CEIPI M2 21 - US & PT

(1)

“[G]enes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.”

(2)

“cDNA does not present the same obstacles to patentability as naturally occurring, isolated DNA segments. As already explained, creation of a cDNA sequence from mRNA results in an exons-only molecule that is not naturally occurring.”

“This human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. Because of this property, which is possessed by no naturally occurring bacteria, Chakrabarty's invention is believed to have significant value for the treatment of oil spills.”

“[T]he patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. _His discovery is not nature's handiwork, but his own; accordingly it is patentable subject matter_.”

(1) Subject matter

new, manmade plant varieties

(2) requirements

ordinary utility patent except:

disclosure and enablement satisfied if written description is as complete as "reasonably possible"

(3) Infringement

reproduction through grafting or other forms of asexual reproduction, or sale of asexually reproduced copies

Congress intended statutory subject matter to "include anything under the sun that is made by man."

No patents on claims on or "encompassing" a human being

An invention is excluded from patentability if the process requires either the prior destruction of human embryos or their prior use as base material, even if the application does not refer to the use of human embryos. Furthermore, the CJEU concluded that scientific research entailing the use of human embryos cannot access the protection of patent law

1960s

1970s

1980-2010

PTO 1996 Guidelines

will accept applications for patents on software on disks

2014

before

1980

1980s-1990s

1996

1998

2010

the machine-or-transformation test is not the sole test for determining the patent eligibility of a process, but rather "a useful and important clue, an investigative tool, for determining whether some claimed inventions are processes under 101."

method of giving a drug to a patient, measuring metabolites of that drug, and with a known threshold for efficacy in mind, deciding whether to increase or decrease the dosage of the drug

(1)

"If a law of nature is not patentable, then neither is a process reciting a law of nature, unless that process has additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself. "

(2)

"Purely "conventional or obvious" "[pre]solution activity" is normally not sufficient to transform an unpatentable law of nature into a patent eligible application of such a law. "

(3)

tie statutory standard directly to underlying policy concern: "that patent law not inhibit further discovery by improperly tying up the future use of laws of nature"

“We have “long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable.” *Mayo* . Rather, “‘they are the basic tools of scientific and technological work’” that lie beyond the domain of patent protection. As the Court has explained, without this exception, there would be considerable danger that the grant of patents would “tie up” the use of such tools and thereby “inhibit future innovation premised upon them.” This would be at odds with the very point of patents, which exist to promote creation.”

If lawmakers in country A think that firms in country A lead in technological development with respect to field X, then they should advocate extension of subject-matter coverage to inventions in field X, both domestically and internationally

If lawmakers in country A think that firms in country A do (and will) lag firms in other countries with respect to field X, then they should advocate elimination of subject-matter coverage to inventions in field X, both domestically and internationally

102(b) now creates a set of 1-year exceptions to the prior art that will invalidate a patent under 102(a)

Vs

(1)

3rd party who derived the information from inventor, or

(2)

3rd party filed after public disclosure by inventor, or

(3)

common assignee for the two patent applications

"a patent is not a hunting license"

(1)

Turning to the “specific” utility requirement, an application must disclose a use which is not so vague as to be meaningless.

(2)

Thus, in addition to providing a “substantial” utility, an asserted use must also show that that claimed invention can be used to provide a well-defined and particular benefit to the public.

no patents for inventions "injurious to the morals, health, or good order of society"

e.g.

“a new invention to poison people, or to promote debauchery, or to facilitate private assassination”

The requirement of “utility” in patent law is not a directive to the Patent and Trademark Office or the courts to serve as arbiters of deceptive trade practices. Other agencies, such as the Federal Trade Commission and the Food and Drug Administration, are assigned the task of protecting consumers from fraud and deception in the sale of food products. As the Supreme Court put the point more generally:

"Congress never intended that the patent law should displace the police powers of the States, meaning by the term those powers by which the health, good order, peace and general welfare of the community are promoted"

Article 53

Exceptions to patentability

European patents shall not be granted in respect of:

(a)

inventions the commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States;

A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, (1)

if the differences between the claimed invention and the prior art are such that

(2)

the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention

(3)

to a person having ordinary skills in the art to which the claimed invention pertains.

