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The Rules have Changed The management of electronic research records is more important than ever before Michael H Elliott Published in Scientific Computing May 2007 A patent provides rights to an inventor to restrict The use of Electronic Laboratory Notebook (ELN) the ability of others to make, use, or sell an technology has risen sharply in the past four years, invention. To obtain a patent, an inventor must biopharmaceutical companies.i ELN has not only government agency. In the scientific domains, led to increases in laboratory efficiency and laboratory notebooks are typically used as the improved leverage of institutional knowledge, but primary evidence to prove inventorship of a also to enhanced protection of Intellectual concept and the details of its first successful use or Property (IP). Based on technology to manage what is known as “reduction to practice.” The the underlying electronic records, ELNs can particulars of the research and associated dates provide the access security, version control, record and times are especially critical to the authentication, and automated time stamping establishment of proprietary rights in the United States. The reason for this is that the U.S., versus other countries, awards patents on a “first- However, for even those who have implemented inventor” basis rather than on a “first-to-file.” This ELN, old habits die hard. Instead of a paper puts the responsibility in the hand of the inventor to printout glued onto a notebook page, data is have accurate and corroborated records to prove they created and successfully demonstrated the application into the ELN. The originating records innovation before others. Being so critically relied are again left to be managed randomly, as the upon, entries in a laboratory notebook must be notebook page is entrusted to be the only record clear to demonstrate how and when the work was required to support a patent. For example, some corroborated by a witness not involved with the immediately, some are kept only as long as the creating scientist is with the company, and others may be kept for a year or longer. Additionally, It is not atypical for copies of printouts from over 70% of companies who have implemented spreadsheets, instrument data systems, images, an ELN still create paper printouts and apply “wet” signatures of the author and witness or what is computer to be cropped and pasted onto a known as the “hybrid model”.ii In these cases, notebook page. Except in areas that fall under organizations have faith that paper records are the control of 21 CFR Part 11, the original sovereign and the underlying electronic records are needed only for knowledge sharing amongst haphazardly on local client computers or servers. The researcher is left to their own devices to come up with a mechanism for file storage and backup. In December 2006, the risk of ignoring the proper management of patent-supporting electronic records changed appreciably with amendments to the United States Federal Rules of Civil Procedure (FRCP). These changes alter the unless solely for impeachment, identifying procedures of discovery, which is the process of requesting, or compelling, information from one party to another in a civil case. Based on the category and location of, all documents, realization that electronic records were the electronically stored information, and
predominant source of corporate records, the tangible things that are in the possession,
Judicial Conference of the United States custody, or control of the party and that the disclosing party may use to support its environment. Since 97% of records have their basis in electronic form, these changes effectively make all discovery now electronic discovery or “e- discovery.” This has a wide-ranging implication “Any party may serve on any other party which affects the retention of research data, IP records management practices, organization of inspect, copy, test, or sample any
Occurring before a trial, discovery can include the designated documents or electronically
collection of laboratory notebooks, documents, stored information — including writings,
presentations, or other information that is deemed necessary to uncover evidence. Before the FRCP changes, one party may have had the information data or data compilations stored in any
in electronic form, but in most cases they could medium from which information can be
produce it in another format, such as paper obtained — translated, if necessary, by
printouts. The previous rules didn’t specifically address the admissibility of e-records (however, form, or to inspect, copy, test, or sample patent cases have been won based on electronic constitute or contain matters within the scope of Rule 26(b) and which are in the Changes in FRCP
In the amended FRCP, electronic records are now explicitly classified as having the same weight as paper records. Specifically, Rule 26(a)(1) A and B land or other property in the possession or specified in Rule 26(a)(1)(E), or to the extent otherwise stipulated or directed by Though one party may desire to provide only paper printouts, the court can compel production information that the disclosing party may of the original source records. Despite a company using a hybrid ELN model with printed and signed requested data is not accessible, the court does notebook pages, these pages are not only redundant, but are now in effect unnecessary. “A party need not provide discovery of Those with a hybrid ELN are somewhat reducing their risks as paper is another form of backup; but sources that the party identifies as not
they are adding to the complexity of their research reasonably accessible because of undue
processes. In fact, they may be causing other problems. If changes are made to the ELN discovery or for a protective order, the database that are not being reflected in the party from whom discovery is sought must
paper version, this makes it much more difficult for show that the information is not
the user to explain to a judge or jury that they reasonably accessible because of undue
have properly maintained their intellectual burden or cost. If that showing is made,
