Making A Move To The Hamptons

luxury home for sale

Live Like A Celebrity And Move To The Hamptons

Given that it is such a brief travel from New York or even New Jersey, the unbelievable amount of natural beauty that exists here in East Hampton is extremely astonishing. If you haven’t been here, there are these long stretches of blue Coast lines that are flowing with golden sands. In addition, the natural landscapes that exist, there are also plenty of city parks that unite to form one of the most relaxing and breathtaking destinations along the upper East Coast. If you live near here and you have money, then you know about the Hamptons! There are mega movie stars and musicians that own beautiful property here, which as a result has attracted fantastic restaurants and dining establishments for those that like the finer things in life. There are posh boutiques popping up all over town, and despite its prevalence, however, East Hampton has worked tirelessly to keep its village-like charm, something you will quickly if you visit on vacation or decide to move to the Hamptons. There are few moving companies we trust in New York and New Jersey to move families into the Hamptons, but the team at Bluebell Moving And Storage has proven time and time again that they are the East Coasts premier moving agency for the upper class on the East Coast

As A New Resident Prepare To Shop And Surf The Hamptons

Due to its astonishing landscape, perfect location, and natural abundance of awesomeness, East Hampton has a lot of activities for you to get into once you move to the Hamptons. Main Beach is the biggest attraction for a lot of East Hampton locals and visitors. Believe it or not, it is among some of the best-ranked shorelines in the country, but it is more than just a place to relax on the beach and soak in some sun rays. Main Beach hosts many of the college’s water sports competitions, there is surfing, biking, paddle boarding, body surfing, and boogie boarding. Those of you that prefer spending money on fashion, you will love what Main Street has to offer, with its fashionable posh boutiques, they cater to the upper class that has money to spend on the nicer things in life. If that is not you, don’t bother moving here because poor people don’t fit in.

Embrace The Lavish Culture Of The Hamptons

If you can tear yourself away from the shore, the city of East Hampton has lots of family-friendly attractions to check out during the day and in the evenings. One of the true gems of Long Island is LongHouse Reserve. The beautifully maintained garden stretches 16 acres across the Hamptons and is filled with amazing eye-catching stone sculptures. The Pollock-Krasner House (once home to the artists Jackson Pollock and Lee Krasner) is just another location that civilization aficionados will not want to miss out on checking out, true history at it’s finest. Folks of all ages will love the fascinating tour, and children will love making their very own Pollock-style drip paintings. Living in the Hamptons offers so many great things to enjoy, and those are just a few. Becoming culturally aware of art and the area will be necessary if you are going to fit in here.

If You Are Lucky Enough To Buy Shorefront Property

If you are lucky enough to buy shorefront property you better soak it up! Most families that buy into this luxury area don’t give up their property that easy. move to the hamptons - family home in east hamptonHouses and land are passed down through the generations over the years and children and grandchildren are often left with vacation homes they rather not sell. The experience living on the shore is unforgettable. Even though the months of June through August are the nicest, September is also a fantastic time to enjoy some good sun and good times. If you are not a sun worshiper, late spring is also an amazing time of year. Temperatures are somewhat milder, but East Hampton nonetheless retains its magical, village-like vibe. For those that want to move to the Hamptson this vibe is priceless, for visitors making a vacation of the Hamptons, they often times do not want to leave!

If You Make The Move To The Hamptons Enjoy The Parks

When you move here you may find that there is an overwhelming amount of things to do at first. Moving in, unpacking, finding your way around and all that fun stuff. But after you get settled, you need to check out the Hampton Parks. East Hampton is home to no less than 8 country parks and two county parks, with Cedar Point County Park being the most popular destination among local residents and out of town visitors. It encompasses over 600 acres of coastal beauty and is famous for its magnificent views of Gardiner’s Bay. There is an abundance of things to do such as fishing, hiking, biking, and playing in the park. Additionally, It plays host to a rich ecosystem of wildlife together with everything from deer to ducks. There are also designated dog areas for the dog lovers of the Hamptons. The rich love their poodles and purse dogs, there is no shortage of those dogs here in our parks. Locals take pride in their parks and we ask that if you move to the Hamptons that you bring your dog out to enjoy the natural beauty with you that you clean up after your animal if they poop in the park grass.