"secret prior art” refers to a patent application that is effective

as a prior art reference as of its filing date, even though it does not become known to the public until its publication date.**

*102 (a)(2): A person shall be entitled to a patent unless [...] the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b)

122(b)(1)(A)

each application for a patent shall be published, promptly after the expiration of a period of 18 months from the earliest filing date for which a benefit is sought under this title

35 USC 102(a)(2)

Patent Awarded to the first inventor to file

A person shall be entitled to a patent unless ... the claimed invention was described in a patent issued [to another] … or in [another’s] application for patent published … [that] was effectively filed before the effective filing date of the claimed invention.

35 USC 112

The specification shall contain

(1)

a written description of the invention, and of the manner and process of making and using it,

(2)

in such full, clear, concise, and exact terms

(3)

as to enable any person skilled in the art

(4)

to which it pertains, or with which it is most nearly connected,

to make and use the same,

(5)

and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.

(6)

The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

**Mechanical and electrical fields are considered predictable -- and thus enablement requirements are less strict;

Chemical and biological fields are considered unpredictable -- and thus enablement requirements are stricter.

failure to disclose best mode is no longer a ground for challenging the validity of a patent

(35 USC 282(b)(3)(A))

(1)

either in litigation or

(2)

in post-grant administrative challenges

35 USC 271(a)

Except as otherwise provided in this title, whoever without authority

(1)

makes, uses, offers to sell, or sells any patented invention

(2)

within the United States or

(3)

imports into the United States any patented invention

(4)

during the term of the patent therefor,

infringes the patent

(1)

Mere possession of a patented machine is not "use", in absence of "threatened or contemplated" use

Calif. Table Grape Comm. (ED Cal. 2007)

(2)

Demonstration at a trade show may not be "use"

Medical Solutions (CAFC 2008)

(3)

Testing is "use"

Waymark (CAFC 2001)

(4)

Continued use of infringing product made and sold before patent grant is infringement

Olssen (1938); Coakwell (Ct Cl 1967)

(5)

Use of a patented product for purposes other than those contemplated by patentee is infringement

Domestic offer, foreign sale

(1)

offer to sell, made in U.S., is not infringement where neither manufacture nor delivery will occur in U.S.

Quality Tubing (SD Tex 1999)

(2)

offer to sell, made in U.S., is infringement, regardless of location of manufacture and delivery

Rotec Industries (CAFC 2000)

271(g)

Whoever without authority imports into the United States or offers to sell, sells, or uses within the United States a product which is made by a process patented in the United States shall be liable as an infringer, if the importation, offer to sell, sale, or use of the product occurs during the term of such process patent.

271(c)

Whoever (1) offers to sell or sells within the United States or imports into the United States a (2) component of a patented machine, manufacture, combination or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, (3) knowing the same (4) to be especially made or especially adapted for use in an infringement of such patent, (5) and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.

*e.g

(1)

distributing brochures advertising sale of infringing equipment

(2)

instructing in the use of patented process

(3)

purchase of articles made through unauthorized use of a patented process

(4)

indemnifying infringer

(5)

inducing licensee to breach license agreement

35 USC 282(b)

The following shall be defenses in any action involving the validity or infringement of a patent and shall be pleaded:

Noninfringement, absence of liability for infringement or unenforceability.

(1)

“[A] patentee’s decision to sell a product exhausts all of its patent rights in that item, regardless of any restrictions the patentee purports to impose or the location of the sale”

(2)

Complete exhaustion triggered by authorized sale of product

(a)

Either in US or overseas

(b)

Either by patentee or by licensee

(1)

P suppresses the invention entirely

(2)

Foreign patentee refuses to “work”

the invention domestically

(1)

Patent Suppression (violation of

“working requirement”) triggers

compulsory license

(2)

Patent Suppression is Patent

Misuse

Invalidity

Intro to US IP Law - Patents

Remedies

Procedure

Collateral Estoppel

35 USC 282(a)

(1)

A patent shall be presumed valid.

(2)

Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims;

(3)

dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim.

(4)

The burden of establishing invalidity of a patent or any claim thereof shall rest on the party asserting such invalidity.

(1)

Finding of invalidity does not bind patentee in subsequent infringement suit against another defendant

Triplett (US 1936)

(2)

Final judgment of invalidity does bind patentee in subsequent infringement suit against another defendant, provided that patentee had a full and fair opportunity to litigate the issue

Blonder-Tongue (US 1971)

(Fall 2021)

@GCFrosio

Patent Misuse

Conduct by the Defendant

Anticompetitive Conduct

Prior User Right

Experimental Use

defendant, who uses a process (or a product in a process) commercially in US more than 1 year prior to filing (or disclosure) by patentee, may continue to do so

common law

plus

regulatory exemption for testing drugs for regulatory approval

(1)

Patent suppression

(2)

Selective Refusal to License

(3)

Demand that licensees purchase supplies only from patentee

(4)

Limits on sale prices of products made with the patent

(5)

Geographically discriminatory royalty structure

(6)

Limits on the regions in which products made with the patent are sold

(7)

In negotiating a patent license with L, Patentee persuades the holder of the patent on a separate, competitive technology not to grant a license to L

CEIPI M2

Defenses and Limitations

Inequitable Conduct

Exhaustion

Applicant have a duty to disclose to PTO all known information pertaining to patentability

Breach of this duty renders the entire patent unenforceable

Traditional Rules

Conduct by the Patentee

Delay

Implied Licence

Temporal Limit on Recovery of Damages

Irrevocable license to use the patent in specific ways may be inferred from the patentee’s conduct, even in the absence of reliance

Wang Labs (CAFC 1997)

35 USC 286

Except as otherwise provided by law, no recovery shall be had for any infringement committed more than six years prior to the filing of the complaint or counterclaim for infringement in the action.

Domestic

authorized sale of a patented

product to consumers carries with it

right to use and resell that product

Parallel Importation

exhaustion applies to sales of goods overseas unless patentee forbids reimportation when products are first sold

Curtiss Aeroplane, 266 F. 71 (CA2 1920)

Necessary Evil

Excessive Scope

Equitable Estoppel

Naturally Occurring Substances

Patents have socially undesirable side effects; they should be used only when essential to stimulate innovative activity that otherwise would not occur

(1)

Patentee misleads defendant into reasonably inferring that patentee does not intend to enforce the patent against him or her

(2)

Defendant relies

(3)

Due to this reliance, defendant will be materially prejudiced if plaintiff is allowed to proceed

Patents should not reach extralarge territories

Proportionality

Sanctity of (Human) Life

Isolated forms of naturally substances that exhibit properties different from the natural versions may be patented

Tax Strategies

The rights conferred by a patent should be proportional to the effort that went into it and/or to the benefit it confers on society

Genes

Eliminated by the Equal Access to Tax Planning Act

PTO begins to grant them

"strategies for reducing, avoiding, or deferring tax liability"

1992-2011

Limiting Principles

1992

2011

Sector-Specific Altruism

aprx. 20,000 patents in USA on isolated DNA sequences

pressure to eliminate these patents grows

longstanding position that isolated natural genes are patentable

Protect Opportunities for Downstream Innovation

Unconstrained curiosity will release uncontrollable evils into the world

Pandora's Box

Nationalism/Mercantilism

Sports

Discourage inventive activity in sectors that will plague humanity

Life Forms

Hubris

What is Protected?

Humans should not assert rights to the work of the gods

Microorganisms

Stem Cells

Equipment

Brustle v. Greenpeace (CJEU 2011)

C-364/13

an unfertilised human ovum whose division and further development have been stimulated by parthenogenesis does not constitute a ‘human embryo’, within the meaning of that provision, if, in the light of current scientific knowledge, it does not, in itself, have the inherent capacity of developing into a human being, this being a matter for the national court to determine.