property. Not only are they introducing doubt, expense and efforts are doubled managing these Rule 34(b) has implications for those allowing scientists to individually manage data or for those using scientific data management systems, instrument data systems, LIMS and other electronic Though “accessible” is not wel defined, this would record generating technologies that may be used be counter to the entire philosophy of an ELN – in the creation of a new compound or product. that research records are readily accessible. In This is whether the data is transferred to an ELN or a the CDS situation, if some are available and others paper notebook. For example, you crop and are not, how could it be that all records are not reasonable accessible? It would be very difficult printouts into your paper notebook. The other to explain to a judge that the original source party may want to re-analyze the data looking for records could not be “reasonably accessible” from peaks that could not be seen on small renditions an ELN when scientists are using it to search and pasted into the notebook, so they ask for access share information every day. However, Rule to the CDS raw data files. Because a lack of 26(b)(2)(B) could be used as a defense if you are consistent data management practices, some files using a paper notebook and have established are available, some are not. The opposing business practices and procedures that require counsel now works to put doubt into the minds of you to delete the source data after a specific the judge or the jury that you have selectively period of time. The key is to have consistent, deleted data you thought would harm your case organization. You can no longer let researchers It is within the rights of the opposing counsel in arbitrarily manage records that were generated discovery to gather these records unless you can for supporting a patent. The “Safe Harbor” clause convince a judge that the records are no longer accessible, it would be a major burden, they are not needed, or the records are confidential information with regards to other projects. If the provide electronically stored information lost as a result of the routine, good-faith
in this form and that they did not have any operation of an electronic information
associated metadata for searching. In this case, the magistrate agreed with the plaintiff saying that TIFFs “differ in design and content from the If you have established records management materials plaintiff designated, are not identical to practices that cal for the destruction of your the documents shown to plaintiff, and contain less research records on a published basis, e.g., once information (especially about the documents every five years, then this could be considered themselves) than the originals.”iv In CP Solutions “good-faith operation.” If you just by Pte., Ltd. V. General Electric Co.v, G.E. produced happenstance delete records, then this isn’t a primarily TIFF images of files, including e-mails. The routine operation of your business. A critical Plaintiff protested, filing a motion for their component of managing your scientific IP is to not production in their native format. Coming before only define your record management practices, the FRCP rule changes, the judge in this case ruled but to prove you actually follow them! If you are that since the files were readable, TIFF was not prepared for e-discovery, you have significant al owed, but any records that were not readable risk of loss of your patent rights. had to be produced in their original format. In the 2006 patent dispute, Nova Measuring Instruments, Ltd. v Nanometrics,, the defendant was Record Production
compelled by the judge to produce all records in If you are compelled to provide your patent their native format including any associated records electronically, what format do you provide? There are conflicting historical cases as to what a judge wil deem acceptable. Under the The format allowed is very dependent on an new rules, 26(f) instructs attorneys to attempt to attorney’s ability to prove need of a specific agree on a number of items at least twenty one record type. At a minimum, if IP records are kept days prior before a scheduling conference, under your business rules, original formats should including record formats and media type. Expect be maintained along with a conversion to a the other party to demand to know what records standard such as PDF/A, TIFF, or human readable you have for the invention, their formats, what media it can be produced on, if there is any software required to view them, any claims of It is not only experimental data that requires confidentiality (data that might also relate to proper maintenance, authentication, security, and another invention for example), and timing for archiving. Other data sources can have a major compliance before these discussions begin. impact on your ability to support a patent. In Re Scott T. Jolley,vii Scott Jolley appealed the There are a plethora of patent cases involving awarding of a patent to Phillip McGraw for a new electronic records where there was a lack of ester lubricant. Jol ey claimed to have established agreement on data format. Recently, Hagenbuch conception of the lubricant on June 2, 1988, while v. 3B6 Sistemi Elettronici Industriali was a patent McGraw claimed to have done so on May 20, case where the format of the electronic evidence 1988. Jolley contended that McGraw did not was in dispute. Hagenbuch requested CDs and have sufficient evidence to prove his asserted DVDs of electronic records in their original format creation date. But, McGraw produced an e-mail but the defendant responded with TIFF images. dated May 20, 1988 exchanged between him, his Hagenbuch claimed the records were not usable co-inventor, and other Dow employees discussing the blending of previously patented compressor lubricants for a new application use. Therefore, an i 2006 Electronic Laboratory Notebook Survey electronic record – an e-mail – was used to Atrium Research & Consulting, Wilton CT USA establish sufficient grounds for the critical date of ii Electronic Laboratory Notebooks: A Foundation invention creation and Jolley lost the case. for Scientific Knowledge Management Edition III Atrium Research & Consulting, Wilton CT USA In summary, electronic records are increasingly iii Cornell Law School “Federal Rules of Civil being used in court proceedings throughout the world. The December 2006 changes to the US Federal Rules of Civil Procedure now explicitly iv Hagenbuch v. 3B6 Sistemi Elettronici Industriali address the admissibility of these e-records. These S.R.L., Case No. 04C3109, 2006 U.S. District Court, changes affect all organizations who file patents in the US. It is essential to establish record retention v CP Solutions Pte., Ltd. V. General Electric Co., policies, business rules, procedures, and controls 2006 U.S. Dist. LEXIS 27053 (Feb. 6, 2006) for all records that support a patent, not just their vi Nova Measur. Instruments, Ltd. v Nanometrics, paper printouts. If not destroyed by such a policy, Inc., 417 F.Supp.2d 1121 (N.D. Cal. 2003) vii In Re Scott T. Jolley, 308 F.3d 1317, 64 USPQ.2d maintained, authentic, accessible, and time (BNA) 1901 (Fed. Cir. Oct. 29, 2002) (Interference Nos. 103525 and 103526) stamped. If you aren’t ready for e-discovery, you



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