In
On appeal, the Court explained that antibodies are made up of amino acids and a specific antibody is typically identified by its sequence of amino acids. The antibody structure influences its function, including its ability to bind to an antigen and to prevent other molecules from doing the same. Scientists design antibodies to aid in treating illnesses. Certain of these lab-made antibodies target the body's proteins, receptors and ligands, such as a PCSK9 inhibitor used to treat patients with high LDL cholesterol.5 PCSK9 is a naturally occurring protein that binds to and weakens LDL receptors. Researchers attempted to produce antibodies that could bind to a specific region of PCSK9 termed the "sweet spot," which was 15 amino acids out of PCSK9's 692 total amino acids. By binding to the sweet spot, an antibody could block PCSK9 from binding to and weakening LDL receptors.
The specification described the amino acid sequences of 26 antibodies that executed these two functions, and it showed the three-dimensional compositions of two of the 26 antibodies.
On appeal, the Court affirmed, observing that the
The Patent Act of 1790 provided up to a 14-year patent term to any individual who "invented or discovered any useful art, manufacture, ... or device, or any improvement therein not before known or used."10 The statute necessitated the applicant to submit a "specification ... so particular ... as not only to distinguish the invention or discovery from other things before known and used, but also to enable a workman or other person skilled in the art or manufacture ... to make, construct, or use the same."11
Current 35 U.S.C. Section 112 requires a patent specification with "a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art ... to make and use the same."12
The Court noted that prior decisions reiterated this plain statutory language:
If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent's specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims. The more one claims, the more one must enable. ...
That is not to say a specification always must describe with particularity how to make and use every single embodiment within a claimed class. For instance, it may suffice to give an example (or a few examples) if the specification also discloses "some general quality ... running through" the class that gives it "a peculiar fitness for the particular purpose." In some cases, disclosing that general quality may reliably enable a person skilled in the art to make and use all of what is claimed, not merely a subset.13
The Court acknowledged, however, that a specification is not automatically deficient even when one of ordinary skill must employ some amount of adaptation or testing to enable the invention to be used or made. That is, a specification may need a reasonable amount of experimentation to make and use the claimed invention and still be considered to be enabled. The Court conceded that what is considered reasonable experimentation depends on the nature of the invention and the prior art.14
With respect to claims 19 and 29 of the '165 patent and claim 7 of the '741 patent, the Court explained:
[W]e do not doubt that
The Court reasoned that the more a party claims, the more the specification must enable the claimed invention. The Court noted that
We cannot agree. These two approaches amount to little more than two research assignments. The first merely describes step-by-step
The Court explained that there is only one enablement standard; however, "the more a party claims for itself the more it must enable."17 The Court reasoned as follows:
Section 112 of the Patent Act reflects
Practical Considerations
The Court's decision makes it more difficult for patent owners to obtain protection for an entire genus of antibodies defined by their function. The decision would appear to encourage patent practitioners to draft more detailed specifications with more examples than perhaps was the previous practice, which might delay the filing of the patent application until additional experiments are conducted. Such specifications might include more structural descriptions of an antibody according to its specific sequence of amino acids instead of the function, to the extent possible.
The decision also emphasizes that the same standard for enablement applies to all inventions. Going forward, patent practitioners will also have to consider whether more detailed claims should be included as a fail-safe should the broader claims be considered not enabled.
The decision affects litigation, licensing and how patents are drafted and prosecuted. For example, patent portfolios should be reviewed to determine whether key patent assets with broad claims should have continuation, reissue or reexamination applications filed with complementary claims to improve/expand patent protection. Litigators might consider enforcing narrower claims while employing the doctrine of equivalents for similar inventions. In addition, the Court's decision should deter lawsuits for patents having overly broad functional claims, arguably allowing companies to focus capital on the development of new inventions.
Footnotes
1.
2. Id., 143 S.Ct. at 1254-55.
3. Id., 143 S.Ct. at 1254-55.
4. Id., 143 S.Ct. at 1248.
5. Id., 143 S.Ct. at 1248-49.
6. Id., 143 S.Ct. at 1250.
7. Id., 143 S.Ct. at 1250.
8. Id., 143 S.Ct. at 1250-51.
9. Id., 143 S.Ct. at 1251 (quoting Art. I, § 8, cl. 8).
10. Id., 143 S.Ct. at 1251 (quoting the Patent Act,
11. Id., 143 S.Ct. at 1251 (quoting the Patent Act,
12. Id., 143 S.Ct. at 1251 (quoting 35 U.S.C. § 112(a)).
13. Id., 143 S.Ct. at 1254-55.
14. Id., 143 S.Ct. at 1255.
15. Id., 143 S.Ct. at 1256.
16. Id., 143 S.Ct. at 1256.
17. Id., 143 S.Ct. at 1257.
18. Id., 143 S.Ct. at 1258.
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