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Patent
University of California, Berkeley School of Law
Merges, Robert P.

Patent Law – Merges 2012

Patent protection is derived from Const. Art. I, Sec. 8, cl. 8 – Congress has the power “to promote the Progress or Science and useful Arts.”

The PTO’s issuance of a patent creates a presumption of validity, rebuttable by a showing of clear and convincing evidence. 35 U.S.C. § 282.

Patentable Subject Matter

Sec. 101. – Inventions patentable

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

What is not patentable?

Law of Nature

Physical Phenomena

Abstract Ideas

Core Cases

Diamond v. Chakrabarty (1980) – The Court explained that while natural laws, physical phenomena, abstract ideas, or newly discovered minerals or plants are not patentable, a live artificially-engineered microorganism is. The creation of a bacterium that is not found anywhere in nature, constitutes a patentable “manufacture” or “composition of matter” under Section 101. Congress plainly contemplated that the patent laws would be given wide scope to cover “products of human ingenuity.” Congress intended statutory subject matter to include anything under the sun that is made by man.

Parke-Davis & Co v. H.K. Mulford Co. (1911) – Upholding a patent for isolated and purified form of a substance, adrenaline, found in nature. A new and useful purified and isolated DNA compound is eligible for patenting because it “it became for every practical purpose a new thing commercially and therapeutically.”

Funk Brothers Seed Co. v. Kalo Inoculant Co. (1948) – Respondent’s discovery that certain strains of each species of the bacteria involved could be mixed without harmful effect to the properties of either was a discovery of their qualities of noninhibition. It was not patentable because it was no more than a discovery of the laws of nature. Respondent’s discoveries did not make the bacteria perform in any other way than their natural way.

JEM Ag Supply (2001): Newly developed plant breeds fall within the subject matter of §101, and neither the PPA nor the PVPA limits the scope of §101’s coverage.

Computer Software

Gottschalk v. Benson (1972) – Method of converting BCD numbers into binary was held unpatentable because abstract mathematical formulas cannot be patented and granting a patent would simply preempt the use of the formula.

Diamond v. Diehr (1980) – Process for curing rubber deemed patentable. Applicants are not seeking to preempt use of the mathematical formula embedded within the process. Post-calculation activity became the new focus of patentability.

Business Methods

State Street Bank v. Signature Financial Group (1998) – The transformation of data, representing discrete dollar amounts, through a series of mathematical calculations, by a machine, into a final share price, does constitute a practical application of a mathematical algorithm, formula or calculation because the transformation produces a useful, concrete, and tangible result. Hence, the transformation is eligible subject matter because it passes the test for utility. The Court laid to rest the ill-conceived business method exception to patentability, paving the way for business method patents.

Prior User Rights: §273: “It shall be a defense to an action for infringement under section 271 of this title with respect to any subject matter that would otherwise infringe one or more claims for a [business] method in the patent being asserted against a person, if such person had, acting in good faith, actually reduced the subject matter to practice at least 1 year before the effective filing date of such patent, and commercially used the subject matter before the effective filing date of such patent.”

Medical Procedures

Infringement remedies are limited on patents for medical procedures. 35 U.S.C. § 287.

Utility

Applicant must assert that the claimed invention is useful for any particular practical purpose (i.e., it has a “specific and substantial utility”) and the assertion would be considered credible by a person of ordinary skill in the art.

Credible Utility: whether a person or ordinary skill in the art would accept that the invention is currently available for its purported use

Specific Utility: Disclosure must specifically point out intended use (“biological activity” is not enough)

Substantial Utility: A claimed invention must have a specific and substantial utility. This requirement excludes “throw-away,” “insubstantial,” or “nonspecific” utilities, such as the use of a complex invention as landfill, as a way of satisfying the utility requirement.

Moral Utility: The fact that one product can be altered to look like another is in itself a specific benefit to satisfy the utility requirement. Juicy Whip, Inc. v. Orange Bang, Inc. (1999).

Drug Products: It is generally sufficient to show a reasonable correlation between evidence and utility. Structural similarity to useful products, data from in vitro and animal testing may be sufficient. As such, pharmacological or therapeutic inventions that provide any “immediate benefit to the public” satisfy § 101. Nelson v. Bowler (1981).

Brenner v. Manson (1966) – A patent is not a reward for the search, but compensation for its successful conclusion; until process claims have been reduced to production of a product shown to be useful, the metes and bound of that monopoly are not capable of precise delineation. “[A] patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.”

In re Brana (1995): A deficiency under 35 U.S.C. 101 also creates a deficiency under 35 U.S.C. § 112, first paragraph. Proof of an alleged pharmaceutical property for a compound by statistically significant tests with standard experimental animals is sufficient to establish utility. Food and Drug Administration approval is not a prerequisite for finding a compound useful within the meaning of the patent laws. Usefulness in patent law, and in particular in the context of pharmaceutical inventions, necessarily includes the expectation of further research and development. The stage at which an invention in this field becomes useful is well before it is ready to be administered to humans.

35 U.S.C. § 112

§112, ¶1: “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

e of the claimed invention were additional, objective metes and bounds of a best mode disclosure.”

Novelty under § 102

Sec. 102(a) – Inquiry is on the actions of persons other than the inventor prior to the date of invention

Sec. 102. – Conditions for patentability; novelty and loss of right to patent

A person shall be entitled to a patent unless –

(a) the invention was [publicly] known or [publicly] used by others in this country, or patented or described in a printed publication in this or a foreign country, before the invention thereof by the applicant for patent, or

(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another before the invention thereof by the applicant for patent

Inherency

In re Robertson (1999): “Anticipation under 35 U.S.C.S. § 102(e) requires that each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference…If the prior art reference does not expressly set forth a particular element of the claim, that reference still may anticipate if that element is “inherent” in its disclosure. To establish inherency, the extrinsic evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference and that it would be so recognized by persons of ordinary skill. Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.”

“That which would literally infringe if later in time anticipates if earlier than the date of invention.” Lewmar Marine v. Barient (1987).

Schering Corp. v. Geneva Pharms., Inc (2003): In the context of determining the validity of a patent, inherent anticipation does not require that a person of ordinary skill in the art at the time would have recognized the inherent disclosure. Where the result is a necessary consequence of what was deliberately intended, it is of no import that the article’s authors did not appreciate the results. Inherency, like anticipation itself, requires a determination of the meaning of the prior art. Thus, a court may consult artisans of ordinary skill to ascertain their understanding about subject matter disclosed by the prior art, including features inherent in the prior art. A court may resolve factual questions about the subject matter in the prior art by examining the reference through the eyes of a person of ordinary skill in the art, among other sources of evidence about the meaning of the prior art.