1. OVERVIEW OF PATENTS: TRIPS and US PATENT EXAMINATION
United States Patent and Trademark Office
Global Intellectual Property Academy
Patent, Trademark, Copyright, and Enforcement – Law and Policy
November 2, 2007
Karin Ferriter
Patent Attorney
Office of IP Policy and Enforcement
USPTO

2. INTERNATIONAL STANDARDS FOR PROTECTING INTELLECTUAL PROPERTY
World Trade Organization (WTO)
WTO is the successor to the General Agreement on Tariffs and Trade (GATT) established in the wake of the Second World War.
Created January 1995
The WTO was developed through a series of trade negotiations, or rounds, held under GATT. The first rounds dealt mainly with tariff reductions but later negotiations included other areas such as anti-dumping and non-tariff measures. The last round — the Uruguay Round — led to the WTO’s creation.
The negotiations did not end there. Some continued after the end of the Uruguay Round. In February 1997 agreement was reached on telecommunications services, with 69 governments agreeing to wide-ranging liberalization measures that went beyond those agreed in the Uruguay Round.
In the same year 40 governments successfully concluded negotiations for tariff-free trade in information technology products, and 70 members concluded a financial services deal covering more than 95% of trade in banking, insurance, securities and financial information.
In 2000, new talks started on agriculture and services. These have now been incorporated into a broader agenda launched at the fourth WTO Ministerial Conference in Doha, Qatar, in November 2001.
Middle Eastern Members:
Bahrain, Kingdom of  1 January 1995 Jordan  11 April 2000
Kuwait  1 January 1995 Morocco  1 January 1995
Oman  9 November 2000
Qatar  13 January 1996 Saudi Arabia  11 December 2005
Observer governments
Afghanistan Algeria Iran Iraq
Lebanese Republic Libya Yemen

3. HISTORICAL PERSPECTIVE
Goals of the Uruguay Round
Update existing international standards and rules
Establish dispute settlement mechanism to resolve conflicts between States
Provide detailed IP enforcement provisions
Transparency requirement
National treatment
Most-favoured-nation treatment (MFN)

4. What is a Patent? It is “Property”: right to exclude others
It is “Territorial”: provides protection only within the United States. No World Wide Patent!
The patentee must enforce the patent once it is granted.

5. TRIPs Article 25 – Industrial Designs
Article 25—Requirements for Protection
Requires that protection for any industrial design that is new or original, or that does not significantly differ from known designs or combinations of known design features.
Designs dictated essentially by technical or functional considerations need not be protected.
Duration at least ten years.
Industrial designs   Back to top
Article 25.1 of the TRIPS Agreement obliges Members to provide for the protection of independently created industrial designs that are new or original. Members may provide that designs are not new or original if they do not significantly differ from known designs or combinations of known design features. Members may provide that such protection shall not extend to designs dictated essentially by technical or functional considerations.
Article 25.2 contains a special provision aimed at taking into account the short life cycle and sheer number of new designs in the textile sector: requirements for securing protection of such designs, in particular in regard to any cost, examination or publication, must not unreasonably impair the opportunity to seek and obtain such protection. Members are free to meet this obligation through industrial design law or through copyright law.
Article 26.1 requires Members to grant the owner of a protected industrial design the right to prevent third parties not having the owner's consent from making, selling or importing articles bearing or embodying a design which is a copy, or substantially a copy, of the protected design, when such acts are undertaken for commercial purposes.
Article 26.2 allows Members to provide limited exceptions to the protection of industrial designs, provided that such exceptions do not unreasonably conflict with the normal exploitation of protected industrial designs and do not unreasonably prejudice the legitimate interests of the owner of the protected design, taking account of the legitimate interests of third parties.
The duration of protection available shall amount to at least 10 years (Article 26.3). The wording “amount to” allows the term to be divided into, for example, two periods of five years.

6. Industrial Designs in the U.S.
35 U.S.C. 171 Patents for designs.
Whoever invents any new, original, and ornamental design for an article of manufacture may obtain a patent therefor, subject to the conditions and requirements of this title.
The provisions of this title relating to patents for inventions shall apply to patents for designs, except as otherwise provided.
Duration is 14 years.

