Patent Law

What are the various transitions that can be used in patent application claims?

"Comprising": Preferred by patentees. An invention "comprising" x and y can also include z and still be protected. "Consisting of": Patentees do not like this, because it really means "consisting only of." So if it includes z, there's no infringement. "Consisting essentially of": A compromise. A potential infringer can include z and the original patentee MIGHT be protected, depending on whether z changes the essential function.

What are the rules for standard setting organizations?

They are permitted in the US, but: - must have a legitimate objective (beyond suppressing competition) - must abide by procedural requirements called ANSI designed to maximize fairness -ability of participating firms to use their IP rights is curtailed (certain duties to disclose and license - must disclose patents that could affect standards, must announce decisions not to abide by constraints, must agree to commit to licensing on particular terms)

What is the reverse doctrine of equivalents?

When a device appears to literally infringe, but does not because the accused device operates on a different principle by performing that same function in a substantially different way. Basically, if the patented device has changed so much that the patent claims no longer represent it, defendant can;t be subject to infringement. This is a pretty minor infringement defense (criticized in Tate Access Floors) currently.

What are some applications of the incentive theory of IP to patent law?

- Idea that IP is a necessary evil and should only extend to innovations that wouldn't be produced sufficiently without it (e.g., maybe med procedures). Justification for novelty and nonobviousness requirements (no need to use patent to provide society benefit of invention). Justification of utility requirement (only need it for socially useful inventions) - Disaggregation: IP rights should be tailored to specific types of inventions. (Counter: increased admin costs and risk of capture)

What general extensions are available for patent duration under 154(b)(1)?

- If PTO is slow in responding to specific submissions - If more than three years have passed between the application and grant and it's not the applicant's fault - extensions for interferences, secrecy orders, and winning appeals

What are the socially beneficial elements of patent protection (under incentives theory)?

- Increase rate of innovation - Channel innovation towards fields where it has large potential social value (people will go where there are customers) - Decrease investment in/reliance on more wasteful tools - Foster socially beneficial industry structures (assumption that small business is more innovative)

What conduct by the plaintiff can serve as a defense to infringement?

- Inequitable conduct - Delay - Equitable estoppel - Implied license

What are the defenses/limitations for patent infringement?

- Invalidity - Sovereign immunity - Conduct by defendant - Conduct by the patentee - Exhaustion - Anticompetitive conduct

Circumstances that mitigate the public goods problem (and reduce need for gov action)

- Lead time protects first mover - Custom/extralegal norms protect first mover - Opportunities to increase excludability through self-help, like contracts, secrecy, encryption - Opportunities for appropriation of benefits of innovation through complementary capabilities (e.g., good marketing, customer services) - Opportunities for speculation in markets in materials related to discoveries - Nonpecuniary motivations like passion, fame, challenge, etc.

What is a reverse payment settlement and what is its role in infringement defense?

When patentees pay infringers not to enter the market. This is generally disliked as being anti-competitive. Under Actavis, this is sometimes anti-competitive behavior enough for a defendant to use it as defense in an infringement suit. Courts decide by examining traditional anti-trust factors like anticompetitive effects, redeeming virtues, etc. Otherwise unexplained big cash payments are probably violations unless there's an unrelated explanation. Lawyers are finding ways to work around this, though.

What are some reasons to exclude things from patentability?

- "Necessary evil" theory - Too large in scope - e.g., can't patent algorithms, would give you too much reach - Proportionality: excluding patents if the territory is too large compared to the effort inputted - If it's upstream of a lot of innovations that would be frustrated by patenting it - Nationalism/mercantalism: Countries should favor its own citizens or firms and so give more protection in areas they're leading/less in areas they're lagging - Hubris (we shouldn't assert rights to "works of gods") - Pandora's Box (too much curiosity introduces evils) - Sector-specific altruism (e.g., Hippocratic Oath) - Sanctity of (human) life

What are some policies that can be enacted at the GLOBAL level to encourage innovation?

- Free trade in products (allows for specialization) - Mobility of labor (innovative people can go to places where it's easier to innovate) - Global systems for overcoming public-goods problem (e.g., WHO funding for small firms working on ebola vaccines) - International work on things that impede investment (like armed conflict, climate change)

What are the socially negative elements of patent protection (under incentives theory)?

- Decrease consumer access to patented goods (by raising prices) - Decrease benefits of knowledge spillovers (building on innovation, though disclosure helps this in long term) - Impede cumulative innovation - Induce wasteful R&D (instead of spreading out areas of research; and of "designing around" patents) - Social value and consumer willingness to pay aren't the same thing, so loss associated with using this as a metric - Administrative costs

Circumstances that exacerbate the public goods problem (and so heighten need for government action)

- High costs of creation (more investment required, so more risk, e.g., pharma industry) - High uncertainty (again, pharma) - Low marginal cost of production (easier for others to copy) - Ease of reverse engineering - Positive externalities for the public good

What are the requirements for design patents?

- Must be an "article of manufacture": man-made tangible object or part thereof. Can be an ephemeral object, like the shape of water in a fountain. - Must be "design." It's all about the appearance and must be visible at some point. In re Webb: his implant sill counts because visible in advertising, etc. prior to implantation. - Must be "ornamental," which has lots of interpretations. Most important one is that it can't be primarily functional; function doesn't dictate design (e.g., LA Gear and the sole of a shoe). Whether there are alternative designs is relevant. - Must be "original" - design can't be copied and only the designer can obtain the patent. - Must be novel - an ordinary observer would think it was overall different from any prior art. Normal provisions apply re: timing, grace periods, etc. - Must be nonobviousness - the relevant prior art is the set of actually built articles of manufacture (not design concepts like writing about design), and secondary factors like the success of a design feature and its popularity can be relevant if connected. The PHOSITA here is a designer of ordinary skill of articles of the relevant type. - Must be reduced to practice - three-dimensional embodiment.

What does the Paris Convention NOT have?

- No minimum standards for patent protection - No guarantees of effective enforcement of patents - No meaningful way to police violations (theoretically could go to ICJ, but this has never happened)

What are types of anticompetitive conduct that may be an infringement defense?

- Patent misuse - Reverse-payment settlements - Standard setting organizations

What are NATIONAL mechanisms for overcoming the public-goods problem?

- Patent system - Education - Anti-discrimination laws (to ensure all potential investors have access) - Anti-trust policy (on assumption that competitive industries are more innovative)

What delay by a plaintiff is defense to an infringement allegation?

Plaintiffs can't recover for any infringement committed more than 6 years ago (35 USC 286). Laches is no longer available as a way to get past this.

Overview of patent protection of plants

- Plant Protection Act - Plant Variety Protection Act - Utility Patents (extended to new, manmade plant varieties). Infringement is via making, using or selling the patented plant - potentially more expansive claims than PPA or PVPA - Nonpatent forms: trademark, contracts, technology

What can the government do to fix the public goods problem?