READ: New Jersey Proposes New Limits……

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Why You Need Orthodontic Insurance Coverage

Why You Need Orthodontic Insurance Coverage

Insurance insures help patients when they want financial aid to obtain the needed service and have a difficulty. Such policies are used by them as a threat coverage tool, and one main policy folks take, is orthodontic insurance if they have been aware about their oral health. Correcting abnormalities and dental issues like misaligned or damaged teeth can improve grin and an individual’s facial features. Sadly, the prices can bite difficult in the lack of quality insurance. Dental treatment from Sky Orthodontist Oklahoma City changes among individuals so, the adolescents; therefore, many parents are under pressure in the adolescents who need to wear good looking braces.

Things become a lot simpler as the cover protects all processes and gear when you’ve got insurance insuring an orthodontist’s treatment. Check whether the policy contains coverage of treatment if you’ve got an existing dental insurance. Should it not have, then contemplate purchasing a supplementary form especially for this to cover your treatment prices. It’ll save you big time if you’ve got family members that want braces or treatment.

Just like your dental or insurance coverage that is routine, you’ll need to pay a monthly or annual premium. More than a few companies pay as much as fifty percent of the overall care expenses. So, if treatment is required by some of your nearest and dearest at once, your financial weight can ease significantly.

A bulk of the expenses come from the price of gear used in the restoration procedure like other additional dental products, braces, and retainers. The price of dental x rays, allowances that are needed, and monthly visits influence the amount being spent on treatment making it higher as opposed to dental care services that are routine. Averagely, the supplier to cater up to a specific quantity of dental care per year after which the maximum annual sum for all the dental prices become your company was just wanted by the typical dental cover.

In several cases, such processes are seen by individuals as being just decorative thus resulting in just several insurance companies providing cover for such a treatment services.

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Is It Necessary To See A Dentist Frequently?

Is It Necessary To See A Dentist Frequently?

The prevention of periodontal disease, cavities, and bad breath is reached with oral direction techniques which are powerful and affordable, easy to perform on a daily basis. A professional should be consulted or more often depending on significant care attempts and dental demands. Dentist OKC offers complete oral health care services to patients to help in the care of a cavity grin that is free. Personal wellness techniques and advanced oral technology are supplied according to individual conditions.

The oral evaluation can discover changes and tooth issues in tissues indicative of major ailments including cancers and diabetes. Some of the most significant measures that people can take to maintain the healthy state of teeth would be to see with the dental offices frequently. A routine checkup contains the detection of tartar, plaque and cavities in charge of gum disease and tooth decay. The formation of a failure and bacteria can improve discoloration, oral deterioration and decay. A failure to correct oral issues including little cavities may lead to important destruction of tissue and enamel including tooth loss and acute pain.

A dentist will counsel patients on easy and affordable suggestions for health care care that is individual to grow strong teeth and gums. This can be a simple and affordable method shield the state of oral tissues and to prevent cavities. Specialized tools are integrated at the practice to supply a professional clean and accomplish places that cannot be reached with flossing and brushing. It shields against spots and decay that undermine the healthy state of pearly whites. A dental practice provides complete oral care helping in treating gum and tooth ailments. Meeting an oral professional often and following day-to-day hygiene measures can best protect and improve the state of your grin.

It is important to get it assessed time to time and to take good care of your dental health and stay healthy. Google “oral health”  if you want to learn more about the oral health.

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Things To Look For In An Attorney Before Hiring Them

Things To Look For In An Attorney Before Hiring Them

Permit me to start by saying that do it yourself has its limitations. Certainly, contracts can be drafted by you by yourself, it is possible to survive discussions that are grotesque with your company customers, a married dispute can be settled by you but you should get an attorney when the demand to come to court appears. Expenses will be incurred, professional fees must be paid and the normally drawn-out procedure must be born. The prices of solving a difficulty are much greater in relation to the prices of preventing the issue. However, hiring a Sugar Land criminal defense attorney can eliminate the complexity, who knows what needs to be done.