Inventions may not be patented where their commercialisation would be immoral or against public order. In particular, the following are not patentable:

• processes for cloning human beings
• processes that modify the human germ line genetic identity
• use of human embryos for industrial or commercial purposes
• processes that may cause suffering to animals when modifying their genetic identity.

Utility Patent

Techniques

Plants

Animals

Sui generis

Plant Protection Act (1930)

Plant Variety Protection Act

Subject Matter

Medical Procedures

Business Method

The overwhelming majority of countries exclude medical procedures

Bilski

Business Methods long said to be outside patent protection (abstract ideas)

PTO guidelines instruct examiners to treat BMPs like any other process patent applications

encourage CAFC to continue to look for ways of limiting BMPs to ensure they advance the purposes of the patent system

VS

2011-2019

Software

Prior User right (1998)

2011 Patent Reform

PTO grants growing number of BMPs

Section 273: Defense to a suit for infringement of a BMP:

defendant had in good faith both

(a)

reduced the invention to practice more than 1 year before filing date and

(b)

commercially used the invention prior to filing date

defendants accused of infringing BMPs in financial services field can initiate post-grant PTO review of the patents

many under auspices of loosening rules concerning software patents

US position after 1996: patents permissible but doctors and "related health care entities" are not subject to patent remedies for "performance" of "medical activities"

CCPA forces PTO to increase availability of patent protection for software

Gradual relaxation of impediments

NO Research Exception

US Supreme Court applies the breaks

Supreme Court applies the breaks again

DuPont v. Berkeley (CA8 1980)

But invention that works imperfectly or crudely or partially passes muster

Bedford v. Hunt (CCDMass 1817)

not necessary that the invention be commercially viable or superior to alternative

JUDICIAL EXCEPTIONS

subject matter that the courts have found to be outside of, or exceptions to, the four statutory categories of invention,

and are limited to

(1)

abstract ideas,

(2)

laws of nature and

(3)

natural phenomena (including products of nature)

Parke-Davis & Co. v. H.K. Mulford Co.(C.C.S.D.N.Y. 1911) (L. Hand)

“[E]ven if it were merely an extracted product without change, there is no rule that such products are not patentable. Takamine [the inventor] was the first to make it available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a purification of the principle, it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent.”

it’s a factor, but not decisive

Bayer Co. v. United Drug Co. (S.D.N.Y. 1921)

Vs

Federal

State

vs

In re Bernhart (CCPA 1969)

Board of Patent Appeals and Inferences (BPI)

Amazon 1-Click Reexamination Request

software for depicting three dimensional objects in two dimensions

A machine programmed in a new and nonobvious way is patentable

Newman-Rifkin Patent [PTO final rejection (2004)]

(3)

Princo v. Int'l Trade Commission (CAFC 2010 en banc)

Non Obviousness Challenge

Patentee has “impermissibly broadened the ‘physical or temporal scope’ of the patent grant with anticompetitive effect”

(1)

Patent is unenforceable until effects of the misuse have been “purged” (practice abandoned and adverse impact dissipated)

(2)

Anyone can raise the defense

Sweat of the Brow

Ariad Pharms v. Lilly (CAFC 2010)(en banc)

Tegal Corp v. Tokyo Electron (CAFC 2001)

Plasma Reactor Apparatus

Constitutive and tissue-specific protein factors which bind to transcriptional regulatory elements of Ig genes (promoter and enhancer)

failure to take action to prevent corporate affiliates from engaging in infringing behavior is not inducement

applicant must describe the invention itself, not just how to make and use it (enablement)

Court of Customs

and

Patent Appeals

International News Service v. Associated Press 248 U.S. 215 (1918)

(CCPA)

1909-1982

Cloned animals are not patentable

Freeman-Walker-Abele test

If the claimed invention

(a)

directly or indirectly recites a mathematical algorithm, but

(b)

applies that algorithm in an otherwise statutory apparatus or process claim, it's patentable

In re Roslin Institute (CAFC 2014)

State Street Bank & Trust Co. v. Signature Financial Group (CAFC 1998)

In re Stephen W. Comiskey (CAFC 2007)

Business method for financial services

(1)

a claim reciting an algorithm or abstract idea can state statutory subject matter only if, as employed in the process, it is embodied in, operates on, transforms, or otherwise involves another class of statutory subject matter, i.e., a machine, manufacture, or composition of matter

(2)

the present statute does not allow patents to be issued on particular business systems—such as a particular type of arbitration—that depend entirely on the use of mental processes

(1)

applications for BMPs should be treated like any other process patent applications

(2)

a process is patent-eligible if it produces “a useful, concrete, and tangible result” — such as the transformation of financial data from one form to another form.

​

System for Mandatory Arbitration

natural right

Newman v. Quigg (CAFC 2007)

Individualistic

while surnames are registrable only with SM, two-part personal names are registrable without SM

Each person has a natural right to the fruits of his or her labor upon land held in common (Second Treatise, Ch. 5)

"Energy Generation System Having Higher Energy Output Than Input"

35 U.S.C. ss. 101

Personality

Fairness

Present

perpetual-motion machine

In re Alappat (CAFC 1994)

Why do we study theories? What are they good for?

software for controlling the illumination of pixels on an oscilliscope to minimize discontinuity and jaggedness

(1)

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof,

(2)

may obtain a patent therefor,

(3)

subject to the conditions and requirements of this title

IP Theories

an algorithm embedded in general purpose computer is patentable

15 U.S.C. ss. 1051 et seq.

(from Real Property Theories)

In re Brana (CAFC 1995)

vs

DDR Holdings v. Hotels.com (CAFC 2014)

Welfare

Cultural

“ The potential scope of DDR's patents is staggering, arguably covering vast swaths of Internet commerce. DDR has already brought infringement actions against ten defendants, including Digital River, Inc., Expedia, Inc., Travelocity.com, L.P., and Orbitz Worldwide, LLC. See J.A. 255-63; ante at 1250. _DDR's claims are patent ineligible because their broad and sweeping reach is vastly disproportionate to their minimal technological disclosure._ See Mayo, 132 S.Ct. at 1303 (In assessing patent eligibility, "the underlying functional concern ... is a relative one: how much future innovation is foreclosed relative to the contribution of the inventor.”).”

Collectivistic

U.S. 102(b)

U.S. Patent Act - 35 U.S.C. ss. 1-376

In re Fisher (CAFC 2005)

U.S. 107

not necessary that a compound have received FDA approval

Prospective

Visual Artist Rights Act 1990

Notwithstanding the provisions of sections 106 and 106A, the fair use of a copyrighted work, [...] for purposes such as criticism, comment, news reporting, teaching (including multiple copies for classroom use), scholarship, or research, is not an infringement of copyright.

Common

Statutory

idea + practical application + complex computer programming

In no case does copyright protection for an original work of authorship extend to any idea, procedure, process, system, method of operation, concept, principle, or discovery, regardless of the form in which it is described, explained, illustrated, or embodied in such work.

(CAFC 2014)

17 U.S. Code 106A

Rights of certain authors to attribution and integrity

"As of the filing date of the ’643 application, Fisher admits that the underlying genes have no known functions.”

Expressed Sequence Tag (EST), a short nucleotide sequence that represents a fragment of a cDNA clone.

v. Torrent Pharmaceuticals (CAFC 2017)

In determining whether the use made of a work in any particular case is a fair use the factors to be considered shall include—

(1)

the purpose and character of the use, including whether such use is of a commercial nature or is for nonprofit educational purposes;

(2)

the nature of the copyrighted work;

(3)

the amount and substantiality of the portion used in relation to the copyrighted work as a whole; and

(4)

the effect of the use upon the potential market for or value of the copyrighted work.

Brenner v. Manson (US 1966)

Chemical compounds (or processes for producing them) whose function is uncertain

Vs

(1)

must show "nexus" between the invention and the commercial success of the product (or process) embodying it

(2)

in addition requires demonstration of nexus between the aspect of the invention that reflects an inventive step and commercial success

a novel process for making a known steroid did not satisfy the utility requirement because the patent applicants did not show that the steroid served any practical function

Method for monetizing copyrighted products: content streamed to user, user required to view advertisement

Juicy Whip v. Orange Bang (Fed Cir 1999)

immorality or deceptiveness not relevant

The United States Congress shall have power "To regulate Commerce with foreign Nations, and among the several States, and with the Indian Tribes."

(Article I, Section 8, Clause 3)

The Congress shall have the power "To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries."

(Article I, Section 8, Clause 8)

ONE-WAY Importation

Omega Watch v Costco Wholesale (9th Cir. 2008)

ONE-WAY

Importation

Kirtsaeng v. John Wiley (2013)

ROUND-TRIP Importation

Commil v. Cisco (US 2015)

Helsinn Healthcare v. Teva Pharmaceuticals

(US 2019)

Quality King v. L'Anza Research Int'l (1998)

Global-Tech Appliances v. SEB (US 2011)

reaffirmed (Pfaff v. Wells) that an invention is considered “on sale” when it is “the subject of a commercial offer for sale” and “ready for patenting.”

the on-sale bar extends to secret offers for sale of an invention, such as those made under a non-disclosure agreement, made more than one year before filing a patent application claiming that invention

KSR International Co. v. Teleflex Inc. (US 2007)

"cool-touch" deep fryer, that is, a deep fryer for home use with external surfaces that remain cool during the frying process

Plaintiff must prove that defendant was aware of

(a)

the patent and

(b)

the acts induced by defendant constitute infringement

Revived the "obvious to try" test rejected by CAFC in In re Deuel (1995)

Defendant’s good-faith belief that the patent is invalid is not a defense

treatment for chemotherapy-induced nausea and vomiting using the chemical palonosetron

Impression Products v. Lexmark (US 2017)

International Exhaustion

Defendant bears the burden of establishing invalidity by clear and convincing evidence

Vs

i4i Ltd. Partnership

(US 2011)

Diamond v. Diehr (US 1981)

Gottshalk v. Benson (1972)

Parker v. Flook (1978)

a process for continuously monitoring the temperature inside a synthetic rubber mold, using a computer and the well-known Arrhenius equation for measuring cure time as a function of temperature and other variables

computerized process for converting binary-coded numerals to pure binary form

eBay Inc. v. MercExchange, L.L.C. (US 2006)

(US 2001)

patentable, because this is an ordinary industrial process that happens to incorporate a computer program

a "burgeoning number" of business-method patents were of "potential vagueness and suspect validity."

unpatentable because the invention claimed consists of no more than a mathematical algorithm; a patent would preempt its use

(2)

"We do not hold that no process patent could ever qualify if it did not meet the requirements of our prior precedents. It is said that the decision precludes a patent for any program servicing a computer. We do not so hold."

(1)

unpatentable, because if one ignores the algorithm on which the process is based, the claimed invention contains nothing new or inventive

Justices Kennedy Stevens, Souter, and Breyer

machine-or-transformation test

Vs

a claim to a process qualifies for consideration if it

(1)

is implemented by a particular machine in a non-conventional and non-trivial manner or

(2)

transforms an article from one state to another

J. E. M. Ag Supply

Alice Corp. v. CLS Bank International (US 2014)

Bilski v. Kappos (US 2010)

Metabolit

Vs

computer-implemented, electronic escrow service for facilitating the exchange of financial obligations between two parties by using a computer system as a third-party intermediary.

