Ariad Pharmaceuticals, Inc. v. Eli Lilly & Co.

Brief Fact Summary.

After a jury found that Eli Lilly & Co. (Defendant) had infringed patent ‘516 held by Ariad Pharmaceuticals, Inc., and others (collectively, “Ariadâ€) (Plaintiff), and found that none of the asserted claims were invalid, the district court denied Defendant’s motion for judgment as a matter of law (JMOL). However, the court of appeals reversed, finding the claims invalid as it lacked a sufficient written description. Plaintiff petitioned for a rehearing, challenging the court of appeal’s interpretation of 35 U.S.C. § 112, first paragraph, as containing a separate written description requirement.

Synopsis of Rule of Law.

Rule of Law: A written description requirement separate from the enablement requirement is contained in 35 U.S.C. § 112.

Facts.

Ariad Pharmaceuticals, Inc., and others (collectively “Ariadâ€) (Plaintiff) brought suit against Eli Lilly & Company (Defendant) for infringing patent ‘516. The inventors of the ‘516 patent were the first to identify NF-kB, a gene transcription factor, and to uncover the method NF-kB uses to activate gene expression underlying the body’s immune responses to infection. The inventors discovered that NF-kB normally exists in cells as an inactive complex with a protein inhibitor, named I-kB, and is activated by extracellular stimuli through a series of biochemical reactions that release it from I-kB. Once free of its inhibitor, NF-kB travels into the cell nucleus where it binds to and activates the transcription of genes containing an NF-kB recognition site. The activated genes (cytokines) in turn help the body to counteract the extracellular assault. However, the production of cytokines can be harmful in excess. The inventors therefore recognized that artificially interfering with NF-kB activity could reduce the harmful symptoms of certain diseases. They claimed methods for regulating cellular responses to eternal stimuli by reducing NF-kB activity in a cell. The claims were genus claims, including the use of all materials that achieve the desired result of reducing the binding of NF-kB to NF-kB recognition sites. The specification also hypothesized three types of molecules with the potential to reduce NF-kB activity in cells: decoy, dominantly interfering, and specific inhibitor molecules. Defendant argued that there was no written description to support the asserted claims because the specification of the ‘516 patent failed to sufficiently disclose how the claimed reduction of NF-kB activity was achieved. Ariad (Plaintiff) responded that Lilly’s (Defendant) arguments failed as a matter of law because Plaintiff did not actually claim the molecules. According to Plaintiff, as there was no term in the asserted claims that corresponded to the molecules, it was entitled to claim the methods without describing the molecules. Alternatively, Plaintiff contended that the specification of the ‘516 patent and the testimony of its expert, Kadesh, provided the jury with the substantial evidence of adequate written description of the claimed methods. The jury found that Defendant had infringed patent ‘516 and also found that none of the asserted claims were invalid. The district court denied Defendant’s motion for judgment as a matter of law (JMOL), but the court of appeals reversed, finding that the claims were invalid for lack of an adequate written description as required by 35 U.S.C. § 112. Plaintiff petitioned for a rehearing, challenging the court of appeals’ interpretation of § 112, first paragraph, as containing a separate written description requirement. The court of appeals granted the petition.

Issue.

Is a written description requirement separate from the enablement requirement contained in 35 U.S.C. § 112?

Held.

