Chapter 3

Three Strands of Utility Doctrine• Operability: Does it work? (Should prophetic

utilities be allowed?)

• Beneficial Utility: Does it produce some social benefit (or at least no social harm)?

• Practical or Specific Utility: Is the utility identified by the inventor a “substantial” utility? See Brenner v. Manson p. 233. (Should substantiality be decided in the abstract or by reference to the potential range of utilities for the invention?).

Examples• New method for freebasing cocaine?• New business model for a bordello? • A method for traveling back in time? • A method for cooking chicken with a cyclotron? • A clever new board game? • An isolated and purified strand of DNA that can

be used as dog food?

Lowell v. Lewis• Story’s view: “All that the law requires is, that

the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society. The word ‘useful,’ therefore, is incorporated into the act in contradistinction to mischievous or immoral.”

• Market should determine utility: “[W]hether it be more or less useful is a circumstance very material to the interests of the patentee, but of no importance to the public. If it be not extensively useful, it will silently sink into contempt and disregard.” This is the real holding of the case, since no party in the case was arguing that the invention was immoral.

Story and Beneficial Utility• Justice Story’s view is both permissive and demanding. An invention

need not be profitable or economic improvement over prior art, but it must comply with society’s morality standards.

• Certain biotechnology inventions have resuscitated at least a debate about the beneficial utility doctrine.

• In 1998, the PTO publicly stated that the beneficial utility doctrine might preclude a patent on a human/animal chimera, but the agency ultimately rejected that patent application on the ground that human hybrids are not patentable subject matter under § 101. See p. 225.

• Congress enacted an appropriations rider (a legal limitation found in an appropriations bill) that precludes the patenting of an human organism. The rider — popularly known as the “Weldon Amendment” — reads: – “None of the funds appropriated or otherwise made available

under this Act may be used to issue patents on claims directed to or encompassing a human organism.” Consolidated Appropriations Act, 2004, Pub. L. No. 108-199, Division B, Title VI, § 634 (Jan. 23, 2004).

Juicy Whip v. Orange Bang: An Under-the-Counter Invention

Juicy Whip v. Orange Bang• Narrow holding: “The fact that one product can

be altered to make it look like another is in itself a specific benefit sufficient to satisfy the statutory requirement of utility.”

• Broader holding: “[E]ven if the use of a reservoir containing fluid that is not dispensed is considered deceptive, that is not by itself sufficient to render the invention unpatentable.” – Other institutions.

• Juicy Whip does not hold that an invention is patentable even if it is illegal in all 50 states. What is the position of TRIPs Art. 27.2 on illegal inventions?

• EPO’s view and Harvard Oncomouse case.

Brenner v. Manson• November, 1956: Ringold and others publish an

article revealing that a number of compounds, including the steroid at issue, were being tested for tumor inhibiting effects. The article also shows that a compound closely related to the relevant steroid was effective in inhibiting tumors.

• December 17, 1956: Ringold and Rosenkranz file a patent application seeking a patent on the new process for making the known steriod.

• October 13, 1959: Ringold and Rosenkranz receive a patent on the process.

• January, 1960: Manson files a patent application for the same process.

Brenner v. Manson• Manson is essentially the Supreme Court’s only decision

on the utility requirement, and the decision is more than four decades old.

• The most controversial part of Manson is its rejection of the reasoning of the Court of Customs and Patent Appeals. Assume that a firm is in the business of producing chemicals; it has no idea why its customers buy the chemicals. Can it patent an improvement in its processes for producing the chemicals?

• The less controversial part of Manson is its holding that a chemical will not be viewed as having a utility merely because it is the subject of scientific inquiry.

• Remember: Manson is a case about NO chemical utility.• The Court is concerned that wide-ranging product and

process claims inhibit further research. We saw similar concern in Morse and The Telephone Cases.

• Note that the Court required Manson to have come up with a utility for the steroid as of his date of invention.

Brenner v. Manson• Narrow reading: Even on the assumption that the

process would be patentable were respondent to show that the steroid produced had a tumor-inhibiting effect in mice, we would not overrule the Patent Office finding that respondent has not made such a showing.” Manson failed to show “sufficient likelihood” that the steroid would have similar tumor-inhibiting effects.

