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Choose Your Weapon: Senate Amendment Pits ANDA/BPCIA Pathway Against Post-Grant Proceedings

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Per Senator Orrin Hatch, the America Invents Act has disrupted the “careful balance” he struck with Senator Waxman in the development of the decades-old Hatch-Waxman Act governing the adjudication of generic drug litigation. On June 13, 2018, Senator Hatch filed an amendment in the Senate Judiciary Committee to remedy the perceived conflict between the “carefully calibrated requirements” of Abbreviated New Drug Application (“ANDA”) litigation under the Hatch-Waxman Act and the “much blunter instrument” of post-grant proceedings before the United States Patent Trial and Appeal (“PTAB”).   According to Senator Hatch, the amendment “will ensure that Hatch-Waxman continues to operate as originally intended by protecting the ability of generic drug companies to develop low-cost drugs while at the same time ensuring brand-name companies have sufficient protections in place to recoup their investments.”  A press release of Senator Hatch’s remarks is available here.

The “Hatch-Waxman Integrity Act” by Senator Hatch is an amendment to the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES Act), legislation designed to help generic drug companies acquire the samples they need to develop generic drugs, particularly for products subject to a risk evaluation and mitigation strategy (“REMS”). The CREATES Act advanced to the Senate from the Judiciary Committee on June 14, 2018, and was been placed on the Senate Legislative Calendar on June 21, 2018.

The Amendment would add to the CREATES Act a section entitled “Preventing the Inter Partes Review Process for Challenging Patents from Diminishing Competition in the Pharmaceutical Industry and with Respect to Drug Innovation; Preventing the Manipulative and Deceptive Use of Inter Partes Review.” The section has three parts and targets both generic drug manufacturers and biosimilar companies.

In the first portion of the Amendment, an ANDA applicant must certify that they have not and will not file an Inter Partes Review (“IPR”) or Post-Grant Review (“PGR”) or forfeit the ability to participate in the Hatch-Waxman litigation procedures.  Additionally, the ANDA applicants must certify that they are not relying in whole or in part on any decision reached by the PTAB in an IPR or PGR proceeding.

Second, the Amendment forces a similar choice for biosimilar applicants.  Those who file an abbreviated Biologics License Application (“aBLA”) must decide, with respect to any patent that is or could be included in the lists of patents that are exchanged as part of the “Patent Dance,” whether to challenge patents in an IPR/PGR or take the path outlined in the Biologics Price Competition and Innovation Act (“BPCIA”).

Third, the Amendment aims to end certain market practices and appears to apply broadly to all parties filing for post grant proceedings. To “prevent[] the Manipulative and Deceptive Use of Inter Partes Review,” the Hatch-Waxman Integrity Act amends the Securities Exchange Act of 1934 to address market manipulation tied to inter partes review petitions, such as that attempted by the Coalition for Affordable Drugs.  Specifically, “a person shall be considered to be using a manipulative or deceptive device” if they file a petition for an IPR and engage in a short sale of any publicly traded security of the owner of the patent at issue in the IPR for the 90 days before and after the filing of the petition.

We will continue to monitor the CREATES Act and the Hatch-Waxman Integrity Act in the future. For more information, please feel free to contact Jamaica Potts Szeliga at any time.

Source: https://www.bioloquitur.com/choose-weapon-senate-amendment-pits-anda-bpcia-pathway-post-grant-proceedings/

Blockchain

Institutional Clients: Get Free Real-Time USD Transfers Through Signature Bank

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Institutional clients at Kraken now have a new way to transfer USD that is free, near-instant and available 24/7. The new funding option is available through our integration with the Signet™ payment platform offered by Signature Bank. 

Fees

  • Deposits: $0
  • Withdrawals: $0

Available currencies

Requirements

  • Kraken Pro business account
  • Account with Signature Bank
  • Both accounts must be under the same name

How to get started  

Note that you must have an account with Signature Bank, so the process is different depending on whether you already have an account or not. Follow the link below for complete instructions and requirements.

Learn more about Signature’s relationship with Kraken and the Signet platform in the Q&A below with Signature CEO Joseph DePaolo. 

Can you talk about your relationship with Kraken? 

We are thrilled to have been working with Kraken for almost three years. Kraken continues to showcase thought leadership and technological innovation in the digital space, which are the critical qualities we look for in a partner. Kraken not only has top security protocols in place for their clients, but also the platform has seen extreme growth recently. I am excited to see what the future holds as the exchange connects to our Bank’s Signet platform and API. 