(Lourie, J.) Yes. A written description requirement separate from the enablement requirement is contained in 35 U.S.C. § 112. The § 112 paragraph at issue provides: “The specification shall contain 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 which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.†The plain language of this paragraph requires that the specification “shall contain a written description of the invention†and contains two separate description requirements: a written description (1) of the invention, and (2) of the manner and process of making and using the invention. Contrary to Ariad’s (Plaintiff) contention, there is nothing in the statute’s language or grammar that unambiguously dictates that the adequacy of the “written description of the invention†must be determined only by whether that description identifies the invention so as to enable one of skill in the art to make and use it. Therefore, the written description requirement exists as an independent statutory requirement. Its purpose is not only to identify the invention that must comply with the enablement requirement, and the description requirement does not cover enablement only. If Congress had intended enablement to be the only description requirement, the statute would have been written differently, because either “and of the manner and process of making and using it†or “[a written description] of the invention†would be surplusage under an interpretation finding a requirement only to describe enablement. Also, Supreme Court precedent supports an independent written description requirement—for the purpose of informing “the public during the life of the patent of the limits of the monopoly asserted, so that it may be known which features may be safely used or manufactured without a license and which may not.†Schriber-Scroth Co. v. Cleveland Trust Co., 305 U.S. 47 (1938). A separate written description requirement also does not conflict with the function of the claims. Claims define and limit the boundaries of the invention’s subject matter, whereas the written description discloses the invention and teaches about it. In addition, the written description requirement applies to all claims, whether amended or original, and requires that the specification objectively demonstrate that the applicant actually invented and was in possession of the claimed subject matter. There is no principled basis for restricting the written description requirement to establishing priority as part of enablement. Plaintiff’s argument that an original claim will always disclose the invention is not always true. Many original claims may satisfy the written description requirement, but certain claims may not. For example, a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, shows that the applicant has invented enough species to support a claim to a genus. The problem is especially acute with genus claims that use functional language to define the boundaries of a claimed genus, since the functional claim may simply claim a desired result, and may do so without describing species that achieve that result. That shortcoming is illustrated by this case: the claims here recite methods encompassing a genus of materials achieving a stated useful result, i.e., reducing NF-kB binding to NF-kB recognition sites in response to external influences, but the specification does not reveal a variety of species that accomplish the result. The test for sufficiency of the written description is whether the disclosure of the application relied upon reasonably conveys to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date. Whether this test is met is a question of fact, based on an inquiry into whether the specification, when it has entered the patent process, has described an invention understandable to a skilled artisan and shown that the inventor actually invented the claimed invention. There is no bright-line rule in this regard. However, a few broad principles can be emphasized. First, the written description requirement does not demand in order to practice either examples or an actual reduction. Instead, a constructive reduction to practice that in a definite way identifies the claimed invention can satisfy the written description requirement. Conversely, actual “possession†or reduction to practice outside of the specification is not sufficient. Instead, the specification itself must demonstrate possession. Also, a description that merely renders the invention obvious does not satisfy the requirement. In some fields, it might be true that there is little difference between describing an invention and enabling one to make and use it, so that written description and enablement rise and fall together. However, in some fields (e.g., chemistry, biology) this is not always true, and requiring a written description of the invention plays a vital role in curtailing claims that do not require undue experimentation to make and use, and so satisfy enablement, but that have not been invented, and therefore cannot be described. The written description requirement also ensures that when a patent claims a genus by its function or result, the specification recites sufficient materials to accomplish that function. This helps to limit claims that only recite a description of the problem to be solved while claiming all solutions to it that as yet have not been invented. Finally, Plaintiff’s complaint that the written description doctrine unfairly disadvantages research universities is futile. Patents are aimed at the “useful arts.†They are not awarded for academic theories, no matter how groundbreaking or necessary to the later patentable inventions of others. Requiring a written description of the invention limits patent protection to those who actually perform the difficult work of “invention,†to those who conceive of the complete and final invention with all its claimed limitations, not to those who just come up with research hypotheses or plans that will later have to be turned into practical applications. Allowing claims to research plans would impose costs on downstream research, discouraging later invention. The written description doctrine appropriately incentivizes actual invention, not “attempt(s) to preempt the future before it has arrived.â€

When the written description requirement area is applied to the facts at bar, the conclusion is reached that Ariad (Plaintiff) did not satisfy that requirement. Plaintiff’s specification suggested only the use of the three classes of molecules to achieve NF-kB reduction. Therefore, to satisfy the written description requirement for the asserted claims, the specification must demonstrate that Plaintiff possessed the claimed methods by sufficiently disclosing molecules capable of reducing NF-kB activity, however, it failed to do so. As to specific inhibitor molecules, of which I-kB is one, I-kB was not disclosed with the first application. Although one of ordinary skill could through experimentation isolate natural I-kB at the time of the application, in the context of the claimed invention, a vague functional description and an invitation for further research does not establish written disclosure of a specific inhibitor molecule. Dominantly interfering molecules are a truncated form of the NF-kB molecule and would block natural NF-kB from inducing the expression of its target genes. The specification provided no samples of this class of molecule, and it also did not disclose that requisite spatial separations in DNA domains required for the dominantly interfering molecules to work properly actually existed. Therefore, if the inventors themselves did not know whether the domains were in fact separate and spatially distinct, one of ordinary skill in the art would be at best just as ignorant. The third class of molecules, decoy molecules, is designed to mimic a region of the gene whose expression would normally be induced by NF-kB, and NF-kB would bind the decoy, and therefore, not be available to bind its natural target. Although the specification did propose example structures for decoy molecules, it failed to describe how to use those molecules to reduce NF-kB activity; there was no descriptive link between the table of decoy molecules and reducing NF-kB activity. Therefore, the ‘516 patent claims are invalid for lack of written description. Reversed in part and affirmed in part.

Discussion.

In a concurring opinion, Judge Gajarsa articulated one of several key positions of many critics of the court’s decision by stating that an independent written description requirement is not a necessity of patent law, since § 112’s enablement requirement is a more than adequate vehicle for invalidating claims that are broader than their disclosure. He points out that the empirical evidence confirms that written description serves little practical purpose as an independent invalidity device and better serves the goals of the Patent Act when confined to the priority context. Similarly, in his dissent-in-part, Judge Linn asserts that any claim that uses purely functional language, or covers a broad genus without enough supporting examples, will not be enabled, so that the enablement requirement is an adequate policer, without the need for a separate written disclosure requirement. Judge Rader, in his dissent-in-part, goes further, and contends that the written description doctrine is a fabrication of the Federal Court of Appeals and that every case before the court’s fabrication of the doctrine in 1997 actually applied the “written description†doctrine to police priority. In his rebuke of the court’s activism, and on its invocation of the patent quid pro quo, he also says “this court’s new creation offers the public nothing more in exchange for a patent than the statutory enablement requirement already ensures.†He also asks, “what ‘teaching function’ does the court propagate by telling an inventor that a patent application must show ‘possession as shown in the disclosure,’ whatever that means? Inventors, to my knowledge, are always quite certain that they possess their invention.†While disagreement over the policy and legal underpinnings of the Ariad decision is strong, as demonstrated by the non-majority opinions, one thing that is fairly certain is that genus claims that recite function will be invalidated.