• Broader reading: The patent must show a “substantial utility” --- i.e., that a “specific benefit exists in currently available form.”

• Concern: “It may engross a vast, unknown, and perhaps unknowable area. Such a patent may confer power to block off whole areas of scientific development, without compensating benefit to the public.”

• Rejects a broad reading of Story’s dicta. Lowell v. Lewis does not state the only test of utility.

Brenner v. Manson• Big question: Why are games and amusements

patentable and yet not compositions of matter that are the subject of scientific curiousity? Do we value Trivial Pursuit more than scientific pursuit?

• Best Answer: The value of the game is unlikely to be improved by additional inventive work, so the inventor will reap the market value of the game. The scientific curiosity is more likely to be improved by subsequent discoveries, and those future inventors will have to share their royalties with the first patentee. Thus, permitting a patent on the scientific curiosity is more likely to lead to excessive reward for the patent holder.

In re Brana• Notably Brana did not cite the Supreme Court’s Manson decision, even

though the PTO appeared to have been following the teaching of Manson that the subjects of active research are not patentable.

• Can Brana and Manson can be reconciled? – Yes. Manson involved a case of no utility. In Brana, some utility

was found for this very drug (it had a proven anti-tumor effect in mice).

– The tenor of Brana and Manson seem quite different.• What is the utility in Brana? Is it curing mice of tumors? Or is it curing

humans? – The opinion seems to suggest that curing mice of artificial tumors is

a “sufficiently specific use.” See p. 242. It is important, however, that this artificial disease was “originally derived from lymphocytic leukemias in mice.”

– By comparison, that the PTO had rejected the application for failing to disclose a “practical utility (i.e, antitumor activity in humans).

– Also, on page 243, the court states that the PTO did not meet its burden of challenging a “presumptively correct assertion of utility” because the PTO’s arguments would be “relevant only if applicants must prove the ultimate value in humans of their asserted utility.”

In re Brana• Structure of Brana opinion: 1) Murine cure is “sufficiently specific

utility”; 2) PTO has not demonstrated that the utility is “inherently unbelievable”; 3) even if PTO did overcome its initial burden, the applicants submitted sufficient evidence to convince a person of skill in the art of the asserted utility.

• Why didn’t the court rely on the in vitro tests against human tumor cells? – Possibly, the court wanted to make clear that an murine antitumor

effect was a sufficient practical utility; effectiveness in humans did not have to be proven.

– Proof of antitumor activity in vitro against human tumor cells does really show much about the therapeutic value of the substance. Many substances that kill cells in vitro may also kill the entire organism and thus have no value.

• Can an inventor file for a patent and continue testing in hopes of showing a utility by the time the examiner starts to ask questions?– No! Manson makes clear that the identification of a utility is part of

invention and must be satisfied by the filing date at the latest! – While the assertion of utility must be made in the specification, the

proof to overcome the PTO’s disbelief can be submitted after filing. See note 16 on p.244.

Ex parte Fisher• Claim is in Parke-Davis form. • What is the alleged utility in Fisher?

– Polymorphism? (Mutation or difference in genetic structure.)

– Probe – useful in looking for promoter active in anthesis? (Compare Brenner v. Manson)

• Compare to microscope – why is that useful? • What’s the cost of allowing these DNA

fragments to be patented? How will resources be misallocated if the PTO allows these patents?

• Paperweight Example: Are new materials for paperweights not patentable? – No! When would they be patentable?

Ex parte Fisher• Note also “comprising” language”. Is this inconsistent

with “substantially purified”? • Why are patents being sought on so many DNA

sequences? Note: over 32,000 sequences here!– One big reason: In re Deuel has interpreted the

nonobviousness doctrine such that, even if the technique for isolating a new chemical composition is obvious, the chemical composition is nonobvious if its structure is nonobvious. This ruling leads to patenting “machines” which can automatically isolate DNA fragments.

– Is this invention?• 112 rejections:

– Enablement – contingent on utility holding.– Written description – satisfied.