- Provide the good itself (lighthouses, roads, etc.) - Select and subsidize private innovations - Issue prizes to successful private producers - Legally reinforce self-help strategies (e.g., trade secret law) - Protect producers against competition (IP law)

What are the behaviors by defendants that can be defenses to infringement?

- Reverse equivalents - Experimental use - Prior user right

What are the four requirements for getting a patent?

- Utility (easiest to satisfy) - Disclosure - Novelty and statutory bars - Nonobviousness

What are TRIPS limits on compulsory licenses?

- authorization considered on the merits; - must first try to obtain authorization on reasonable commercial terms; - scope and duration limited to original purpose; - nonexclusive; - nonassignable; - authorized predominantly for the use of the domestic market; - license ceases when the circumstances no longer exist; - "appropriate compensation" for the use, "taking into account the economic value of the license"; - validity of license subject to judicial review; - appropriate compensation subject to judicial review; - anti-competitive practices by the patent holder taken into consideration

What are secondary factors used to assess nonobviousness?

- commercial success - long-felt need - failure of others - unexpected results - skepticism of experts prior to invention - industry praise after invention - copying by others - public recognition of the patentee as the inventor (e.g., by licensing) - simultaneous invention by others (given very little weight)

Strategy tips for patent litigation

- present case to judge, jury, and appellate judge at the same time - simple, simple, simple - be brief and clear - be the teacher and educator - know that jurors give the PTO great deference - but that they also don't like monopolies - they intuitively interpret "infringement" to mean intentional - build case around understandable story and themes

What is the prior user right defense?

A defendant who uses a process (or product in a process) commercially in the US more than a year prior to someone else's filing of a patent for it can keep using it. Practically speaking, this protects people who develop a process and protect it with trade secret law from others patenting it.

Based on the benefits and drawbacks of an IP system's effect on social welfare, what are our guidelines for reforming patent law?

1. Adjust IP doctrine to maximize social welfare benefits and minimize costs. 2. Supplement or replace IP system with systems that are better in certain areas.

What are the main limitations on the doctrine of equivalents?

1. Doctrine of prior art 2. Material disclosed but not claimed 3. Prosecution history estoppel

What are the three aspects of the disclosure requirement?

1. Enablement 2. Best Mode 3. Written Description *Disclosure looks at the specification component of the patent app, not the claims.

What are two special types of claims w/r/t claim construction?

1. Means and function elements under Section 112(f): An element of a claim that's expressed as "a means or step for performing a specified function." Basically, some complex inventions are more easily described as their means or step for performing their function, instead of their structure. When this is the case, claims will still be construed to cover that structure, material or acts. However, using the word "means" isn't enough to guarantee this, though it does create a presumption. 2. Product by process claims: Products made through a particular process. Construed as product patents, but with the process elements as important limitations. If someone else finds a way to make the same product via a different process, it's not infringement.

What factors are considered re: nonobviousness?

1. Scope and content of the prior art. Prior art includes everything it does for novelty, including secret prior art, as long as the prior art is "analogous." That means it must be either within the fame field or endeavor as the invention or reasonably pertinent to the same problem as that addressed by the invention. 2. Gap between prior art and claims. 3. Level of skill in the art. This can include the education level of a typical worker in the field, the education level of the inventor, the types of problems typically encountered in the field, the pace of innovation in the field, and the sophistication and difficulty of technology in the field. These are the three main factors. There are also numerous "secondary factors," which are important - CAFC will reverse if they're ignored. These include: - commercial success (with connection between the product/process and the invention embodying it, and between the inventive step and the success) - long-felt need - failure of others - unexpected results - skepticism of experts prior to invention - industry praise after invention - copying by others - public recognition of the patentee as the inventor (e.g., through licensing) - simultaneous invention by others (given little weight)

Definition and characteristics of "process"

101 definition: "Process, art, or method, and includes a new use of a known process, machine, manufacture, composition of matter, or material" - includes "new use" patents - new uses of old things - the sequence of steps is crucial - ex: laser pointer used for cat exercise

Sovereign immunity defense

11th Amendment gives states, their instrumentalities, and their employees acting in official capacity immunity against infringement liability (Florida Prepaid). This also goes for Native American tribes. It also applies to cases challenging their patents in PTAB.

What are design patents?

171(a): Whoever invents any new, original and ornamental design for an article of manufacture may obtain a patent therefore, subject to the conditions and requirements of this title. The design patent system is governed by a separate statute.

Plant Protection Act

1930. Special statute apart from regular patent system to deal with creation of new plant varietals. Easier to get, but less protective. However, you can still use normal patent system (Pioneer Protection). In practice, shields nurseries against reproduction of ornamental plants and fruits; largely irrelevant to fruit staples. Details: -Deals with new, manmade plant varietals (subspecies showing distinctive characteristics). - No protection for naturally occurring varieties, but yes to spontaneously arising cultivated new varieties. - Requirements are like for ordinary utility patents, except disclosure and enablement satisfied if written description is as complete as "reasonably possible." - Infringement is reproduction via grafting, other asexual repro, or selling asexually repro-ed copies (not infringement through seeds or independent invention)

What is the general duration of patent protection?

20 years from the time of the patent application. The clock starts running earlier if the patentee refers back to an earlier US application (we didn't talk about what this means) or a PCT app naming the US (but not a Paris Convention one, for some reason). Various extensions are availably, and about 75% of patentees use some form of extension. The longest possible extension from tacking is 5 years, which is rare.

What is the statutory basis of the utility requirement?

35 USC 101

What is the statutory basis of patent law?

35 USC 101: "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 therefore, subject to the conditions and requirements of this title."

What is the statutory basis of nonobviousness?

35 USC 103

What is the statutory basis of disclosure?

35 USC 112

What is the statutory source of infringement defenses?

35 USC 282(b), but most of the doctrine has been shaped by case law.

What's an example of an application that failed the enablement requirement?

A classic example is the lightbulb. Edison had figured out (through lots of experimentation) that a certain type of bamboo glowed without burning, but he didn't limit the patent to this bamboo, but to "carbonized fibrous or textile material." This didn't meet the enablement requirement.

What is the inequitable conduct defense and what is the standard?

A common but controversial defense to patent infringement alleging the patentee didn't disclose enough to PTO with their application. Patent applicants have a duty to disclose to PTO all information known about patentability, including prior art that they know about, and if they don't, the entire patent becomes unenforceable against anyone (huge penalty). It is a decently high bar to establish and usually fai.ls. Defendant must specify in detail what the patentee didn't disclose (Exergen) and must prove by CCE that the missing info was material and that they intended to deceive the PTO (Therasense).

What is the Hatch-Waxman Act?

A law creating a separate set of patent duration rules for pharmaceuticals. A lot of time is taken up with regulatory review, so this is designed to compensate. It also wanted to compromise with the interests of generic drug manufacturers, who would try to "jump the gun" by doing research before patent expiration.

What is infringement through equivalents?

A product can infringe if it's product/process isn't exactly like the earlier one, but is, in effect close enough. Plaintiffs usually lose on equivalent arguments (unclear if this is because they just throw them in with better arguments or for other reasons).

What is the TSM test for nonobviousness?

A test rejected as necessary in KSR, but whose circumstances may still be relevant as an ancillary test. "Whether, at the time the invention was created, something would have taught, suggested, or motivated a person of ordinary skill to combine prior art elements to create the claimed invention. That 'something' includes the prior art, knowledge of one of ordinary skill in the art, or the nature of the problem to be solved."

Paris Convention

A very old treaty (1883) that has been revised several times and is still very important for patent law. Major provisions: - National treatment deals with how we overcome countries' biases in favor of their own nationals. Each member country agrees to protect foreign nationals at the same level as their own. - Right of priority: If you file in one of the member countries, you have a year to file in any of the other member countries using your first filing date (priority date). This allows applicants to file gradually over the year without losing the protection of that earlier date. How this is applied in the US: Implemented in 35 USC 119, and you only get this benefit if the original application was detailed enough that it would pass the enablement requirement under 112. - Restrictions on compulsory licenses: orders within a country that patentees must grant a license on specialized terms. These limitations are pretty modest and are, in effect, replaced by more restrictive TRIPS provisions. No limits on grant of CLs in the public interest. - Member states may form "special agreements" with their own tighter rules. **The PCT route has become increasingly common, but this is still significant. Parties may use if when they're not as cost-sensitive and want faster protection.

What is the procedure for expedited generic drug approval by the FDA?

ANDA (Abbreviated New Drug Application) comes from the Hatch-Waxman Act. 1. Must show bioequivalence - this drug is the same as the main drug. 2. Must show there's no patent impediment to commercial distribution of the drug. Can show any of the following: - The drug hasn't been patented - The patent on the drug has expired - The patent on the drug will expire on x date, so we can start marketing then - The patent is alive, but invalid or this won't infringe. This is a major way that drug patents are challenged, as it's easy and damage-free.

TRIPS

Adopted in 1994 and has become very significant. Debate on origins: some say developed countries forced others to accept IP systems that didn't benefit them at the urging of big industries; some believe the opposite, that less developed countries wanted this but couldn't get it done otherwise; some believed it was a rational trade-off by less developed countries for more access to global markets. Still, general view that so far it has really helped pharma while disadvantaging developing countries. Goes further than past treaties to limit individual countries' discretions over own patent systems. Main provisions: - Same national treatment principle - MFN principle: If you extend a protection to nationals of one country, you must extend it to nationals of all other countries - Mandatory subject matter coverage. Countries must grant patents for all inventions (products and processes) that are novel, involve an inventive step, and capable of industrial application - Mandatory entitlements: must prevent third parties from making, using, offering for sale, selling or importing without consent (and same idea for processes); right to assign and license. Some limited exceptions are allowed, like public health and experimental use defense, where it doesn't unreasonably conflict or prejudice interests legit interests of patent owner. - Minimum term of 20 years from filing and no maximum - Countries may not discriminate on the basis of the field of technology (the big one is pharma, to force India to recognize drug patents), place of invention, or local production. However, they CAN deny patents for certain medical methods, for plants and animals (other than micro-orgs) and methods that create them, and generally for reasons of public order or morality. - Limits on compulsory licenses are fairly strict. - Mandatory enablement requirement - Mandatory enforcement: must be "fair and equitable" procedures with decisions in writing and opps for damages and injunctions. - Dispute resolution procedure with consultation among disputants, WTO Panel, and WTO appeal Areas where there's still discretion: Subject matter exceptions, requirements for obtaining a patent (e.g., standard for non-obviousness or inventive steps), scope of doctrine of equivalents, size of mandatory use exception, exhaustion, and others.

Patent Law Treaty

Adopted in 2000 and currently only 39 members (relatively small). Aim was to standardize patent applications by specifying how to interpret terms (e.g., date of application) and forbidding members from adopting more onerous requirements.

Patentability of sports

Advances in sports equipment are definitely patentable. Sports techniques are also patentable, but more controversial. Classic examples were a way of holding a golf club and a way of going over a pole backwards while moving arms for pole jumping (no idea what that sport is called). These are weirdly anti-competitive.

What is the "obvious to try" test?

An ancillary test for nonobviousness revived in the SCOTUS KSR case. At the time of the invention, would it have been obvious to a PHOSITA to try the particular combination of elements that eventually produces the invention? If so, obvious.

Status of animals

Animals are patentable. But no patents on claims on "emcompassing" a human being. Cloned animals are NOT patentable - no alteration of genes (Roslin Institute) - but the processes can be patentable. Human-engineered organisms are also patentable (bacteria that eats oil slicks - Diamond case).

What kinds of prior art will lead to a novelty failure? What is the rule for analyzing prior art re: novelty?

Anything that, anywhere in the world, has been on sale, in public use, available to the public, described in a publication, or patented. If the prior art was described in a patent application before you filed but not published until after you filed (since there's usually an 18 month gap), it's still fatal. This is called "secret prior art."' The analysis is done under "strict anticipation rules": each element of the claimed invention is disclosed in a single prior-art reference or embodied in a single prior-art device.

What is the written description requirement?

Applicants must describe the invention in sufficient detail to show they were "in possession" of the invention - at the time of filing, they fully understood what the thing eventually claimed did and how it worked. Today, though, it's less clear. It was traditionally invoked when applicants amend their applications. Amended apps get the same priority date of original filings (Section 120) and the amendment can't introduce new matter into the disclosure (Section 132). However, recently, CAFC has applied it outside of the extension context to say that the applicant must describe the invention itself, not just how to make and use it. E.g., in Ariad Farms, said written description rule applied to original claims and this one is too general.

What is the constitutional basis of patent law?

Article 1 Section 1 Clause 8: "The Congress shall have power...to promote the Progress of science and useful arts, by securing for limited time to authors and inventors, the exclusive right to their respective Writings and Discoveries." (Pretty expansive, but does suggest unlimited temporal protection could be a problem.)

Is prior art fatal if known and then forgotten?

At least under old rules analysis, no. But the governing case (Gayler) is so old it's unclear if it really applies.

What is a declaratory judgment?

Available to putative infringer if he can demonstrate that "the facts alleged, under all the circumstances, show that there is a substantial controversy, between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment."

How do you assess infringement through equivalents?

Break the claims down to their elements and evaluate them against each other. If the claims aren't exactly the same, but the ones that differ are equivalents, there's infringement. There is no bad faith requirement. There are a few tests to determine whether elements are equivalents. - Do they perform the same function in substantiall the same way to achieve the same result? ("Function-to-way" test, most common) - Are the differences insubstantial? - An older test was more lenient if the original was pioneering, but this has been largely abandoned

How do you assess literal infringement?