(2006)

A method for detecting a deficiency of cobalamin or folate in warm-blooded animals

(2)

depositing seeds in depository open to the public is sufficient for disclosure

(1)

utility patents may be issued for manmade crops and other flowering (sexually reproducing) plants

no patent on process that merely restates a natural phenomenon

(1)

administer a drug for inflammatory bowel disease

(2)

test for levels of resultant metabolite in the blood

(3)

administer more or less of the drug, depending on whether metabolite levels fall above or below specified range

We have described step two of this analysis as a search for an “inventive concept”—i.e., an element or combination of elements that is “sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the [ineligible concept] itself.”

framework for distinguishing patents that claim laws of nature, natural phenomena, and abstract ideas from those that claim patent-eligible applications of those concepts:

Step 1

First, we determine whether the claims at issue are directed to one of those patent-ineligible concepts.

Step 2

If so, we then ask, “[w]hat else is there in the claims before us?” To answer that question, we consider the elements of each claim both individually and “as an ordered combination” to determine whether the additional elements “transform the nature of the claim” into a patent-eligible application.

Vs

method of hedging risks in commodities trading

(3)

Infringement: "make, use, or sell" the patented plant

(US 2012)

Animals are patentable

Funk Brothers Seed v. Kalo Inoculant (US 1948)

Association for Molecular Pathology

VS

(US 2013)

(1)

Inventor discovers that certain strains of bacteria that help some plants remove nitrogen from the air do not interfere with one another

(2)

Inventor combines the strains into a single inoculant -- and seeks a patent on it

"claimed polyploid oysters are nonnaturally occurring manufactures or compositions of matter within the meaning of 35 U.S.C. 101"

Composition is not eligible for protection because inventor did not alter the bacteria

“ Here, as in Myriad, Roslin "did not create or alter any of the genetic information" of its claimed clones, "[n]or did [Roslin] create or alter the genetic structure of [the] DNA" used to make its clones. Myriad, 133 S.Ct. at 2116. Instead, Roslin's chief innovation was the preservation of the donor DNA such that the clone is an exact copy of the mammal from which the somatic cell was taken. Such a copy is not eligible for patent protection.”

Ex Parte Allen (Bd.Pat.App. & Int.1987)

Contributory Passing Off

EL first made and marketed, a liquid preparation containing quinine and other drugs compounded with chocolate to give it color and flavor and to aid in suspending the quinine. Warner then, using chocolate, produced an article of the same taste and appearance, but sold cheaper, and, to reap EL's trade, suggested to retail druggists the feasibility and economy of passing off the one for the other when dispensed out of the bottle, which was done in many and diverse instances.

Alexander Milburn v. Davis-Bournonville (US 1926)

Delays in the patent office should not deprive the public of an invention that would have, in the fullness of time, gone into the public domain.

William R. Warner & Co. v. Eli Lilly & Co. (US 1924)

Diamond v. Chakrabarty (1980)

International Framework

In that case, it would have been the date the first patent issued. Now that applications are published, it’s the date of publication.

Inwood Laboratories v. Ives Laboratories ((US 1982)

generic drug manufacturer supplies drugs to pharmacist known to be mislabeling them

Integration

& Harmonization

Secondary Liability

271(b)

“Whoever actively induces infringement of a patent shall be liable as an infringer”*

Inducement

Contributory Infringement

BUT

inaction is not inducement

(1)

scienter requirement

necessary that the defendant knew that the combination for which he was supplying a part was both patented and infringing

PLUS

scienter

(2)

defense

substantial noninfringing uses

Make

Import

Use

Use of patented products made without authority by someone else is infringement

importation of products made overseas with patented process

Importation of a Patented Product

271(a)

whoever without authority ... imports into the United States any patented invention during the term of the patent therefor, infringes the patent.

Forbidden Actions

Patent Reform 2011

Offer to Sell

Sell

First to File

First to Invent

Vs

Govern applications filed or patents granted before March 16, 2013

Govern applications filed on or after March 16, 2013

first-sale doctrine

presumed that sale of the patented product to consumers carries with it right to resell

Novelty

Grace Periods

What's the advantage?

