Pay-for-Delay: Using Patent Settlements to Preserve Market Exclusivity
"Specialty Pharmacy Times spoke to intellectual property expert D’vorah Graeser, PhD to learn how pay-for-delay works, its history in the pharmaceutical industry, and if it will become a general practice within the specialty field..."
SCOTUS pleases BIO, PhRMA, but Congress may seek more pharma money
" The ruling preserves PhRMA's deal with the White House and the Senate Finance Committee to pay more than $80 billion in taxes, rebates and fees over 10 years in exchange for a larger market, no rebates for beneficiaries who are eligible for both Medicare Part D and Medicaid, and no drug importation. It also preserves the biosimilars pathway and the 12-year exclusivity period for innovators that was a hot button for BIO....."
The ACA Ruling: What it Means for Specialty Pharmacy
"Much has been made about the recent US Supreme Court decision upholding the Affordable Care Act (ACA). Although specialty pharmacy has not been a central focus of the discussion, it is clear that certain provisions of the ACA directly impact the future of specialty pharmacy, and especially the future of the development and approval of biosimilar products in the United States.
To get perspective on the ACA ruling’s impact on specialty pharmacy, Specialty Pharmacy Times interviewed D’vorah Graeser, PhD, about the Biologics Price Competition and Innovation Act (BPCIA). The BPCIA, which was included as part of the ACA, provides a pathway for the approval of biosimilar products..."
3 Keys to Avoid FDA Backlash When Using Social Media
"While social media networks like Facebook, Twitter, LinkedIn and Google+ originated as venues for individuals to connect and communicate, they quickly evolved into new channels for brands and businesses to interact with their target audiences and competitors. From reputation management to customer relations, social media has become as much a part of the corporate world as it is within private circles...."
How to effectively protect your IP with a non-compete clause
"Also known as brain drain, talent poaching means a competitor lures valuable or even mission critical employees away from your business, either with a more lucrative positions or benefits. Often, these valuable employees are privy to highly sensitive business intelligence, particularly with regard to trade secrets, which must remain secret, as well as temporarily secret information, such as inventions for which a patent application has not yet been filed or has not yet published. Another sensitive area for many employers is customer databases with customer information, as well as the relationships which the data represents...."
Spotlight On: Biosimilars facing further delays in the US?
"Speaking to FirstWord Pharma, D'vorah Graeser, CEO of Graeser Associates International, pointed to the example of the Hatch-Waxman Act, which experienced similar challenges that were not upheld. "You can point to the example of what happened with small molecules where there was a change. Companies weren't happy but they had to get over it," Graeser said. However..."
As Software Industry Patent Wars Rage, the Consumer Is Not Without an Advocate
"Microsoft’s recent acquisition of a $1 billion chunk of AOL’s patent portfolio, followed hot on its heels by Facebook’s payment to Microsoft for access to a significant part of that portfolio, is just the latest intrigue in what has become a worldwide intellectual property mêlée between the tech giants. No longer a means to an end, technology and software patents are now considered expansionary, strategic assets..."
U.S. Biosimilars Under Threat?
"While the FDA continues to develop its guidance for U.S. biosimilars, including a one-day public hearing on May 11, 2012, the basic legal underpinnings of biosimilars in the U.S. may be under threat, as the Supreme Court debates the healthcare law, a large chunk of which includes provisions for biosimilars."
Preventing open source software contamination
"As more software companies use open source software (OSS) to create proprietary software products, the risk of OSS contamination has grown increasingly high. There is no doubt that utilizing OSS can cut back on development cycles and help plug the gaps of your proprietary software. But if not executed properly, companies can quickly fall victim to the costly consequences of software contamination..."
Biosimilar products development gets a USFDA norms boost
"The United States FDA did emphasise the importance of highly similar structure," says D'vorah Graeser, who heads a biomedical-focussed healthcare intellectual property firm called Graeser Associates International."The United States FDA did emphasise the importance of highly similar structure," says D'vorah Graeser, who heads a biomedical-focussed healthcare intellectual property firm called Graeser Associates International..."
Still murky, naturally
"The U.S. Supreme Court's ruling in Mayo Collaborative Services et al. v. Prometheus Laboratories Inc. did little to remove uncertainty about what molecular diagnostic claims are patentable under Section 101 of the Patent Act.
By a 9-0 vote last week, the high court struck down Prometheus' diagnostic patents but gave no guidance on what would have made the claims patentable...."
FDA unveils biosimilars guidance
" Ultimately, the FDA provided few concrete details about what would be required, preferring to judge on a case-by-case basis. That offers flexibility, but companies may be deterred by the lack of specificity, cautions D'vorah Graeser, a patent agent at Graeser Associates International, a law firm based in Chicago and Israel. "I don't think [the FDA] gave much guidance," she says, noting that the first few companies to jump in are still taking on a big risk. "They may be rejected and have to go back to the drawing board several times," she says. "And that's tough..."
The benefits and risks of open source licensing
"In today’s tech savvy business world, the ability to develop software quickly and effectively is essential to beating your competitor to the market. To reduce cycle time, software designers often turn to established proprietary source code as a base, allowing them to build out the framework of their software quickly while focusing most of their attention on unique their algorithms or functions...."
FDA’s Biosimilars Guidance
“I don’t think [the FDA] gave much guidance,” D’vorah Graeser, patent agent at Chicago and Israel-based law firm Graeser Associates International, told Nature. Companies launching into the biosimilars game “may be rejected and have to go back to the drawing board several times,” she added..."
Pharm Exec's 2012 Pipeline Report
"D'vorah Graeser, CEO of Graeser Associates International, a healthcare IP firm, explains iRNA therapies as blockers; they are developed synthetically, and then sent into the body to connect to messenger RNAs (or mRNAs) in cells that have gone rogue. Adjusting the mRNA tones down the protein that's being expressed. "Many times one particular part of the cell's process has gone haywire in cancer, and if you can block one protein from being expressed, then you can hopefully cure cancer," says Graeser. Interfering RNAs are extremely targeted, and could be applicable to whole categories of cancer that have a common mechanism. "Instead of treating cancer according to where in the body it originated, it could be treated by targeting the general mechanism, which has been identified for that particular cancer type," says Graeser..."
Q&A: Patent expert on IP strategies, U.S. reform
"D'vorah Graeser, Ph.D., founder and CEO of Graeser Associates International, talked with R&D Directions about key intellectual property strategies companies are using in niche research areas such as siRNA, as well as the impact of recent U.S. patent law reform for life sciences companies overall..."
Doing Business in China While Protecting Your Innovations
"Realizing that many readers won’t be able to attend in person I reached out to one of the panel members presenting at the Inovia event, Dr. D’vorah Graeser. Dr. Graeser holds a B.A. in chemistry from Harvard University, a Ph.D. in pharmacology from the University of Michigan, is a registered U.S. patent agent and founder of Graeser Associates International, a global healthcare IP strategy and solutions provider. Dr. Graeser has a good deal of experience working with clients on developing a China strategy, and she agreed to answer a few questions about doing business in China..."
Comparing IP Examinations in U.S. and China
"Dr. D’vorah Graeser is the founder and CEO of Graeser Associates International (GAI), an international intellectual property firm specializing in the preparation, filing and prosecution of medical device, biotechnology, pharmaceutical, bioinformatics and medical software patents. GAI develops customized intellectual property strategies for companies interested in selling their ideas and products internationally..."
3 ways to sidestep common cultural pitfalls in China
בנוסף, פרסומים במגזינים יוקרתיים בעיתנות המודפסת: