Disclosure requirements

The disclosure requirement provides that the patent be a teaching document, and enhance the breadth of knowledge held by the pubHc. By increasing the breadth of knowledge within the pubHc sector, a given patent faciHtates further technological development and growth, which in turn results in the issuance of additional patents. 

The FDA Modernization Act of 1997 contains a requirement for public disclosure and congressional reporting by October 2001 of Phase IV studies. FDA intends to meet the public disclosure requirement by posting Phase IV study commitments, the projected end of the study, and the current status of the study on their web site [102]. Sponsors whose new drug was approved with a Phase IV study requirement must submit an initial status report to FDA within one year of approval. According to data compiled by Public Citizen s Health Research Group [103], not one of the Phase IV study commitments for 107 new molecular entities approved between January 1995 and December 1999 had been completed as of December 1999. 

QA/QC at Oyu Tolgoi Cu-Au Project South Gobi, Mongolia - Ivanhoe Mines Mongolia Inc. Meeting and Exceeding Technical Disclosure Requirements Dale A. Sketchley... 

Sponsors of broadcast advertisements are also required to present a brief summary or, alternatively, may make adequate provision. .. for dissemination of the approved or permitted package labeling in connection with the broadcast presentation (21 CFR 202.1(e)(1)). This is referred to as the adequate provision requirement. The regulations thus specify that the major statement, together with adequate provision for dissemination of the product s approved labeling, can provide the information disclosure required for broadcast advertisements. 

Unfortunately, that does not leave much in the way of a good mnemonic but if you find this sort of thing helpful, take a look at Figure 6.1. The last three requirements are grouped together (WEB) because they all relate to the level of disclosure required in the patent application.2 Here and in subsequent chapters, we will delve into each of these patent commands in more detail. 

Two rival standards have been applied to determine whether practitioners satisfy disclosure requirements a professional commimity standard and a reasonable patient standard. 

Based on these disclosure requirements, the application normally contains the following ... 

Basic professional development courses offered by SCHC are MSDS and Label Preparation Workshops Science, Toxicology and Industrial Hygiene for Hazard Communication and Hazard Determination Risk Assessment. Regulatory courses include Canadian Mexican Hazard Communication Pesticide Consumer Product Labeling Component Disclosure Requirements European Union Hazard Communication Transportation Classification Labeling HMIS/NEPA Labeling and International Chemical Control Laws. 

One solution to this problem is to make a restricted deposit of the cell in a public depository, which provides a unique accession number identifying the deposit. By agreement with the depository, the restriction is lifted in the future, for example, when a patent issues referring to the cell. The applicant can then meet the disclosure requirement by providing the deposit s accession number in the specification. This approach works best if only one country is involved but does not work as well with multiple international filings, as the patent office in each country may have its own rules as to what constitutes an acceptable depository, acceptable restrictions on access to the public, and so on. 

In New Zealand, the 1991 Resource Management Act outlined disclosure requirements, but these were mainly limited to local authorities. However, matters are now progressing further, as the government is proposing a policy initiative to develop state of the environment reporting and to amend the 1993 Companies Act to introduce a requirement for statutory disclosure of environmental impacts by companies. 

Patentability can also be jeopardized during the application process by failure to disclose critical items in connection with the invention. One is the best mode of the invention, which is the favored embodiment or means of implementing the invention, particularly the one example that functions the best or enables the invention to perform to its utmost advantage, as known to the inventor at the date of applying for the patent. The best mode must be included in the text of the patent application, and cannot be reserved as a trade secret. A second disclosure requirement is the disclosure of relevant prior art that the inventor is or becomes aware of. This is a continuing requirement that lasts until the issuance of the patent, and encompasses any publications, disclosures, uses, sales or offers, and other acts or documents that qualify as prior art. 

Although trade secrets potentially offer protection for an unlimited duration (i.e., so long as secrecy is maintained), in practice the time of protection is often relatively brief One estimate is that most trade secrets have an average life expectancy of about 3 years (274). Because of the intense competition, employee mobility, and FDA disclosure requirements, the lifetime of an average trade secret in the drug discovery and development industry may be even shorter. 

Trade secret and patent protection have coexisted in the United States for more than 200 years. The U.S. Supreme Court in 1974 made it clear that federal patent law does not preempt state trade secret law (275). Nonetheless, the disclosure requirement of patent law and the secrecy requirement of trade secret law are often in conflict. The Patent Statute requires a patent specification that teaches one of ordinary skill in the art how to make... 

Employee Retirement Income Security Act of 1974, Public Law 93-406 (ERISA) this law mandates reporting and disclosure requirements for group life and health plans. It also exempts many self-insured employers from many state health insurance regulatory requirements, employer contribution the amount an employer contributes toward the premium costs of the contract. This amount carries widely among employers and is a critical variable in any risk analysis. Employer contributions can be based on dollar amounts, percentages, employment status, length of service, single or family status, or other variables or combinations of the above. 

Patent Disclosure Requirements and Trade Secret Protection... 

These laws illustrate the lack of understanding and support among part of the public for many of the pharmacy benefit management strategies now taking place. Such restrictions and disclosure requirements can be expected to continue and to become more widespread if the pubhc perceives PBM and payer activities as being motivated more by cost containment than by health care quahty considerations. 

THE AUTHOR, CHARLES VINCENT, ACKNOWLEDGES THE VALUABLE WORK OF THE OFFICE OF SAFETY AND QUALITY IN HEALTHCARE (OSQH) AT THE WESTERN AUSTRALIAN DEPARTMENT OF HEALTH IN DEVELOPING THE WA OPEN DISCLOSURE POLICY COMMUNICATION AND DISCLOSURE REQUIREMENTS FOR HEALTH PROFESSIONALS WORKING IN WESTERN AUSTRALIA (2009) ON WHICH THIS OPEN DISCLOSURE PATIENT INFORMATION PAMPHLET IS BASED. CHARLES VINCENT THANKS THE OSQH FOR PERMISSION TO USB THIS DOCUMENT)... 

Any risk or impact to the environment and human health posed by fracking fluids depends in large part on their contents. Federal law, however, contains no public disclosure requirements for oil and gas produces or service companies involved in hydraulic fracturing, and state disclosure requirements vary greatly. Although the industry has recently announced that it will soon create a public database of fluid components, reporting to this database is strictly voluntary, disclosure will not include the chemical identity of products labels as proprietary, and there is no way to determine if companies are accurately reporting information for all wells. 

In compensation for the benefits of limited liability, the law imposes on limited companies a requirement to disclose information about their operations. All limited companies must submit an aimual return and copies of their accounts to the Registrar of Companies. Over and above this requirement, public companies that wish to have their shares listed on a stock exchange must satisfy the disclosure requirements of that exchange. For the London Stock Exchange, these requirements are listed in a document known as the Yellow Book . 

---