7. INDUSTRIAL DESIGNS
Design may consist in configuration or ornamentation or both.
In re Schnell, 8 USPQ 19 (CCPA 1931)
As discussed, a design patent can show the surface ornamentation with the article shown in dotted lines to illustrate that the shape of the cup is only an example.
(2) Shows an article that is protected, with no surface ornamentation.
(3) Shows the combination being protected.
(1)
Surface ornamentation applied to an article
(2)
Configuration embodied in an article
(3)
Configuration and Surface ornamentation for an article

8. Hague Registration DM/062882
INDUSTRIAL DESIGNS
Hague Registration DM/062882
Industrial designs - The Hague system of international registrations of industrial designs is applicable among the countries party to the Hague Agreement. It is administered by the International Bureau of WIPO located in Geneva, Switzerland.
This system gives the owner of an industrial design the possibility to have his design protected in several countries by simply filing one application with the International Bureau of WIPO, in one language, with one set of fees in one currency (Swiss Francs). An international registration produces the same effects in each of the designated countries as if the design had been registered there directly unless protection is refused by the competent Office of that country.
The Hague system simplifies greatly also the subsequent management of the industrial design, since it is possible to record subsequent changes or to renew the registration through a simple single procedural step with the International Bureau of WIPO.
Picture- parachuting suit

9. TRIPs Article 27 - Inventions
Article 27(1)--Patentable Subject Matter
Requires that patents be available for any invention, whether products or processes, in all areas of technology provided that they are new, involve an inventive step, and are capable of industrial application.
This general rule regarding eligibility for patentability is subject to specific exceptions set forth in paras. (2) & (3) of Article 27.
New –
Inventive step – obviousness
Capable of industrial application – useful
The exceptions are covered in a few slides---
Article 27, paragraph (2) exclude from patentability inventions the commercial exploitation of which is necessary to protect the public order or morality, including to protect human, animal or plant life.
Article 27(3) may exclude from patentability diagnostic, therapeutic and surgical methods or the treatment of humans and animals.
Machine – screwdriver
Improved machine – better screwdriver
Compositions – new drugs
Methods of making
Methods of Using
Methods of Treatment, e.g., a method for treating a disease
Business Methods

10. TRIPs Article 27 – Inventions in the U.S.
Novelty is set forth in 35 USC 102
Inventive step is the same as unobvious- see 35 USC 103
Industrial application is essentially the same as our utility standard set forth in 35 USC 101
New –
Inventive step – obviousness
Capable of industrial application – useful
The exceptions are covered in a few slides---
Article 27, paragraph (2) exclude from patentability inventions the commercial exploitation of which is necessary to protect the public order or morality, including to protect human, animal or plant life.
Article 27(3) may exclude from patentability diagnostic, therapeutic and surgical methods or the treatment of humans and animals.

11. TRIPs Article 29 - CONDITIONS ON PATENT APPLICATIONS
Article 29(1) & (2)--Disclosure Requirement
Members shall require patent applications to
1. disclose the invention in a sufficiently clear and complete fashion.
Members may require patent applications to
1. indicate the best mode and
2. provide information concerning corresponding foreign applications and grants.

12. TRIPs Article 29 - Conditions On Patent Applications in the U.S.
35 U.S.C. 112 Specification.
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.

13. Contents of a U.S. Patent Application
A complete application comprises:
(1) A specification as prescribed by 35 U.S.C. 112, including a claim or claims
(2) An oath or declaration
(3) Drawings, when necessary; and
(4) The prescribed filing fee, search fee, examination fee, and application size fee.
Applicants are encouraged to file an information disclosure statement in nonprovisional applications.

14. TRIPs Article 27 - Inventions PATENTABLE SUBJECT MATTER
Article 27(1)--Prohibition Against Discrimination
Patents shall be available and patent rights enjoyable without discrimination as to:
1. place of invention;
2. field of technology; or
3. whether products are imported or locally
produced.

15. TRIPs Article 27 - without discrimination as to place of invention
Part of USPTO annual report, showing selected MENA countries.