When locating a lawyer so, search for a “competent” attorney. Before you start to share your innermost secrets together it’s absolutely ethical to require a lawyer permit. Generally though, their certifications would hang. He may be a professional in any among the following types of law: taxation law, labor law, civil law, international law, litigation, or criminal law. These are the important types. Therefore, you may learn of an immigration lawyer or a litigation attorney. Note however, that attorneys’ specialties are “obtained” through expertise, not only because they believe they have been excellent at it.

This can be one facet of being a lawyer where a youthful, inexperienced attorney can in fact get ahead of a seasoned one. Young attorneys usually are sympathetic, encouraging and lively. They have a tendency to treat their customers like their infants. They take care of every small detail, even the ones that are unimportant. But this just is paying customers desire to be treated. Customers often believe that they’re getting their money’s worth with the type of focus they can be becoming.

The personal qualities to try to find in an attorney depend significantly on the type of customer you might be. Should you be the no nonsense sort, you may choose to hire an old attorney who is about to retire. These kinds of attorney are interested in what you will need to say. Occasionally, they’re not thinking about what they must say. But their expertise is impeccable. The credibility of an attorney may be viewed in several circumstances. It can be built on charm coupled with referrals from previous satisfied customers. To be sure, no attorney can get customers if he’s not trustworthy and believable.

So at this point you have a credible, skilled and competent attorney having the individual qualities you try to find. Another matter to contemplate is whether that attorney can be acquired to attend to your own issue. Your attorney will say he is capable, willing and happy to help you. He said the identical thing to last week, and several others this morning, and the week. The point is, an attorney can only just do so much. He can not all be attending hearings all. He’d likely resort to rescheduling or cancelling hearings and assemblies that are significant to make ends meet. If your preferred attorney has a law firm, there will surely be other attorneys who can attend in case he is unavailable to you personally. You’ll find this satisfactory but not until your case continues to be reassigned to another from one hand.

The representation starts when you meet with your customer. This, nevertheless, isn’t what defines professionalism. So don’t be misled by the attorney-appear alone. It’d be amazing if your attorney can pull it away with the professionalism that is authentic and the attorney appearance though.

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House and Senate Bills Would Require Reporting of Biosimilar Agreements to the DoJ and FTC

House and Senate Bills Would Require Reporting of Biosimilar Agreements to the DoJ and FTC

By Kurt R. Karst

Last month, Representatives John Sarbanes (D-MD) and Bill Johnson (R-OH) introduced H.R. 6478, the “Biosimilars Competition Act of 2018.”  The bill would amend the Public Health Service Act (“PHS Act”) to require that certain agreements between biosimilar applicants and reference product sponsors be reported to the Department of Justice (“DoJ”) and to the Federal Trade Commission (“FTC”).  According to Rep. Sarbanes, the bill is intended to address so-called “pay-for-delay” agreements.

Specifically, H.R. 6478 would amend PHS Act § 351(l) to add item “(10)” to require the reporting of any agreement between a biosimilar applicant and a reference product sponsor, or an agreement between two or more biosimilar applicants, regarding the manufacture, marketing, or sale of the biosimilar product(s) for which a 351(k) aBLA was submitted to FDA, or the brand-name reference product. Such agreements also include agreements that are contingent upon, provide a contingent condition for, or that otherwise relate to an agreement regarding the manufacture, marketing, or sale of the biosimilar or reference products. Agreements that solely concern purchase orders for raw material supplies, equipment and facility contracts, employment or consulting contracts, or packaging and labeling contracts would be excluded from reporting under H.R. 6478.