First Inventor to File

Prior Art does not include disclosures made

(less than 1 year before filing date)

by 3rd parties in patents or patent applications if

NO penalty for dislosing your invention

Prior Art does not include disclosures made

(less than 1 year before filing date)

by the inventor or derived (directly or indirectly) from disclosures made by the inventor

Forfeiting the benefit of first to file

(1)

filer derived the invention from someone else

(2)

filer abandons or suppresses the application

Incentive to disclose your invention early

Prior Art does not include disclosures made

(less than 1 year before filing date)

by 3rd parties after a "public" disclosure by the inventor

Invention was described in an issued US patent or in a US patent application filed before applicant's filing date

Known

idea sufficiently well developed that a PHOSITA could reduce it to practice

Used

reduced to practice

by others

reasonably accessible to the public

Infringement

35 USC 102(a)

Invention was Patented or Described in a Printed Publication anywhere in the world

Invention was available to the public anywhere in the world

"known or used by others"

Public

Printed

including digital form

must be accessible to members of the public interested in the art, exercising reasonable diligence

Claim Construction

Fatal Conditions

35 USC 102(a)

Invention was in public use anywhere in the world

35 USC 102(a)

Invention was on sale anywhere in the world

hidden public use

non-informing public use

actively hide your invention from the public

commercialization of an object embodying the invention, which is impossible to reverse engineer

commercialization of the output of the invention, while concealing the invention

Written Description

Types of Infringement

What is Protected?

General

Infringement

no patents for inventions that violate generally accepted scientific principles

The description must be sufficient to enable a PHOSITA to make and use all of the embodiments of the invention claimed in the patent

practical

Enablement

Disclosure

Factors

State of mind

Utility

Specific

bad intent on part of defendant is unnecessary

Literal

(1)

Quantity of experimentation necessary that a PHOSITA would need to do

(some experimentation to practice the invention is OK)

(2)

Amount of guidance provided by the patent

(3)

Presence in the patent of working examples

(4)

Nature of the invention

(5)

State of prior art

(6)

Skills of PHOSITAs

(7)

Predictability of the art*

(8)

Breadth of claims

Equivalents

very low threshold

all-elements rule

Test

or

all aspects identified in a claim must be infringed

(1)

“Function-way-result”

D’s product must perform substantially the same function in substantially the same way to achieve the same result as P’s product

OR

(2)

Are the differences between the two products “insubstantial”?

Best Mode

Beneficial

BUT

Duration

(1)

can be used by PTO to reject an application and

(2)

falls within a patent agent’s duty of candor

good for society

Requirements

Entitlements

Do I have defense from liability after infringement has occurred?

35 USC 103

Licences and

Assignments

Scope and Content of the Prior Art

"Obvious to Try" Test

(1)

"prior art" now includes all types of prior art under 102

including secret prior art under 102(a)(2)*

(2)

provided prior art in question is "analogous"

(a)

either within the same field of endeavor as the invention

(b)

or reasonably pertinent to the same problem as that addressed by the invention

filing Application Patent B

filing ApplicationPatent A

publication Application Patent A

Prior Art

9/6/2021

9/12/2019

9/12/2020

18-months

3 Variables

Gap between Prior Art and Claims

At the time of the invention, would it have been obvious to a PHOSITA to try the particularly combination of elements that eventually produced the invention?

Level of Skill in the Art

Against this background, would the invention, as claimed, have been obvious to a PHOSITA?

(1)

Education level of typical worker in the field

(2)

Education level of the inventor(s)

(3)

Kinds of problems typically encountered in the field

(4)

Pace on innovation in the field

(5)

Sophistication and difficulty of the technology in the field

Nonobviousness

Secondary Factors

(1)

commercial success

(2)

long-felt need

(3)

failure of others

(4)

unexpected results

(5)

skepticism of experts prior to invention

(6)

industry praise after invention

(7)

copying by others

(8)

public recognition of patentee as the inventor (e.g. through licensing)

(9)

simultaneous invention by others