產(chǎn)品知識(shí)產(chǎn)權(quán)技術(shù)協(xié)議寫作方法
Patents may not enable us to preclude competitors from commercializing drugs in direct competition with our products, and
consequently may not provide us with any meaningful competitive advantage. See Risk Factors.
我們的產(chǎn)品在商業(yè)化的藥物專利可能不能使我們排除競(jìng)爭(zhēng)對(duì)手的直接競(jìng)爭(zhēng)，因此，可能沒(méi)有為我們提供任何有意義的競(jìng)爭(zhēng)優(yōu)勢(shì),c存在風(fēng)險(xiǎn)因素。
We are aware of intellectual property rights held by third parties that relate to products or technologies we are developing. For
example, we are aware of others investigating methylnaltrexone and other peripheral opioid antagonists as well as PSMA or related
compounds, and of patents and applications held or filed by others in those areas.
我們都意識(shí)到相關(guān)的產(chǎn)品或技術(shù)的重要性，我們正在開(kāi)發(fā)使用第三方持有的知識(shí)產(chǎn)權(quán)。例如，我們都知道甲基納曲酮和其他外圍阿片受體拮抗劑以及PSMA的相關(guān)化合物，以及由他人持有或申請(qǐng)在這些領(lǐng)域的專利和應(yīng)用。
While the validity of issued patents, patentability of claimedinventions in pending applications and applicability of any of them to our programs
are uncertain, patent rights asserted against us couldadversely affect our ability to commercialize or collaborate with others regarding our products.
Research, development and commercialization of a biopharmaceutical product often require choosing between alternative
development and optimization routes at various stages in the development process. Preferred routes depend upon subsequent discoveries and
test results and cannot be identified with certainty at the outset. There are numerous third-party patents in our field, and we may need to obtain
a license under a patent in order to pursue the preferred development route of one or more of our product candidates. The need to obtain a
license would decrease the ultimate profitability of the applicable product. If we cannot negotiate a license, we might have to pursue a less
desirable development route or terminate the entire program altogether.http://www.mythingswp7.com/Thesis_Tips/
Government Regulation 政府條例
Progenics and its product candidates are subject to comprehensive regulation by the U.S. FDA and comparable authorities in other
countries. Pharmaceutical regulation currently is a topic of substantial interest in lawmaking and regulatory bodies in the U.S. and
internationally, and numerous proposals exist for changes in FDA and non-U.S. regulation of pre-clinical and clinical testing, safety,
effectiveness, approval, manufacture, labeling, marketing, export, storage, recordkeeping, advertising, promotion and other aspects of
biologics, small molecule drugs and medical devices, many of which, if adopted, could significantly alter our business and the current
regulatory structure described below. See Risk Factors.
FDA Regulation. FDA approval of our product candidates, including a review of the manufacturing processes and facilities used to
produce them, are required before they may be marketed in the U.S. This process is costly, time consuming and subject to unanticipated delays,
and a drug candidate may fail to progress at any point.
None of our product candidates other than RELISTOR has received marketing approval from the FDA or any other regulatory#p#分頁(yè)標(biāo)題#e#
authority. The process required by the FDA before product candidates may be approved for marketing in the U.S. generally involves:
我們的產(chǎn)品候選人以外的RELISTOR營(yíng)銷，需要批準(zhǔn)或獲得任何其他監(jiān)管權(quán)威的允許。 FDA要求的產(chǎn)品前，產(chǎn)品可能被批準(zhǔn)上市，在美國(guó)大致如下：
????? pre-clinical laboratory and animal tests;
????? submission to and favorable review by the FDA of an IND (Investigational New Drug) application before clinical trials may
begin;
????? adequate and well-controlled human clinical trials to establish the safety and efficacy of the product for its intended indication
(animal and other nonclinical studies also are typically conducted during each phase of human clinical trials);
????? submission to the FDA of a marketing application; and
????? FDA review of the marketing application in order to determine, among other things, whether the product is safe and effective
for its intended uses.
Pre-clinical tests include laboratory evaluation of product chemistry and animal studies to gain preliminary information about a
product’s pharmacology and toxicology and to identify safety problems that would preclude testing in humans. Products must generally be
manufactured according to current Good Manufacturing Practices, and pre-clinical safety tests must be conducted by laboratories that comply
with FDA good laboratory practices regulations.
Results of pre-clinical tests are submitted to the FDA as part of an IND which must become effective before clinical trials may#p#分頁(yè)標(biāo)題#e#
commence. 臨床前測(cè)試結(jié)果需要作為IND一部分提交給FDA的，臨床試驗(yàn)之前必須是要有有效的開(kāi)始的試驗(yàn)的。
The IND submission must include, among other things, a description of the sponsor’s investigational plan; protocols for each
planned study; chemistry, manufacturing and control information; pharmacology and toxicology information and a summary of previous
human experience with the investigational drug. Unless the FDA objects to, makes comments or raises questions concerning an IND, it
becomes effective 30 days following submission, and initial clinical studies may begin. Companies often obtain affirmative FDA approval,
however, before beginning such studies.