While the House considers H.R. 6478, the United States Senate is considering legislation concerning the reporting of patent settlement agreements involving biosimilars. Specifically, S. 2554, the “Patient Right to Know Drug Prices Act,” would amend the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (“MMA”) – and, in particular, Sections 1111-1118 – to require that certain agreements reached between biosimilar applicants and reference product sponsors be reported to the FTC. Section 1112 of the MMA requires that certain types of agreements executed on or after January 7, 2004 between a brand-name drug company and a generic drug applicant be filed with the FTC and the DoJ; MMA § 1113 states that “[a]ny filing required under Section 1112 shall be filed with the DoJ and the [FTC] not later than 10 business days after the date the agreements are executed;” and MMA § 1115 provides that the failure to timely file applicable agreements may result in a civil penalty of $11,000 for each day that a required filing has not been made. (For additional information on current FTC reporting requirements and reports, see here and here.)

The reporting requirements proposed in S. 2554 for biosimilar agreements would be similar to the requirements currently in place for drug products regulated under the FDC Act. S. 2554 is making its way through the Senate as calls for reporting of biosimilar agreements to the FTC have increased in the past couple of months (see here).

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Its Getting Bulkier Every Day for This Section 503B Facility: Athenex Announces a Product Launch, Moves to Intervene in the Endo/Par Bulks Lawsuit Against FDA, and Files a Declaratory Judgment Complaint

By Karla L. Palmer

On August 13, 2018, Buffalo, New York-based Athenex Pharma Solutions, LLC and Athenex Pharmaceutical Division, LLC (Athenex) announced the launch of their vasopressin compounded formulation injection ready-to-use product line (see Press Release here). It also moved to intervene (either as of right or permissively) in a pending lawsuit filed in October 2017 by Par Sterile Products and Endo Par Innovation Company (Endo/Par) (blogged about here). In yet a third punch, Athenex also filed a declaratory judgment action against Endo/Par in the United States District Court for the Western District of New York alleging non-infringement and invalidity claims for several of the defendant’s Vasostrict® patents.

The 2017 Endo/Par lawsuit against FDA involves seeking a judicial determination about whether FDA’s inclusion of vasopressin (the active ingredient in Endo/Par’s FDA-approved drug product Vasostrict®) on FDA’s Section 503B Bulks List is appropriate. Endo/Par’s lawsuit also seeks a determination concerning whether FDA’s 2017 Section 503B Bulk Substances Interim Policy violates the Administrative Procedures Act’s notice and comment rulemaking requirements. Recall that Endo/Par stated in a press release earlier this year that, based on FDA’s January 2018 public statements reflecting the Agency’s “intent to alter its compounding policy and comply with the DQSA, as well as subsequent discussions among the parties’ counsel, Endo previously agreed to FDA’s request to stay the litigation until March 30, 2018.” (See Press Release here). After FDA’s publication of new draft guidance revisiting the 503B bulks nomination process in March 2018 and discussions between the parties, Endo/Par agreed to extend the stay of the lawsuit for an additional 180 days as “FDA works toward implementation of the new compounding policy.” Under the terms of the proposed stay, Endo stated that it “will retain the ability to terminate the stay by notifying FDA that it believes that an entity has commenced or is likely to commence bulk compounding of any vasopressin-containing drug product under Section 503B.” Most interestingly, FDA released a new Bulks List on July 25, 2018, here, which list still includes vasopressin on Bulks List 1.

FDA’s March 2018 draft guidance indeed seeks significant changes to the nomination process for bulk substances for use in Section 503B Outsourcing Facilities. FDA’s proposed changes come almost six years after implementation of the Drug Quality and Security Act (Title 1), which created Outsourcing Facilities, and almost four years after FDA published its detailed bulk substances interim policy… pursuant to which the compounding industry nominated hundreds and hundreds of bulk substances, and after FDA, with the assistance of the Pharmacy Compounding Advisory Committee (PCAC) already made determinations concerning the propriety of using those substances in compounded medications. After receiving a nomination for the bulk substance vasopressin, FDA added that substance to the list in the summer of 2017. That listing decision led to the Endo/Par lawsuit against FDA described above.

Next enters Athenex and its Motion for Intervention in the Endo/Par litigation. Evidently it was Athenex’s nomination for vasopressin that FDA reviewed (and thus added the substance to Bulks List 1) last July. Athenex’s Memorandum in Support of its Motion to Intervene describes the Company’s significant investment in, and commitment to, its 503B outsourcing facility operations, and its flagship compounded formulations, including ready-to-use vasopressin products. It also describes in detail how Athenex has devoted considerable financial and other resources to preparing compounded vasopressin products in reliance on FDA’s 2017 inclusion of the substance on Bulks List 1.

Athenex also notes that vasopressin been used intravenously in hospitals, mostly in emergency scenarios, from almost 100 years. Notwithstanding, Athenex alleges that after Par received FDA approval for its product, Par “leveraged its exclusivity to maximize sales,” and the “average wholesale price of intravenous vasopressin surged 3141% — from $4.27 to $148.40 per vial. (Memorandum in Support at 8, 21). From 2013 to the present, annualized sales increased from $4 to $400 million. We have heard this very familiar sounding Shkrellianesque tale through the years…but will the pricing trevails move the Court? Athenex also describes the many differences between the FDA-approved version (Vasostrict®) and compounded formulations of vasopressin, including the ready-to-use compounded form offered by Athenex.

In addition to other arguments supporting its intervention in the lawsuit, Athenex argues that compounding from bulk substances (nonsterile-to-sterile compounding) is safer than compounding using the approved product (i.e., using Vasostrict® in a sterile-to-sterile compounding process). And, it claims that, contrary to Endo/Par’s allegations, compounding with vasopressin is not unsafe and there is a clinical need for the compounded product. Athenex argues that because answers to these issues are also “central” to deciding the underlying lawsuit, the district court should grant its motion to intervene.

For those in the continuing compounding regulatory fray, these latest events are noteworthy. The Motion is, in turn, supportive of FDA’s efforts in the nomination process, and one could argue defends the Agency’s prior actions (and considerable efforts) involving its earlier bulks list determinations. It also challenges whether Endo/Par’s lawsuit is appropriate on its face because FDA’s earlier interim bulks policy is not “final agency action” upon which the lawsuit may be based. Furthermore, it states FDA’s decisions on bulk substance nominations to date, in particular the Agency’s exercise of enforcement discretion, is not reviewable by a court, at least at this point. Stay tuned for updates on this continuing saga.

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FDA’s IVD TA: It’s Not Just Technical Assistance

FDA’s IVD TA: It’s Not Just Technical Assistance

By Jeffrey N. Gibbs

Since 1992, the Food and Drug Administration’s (FDA’s) efforts to regulate laboratory developed tests (LDTs) have been one of the most controversial device regulatory topics.  We have written about this topic multiple times (see our list at the end of this post).

The focus of many of these posts has been FDA’s efforts to use guidance documents to regulate LDTs under the Federal Food, Drug, and Cosmetic Act.  In short, we have questioned the legality of those efforts, and given the constraints imposed by the existing legal framework, its desirability.

However, there is another way to approach LDT regulation: by enacting legislation.  That would address the legality issue, and, if properly crafted, its desirability.  A new law could provide an unassailable legal framework, while also addressing multiple concerns that have been raised: LDTs and kit manufacturers should be on a level playing field; the regulatory requirements should be based on the clinical role and risk of the test, not whether it was an LDT or distributed test kit; the role played by laboratories in innovation and meeting underserved populations; recognition that labs are already subject to extensive regulation under the Clinical Laboratory Improvement Amendments (CLIA); etc.  FDA was asked to provide Technical Assistance (TA) regarding legislation, the Diagnostic Accuracy and Innovation Act (DAIA), that is designed to accomplish these and other goals.

In response, FDA went much further than providing technical comments on the legislation.  FDA has instead advanced a different framework, with different statutory language, which would substantially change the regulatory regime for in vitro diagnostics (IVDs).  As FDA said in accompanying comments, the agency is “taking a fresh look at how the Agency is encouraging the development of innovative tests and continuous improvements to diagnostics already on the market.”  Underscoring that the TA is not just tweaking existing mechanisms, FDA says it “believes it is necessary to create pathways” (emphasis added).

