PATENT LAW MANDEL
I. PATENT REQUIREMENTS
A. Patent: Inventor gets a monopoly for a limited period of time. A lot of things developed without patent rights (Internet);
Utility patent (patent that is useful)
Design patent (ornamental design)
Patent Pending: No rights for applicant while patent is pending.
i. REASONS FOR PATENTS: Keep these ideas in mind. Goals to achieve:
a. Patent law creates an incentive to invent;
i. Invention might not even occur absent patent law (e.g. pharmaceuticals which spend a lot on R+D
b. There is an incentive to Innovate (i.e. commercialize);
i. If there was no disclosure, then one might try to keep something a secret (trade secret);
c. There is an incentive to Promote Disclosure;
d. Licensing efficiency
e. Labor theory of property (Locke):
i. You invented something and hence have a right for it.
ii. Constitution had a clause with 2 sets of powers:
a. Writers (basis of copyright)
b. Inventors (basis of patent)
a. Policy: This clause does not create a right. It just gives Congress the Right to do this.
b. Only restrictions are:
i. Limited times-however this is not defined
ii. Useful arts-think technological artsàneed utility
iii. Only inventor can get patent right
iv. Has to promote the Progress
i. Congress decides what is Progress (Eldred)
ii. ACTS OF CONGRESS
1. 1789-Congress adopts Patent Act of 1790
2. 1793 Act adjusted it (similar to what we have today)
3. 1836: Added registration system
4. 952: Added non obviousness requirement
a. Average time for issuance of patent is 3 years; this was 1 year
b. Parts of a Patent
i. Independent Claim: Can stand on its own
1. PTO limited patent to 25 claims and 5 independent claims unless applicant stated why he needed more. This rule was struck down and right now there is no limitation;
ii. Dependent Claim: Depend on another claim
1. Dependent claim adds a limitation. Dependent claim is NARROWER since it adds further limitations;
a. Policy: If independent claim is found to be invalid by being too broad, then its good to have a narrower claim.
i. Inventors want their claims to be broad which gives protection;
b. Patents have an inverse pyramidical structure. By having a large number of claims, you guarantee you don’t get some huge one lost.
iii. Infringement: To show infringement, need to identify a claim that is valid and that there was infringement.
1. So there is almost always a challenege to the patent’s validity and whether or not there was infringement
iv. Patent Prosecution:
1. File application with PTO; Forward to appropriate art group; assigned to examiner. Examiner will check formality of application; look at prior art; non-obviousness; novelty; utility; sufficient disclosure; claims drafted appropriately; claiming single invention;
2. Once they work through it, they will notify applicant of office action (running claim by claim)
a. Usually goes AT LEAST 6 months; On average, examiners spend 16-17 hours on a patent application;
b. Published 18 months after filing, unless the applicant certifies that they will not file in another country;
i. Policy: Applicant faces choices of whether to keep it quiet. If they abandon the application, they keep it as trade secret (but they don’t get patent).
1. There has been some recent movement to publish all non-abandoned applications after 18 months (which would harmonize U.S. law)
3. Patent Examiner can:
a. Reject the application:
i. Applicant can traverse by arguing rejection was improper
ii. Applicant can traverse by amending the application/claims
b. Accept Application
i. PTO issues notice of allowance; Applicant pays a fee and a patent will be granted. 9 months is shortest time
1. There are about 1 million patent backlog at PTO.
4. Presumption of Validity: Once Patent is granted, there is a presumption of validity.
a. However, validity can be challenged in litigation. To overcome this , the standard to overcome is clear and convincing evidence.
b. Policy: Presumption is somewhat questionable because
i. 1) Limited review PTO conducts and
ii. 2) Some parts of patent not reviewed at all.
c. Final Rejection: If Application revised and still not liked, then there is a FINAL Rejection. Then applicant has 3 choices:
i. Abandon application
ii. Appeal: 2 routes
1. ExamineràBrd of Pat. ApplsàDist Ct. àFed. CiràSCOTUS
2. ExamàBd. Of Pat. AppealsàFed. CircuitàSCOTUS ?????
a. Can introduce additional evidence in district court so hence makes sense to file there.
b. Federal Circuit introduced in 1982. Pro patent attempt to bring uniformity to patent law. Federal Circuit adopted law of its predecessor courts.
d. File Continuing application
1. Initial 2 bites at the apple isn’t that much time. This allows you more time to work back and forth.
2. Cannot containt additional subject matter
3. Keep an original filing date
ii. Continuation in Part (CIP)
1. Continuation application that does include new subject matter
2. Keep original filing date for old matter; get new filing date for new matter.
a. Policies: Division between old and new subject matter isn’t always clear. Boundaries are defined with words which aren’t always as precise.
i. Strategically for an attorney, CIP are convenient for an applicant/attorney who wants to say that as much of the original patent is valid as possible.
ii. By filing a CIP , you are estopped from claiming that nothing was new
1. If inventor thinks that you have two or more inventions in application, he will let you file divisional
a. Retain original filing date
2. There is also a Request for Continued Examination (RCE) for a fee after final rejection. Essentially applicant gets to reargue the case.
b. Provisional Application: This is essentially just the patent specification. No claims filed. It is kept confidential and not examined. Doesn’t secure any rights per se. Later filed standard application can get the benefit of the provisional date.
i. You see a lot of provisional applications filed but rare where that provisional date is critical.
ii. For nearly everything that happens at the PTO, and the examiner misses something, it can be litigated.
c. Interferences (§ 135): If another application pending on same subject matter or if another patent issued within a year, then PTO can declare interference. You get an adversarial hearing by the board of
ul in itself.
1. Mandel: Both majority and dissent have the same social goals in mind.
4. RULE: (Ignoring Brenner) A product/process viewed as useful by a POSITA meets utility; there is an expectation of future research/development. Animal testing meets this in the pharmaceutical field.
a) Rule: Proof of an alleged pharmaceutical property for a compound by statistically significant test with standard experimental animals is sufficient o establish utility.
5. PTO standards are not based on other administrative agencies. Even if the FDA has not approved, that is not a reason to deny a patent.
a) In Re Brana, 1995, p. 149
A chemical compound only slightly different than a previous one provides better anti-tumor properties, a result not expected. The PTO said the experimentation on mice was inadequate to prove utility in humans. The PTO also said that the application did not identify a specific disease. The mice were injected with a disease. The court said there’s no need to test on humans to prove utility. There is a presumption that a claim of usefulness is valid and the PTO is then burdened to prove otherwise. The compound’s similarity with the previous compound shown to be successful at inhibiting tumors is sufficient, even if the FDA does not find it so. PTO’s standards are not dependent on the FDA’s.
i. Court says the applicant doesn’t have to test in vivo – that would take too long. Statistically significant proof of success in experimental animals. This is not the Supreme Court, but they ignore Brenner. They say that there’s an expectation of future research.
ii. An invention has a well-established utility if – a POSITA would appreciate the usefulness, and the utility is specific, substantial and credible. This is the PTO guideline for utility.
a. Mandel: Utility is different for pharmaceutical areas. In most inventions, standard falls under juicy fruit standard.
i. Hard to reconcile this case with Brennen
6. Biotech specific RULE. – Utility of a process/product must be credible, substantial, and specific. If a product performs an action that every other of its type performs is not specific.
i. The PTO guidelines ARE NOT Binding on federal courts but just on PTO
a) Substantial utility is defined as a real world value and presently available.
b) Specific – applicant must disclose a use beyond vague/meaningless. Credibility is from the point of view of the POSITA.
7. In re Fisher, 2005, handout
RULE: Credible utility is not enough. It has to be credible, substantial, and specific.
a) ESTs are tags for maize to identify genes, used in the process of understanding the maize genome, but does nothing in itself. There’s also an assertion that the ESTs can identify polymorphisms or isolate promoters, but no evidence of this. These ESTs do nothing that any other EST would not do. Hence, no patent.
ESTs have no function on their own, and the function of the parent gene may not be known yet. Fisher argues that “utility” should mean that it does what it is supposed to do. There’s nothing about Fisher’s utilities that are specific to his ESTs. These are all things that can be accomplished by other things. Lowell says that you need general utility, not specific utility.
(a) ESTs are research tools. They are useful to isolate protein-encoding genes. Requiring that there be a known end for the tool to be patentable would hider future research. It would be impossible to determine what is “substantial” and what is “insubstantial” until the research has been completed.
III. NOVELTY -STATUTORY BARS
a. 2 categories (1) statutory bar and 2) originality). This is statutory bar.