BREAKING NEWS - Successful Pre-Clinical Trial Application Consultation with The Therapeutic Products Directorate of Health Canada
Proposed Phase I clinical study of smoked cannabis
“This is the first step in establishing a key clinical research program aimed at developing the use of inhaled Cannabis as a prescription drug and will provide physicians with evidence on the safety and efficacy of inhaled Cannabis which remains the most commonly preferred form of ingestion by Medical Cannabis Patients,” stated Dr. Chamberland, Chief Scientific Officer and Regulatory Affairs
In order for me to enter this in Pres DD & LL, it needs to be a single link to feature it in Pres DD.
Thank you Dr Fred, Dischino.
This is just my own observation and opinion , it is quite possible other reasons for delay of its publication .
Eighteen-Month Publication of Patent Applications [R-5] - 1100 Statutory Invention Registration (SIR) and Pre-Grant Publication (PG Pub)
1120 Eighteen-Month Publication of Patent Applications [R-5]
35 U.S.C. 122 Confidential status of applications; publication of patent applications.
(1) IN GENERAL.-
(A) Subject to paragraph (2), each application for a patent shall be published, in accordance with procedures determined by the Director, promptly after the expiration of a period of 18 months from the earliest filing date for which a benefit is sought under this title. At the request of the applicant, an application may be published earlier than the end of such 18-month period.
(B) No information concerning published patent applications shall be made available to the public except as the Director determines.
(C) Notwithstanding any other provision of law, a determination by the Director to release or not to release information concerning a published patent application shall be final and nonreviewable.
(A) An application shall not be published if that application is-
(i) no longer pending;
(ii) subject to a secrecy order under section 181 of this title;
(iii) a provisional application filed under section 111(b) of this title; or
(iv) an application for a design patent filed under chapter 16 of this title.
Should we go public?
(An overview of H.R.400 - Title II)
by Peter Nieves
Some controversy arises upon discussion of the 18 month patent publication provision of H.R. 400. It is in hope of clarifying such controversies that I provide this summary of the issues addressed
by Title II of H.R.400.
Article I. §8, clause 8 of the U.S. Constitution provides that “The Congress shall have Power To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and
Inventors the exclusive Right to their respective Writings and Discoveries.” This section of the constitution allows Congress to change and pass new laws which affect the patent system. This is
the case with H.R.400. H.R. 400 was introduced January 9, 1997 intothe 105th congress by the Honorable Howard Coble. This bill was formerly H.R. 3460 in the 104th congress which
encompassed 6 titles, Title II of which was the Honorable Moorhead’sH.R. 1733 that addressed the 18 month patent application publication.
With the history behind us the most important issues are now reviewed. Title II of H.R. 400 provides for the prompt publication of filed patent applications after the expiration of a period of 18 months from the earliest filing date, and even for earlier publication upon request of the patent applicant. The first controversy raised is that of what are the repercussions on the inventor. The 18 month publication allows for early disclosure of the inventions and technologies already addressed in one’s field. The implications of this are vast. Currently, an inventor may spend thousands of dollars and many years of their valuable time only to find that after filing for a patent, the invention has already been filed for and is pending issuance. With the present bill, inventors may obtain early access to the detailed descriptions of patents awaiting issuance and can focus their time, energy, and money on either improvements or other inventions. The early publication in turn allows for better fund management, use of resources, and quicker advancement of technology.
An advantage of the 18 month publication is the availability of Provisional Royalties. Presently, if a patent application is infringed upon no remedy is available until issuance of a patent, upon which
the patentee may enforce their right to exclude others from making, using, or offering to sell the patented invention. With the 18 month publication, upon the issuance of a patent, the patentee shall have the right to obtain a reasonable royalty from any party who infringed their invention during the time from the date of publication of the application to the grant of the patent. The combination of the present 20 year patent term and the 18 month publication willprovide at least 18 1/2 years of patent protection rights to a successful patent applicant and potentially more to an applicant who requests publication of their patent application before 18 months.
A specific concern of inventors is that the 18 month publication willtake away their chances of maintaining a trade secret due to inevitable publication of their patent application by the PTO. This concern has been addressed by H.R.400 and the patent statute innumerous ways. First, the PTO is under a duty of confidentiality under 35 U.S.C. §122 to keep all patent applications and information
concerning the same in confidence unless given the authority to do otherwise by the applicant.
Therefore, an applicant may request cancellation of their patent application at any time before the 18 month period and the PTO shall remain bound by their duty of confidentiality, thereby keeping the applicant’s technology secret. Secondly, H.R. 400 has also addressed this concern by proposing that if at the time of filing the patent application the applicant so requests, the application will not be published at the 18 month mark until 3 months after an initial patentability determination by the PTO. The only requirement for this proposition is that the applicant certify that they did not also file in a foreign country. This provision ensures that the patent applicant will be given plenty of time to analyze all aspects which concern the patentability of their invention such as the chances of receiving a patent, the future costs of the prosecution of the patent application, and the time it will take until a patent will be awarded by the PTO, and if they feel that patentability is not a likely outcome, to pursue trade secret status.
Another matter addressed by the 18 month publication is that patent applications of foreign origin will be translated into English within 18 months. Presently, U.S. inventors must wait until a foreign patent application is issued as a patent before they will have the benefit of the disclosed technology within. Unlike the present situation in the U.S., foreign countries such as Japan publish patent applications at 18 months thereby revealing to their inventors the vast knowledge and technology contained in a patent application and giving them a “head start” in the inventing of new technology. The 18 month publication proposes to lead to faster advancement in technology in the U.S. and a more even “playing field” between U.S. and foreign inventors.