Break the patentee's claim down into its elements and compare those with the accused invention. If the accused device has all of the same elements, it's literal infringement. If one of the elements is different or missing, it's not.

What's the actual method for putting pieces together to construct claims?

Ca. 2002 there was a trend towards "plain meaning" analysis, which judges began broadening a few years later. The most recent defining case here is Phillips, which adopted an open-ended "holistic" approach. No magic formula, required sources, or required order of steps. Still, some things may be more important than others. So it seems like this holistic approach has won over a more procedural approach that wants x steps in y order (the latter of which W&P thought were "winning" overall before). However, note that Wagner & Petheridge analysis suggests that Phillips hasn't had much impact in resolving how this is done and just made it more confusing.

What are the two main types of claim construction, and where does the US lie?

Central claiming: regime under which inventor identifies the essence of the invention, the government (typically a court) determines the scope of her monopoly power/property right in the course of infringement litigation, and the primary criterion in determining the scope is the amount of contribution to technology or society. Peripheral claiming: The inventor marks the boundary of the property right. In litigation, the gov (still typically a court) just enforces her boundaries. The scope of the right is determined earlier in the process, in the "threshold struggle" between the inventor and the representative of the state (the patent office). The US started with central claiming, but has moved much more towards peripheral claiming, though central elements are still important and the pendulum may be swinging back in that direction.

What is the doctrine of misuse?

Comes from the equitable doctrine of unclean hands and becomes associated with anti-trust analysis. Occurs when the patentee has impermissibly broadened the scope of its patent with anti-competitive effect - then, a defense to infringement and patent is unenforceable until the misuse has been abandoned and the bad effects dissipated. There are a bunch of ways this can happen: - demand that licensees purchase supplies only from patentee (selling unpatented material for use with a patented product - this is the staple vs. nonstaple thing. Staple = only can be used in accordance with the thing, and that's what presents a potential problem) - limits on sale prices of products made with the patent - geographically discriminatory pricing - nonmetered licenses unless voluntary (an agreement to allow a patent's use in exchange for a flat percentage of sales, without consideration to how much the patent is actually used) - maybe grantback licenses (a licensor can ensure that when licensing out patents covering its technology, any improvements by the licensee are granted back to the licensor) - etc.

What are the two types of damages in infringement cases and which do plaintiffs prefer?

Compensatory damages and reasonable royalties. Patentees almost always prefer the former, but if the can't show them or if they're tiny, will go for the latter.

What kinds of secondary liability exist for infringement?

Contributory infringement: Selling something knowing it's going to be used in infringement is contributory infringement. Scienter requirement: necessary that the defendant knew that the combination for which he was supplying a part was both patented and infringing. A rebuttal to this is substantial noninfringing uses. (Not if a staple article?) Inducement: Whoever actively induces infringement of a patent shall be liable as an infringer." Scienter requirement: Plaintiff must prove that defendant was aware of (a) the patent and (b) the acts induced by defendant constitute infringement. Good-faith belief that the patent is invalid isn't a defense. Some examples: - distributing flyers advertising sale of infringing equipment - instructing in the use of a patented process - purchased of articles made through unauthorized use of a patented process - indemnifying infringer - inducing breach of license agreement - inaction is not inducement

What are the main elements of the Hatch-Waxman Act?

Section 156: Patent extensions of up to five years for drug manufacturers to offset regulatory review periods. Section 271: Permits generic manufacturers to begin experimenting, but not selling, the drug prior to the patent expiration. Section 271(e)(2): Creates a cheaper, easier procedure for generic drug manufacturers to get FDA approval so they can launch ASAP once patent expires. More info on another notecard.

What are enhanced damages and how do you get them? Standard of proof, frequency?

Courts can, in their discretion, enhance damages (up to 3x) for "egregious" conduct by defendant. The meaning isn't totally clear, but willful, wanton, malicious, bad faith, "characteristic of a pirate" (Halo). Preponderance standard, so pretty low. Found about half the time juries find willfulness.

How likely are you to get a permanent injunction in an infringement case?

Current standards are harder than they have been in the past, which has led to a faster decrease in in number requested. However, plenty are still granted. Seaman found the number to be around 2/3. It's even higher in pharma and biotech, but lower in software.

Patent Cooperation Treaty

Effective in 1970 and limited to members of the Paris Convention. A procedural treaty, not a substantive one, that makes international filing less expensive ($1500ish + domestic costs). It takes longer, but this is actually a good thing, because you get the priority date plus a longer window to test, market, etc. in preparation for international assessments. Administered by World Intellectual Property Organization. Procedures for international patent application: 1. Instead of using the one-year priority date system to file in lots of countries individually, you can file domestically and file a PCT international patent application with designated "receiving offices" and list the countries you want to be protected in (still getting the priority date). 2. You designate in the PCT application an "international search authority" patent office that issues a search report classifying the invention, stating what fields it's searched for prior art, and citing the prior art. Basically, this is just information gathering to be used as raw material in patent evaluation. This is usually published 18 months after the priority date. 3. Optional international preliminary examination that indicates likelihood of application's success (few utilize this) 4. National patent examinations - These materials are delivered to the countries you indicated and they process under their domestic requirements.

What are the two types of relief sought in infringement suits?

Equitable relief (injunctions) and damages

What are the four theories of IP?

Fairness: Reward people with property rights for the efforts of their investment. One subset is Labor-Desert theory. In classic form, Lockean idea that there's a natural right to fruits of labor. Modified form is equity theory, more about distribution based on input to the venture. Patent implication: justification of nonobviousness requirement. Welfare: Various sub-theories, but based in utilitariamism. This is traditionally the most important in patent law. Personality: Looks at the conditions necessary to afford people (especially artists) appropriate protections to let them "achieve full personhood," on the idea that iP is a manifestation of the person who created it. More prevalent in Europe. Roots in personhood theory of "real" property that human needs should be served by private property rights. Difficulties: should visual artists be able to prevent imitations; can you alienate this righte; celebrity personas vs. commercial exploitation? Might preach for a heightened nonobviousness requirement. Culture: Shaping the IP system to contribute to a just and flourishing culture (inc. enhancing human life). One relevant application to our class is modifying patent law to increase access to drugs in developing countries. But concerns about paternalism, hazards of government.

What is a grace period re: novelty?

For a one-year period ending at the date of patent application filing, an inventor can do more to publicly disclose the invention without forfeiting the right to the patent. Prior art won't include the inventor's own disclosures or disclosures derived from her disclosures. This comes from Section 102. Prior art also doesn't include disclosures within that year made by third parties after a "public" disclosure by the inventor or third parties who derived the info from the inventor, filed after public disclosure by the inventor, or were a common assignee for the two patent applications. These haven't really been construed by the courts yet. The resulting incentives is that firms seeking protection only in the US will want to disclose as early as possible, to become prior art for others without hurting themselves. If they want global protection, they are still incentivized to file as soon as possible (EPC and Japan have no grace period). Under the old rules, there were additional statutory bars for applicant behavior that could "shoot themselves in the foot." I think some of these are essentially encompassed in the new rules?