Can you give a quick overview of the Signet Platform and how it leverages blockchain tech?

Signet is the first proprietary, blockchain-based, digital payments platform that can be integrated directly into client’s businesses and technology systems. Signature Bank launched Signet on January 1, 2019, to enable its commercial clients to make instant and free payments in U.S. dollars. 

Through Signet’s design and features, Signature Bank clients have used Signet’s API to merge their proprietary systems with the Signet platform for full transactional capabilities. These API enhancements allow clients to continue to leverage Signet’s real-time, 24/7/365 benefits and transactions safety and securely. 

Signet’s blockchain technology is largely influenced by Ethereum’s code and allows for the minting of signets, which are tokenized representations of USDs, to instantly send and settle payments between clients. However, rather than operating a public ledger where anyone has access to the transaction history, Signet is a private, closed loop blockchain for use by Signature Bank clients only.

Why did you start a niche for small businesses? What is missing among the “big banks”?

Signature Bank was founded 20 years ago with a mission to provide excellent client service and care to small- and mid-sized businesses, values that we share closely with Kraken. Our private client banking teams serve as a single point of contact to meet all clients’ banking needs – unique when compared to mega-banks where clients are typically parsed out to different departments. This single-point-of-contact approach has become the hallmark of the Signature Bank franchise.

As the Bank grew and diversified, it appointed a Digital Assets private client banking team in January 2018 to serve the rapidly evolving digital asset community. 

Kraken is proud to offer our institutional clients this fast and convenient new funding option. For more information and instructions on how you can enable Signet for your account, visit our support page here.

Source: https://blog.kraken.com/post/8020/institutional-clients-get-free-real-time-usd-transfers-through-signature-bank/

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Blockchain

Bill Gates explains why he associates Bitcoin with tax avoidance and illegal activity

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Billionaire Microsoft co-founder Bill Gates said he doesn’t hold Bitcoin, nor is he short against it. Instead, Gates claims he holds a neutral position as far as the leading cryptocurrency is concerned.

However, his follow-on comments contradict his opening statement. While he’s all for the digitization of money, he believes Bitcoin encourages tax avoidance and illegal activity. Instead, Gates prefers the central bank digital currency approach to digital money, with reversible transactions and direct identity association.

“I don’t own Bitcoin. I’m not short Bitcoin. So I’ve taken a neutral view. I do think moving money into a more digital form and getting transaction costs down, that something the Gates Foundation does in developing countries.

But there we do it so you can reverse the transaction, you have total visibility of who’s doing what, so it’s not about tax avoidance or illegal activity.”

Gates pivots towards charity work

Cutting edge pioneer or industrial pilferer? Whichever side you take, there’s still no getting away from Gates’ impact on the digital age.

Since leaving his position as Microsoft’s chief software architect in 2000, Gates has increasingly focused on charity work via the Gates Foundation.

In 2020, he decided to dedicate more time to this cause and cut ties with Microsoft by resigning from its board. However, he mentioned that he’s always available in a consultation capacity.

“dedicate more time to philanthropic priorities including global health and development, education, and my increasing engagement in tackling climate change.”

Bitcoin community chimes in on Gates’ comments

Throughout this transition, Gates has become less known as a tech innovator and more as a philanthropist. Bitcoin-bull Anthony Pompliano implied this had dulled his understanding of disruptive technology.

It is wild to hear one of the smartest men in the world sound so uninformed and uneducated on one of the most disruptive pieces of technology.

Equally, Binance CEO Changpeng Zhao tried to pass off Gates’ ill-informed comments by saying he’s earned the right not to be “bleeding edge” any longer.

He’s at a different stage in life though. He is not on the bleeding edge, leading, push, etc. He doesn’t have to.”

Growth lead at Kraken exchange Dan Held said there’s some merit to Gates’ comments on high fees and excessive energy consumption. But overall, Held believes that Gates hasn’t taken the time to understand Bitcoin.

As a former board member of Berkshire Hathaway and close friend of Warren Buffett, Gates’ position on Bitcoin should surprise no-one.

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Source: https://cryptoslate.com/bill-gates-explains-why-he-associates-bitcoin-with-tax-avoidance-and-illegal-activity/

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EEA Member Spotlight with Alexandre Bourget, StreamingFast’s Co-founder and CTO

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EEA Member Spotlight with Alexandre Bourget, StreamingFast’s Co-founder and CTO
As an EEA member, StreamingFast will be part of the EEA community of organizations working to advance Ethereum and drive industry adoption. In the Q&A below, the EEA interviewed Alexandre Bourget on the ways StreamingFast helps the ecosystem achieve the potential impact of Ethereum.

