Updates on Intellectual Property Law (Part II)

By Atty. Juris Bernadette M. Tomboc

This contribution contains updates on topics in Intellectual Property Law in a question and answer format. The author is grateful to Fr. Ranhilio C. Aquino, Ph.D., J.D., Dean of the San Beda Graduate School of Law, for providing the questions and hypothetical cases that serve as vehicle for the discussions.

1. Aspirin was confected to combat fever and aches. Lately, cardiovascular experts found out that it is highly effective in the prevention of strokes for hypertensive patients. May the cardiovascular expert who first made the discovery obtain patent for this use of aspirin?

ANSWER: The cardio-vascular experts who were first to discover the efficacy of Aspirin in the prevention of strokes among hypertensive patients may obtain a patent for the same under what is known as a “Swiss-type claim.” A document directly and unambiguously reflecting a therapeutic application would be a very strong inventiveness citation.

Other documents stating that the substance is used to treat the particular disease without describing actual clinical data may also be cited for novelty. However, claims may be open to challenge by subsequent applicants if the former do not constitute evidence of therapeutic use.

However, if we were to examine the discovery of Aspirin from a historical perspective, then it would be Sir John Vane who first discovered the mode of action of Aspirin and related compounds in 1971 earning him the Nobel Prize in Physiology or Medicine in 1982 and a knighthood who should be entitled to patent protection.

Sir John Vane discovered that aspirin and related drugs inhibit the synthesis of a group of hormone-like substances known as prostaglandins by inhibiting cyclooxygenase enzymes that normally drive prostaglandin production.

Hence, from this viewpoint, the use of Aspirin for the treatment of hypertensive patients may be considered as obvious and as prior art. Thus, the cardiovascular experts may no longer secure a patent for the same.

However, second and subsequent medical claims on the use of Aspirin, if any, for the treatment of other ailments such as cancer, hair loss, astigmatism or scoliosis, or in the manufacture of a new medical substance or compound for the treatment of such medical conditions which are not related to the earlier discovery by Sir John Vane may be considered as inventive and subject to patent.

References:

American Chemical Society (2005). Aspirin.
http://pubs.acs.org/cen/coverstory/
83/8325/8325aspirin.html

Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Patent Office (March 2004).
http://www.patent.gov.uk/patent/
reference/mediguidlines/second.htm

Intellectual Property Code of the Philippines, as amended by Republic Act No. 9150 (2001).
http://www.chanrobles.com/legal7patents.htm

Pharmabiz.com (2005). Patentability Issues: New Uses of Known Substances.
http://www.pharmabiz.com/article/
detnews.asp?articleid=26678§ionid=46

Wikipedia
http://en.wikipedia.org/wiki/Claim_(patent)

2. Carlito, an information technology student, devised a cell phone adapter that allows visually impaired persons to read text messages. He completed the device in January 2005 and allowed his friends whom he trusted with his confidence to test the device. He applied for patent registration in March 2007. Will his application be barred on the ground of prejudicial disclosure?

ANSWER: No. His application will not be barred by either prejudicial or non-prejudicial disclosure if he authorized his friends to use the device only for purposes of experimental testing. Experimental testing is an exception to the rules that apply to both prejudicial and non-prejudicial disclosure and thus is not subject to the one-year limitation period that applies to the latter for purposes of filing the application for patent registration.

The World Trade Organization (“WTO”) Agreement on the Trade-Related Aspects of Intellectual Property Rights (“TRIPS”) lays down the universal requirements of patent, viz.:

“Subject to the provisions of paragraphs 2 and 3, patents shall be available for inventions, whether products or processes, in all fields of technology, provided that they are new, involve an inventive step and are capable of industrial application.”

Section 23 of Republic Act No. 8293 defines novelty as that which does not form part of prior art. Section 24, on the other hand, defines prior art as: (1) that which has been made available to the public anywhere in the world before the filing date of the priority date of the application or (2) that which forms part of an application whether for patent, utility model or industrial design, effective in the Philippines, provided that: (i) the inventors or applicants are not the same; (ii) the contents of the application are published in accordance with the requirements of patent application rules; and (iii) the filing date of the prior art is earlier.

Prejudicial disclosure is synonymous with prior art, i.e., disclosure that anticipates, and thus legally impedes, an application. The World Intellectual Property Organization recognizes three types of disclosures, namely: (1) the description of the technical solution in writing that is published (disclosure by publication); (2) the description of the technical solution in spoken word that are uttered in public (oral disclosure); and (3) the use of the technical solution in public or by putting the public in a position that any member may use it (disclosure by use).

In In re Theis, 610 F.2d 786, the Court held that the subject invention was ineligible for patent protection due to prejudicial disclosure since it was not persuaded that although the appellant’s work had been available to the public the said availability was intended for experimental purposes (Aquino 1998). What is significant in the aforementioned ruling is that it implies that disclosure for experimental use may be considered as an exception to the rule on prejudicial disclosure.

