.7
Company X owns a U.S. patent claiming a pharmaceutical composition for treating head and neck tumors comprising (i) Compound A, (ii) Compound B, and (iii) a pharmaceutically acceptable carrier. Compound A is an approved drug for treating breast cancer and is covered by Company A’s unexpired U.S. patent. Compound B is also an approved drug for treating breast cancer and is covered by Company B’s unexpired U.S. patent.
Company X has the right to stop a third party from making, using, offering for sale, or selling its claimed composition in the United States and from importing it into the United States.
However, Company X would not be free—absent permission from both Company A and Company B—to make, use, offer for sale, or sell its own patented composition in the United States or to import it into the United States. This is because Company A has the right, by virtue of its own patent to Compound A, to stop Company X from making, using, offering for sale, or selling Compound A in the United States and from importing it into the United States. This is true even though Company X’s patented composition contains more than just Compound A. Company A’s patent is therefore a blocking patent with respect to Company X’s patented composition. Likewise, Company B’s patent is a blocking patent with respect to Company X’s composition, since the composition contains Compound B.
Company X’s U.S. patent therefore does not give Company X an affirmative right to practice its own invention. In this scenario, Company A’s patent and Company B’s patent each blocks Company X from doing so, absent permission from both companies to the contrary.
This is true even though it was the scientists at Company X who conceived of combining Compounds A and B to treat head and neck tumors. It is of no help to Company X that scientists at Companies A and B never contemplated using their respective breast cancer drugs to treat head and neck tumors, and never understood the synergy between these drugs for that purpose.
FIGURE 1.2 This Venn diagram illustrates the overlapping negative rights described in example 1.7. Circle A represents the scope of Company A’s patent. Circle B represents the scope of Company B’s patent. Company A’s patent would preclude an unauthorized third party, such as Company X, from making, using, selling, offering to sell, or importing Compound A. The same is true for Company B’s patent regarding Compound B. The area of overlap between A and B, designated X, represents subject matter that a third party may not make, use, sell, offer to sell, or import without permission from Companies A and B. Since Company X’s patented invention contains Compounds A and B, it falls within X.
As these examples show, a patent is a negative right to stop another from practicing the invention defined by the patent’s claims. In no way does it function as a green light to practice an invention—however brilliant—the component parts of which are the patented inventions of others.