16. US Patent issued to Jordanian Inventor w/Jordanian Assignee
Inv- Farouk Hussni Al-Hajjar (Amman)
Assignee- Dar Al Dawa Development and Investment Co. (JO)

17. TRIPs Article 27 - PATENTABLE SUBJECT MATTER
Article 27(2)--Exclusions from Patentability
Members may exclude from patentability inventions under the following conditions:
1. the prevention is necessary to protect ordre public or morality, including protecting human, animal, or plant life and the environment; and
2. exclusion is not made because exploitation is prohibited by law.
Possible discussion topic US Patent No. 4,736,866 (an expired patent)
The Oncomouse or Harvard mouse is a type of laboratory mouse that has been genetically modified using modifications designed by Harvard University and DuPont to carry a specific gene called an activated oncogene. The activated oncogene significantly increases the mouse’s susceptibility to cancer, and thus makes the mouse suitable for cancer research.
Patent applications on the oncomouse were filed back in the mid-1980s in numerous countries such as in the United States, in Canada and in Europe through the European Patent Office (EPO).
European patent application was filed in June 1985 by "The President and Fellows of Harvard College". It was initially refused in 1989 by an examination division of the European Patent Office among other things on the grounds that the European Patent Convention (EPC) excludes patentability of animals per se. The decision was appealed and the Board of Appeal held that animal varieties were excluded of patentability by the EPC (and especially its Article 53(b)), while animals (as such) were not excluded from patentability (T 19/90 [1]). The examination division then granted the patent in 1992 (its publication number is EP ).
The European patent was then opposed by several third parties, more precisely by 17 opponents, notably on the grounds laid out in Article 53(a) EPC [2], according to which "inventions, the publication or exploitation of which would be contrary to "ordre public" (public order) or morality" are excluded from patentability. After opposition proceedings took place in November 2001, the patent has been maintained in amended form. This decision was then appealed and the appeal decision was taken on July 6, 2004 (T 315/03 [3]). The case was remitted to the first instance, i.e. the opposition division, with the order to maintain the patent on a newly amended form.
The Supreme Court of Canada ruled in 2002 that a genetically modified mouse, developed by Harvard University to be used in cancer research, is not an invention (does not qualify as a composition of matter) and cannot be patented under Canadian law.

18. TRIPs Article 27 - PATENTABLE SUBJECT MATTER
Article 27(3)--Plant Variety Protection
Members must provide for the protection of plant varieties either by patents or by an effective sui generis system or any combination thereof.
UPOV is an excellent example of a sui generis system. 64 countries are a member of UPOV.
The International Union for the Protection of New Varieties of Plants (UPOV) is an intergovernmental organization with headquarters in Geneva (Switzerland). UPOV was established by the International Convention for the Protection of New Varieties of Plants. The Convention was adopted in Paris in 1961 and it was revised in 1972, 1978 and The objective of the Convention is the protection of new varieties of plants by an intellectual property right.
Plant Variety Protection Act
Complies with the 1991 UPOV Convention
Enacted in 1970, Amended in 1980 & 1994
Plant must be New, Distinct, Uniform and Stable
In U.S. applies only to sexually reproduced plants and tuber propagated plants
20 year protection from date of grant
Exclude others from selling, offering for sale, multiplying, conditioning, importing, exporting and stocking the variety
Protects a single variety having a common trait
Provides for Breeder’s Exemption
Private acts for non-commercial purposes
Acts done for experimental purposes
Acts done for breeding other varieties
Provides for Farmer’s Exception under limited circumstances

19. Plant Patent 10,000

20. TRIPs Article 28 - RIGHTS CONFERRED
Article 28(1)--Exclusive Rights Conferred
Patents for products confer the right to prevent others from making, using, offering for sale, selling or importing for these purposes the patented product without the consent of the patent owner.
Applies to process patents and protects at least the product obtained directly by the patented process.

21. TRIPs Article 28 - RIGHTS CONFERRED
Article 28(2)--Transfer of Patent Rights
Patent owners shall have the right to:
1. assign the patent;
2. transfer by succession; and
3. conclude licensing contracts.
Note that the owner of the patent is generally the inventor, unless they assigned the patent.