The Medical Device Amendments of 1976 placed diagnostics into the same category as all other devices.  The definition of device included the term “diagnosis,” but otherwise did not recognize that IVDs existed except as part of the broader world of devices.  Although the statute has been amended multiple times since then, diagnostic products have continued to be lumped in with all other devices.  The issue that FDA has decided to address head on is whether that should continue.  And FDA answered with a strong “no,” by introducing novel concepts such as “priority review,” “precertification,” “provisional approval,” and “test groups.”

FDA’s TA document is not tinkering with the regulatory regime for IVDs. It is a revamp of how all IVDs should be regulated, LDTs and distributed diagnostic products alike.  (DAIA, of course, also proposed significant revisions to how diagnostic tests are regulated; the purpose of this blog is not to compare and contrast the new proposals.  Notably, the TA does not attempt to address the role of CLIA.)

For LDTs, it would mean a new regulatory framework.  Some labs have voluntarily submitted 510(k)s or premarket approval applications (PMAs) to FDA.  If FDA’s proposal were adopted, labs and manufacturers would be subject to the same criteria for when applications would need to be submitted.  Labs would also be subject to other FDA requirements beyond the submission of marketing applications.

Putting kits and LDTs on the same footing, though, is not the most striking aspect of the proposal.  Rather, it is FDA’s rewriting of the IVD regulatory process, both for entering and remaining on the market.  Many of the regulatory terms and constructs that have governed IVD regulation for decades ‒ would be discarded.  A whole new vocabulary would be adopted, complete with their own statutory definitions, e.g. “in vitro clinical test” and “developer” and “test group” and “analytical validity” and “first-of-a-kind.”  This legislation, although it borrows from some past concepts, should be viewed as revolutionary, not evolutionary.

We will be writing about more of the details later.  One example, though, suffices to show how FDA’s proposal would dramatically alter the regulatory system.  For 42 years, the primary route for FDA review of new IVDs has been the 510(k) premarket notification.  To obtain a 510(k) clearance, a company has had to show “substantial equivalence” to a “predicate device.”  Those terms ‒ 510(k), substantial equivalence, and predicate device ‒ have been part of regulatory lingo for over four decades.  Under FDA’s framework, they would disappear.

The concept of “predicate device” is dropped.  A new phrase is created: “test group.”  The squishiness of the term “predicate device” vanishes; a more precise and multifaceted term is created.   A test group means tests that have the following common elements: 1) the substance measured, 2) the type of specimen, 3) the test method, 4) the test purpose, e.g., screening or monitoring, 5) the disease or condition, 6) the patient population, and 7) the place of use, e.g., OTC or clinical lab.  Yet, the role the “test group” concept plays is not analogous to that of ‘predicate devices.’”  The TA is not simply displacing one definition with another, but falling within – or outside ‒ a “test group” has different consequences than being able to cite a single device as a predicate for a 510(k), e.g., it becomes a factor in determining whether a modification to a marketed device needs prior approval.

FDA’s TA will unquestionably be controversial.  There will certainly be numerous questions about the specifics.  One provision reads: “any interested person may obtain review, in accordance with section [appeals], of an order of the Secretary approving an application.”   As written, this would suggest third parties could readily challenge an approval obtained by another company, an outcome that FDA would not want.  Another example: limiting the criterion for exemption for rare diseases to fewer than 8000 patients in the U.S. who require testing will substantially limit the utility of this provision. And another one: The TA would also confer upon FDA the power to withdraw the approval of a product if “there is a reasonable likelihood that the in vitro clinical test would cause death or serious adverse health consequences, including by causing the absence, delay, or discontinuation of appropriate medical treatment.”  This would give FDA a power that it currently lacks for 510(k)-cleared tests, as well as tests that have gotten de novo authorization.