Please introduce your company and yourself briefly.
StreamingFast is a radically different infrastructure product for Ethereum and for empowering developers with better queries and streaming semantics than blockchain nodes. The founding team is made up of serial entrepreneurs, with deep expertise in big data, cybersecurity, dev ops and blockchain. Combined, we have built and sold 6 companies, with the last one being sold to Intel. We have a passion for blockchain technology, and our goal is to help developers build performant applications by organizing the world’s decentralized data.

Having built big data solutions at Intel, my team and I understand the data engineering challenges of maintaining large swaths of data like blockchain data, but very few people are working on how to quickly and reliably read from this data. That’s where StreamingFast comes in, with a radically different streaming-first approach. The StreamingFast core value proposition: it’s the simplest, fastest, and most reliable blockchain data stream in the industry, for real-time as well as historical data.

What first brought you to the EEA, and why did you decide to become a member?
Enterprises that are working within the blockchain space will be helping to drive technology for the next decade to come. While core protocols tend to focus on the best write speeds to the underlying blockchain databases, it often creates a lot of compromises when it comes to reading that data. We’ve devoted ourselves to working on those solutions, and we believe that the EEA – as the first stop for those Enterprises seeking out guidance – is the perfect fit to help us share our knowledge, tooling, and expertise to save these companies months of engineering time.

What are you currently working on with regards to Ethereum? How will end-users benefit from your work?
We recently publicly released StreamingFast, a radically different infrastructure product for Ethereum. By empowering developers with better queries and streaming semantics, blockchain nodes can be optimized for a different role than they could ever natively provide. Well-known companies have been utilizing our APIs for some time and the feedback we’ve received so far has been incredibly positive. Many of the development teams we speak with utilized multiple service providers for redundancy, occasional latency issues, and feature completeness. After trying out StreamingFast, some of our users have been able to drop all of their other providers, as we were able to provide a single solution that just simply worked when they needed it. The main value propositions of StreamingFast include:

Simpler: use 90% less code. Single integration for accessing a low-latency stream of Ethereum data, from block 0 to the tip of the chain. No need for complex retry logic.
Cheaper: cut down on 99% of your Web3 calls. Avoid out-of-sync calls. Use in-stream updates to ERC-20 balances, Uniswap reserves, or any other contract’s state update.
More reliable: read linearly, no more polling. Paradigm-shifting use of a cursor for reliable linearity of the stream, guaranteed across disconnections and in fork situations. Something native nodes with WebSockets can only dream about.
Faster access to real-time blocks: Get data earlier than any other traditional node provider. Our nodes race to push out data, instead of you hitting one load-balanced node out of 1000, most of which are lagging because of propagation delays.
Complete: full history at your fingertip. Stream data and state changes from genesis. Let go of your archive nodes.
Data-rich, industry-wide. EVM-call level introspection: full call graph, all state changes, logs, keccak data, gas costs, Ether balance changes, internal transactions, input data & return data plus some decoded events and state changes.

StreamingFast is available for both Ethereum mainnet and private Ethereum deployments.

How will the EEA enhance your organization’s current efforts?
One comment we have received multiple times in the past was “How come we didn’t have StreamingFast when we started building?” We want to meet Enterprises before they start building. We know that we can save them time and money, and make sure Ethereum remains their first choice of protocol. By removing a lot of the added blockchain complexity around things like fork resolution, Enterprises will be able to get to production faster and simplify the experience for their developers. Our relationship with the EEA will provide Enterprises with exposure to the solutions they need, at the time they need them.

What EEA programs are you most excited about?
We are excited to participate in the Interest Groups as well as the Working Groups. We have been involved with blockchain enterprise deployments for multiple years. As such, we are looking forward to sharing use cases, discussing industry requirements and collaborating to develop open, standards based-specifications to accelerate the adoption of Ethereum-based enterprise solutions.

Learn More and Connect with the EEA
The EEA enables organizations to adopt and use Ethereum technology in their daily business operations. We empower the Ethereum ecosystem to develop new business opportunities, drive industry adoption, and learn and collaborate. Our global community of members is made up of leaders, adopters, innovators, developers, and businesses that collaborate to create an open, decentralized web for the benefit of everyone. Join us and contribute to our work!
Learn more about EEA membership, sign up for the latest updates and contact [email protected]

Source: https://entethalliance.org/eea-member-spotlight-with-alexandre-bourget-streamingfasts-co-founder-and-cto/

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