Disclosure requirement issues

1. DISCLOSURE REQUIREMENT ISSUES IN
BIOTECHNOLOGY PATENTS
Shadab Ali
M.tech/Biotech
Reg-161442101004

2. Introduction
 A patent application must meet four deceptively simple disclosure
requirements, which are listed in Section 112 of the patent statute.
 First, the application must contain a written description of the
invention.
 Second, it must enable others to make and use the invention.
 Third, it must disclose the "best mode" known for carrying out the
invention.
 And fourth, it must conclude with claims "particularly pointing out
and distinctly claiming" the invention.
 The fourth requirement is technically a claim requirement rather
than a disclosure requirement, nevertheless, it and the other three
requirements are all contained in Section 112.

3.  The enablement requirement, which relates primarily to the scope
of a claim, and the best-mode requirement will be initially
examined in the following section.
 This is followed by a discussion of the deposit requirement—a
unique, nonstatutory requirement that arises because, for some
biotechnology inventions.
 A deposit of living biological material may be the only way to
satisfy the statutory enablement and best-mode requirements.

4. THE ENABLEMENT REQUIREMENTAND CLAIM
SCOPE
 Section 112 of the patent statute requires that a patent teach how to
make and use the claimed invention. The make and use aspects
together form what is known as the enablement requirement.
Judicial decisions typically ask whether someone skilled inthe art
can make and use the claimed invention without "undue
experimentation
 Enablement issues are primarily issues of the scope of a claim. The
underlyingpolicy concern is that patent claims that are unduly
limited in scope fail to promoteprogress in the art by failing to
provide adequate economic incentives to inventors
 On the other hand, overly broad patent claims tend to defeat this
goal by improperlydominating an area of research and discouraging
further invention by others.ndeed,Chief Judge Markey aptly
summarized the issue by stating that questions ofenablement "orbit
around the more fundamental question: To what scope of
protectionis this applicant's particular contribution to the art entitled

5. THE BURDEN OF PROVING ENABLEMENT IN THE PATENT
AND TRADEMARK OFFICE.
 A patent application must satisfy the enablement requirement as of
the date that application is filed.
 However, it is critical to note that when filed, an application need
only "objectively" enable the practice of the Invention it claims.
 When the PTO seeks to reject claims as nonenabled, it must state
specific reasons for doubting that the claimed invention can be
practiced without undue experimentation— a requirement that often
can be met by referring to literature that shows the known
unpredictability of the particular biotechnology.
 After the patent issues, those who contend that it does not satisfy
the enablement requirement must use facts proven by clear and
convincing evidence to show that the requirement has not been met.

6. THE BEST-MODE REQUIREMENT
 The U.S. patent statute, unlike the patent laws of most other
countries and jurisdictions,requires patent applicants to disclose the
"best mode" known for carrying outthe invention at the time a
patent application is filed.
 The best-mode requirement is clearly distinct from the enablement
requirement. It is entirely possible for someone to disclose a
claimed invention in sufficient detail to enable others to carry out
the invention, including numerous variations encompassed by a
generic claim
 The relation of the best-mode requirement to the claims is also
illustrated in Amgen. Since the best-mode argument related to the
disclosure of CHO cells, only those claims that were directed to a
host cell were potentially affected. Other claims, such as those
reciting isolated DNA or vectors, would not have been affected
without a showing of inequitable conduct.

7. THE DEPOSIT REQUIREMENT
 The deposit requirement evolved in the area of microbiology, since
patent applications related to the uses and products of newly
discovered micro-organisms often were rejected for failing to satisfy
the enablemen requirement (the micro-organisms themselves were
not patentable subject matter at the time).
 An example is Ex parte Kropp, in which claims to a method of
producing an antibiotic with a newly discovered organism that was
not considered readily available were held unpatentable.
 It was found that reproducing the invention would require "the
initiation of a screen ing program similar to the screening programs
followed in discovering antibiotics in he first instance" and central
issue of whether a deposit of biological materials should be required
is stated in the PTO deposit regulations

8. THE WRITTEN-DESCRIPTION REQUIREMENT
 In addition to providing an "enabling" disclosure of the invention, a
patent application also must contain a "written description" of the
invention.
 It may seem that there is little difference between these two
requirements; in fact, some would argue hat there should be no
written description requirement separate from the enablement
requirement.
 The need for the written description requirement stems from the fact
that science progresses after patent applications are filed.
 Although applicants try to anticipate and describe alternate forms of
their basic invention when they file applications, Still, applicants
always want to obtain claims that narrowly cover the commercially
important aspects of their inventions because such claims are easier
to enforce in court.

9. THE CLAIM DEFINITENESS REQUIREMENT
 Section 112 of the patent statute includes, The specification shall
conclude with one or more claims particularly pointing out and
distinctly claiming the subject matter which the applicant regards as
his invention.
 The purpose of the claim definiteness requirement is to make it
possible for others to avoid infringing the patent, whether by
keeping far outside the scope of the claims or by deliberately
designing around the claims.
 An instructive recent case is Amgen, Inc. v. Chugai Pharmaceutical
Co.,In which the Federal Circuit held claims 4 and 6 of Genetics
Institute's patent on purifiedEPO invalid as indefinite.

10. CONT…
 Homogeneous erythropoietin characterized by a molecular weight
of about 34,000 daltons on SDS PAGE, movement as a single peak
on reverse phase high performance liquid chromatography and a
specific activity of at least about 160,000 IU per absorbance unit at
280 nanometers.
 The word about seemed to the court to be an attempt to recapture
some of what had been given up by the amendment without learly
specifying what the boundary was between infringement and
noninfringement.
 Hence, the court concluded that "[w]hen the meaning of claims is
in doubt, especially when, as is the case here, there is close prior
art, they are properly declared invalid.“ The court went on to
caution that use of the word about in claims was not necessarily
improper in other situations.

11.  Biological inventions are sometimes less amenable to precise
definition than other chemical inventions.
 If the claims necessarily involve elements that cannot be
described with extremely rigorous precision, then it is
sometimes said that the claims need only be as precise "as
the subject matter permits .
 "Nevertheless, in light of the claims held invalid in Amgen,
terms used in claims should be defined as precisely as
possible.
Cont…

12. REFERENCES
 Walterscheid, Insufficient Disclosure Rejections (Part III), 62 J. PAT. & TRADEMARK
OFF. SOC'Y 261 (1980).
 Walterscheid, Insufficient Disclosure Rejections (Part V), 62 J. PAT. & TRADEMARK
OFF. SOC'Y 387 (1980).
 Genentech I/Polypeptide Expression [1989] 1 European Patent Office Reports 1