Free Trade Agreements

Framework on top of TRIPS. US is party to about 20 bilateral ones. Not nearly the scope of TRIPS, but increasingly important. The US uses these to bring other countries' patent systems even closer to ours. Generally require longer patent terms, stricter limits on compulsory licenses, stricter limits on parallel importation, limits on access to clinical testing data, and prohibition on registration of generic drugs until expiration of the drug patents. Some are regional (vs. bilateral), e.g., NAFTA. Some things about NAFTA: - defines "inventive step" as non-obvious and "capable of industrial application" as useful - mandatory entitlements: rules for patent revocation - stricter compulsory licensing rules - in process patent litigation, burden of showing the product was made by a non-infringing process is on defendant

What are the three types of utility that (at least theoretically) must be satisfied?

General utility: The thing is operable (it does something). This is a very low bar - it can work pretty poorly and still satisfy this. However, inventions that violate generally accepted scientific principles will fail (like perpetual motion machines). Specific utility: Must show a general purpose or principle (you kind of know what the thing does). Also a pretty low bar; doesn't have to be better than other alternatives, commercially viable, or, for drugs, already approved by FDA. However, this meaningfully blocks two cases: 1. Chemical compounds (or processes for producing them) whose functions are unknown (Brenner). 2. Express sequence tags (short sequences of DNA), as people generally don't know what they do (Fisher). Note that there are policy arguments over whether this should be higher/lower. Lower: stimulate R&D, encourage disclosure, avoid costly review. Higher: could also block disclosure and inventives, could give people too much territory, efficient-boundary theory (wait until we know what the "land" looks like to assign property rights). Beneficial utility: No longer exists, but was the idea that inventions injurious to morals, health, or good order of society weren't patentable. E.g., license plate cover that blurs it in speed trap photos still patentable. Also policy arguments on both sides here. Pro: market shouldn't be trusted; gov responsibility to direct innovation; term isn't unlimited. Anti: No institutional competence, trust markets re: social utility, morals evolve rapidly.

What kind of imports constitute infringement?

Importing a patented product (271(a)) or importing products made overseas with patented processes (271(g)) UNLESS the product is materially changed by subsequent processes or the process becomes a trivial or nonessential part of another product.

Status of genes

Has changed and generated lots of controversy, but current state of things comes from Myriad Genetics. Genes are only patentable if there's been some modification - just doing the work of pulling it out isn't good enough. (Note that this isn't the case in Japan and EU, for now.)

What constitutes joint infringement?

If parties work together in a reasonably formal way (e.g., if one controls or directs the other or they form a joint enterprise), then their actions combined add up to infringement. This is going through the courts right now in Akamai case. Said that: - Doctrine of inducement can't be used to extend liability - But CAFC at SCOTUS's suggestion loosened definition of "directs or controls" and "joint enterprise" - "Directs or controls" includes when one party conditions some participation or benefit on E2 doing the thing, and tells them how or when to do it - "Joint enterprise" requires only an express/implied agreement, a common purpose, a community of pecuniary interest in that purpose, and an equal right to a voice in the direction of the enterprise. Note that we didn't cover this in class.

What is the defense of equitable estoppel?

If the patentee misleads the defendant into reasonably inferring that the patentee won't enforce the patent against them, and due to the reliance the defendant will be materially prejudiced by an infringement suit, then there's no infringement. Sort of an easement by estoppel.

What is the principle of exhaustion?

In an authorized sale of a patented product to a consumer, either by patentee or a liecnse in in the US or overseas, the consumer acquires the right to use and resell the product, including from outside of the US back in (parallel importation). After Lexmark, this is a pretty straightforward rule and patentee can't get around this by specifying limits at the time of sale or by contracting. (Patentee can bring a breach of contract suit, but not an infringement suit. This isn't that helpful, though, because it's hard to go after non-parties - tortious breach of contract is hardly as protective as patent law - and it looks pretty bad to sue customers.)

Plant Variety Protection Act

In practice: Mostly shields new forms of staple crops. However, pretty easy to circumvent because very difficult to infringe unless you begin with the protected variety itself. Success has been debated. Protects plant varieties ("a plant grouping within a single botanical taxon of the lowest rank"). Must be new, distinct, uniform, stable. Requires examination by Plant Variety Protection Office and has own appeal system. Infringement is buy selling, offering to sell, giving, importing, exporting, reproducing, or using to produce a hybrid. Some exceptions: research, plant breeding, saving seed for own use, generally private/noncommercial acts. 20 years, or 25 for trees/vines.

How long do PTO officers usually spend reviewing a patent?

In the US, average total patent consideration time is only 12 hours. (Sometimes there are later challenges on grounds that examiner made a mistake.)

What are the sub-branches of welfare theory?

Incentive theory: Government, including through IP, should promote the greatest happiness for the greatest number of people. Big in patent. Deals with the public goods problem (there are things we need that are nonrivalrous and nonexcludable but very widely beneficial that might otherwise not be produced, e.g., lighthouses). Signaling theory: IP rights can generate private AND social value if they facilitate efficient communication of information to potential investors. Can increase firms' incentives to research and/or efficiency of whole capital market. Caveats: firms can send misleadingly optimistic signals; costs of the system. Some evidence here, but investors seem more likely to pay attention to other things. Source-identification theory: This one is about trademark law. Idea it should be shaped to protect its economic functions and mitigate its drawbacks.

What INDUSTRY-specific characteristics can help overcome public-goods problem?

Industry structure refers to monopoly vs. competitive (vs. others). Often, people belief competitive industries generate more innovation, because firms with smaller market shares benefit more from innovating (Arrow) and "fear of dying" motivates innovation (Scherer). But Shopiner (sp?) argues that monopolistic firms will innovate more mostly because of their greater resources.

What sources can judges look at to resolve ambiguity in an application to help define what the patented thing is?

Instrinsic sources (inside the application) are preferred. These include the claims themselves, the specification, the drawings, and the file wrapper (publically available record of interactions between applicant and examiner, which includes references to prior art the applicant employed). If these are helpful enough, you don't need to use any extrinsic sources. However, these less favored extrinsic include dictionaries available at time of application, non-cited prior art, and expert testimony. Technical experts are best, then patent attorneys, and patentee testimony is worst.

Procedure of the invalidity defense

It's an affirmative defense. It's asserted on a claim-by-basis, although someone could challenge all of the claims. Defendant bears the burden and there's a CCE standard. There is a collateral estoppel effect - a final judgment of invalidity DOES bind the patentee in other infringement suits as long as there was a full and fair opportunity to litigate.

What is the defense of an implied license?