22. TRIPs Article 30 - EXCEPTIONS TO RIGHTS CONFERRED
Article 30--Exceptions to Patent Rights
Permits exceptions to the exclusive rights conferred by a patent provided that
1. such exceptions do not unreasonably conflict with normal exploitation of the patent and
2. do not unreasonably prejudice the legitimate interests of the patent owner, taking into account the legitimate interests of third parties.
e.g., Bolar amendment and prior user rights

23. TRIPs Article 31 – UNAUTHORIZED USE
Article 31 of the TRIPs Agreement sets forth conditions when nonvoluntary licenses (compulsory licenses) may be granted by a government.
These conditions are safeguards to ensure that a patent owner’s rights are not abrogated unjustifiably or unnecessarily.
Members that grant compulsory licenses must comply with the terms and conditions for granting compulsory licenses as specified in paragraphs (a)-(l) of Article 31.
Compulsory licensing is allowed, but are made subject to conditions aimed at protecting the legitimate interests of the right holder. The conditions are mainly contained in Article 31. These include the obligation, as a general rule, to grant such licences only if an unsuccessful attempt has been made to acquire a voluntary licence on reasonable terms and conditions within a reasonable period of time; the requirement to pay adequate remuneration in the circumstances of each case, taking into account the economic value of the licence; and a requirement that decisions be subject to judicial or other independent review by a distinct higher authority. Certain of these conditions are relaxed where compulsory licences are employed to remedy practices that have been established as anticompetitive by a legal process. These conditions should be read together with the related provisions of Article 27.1, which require that patent rights shall be enjoyable without discrimination as to the field of technology, and whether products are imported or locally produced.
Patent owner still has the right to be paid an adequate royalty.
In 2003, as a temporary solution, a provision of TRIPS was waived to allow generic copies made under compulsory licences to be exported to countries that lack production capacity, provided certain conditions and procedures are followed. At the December 2005 Ministerial, members made this permanent.
If the laws of a country contained the Article 31(f) limitation of authorization only for supply of the domestic market, they need to be amended to permit this solution to be implemented.

24. TRIPs Article 31 – CONDITIONS FOR GRANTING COMPULSORY LICENSES
Application must be considered individually.
Must demonstrate reasonable efforts to obtain authorization from the patentee on reasonable terms. [May be waived in cases of national emergency & nonpublic commercial use.]
Limited to authorized purposes.
Shall be nonexclusive & nonassignable.
Primarily for the supply of the domestic market.
Terminated if circumstances that led to issuance cease to exist and are unlikely to recur.
Requires adequate remuneration.
All decisions relating to the unauthorized use shall be reviewable.
Emphasize that as a Judge, they may have to review whether adequate remuneration was given.
*5- talk about in my next presentation

25. TRIPs Article 32 - REVOCATION/FORFEITURE
Article 32 requires Members to provide an opportunity for judicial review of any decision to revoke or forfeit a patent.
The term “judicial” implies that where the authority in question is not a court of law, it must follow the formal legal procedure of a court, such as opportunity to be heard.

26. TRIPs Article 32 - REVOCATION/FORFEITURE
In the U.S., there are judicial procedures wherein the validity of a patent may be litigated. The U.S. also provides for a patent to be challenged in a “Reexamination Proceeding.”

27. TRIPs Article 33 - TERM OF PROTECTION
Article 33 provides that the term of protection for a patent shall not end before the expiration of a period of twenty years counted from the filing date.
Leaves open the possibility of patent term extensions in instances when circumstances warrant patent extension.

28. U.S. Patent Term Extension Certificate

29. TRIPs Article 34 - PROCESS PATENTS: BURDEN OF PROOF
Article 34 specifies situations in which the burden of proof lies with the alleged infringer. In such cases, the alleged infringer must prove that the process to obtain an identical product is different from the patented process.

30. TRIPs Article 34 - PROCESS PATENTS: BURDEN OF PROOF
Presumption of infringement in at least one of the two specified circumstances is required:
(a) product obtained by patented process is new or (b) substantial likelihood that the identical product was made with patented process.
35 USC Sec 295-
Presumption- Product Made By Patented Process- in actions alleging infringement:
*if substantial likelihood exists that product made by patented process, and
plaintiff has made reasonable efforts to determine process actually used—
product shall be presumed to have been so made & burden shifts to defendant

31. Thank You! QUESTIONS??? Contact: Karin Ferriter Tel: 1-571-272-9300