Section 25.1 of Republic Act No. 8293 provides another exception to the rule that public use constitutes prejudicial disclosure (or prior art). Disclosure of information contained in an application for patent within twelve months preceding the filing date or the priority date of the application does not constitute prior art and will not prejudice the applicant on the ground of lack of novelty if such disclosure was made by: (1) the inventor; (2) a patent office and the information was contained in (a) another application filed by the inventor and should not have been disclosed by the office, or (b) an application filed without the knowledge or consent of the inventor by a third party which obtained the information directly or indirectly from the inventor; or (3) a third party which obtained the information directly or indirectly from the inventor.

Thus, disclosure by the author himself of his work within twelve months before the filing of the application for patent registration even if the disclosure was for the purpose of making a profit will not be a bar to patent registration (Aquino 1998). In addition, according to Rosenberg the one-year period should only commence running when use has ceased to be experimental and has become public (cf. Aquino, 1998). Hence, mere experimental testing is likewise excluded from the one-year period that applies to non-prejudicial disclosure.

As a rule, the testing of an invention within the normal context of its technological development is within the realm of permitted experimental activity. Likewise, experimentation to determine utility may also constitute permissible activity (MPEP 1998 citing General Motors Corp. v. Bendix Aviation Corp., 123 F. Supp. 506, 521, 102 USPQ 58, 69 [N.D.Ind. 1954]).

However, experimentation done to determine the product’s acceptance by the market, i.e., market testing, may already constitute prejudicial disclosure. Market testing is a trader's and not an inventor's experiment and hence not within the area of permitted experimental activity. (MPEP 1998 citing Smith & Davis Mfg. Co. v. Mellon, 58 F. 705, 707 [8th Cir. 1893]).

References:

Aquino, R.C. (1998). Intellectual Property Law.

Legal Information Institute – United States Code Collection
http://www4.law.cornell.edu/uscode/html/ uscode35/usc_sec_35_00000101----000-.html

Manual of Patent Examination Procedure, Section 2133.03, Rejections Based on 'Public Use' or 'On Sale'
http://www.bitlaw.com/source/mpep/2133_03.html

United States Patent and Trademark Office – Permitted Experimental Activity and Testing
http://www.uspto.gov/web/offices/pac/
mpep/documents/2100_2133_03_e_6.htm

World Trade Rules – Trade Related Intellectual Property Rights
http://www.inquit.com/wtr/trips/TripsManual.html

3. The Makati Business Club issued the results of its formal commissioned study with which its members concur that the use by the patentee of a fuel-saver is anti-competitive. On this basis, can a compulsory license be issued in favor of Ener-Savers Philippines for the commercial exploitation of the patent?

ANSWER: A compulsory license may not be issued on the sole basis of the study. Under Section 95 of Republic Act No. 8293, a compulsory license can only be issued after the petitioner has made efforts to obtain authorization from the patent owner on reasonable commercial terms and conditions but such efforts have not been successful within a reasonable period of time.

Thus, there must be a prior attempt to negotiate with the patentee for a voluntary license on reasonable commercial terms and conditions. Only if negotiations for such a voluntary license are unsuccessful within a reasonable period of time may the Makati Business Club be granted a compulsory license.

Further, although Section 95 of Republic Act No. 8293 provides that anticompetitive practice may be considered as an exception to the requirement of obtaining a license on reasonable terms, it may be availed of only after a determination of the same through judicial or administrative process.

Section 98 of Republic Act No. 8296 requires notice and hearing prior to the issuance of a compulsory license. The requirements of Republic Act No. 8293 are in consonance with the WTO Agreement on TRIPS.

4. Are prosthetic devices for the replacement of genitals intended for use in sex change operations subject to patent registration?

ANSWER: One of the requirements of an application for patent is industrial applicability. An invention may be considered as capable of industrial application if it can be made or used in any kind of industry. Human body parts in themselves cannot be regarded as applicable to any kind of industry and thus may not be subject of a patent. In addition, any claim with respect to said human body parts would lack novelty. Thus, a patent may not be issued to cover human body parts for use in surgery. Further, methods of surgery in which the said body parts are used may not be considered as industrial application and thus may not be covered by a patent.

However, prosthetic devices and processes to produce them, for example, from pieces of animal body or bone through procedures such as machining, demineralization or tanning outside of normal surgical procedures may be considered as industrial application and thus may be covered by a patent. An organ from a genetically modified animal produced for transplantation to humans would also be a product of a technical process that may be subject of a patent.

References:

Examination Guidelines for Patent Applications relating to Medical Inventions in the UK Patent Office (March 2004).
http://www.patent.gov.uk/patent/reference/
mediguidlines/surgery.htm#42

Ladas and Parry LLP (2002). United States Patent Law and Practice with Special Reference to the Pharmaceutical and Biotechnology Industries.
http://www.ladas.com/Patents/Biotechnology/
USPharmPatentLaw/USPhar_c.html