Irrevocable license to use the patent in specific ways may be inferred from the patentee's conduct, even in the absence of reliance. This is a sort of vague catchall category.

What is the standard of review for nonobviousness?

It's a legal question, so de novo. But the underlying facts are reviewed under different standards: - If made by the PTO or a jury, "substantial evidence" test - If by a District Court judge, "clearly erroneous" standard

Status of patents for tax strategies

No longer available in the US as of 2011 (PTO memo), but eliminated prospectively, so some old ones are still valid. Really only Australia still allows them.

What is the gist of the disclosure requirement?

It's essentially the trade-off of the patent system: inventors get protection for certain time periods in exchange for telling others how to make the product (the whole quid pro quo). It also lets others know what they can and can't do, helps courts construe claims, prevents patentees from getting too much territory, and denies priority dates to people who haven't fully figured out their inventions. Note, however, that there are critiques that our current system doesn't really meet these goals. Lots, but e.g., patents are often used for things that can be reverse-engineered and enhanced damage threats can deter people from even reading patents in the first place. Plus applicants try to be as murky as they can get away with in their drafting.

What are the two types of patent infringement?

Literal and equivalents

What is literal infringement?

Literal infringement happens when a new product/process contains all elements of the original one's claim. This is the "all-elements" rule. What counts as an element is fuzzy and CAFC has acknowledged this without offering any guidance. It's "any limitation found in the claim language," or, roughly, an aspect or characteristic of the claim. Some aspects may not be limitations, but may be components (ways of achieving the limitation). If the same limitation is there with a different way of achieving it, it's still a match for infringement purposes.

What are compensatory damages and what are the requirements?

Lost profits from sale of patented products. Requires that patentee show: 1. Demand for the patented product, which is usually pretty easy to show 2. Absence of acceptable non-infringing substitutes: the infringer can escape if there's a non-infringing product made by a third party that's similar price and characteristics to consumers and thus could have caused the harm instead of defendant. The infringer can also escape if they can show they were ready and able to make a non-infringing product, but didn't for cost reasons. Patentee can rebut by showing he had stable share of multi-supplier market. 3. Patentee had the capacity to exploit the demand - could have supplied the goods to cover infringer's sales, either on its own or by licensing the technology to others (but must be a practicing entity). 4. The amount of profit patentee would have made. Lost revenues - incremental costs + diminution of profits from the market if you had to drop your price to match the infringer's (price erosion). If you also lost sales of related products that function with this product, you can count it ("entire market value" rule, e.g., Juicy Whip) - but can't count a decline in stock price (Rite-Hite).

Three traditional types of "products"

Machines, compositions of matter, and articles of manufacture

What is innovation, and what are the three main related activities?

Making new things and adapting! Dominant view (reflected throughout patent law) that it's one of the primary drivers of economic growth and should be encouraged. Invention: creating a new product or process. Innovation: Producing something new, then adapting for industrial production and distribution. Diffusion: Selling the thing, or embodying the process in a thing that's sold.

What is the "material disclosed but not claimed" limitation on the doctrine of equivalents?

Material disclosed but not claimed cannot be recaptured under the doctrine of equivalents. Often, patents will discuss the technology a lot in the specification section, but fail to list all of it in the claims. In this case, those not claimed parts can be used by others without infringement. We don't want to protect patentee from easily predictable things.

What is the prior art "taught away" test for nonobviousness?

Obviousness may be defeated if the prior art indicates that the invention would not have worked for its intended purpose or otherwise teaches away from the invention. A reference teaches away when a person of ordinary skill, upon reading the reference, would be discouraged from following the path set out in the reference, or would be led in a direction divergent from the path that was taken in the claim.

What is a broad overview of the rights patent protection provides?

NOT technically a right to practice the invention - this is usually practically the case, but there may be a blocking patent situation. Technically, a right to prevent others from making, using, selling, offering to sell, or importing the invention. These come from 35 USC 271(a).

In the US, it's said you can't patent these three things:

Natural phenomena, laws of nature, and abstract ideas

What is the enablement requirement and how is it assessed?

One of the three aspects of the disclosure requirement. The description must be sufficient to enable a person having the relevant skill in the art (PHOSITA) to make and use all of the embodiments of the invention claimed in the patent. A PHOSITA standard is much higher than a layperson, but not the highest imaginable. It is assessed by applying the Wand factors. - quantity of experimentation necessary (OK if some is required to figure out how to use the invention, but can't be undue) - amount of guidance provided by the patent -presence of the patent in working examples, often drawings (helpful, but not necessary) - nature of the invention - state of prior art - skill of PHOSITAs - predictability of the art (e.g., electrical and mechanical fields are more predictable, so looser enablement requirements vs. chemical or biological fields) - breadth of claims

What is prosecution history estoppel?

One of the three limitations on the doctrine of equivalents. Patentee is bound by representations made during patent prosecution and can't use the doctrine of equivalents to recover territory they gave up in the course of patent protection. Background: Patent prosecution (decision to grant or not) often involves a lot of back-and-forth and dropping some stuff you tried to get in your original application in order to get approval. The current rule for assessing this under Festo is the "foreseeable bar rule." It's more forgiving to plaintiffs than a complete bar rule. Estoppel does not apply when: - equivalents were unforseeable at the time of the amendment, or - rationale for amendment bears only "tangential relation" to the equivalent at issue, or - patentee could not be reasonably expected to have described the insubstantial substitute Burden of proving those is on the plaintiff.

When is something infringement by "use" of a patented product?

Possession isn't illegal - must actually use or at least contemplate/threaten to use. Testing counts as use. Use before the patent grant is still use. Using it for not contemplated purposes is still use. Sales demonstrations are still use (but this now falls under "offer to sell"). It is unclear if demonstrations at a trade show are use.

What is the first-sale doctrine?

Presumption that the sale of the patented product includes a right to resell. Thus, one who properly owns a patented product may generally resell it without infringing.

Can attorney fees and costs be awarded in infringement cases?

Presumption that the winning party gets costs. "Exceptional" cases may get attorney fees, but that bar isn't as high as it sounds and is very discretionary.

What is a reasonable royalty and how is it calculated?

Reasonably royalty is the type of monetary damages used if the patentee is unable to show compensatory damages, or, sometimes, if they're very small. They are usually paid out via a "running royalty" (a fixed PPU or a percentage of revenues from sales) or, more rarely, a lump-sum payment. There are two possible ways to calculate them. 1. Hypothetical negotiation approach - more common. A fiction that tries to get at the royalty that would have been negotiated by the willing parties at the time infringement started. Relevant factors: industry custom, availability of non-infringing substitutes, losses associated with forfeiture of monopoly, "doing justice to patentee" often tacitly leads to a premium, Georgia Pacific factors we didn't go over. Does NOT consider infringer's actual profits or the likelihood a patent woud be upheld (which can be v relevant to real negotiations). 2. Analytical approach - much simpled. Just a share of the infringer's profit. Figure out what profit margin they anticipated and give it to the patentees (courts let the parties figure this out by hiring an economist, e.g.).

What canons of construction can judges use in claim construction?

Remember Llewellyn's dueling canons! - Reading claims through the eyes of a PHOSITA - Start with the claims (this is the patent law version of plain meaning). One common conclusion here is that "substantially as described" is surplusage with no meaning. - Role of the specification: various competing canons here. It should only be looked at if the claim uses a term that needs a definition. "Every patentee may be his own lexicographer" (if you define a term a certain way in the specification, the court will use it that way). If it's disclosed but not claimed, it's not patented. Don't read into the claim limitations from the specification. (These last two are in direct competition.) - Role of extrinsic evidence: only use it when intrinsic leaves it ambiguous (Vitronics) - To resolve ambiguity: Avoid interpretations that lead to redundancy. Avoid interpretations that don't give the inventor his actual invention. There are canons both ways re: who should win when it's ambiguous. - More generous interpretations for pioneering inventions (Westinghouse)

When is something "on sale" enough to be fatal prior art under novelty analysis?

The actual sale or the offer to sell the embodiment of the invention counts as sale; the sale/offer to sell of the patent rights does not. The thing on sale must be the invention itself or make the invention (as claimed) obvious. The invention has to be "ready for patenting" - after conception, but not necessarily all the way to reduction to practice.

Status of purified forms of naturally occurring substances

These were held patentable in the early 20th century (Parke-Davis, Hand), BUT they have to have properties different from unpurified versions (e.g., adrenaline). Unaltered substances cannot be patented (Funk Bros.).

Is software patentable?

The US has gone back and forth, but currently, patents on software are pretty hard to get. Many have been rejected (36,000 in two years) or abandoned following Alice decision. To get around this and still get a software patent, firms will (a) write firms in lots of technical detail, with focus on how software makes a computer function better, and (b) make patent apps as technical and hard to understand as possible. Alice case announced a test for figuring out if patents that are applications of patent-ineligible concepts are still valid. Step 1: Is the claim directed at a patent-ineligible concept (law of nature, natural phenomena, abstract idea)? If yes, move on to step 2. If no, patent is valid. Step 2: Is there any "inventive concept" that lifts the thing above that category and transforms it?

What is the best mode requirement?

The best mode requirement obligated patent applicants to tell PHOSITAs how to best practice the invention to allow competitors to be able to enter the field ASAP and avoid redundant research. The two-part inquiry was: (1) Did the applicant consider a particular way of implementation to be the best? (2) Did the application adequately enable that way? (Didn't have to be highlighted, but had to be in there somewhere.) Post-2011, because it was super increasing the costs of patent litigation, this is no longer grounds for challenging a patent. However, it can still be used by the PTO to reject an application, usually falling within the applicants' duty of candor. Old rules also still apply to proceedings commenced pre-September 2011.

What FIRM-specific characteristics can help overcome the public-goods problem?

The big debate here is firm size - are big or small firms more innovative? The small firm argument is that small firms are afraid of dying and this hustle will spur innovation, or that they'll benefit more from innovating. Also, there can be more direct communication between scientists and managers that leads to more beneficial and profitable use of inventions while having more autonomy for the scientists sans excessive bureaucracy. The big firm argument is that they have more resources and don't need to worry about the capital hustle so can put more money towards R&D, plus, they'll be able to reap their innovations for a larger market. There may also be economies of scale in R&D (i.e., a team of scientists is worth disproportionately more than the individuals). Also greater likelihood they're diversified and can put an unexpected innovation to use. Empirically, small firms tend to generate more "transformative" advances while big ones generate more "incremental" ones.

What does nonobviousness analysis look like in practice - what was the reasoning in Kellogg v. Kraft?

The case was about a resealable top of an Oreo container and a later resealable top of a Chip's Ahoy container. Kraft brought an infringement suit and Kellogg's defended by saying their patent was obvious and so invalid. Prior art: Wet wipes containers and certain other cookie containers. The type of packinging had also been described in publications. The parties agreed the PHOSITA had at least a bachelor's degree in ME or packaging design or a related field, plus industry experience. Kraft defended its patent using secondary factors. The packaging won industry awards, increased sales, and was copied. The court bought this, but wasn't enough to overcome prima facie obviousness finding.

What is the test for infringement of a design patent?

The current test under Egyptian Goddess is a development of the ordinary observer test. A defendant's product infringes a design if it appears the same to an ordinary observer who will "glance" towards prior art. E.g., glancing may show that this is a crowded field so products would have to be really similar to infringe (Sunbeam with coffee makers) or show that everyone has these features in common. There may be a two-step analysis: put the two side-by side and ask if they appear the same. If no, no infringement. If so, look to prior art.

What is the experimental use defense?

The defendent was using the patented invention, but not to make things themselves, only to conduct experiments. This is an extremely limited defense for narrow experimentation (like strictly philosophical inquiry), except for pharmaceuticals.

What is disaggregation and what are the general policy arguments about it?

The different treatment of different fields under IP law, including patent law. Pros: - different fields are different, esp. in how much incentivization is necessary to spur innovation - practically speaking, standards for the four requirements can be different in different in different fields (e.g., harder to be non-obvious in software, but easier to disclose because PHOSITA are sophisticated and technology is mature) Cons: - Boundaries are confusing - Political economy and specializationq

What is the general rule of the nonobviousness requirement?

The idea is that we don't make things patentable when prior art is such that the new invention was obvious. Or, more officially, a patent may not be claimed if the invention, while not identically disclosed to any prior art, is similar enough such that the claimed invention as a whole would have been obvious before the filing date to a PHOSITA.

When is a piece of prior art sufficiently developed to lead to novelty failure? (NOT SURE ABOUT THIS)

The idea must have been sufficiently well developed that a PHOSITA could use it. This comes from the definition of "known" in the old rules. "Use" basically means reduction to practice under the old rules (physical embodiment + complete embodiment, not equivalent + testing sufficient to show utility and success).

What are the elements of a patent application?

The main elements are the specification and the claims. Specification includes the following: the inventors, the title, the abstract, the background (what problem the invention is designed to address), sometimes drawings and descriptions of them, and a detailed description of the invention. Claims: Describe what the essence of the object is, and thus what the patent covers. The standard format is preamble ("a disposable rodent trap") + transition ("comprising") + body ("x, y, and z"). There are often several claims, as patentees seek protection against as many other products as they can get away with - but they list all of the options individually to avoid using just the broadest one and having it struck down on nonobviousness grounds.

What kinds of uses are NOT infringement?

The main exceptions is repair. Repairing a patented product you had a right to use isn't infringing (e.g., replacing patented convertible top; upgrading a patented fish canning machine). The idea is that it's a tacit term of the original sale (and we don't want planned obscolescence). However, repairing a patented product you DON'T have the right to use is still infringing. Reconstructing a product, even if you had the right to use it, is still infringing. Fuzzy line, but the basic idea is that you can do minor fixing up, but not major.

Are business methods patentable?

They are now governed by Alice, like software patents, and so are pretty difficult to get. There is a lot of overlap - a lot of business methods are implemented through software.

How do courts decide if they should grant equitable relief?

The standard has changed and now, under eBay, is more difficult than it was in the past. The rule is that courts must apply traditional rules of equity, with a nexus requirement: - plaintiff has suffered an irreparable injury and there's a "casual nexus" (some connection) between the harm (usually loss of market share) and the infringing features (typically by showing that they drive market demand) - monetary damages are inadequate to compensate for the injury - the balance of hardships favors the plaintiff, and - the public interest would not be disserved by a permanent injunction Seaman thinks that courts will look to where P practices the invention, evidence of actual harm, whether the parties are competitors, P's history of licensing patents, laches, public interest in health or product diversity. (This is all for permanent injunctions - we skipped preliminary injunctions, though the rules there are the same plus likelihood of success on the merits.)

What is the prior art limitation on the doctrine of equivalents?

There's no infringement if the accused infringing product is so similar to prior art that if infringement were found, the patent shouldn't have been granted in the first place on nonobviousness grounds. (Basically, patentee's can't claim prior art is really different but similar new inventions are the same.) This is the Wilson golf ball case. This does NOT invalidate the patent, it just finds no infringement.

Overview of the invalidity defense

There's no patent infringement because the patent is invalid. Successful over 40% of the time, so a really important defense. Challenges are usually to non-obviousness or, increasingly, subject matter.

What are some procedural qualities of design patents?

Their term is 15 instead of 20 years. Most are granted in under a year (unlike utility patents). The specifications are usually just drawings of the thing from different views and claims are "I claim what's in the drawings." It is possible to secure a utility and design patent for the same thing, but you can only get one damages award for infringement. Under Samsung, the article of manufacture can mean the component and not the whole product, which means profits attributable to piece get harder to prove.

What if an infringer gets an injunction but wants to keep producing?

They can negotiate a license fee, but they have no leverage, so it will be pretty big.

What INDIVIDUAL characteristics can help motivate the public-goods program?

This is a hard question to get at and it hasn't been studied very deeply. But, some ideas: natural curiosity; risk preference; altruism; sociability; education; etc. There are also individual motivations within industries, like scientists wanting to be published.

What is the gist of the novelty requirement?

To be patentable, an invention must contribute something NEW. SO, usually, a patent is killed by an earlier product/drawing that embodies every feature of the invention. It's a very technical requirement and the relevant part of the statute (Section 102) was a mess.

Treaties governing IP protection of plants

UPOV: Member states must provide protection for new, distinct, uniform, stable plant varieties. Rights to protected varieties include rights to reproduction, conditioning for the purpose of propogation, sale or offering to sell, importing or exporting. Has exceptions. Term = 20 years from grant or, for trees and vines, 25 years. (USA is a party.) TRIPS: Member states may decline to provide patent protection for plants, but then must provide "sui generis" protection.

Is an offer to sell something internationally infringement in the US?

Unclear. Previously, a district court held that a domestic offer to sell where the manufacture and transfer will occur outside of the US is not infringement (Quality Tubing). However, later CAFC dicta suggests otherwise (Rotec Industries).

For novelty analysis, when was prior art "in public use"?

Under Egbert case, pretty low bar. A man made a new corset for his wife that she wore out in public. Even though it was just her and the invention wasn't actually visible, this was enough to make it public use. Unclear how public a venue has to be, but a party and a lab are public enough to be fatal. Remember, though this is harsh, an inventor can do it for a year prior to filing, just not earlier.

Status of medical procedures patents

Under TRIPS Article 27, countries are NOT required to grant patents for medical procedures for humans or animals. Currently in the US, they are patentable, but with a limitation on remedies under 287(c). Doctors and related healthcare entitles can't be sued - patent holders can only go after others who make that infringement possible (like companies making the instruments) via secondary liability. However, if the procedures are simply processes "reciting a law of nature," not patentable (Prometheus). E.g., giving more of that IBS drug if metabolite levels higher in the blood - that's just a discovery that metabolite levels are related. This has shrunk protected medical procedures and lead to more successful challenges.

What time period is the "danger zone" for novelty?

Under the new rules, anything prior to the filing of the application (used to be prior to the invention itself, which could be different). This is called the first-to-file principle.

What is the date of an invention for purposes of novelty analysis?

Unless you specify otherwise, the date you file the patent is the date of invention. (Under the old rules, you could give the examiner some older date where you invented it, aka had a working version and knew it worked or, if you have evidence, when you thought of it as long as you were diligent in making it after that.)

Overview of jury trials in patent law

Used to be very rare, now happen about 80% of the time. Argument over whether this is good and these complex issues are truly understood by juries. Statistical evidence doesn't really support this.

When does someone infringe a patent by "making" a patented invention?

Usually pretty straighforward, but can be less obvious in certain cases. If there's a combination patent, it's only "made" once all the pieces are put together. Producing the individual parts and never combining them isn't infringement. However, Congress has decided that making the individual pieces in the US and shipping them overseas for assembly does constitute infringement if you "actively induce the combination."

What are provisional royalties?

We didn't talk about them in class, but they're royalties for a period between publication of the application and grant of the patent availably retroactively after the grant. Requirement that the invention claimed in the final grant is substantially identical to the one in the published application and that the infringer had actual notice of the published application.

What are the procedural elements of the claim construction process? Standards of review, PTAB duties?

Weirdly, there is no right to a jury trial (even though there is for infringement), because it's a question of law so no 7th Amendment right. So there's usually a separate hearing about this with just the judge (a Markman hearing). It can take place at various times, but usually after discovery but before trial. Under Teva Pharmaceuticals, the current standard of review for DC court findings is de novo if basde on intrinsic evidence, or CCE if based on extrinsic (more deferential because more factfinding). This hasn't made a big difference yet, but might affect litigation strategies (changing evidence presented based on whether you think the judge likes you). If the PTAB does claim construction, they now have a duty to determine the proper meaning of the claim, not the broadest reasonable one (which used to be the case). (Applies to inter partes review, ex parte reexaminations, and ex-parte post-grant reviews).

What are the policy reasons for the obviousness requirement under IP theory?

Welfare theory: - Avoid unnecessary social costs by giving protection to inventions that would have emerged anyway (Posner in Roberts) - Help offset distortions caused by risk aversion (encourage people to be "riskier" with R&D) Fairness theory: - Only especially creative labor deserves this reward (Becker) - Locke's "sufficiency" proviso says we shouldn't give IP to things that would soon be invented by others - leaves consumers and other inventors worse off

Can you infringe if your invention wasn't technologically possible at the time the original was patented?

Yes

Are stem cells patentable?

Yes (in the US).