Rewriting the laws for IVDs is a complicated business, and every word needs to be scrutinized, both for what is intended and for potential unintended consequences.  There are multiple pieces to the new jigsaw puzzle FDA has proposed.  When all the pieces are placed together, will they create a coherent image?  In its transmittal explanatory note, FDA states, “DAIA could have the unintended consequence of creating inconsistencies in the marketplace.”  FDA’s proposal also needs to be carefully vetted for its own possible unintended consequences.

But beyond the question of the specifics of the legislation, there is the most basic question of all: should the laws governing the entry on to the market of IVDs be updated.  There are good reasons to say the answer is yes.

Over time, the fit between novel IVDs and the existing regulatory framework has become increasingly uneasy.  Today’s IVDs are much more heterogeneous than when the FDC Act was enacted.  IVDs play widely divergent roles.  They are evaluated in ways differently than most other products, with the need to show analytical performance.  (The TA has multiple provisions explicitly dealing with analytical testing.) Clinical performance is judged through different kinds of metrics, such as sensitivity and specificity, positive predictive value and negative predictive value, positive and negative percent agreement.  Those concepts don’t always align neatly with the language of substantial equivalence or even de novo.  Yes, other devices have their own vocabulary and requirements, but this issue of fit is even more pronounced for IVDs as a class of products.

More pressing, the rate of change in the industry is accelerating.  With next generation sequencing and proteomics and metabolomics and artificial intelligence and deep learning and liquid based biopsies (predicted to be a $2 billion market in four years) and other new tools and methods, the ability of IVDs to be cut or tugged into the standard regulatory Procrustean bed is fraying.  The challenge of squeezing these new tests into the existing framework is made even worse by the need for these IVDs to be updated rapidly.  The plodding model of obtaining 510(k) clearance/de novo/PMA using standards that do not take into account some of the unique attributes of IVDs, assess whether a change requires a new application (note that the guidance document for when to submit a 510(k) for changes devotes many pages to IVDs), and then submitting and waiting for a decision simply will not work for some of these new products, where the clinical market needs much faster modifications and updates.  The current approach also causes its own headaches for FDA and how it does reviews and allocates resources.  The statutory provisions governing regulation and product review should be more explicitly based on risk.

The momentum for overhauling the way IVDs are regulated is growing.  Multiple stakeholders have endorsed the concept. FDA’s TA is consistent with the principle that change is necessary, albeit there are numerous differences in approach and details.  FDA was asked for its views, and it was not going to throw away its shot by limiting itself to minor technical comments.

Last week, two of my colleagues began their blog post by quoting Foreigner.  For this post, a somewhat more obscure song reference (War of the Worlds) seems appropriate.  While I would not analogize FDA’s TA to post-apocalyptic Earth after a Martian invasion, the lines “In a brave new world  . . . We’ll start all over again” seem appropriate for labs, manufacturers, and FDA.

FDA Law Blog LDT Posts

  • FDA Considers Fundamental Shift in Federal Oversight of Laboratories (link) – June 20, 2010
  • FDA Reopens Oversight of Laboratory-Developed Tests Comment Period; Will Accept Comments Until September 15 (link) – August 19, 2010
  • FDA Plans to Regulate Laboratory Developed Tests; Many Questions Remain as to Details of Regulatory Scheme (link) – July 27, 2010
  • FDA Commissioner Calls for More Active FDA Regulation of Laboratory-Developed Tests, and ACLA Promptly Responds with a Petition Opposing FDA (link) – June 5, 2013
  • FDA Notifies Congress of Draft Guidance Documents Regarding LDTs (link) – Aug. 4, 2014
  • TRICARE Announces Demonstration Program that Would Expand LDTs Eligible for Coverage During 3-Year Period and Possibly Beyond; Coalition Urges FDA to Create Single Framework for both Diagnostic Kits and LDTs (link) – June 27, 2014
  • Senators Send Letter to OMB Requesting Release of LDT Draft Guidance (link) – July 6, 2014
  • FDA Issues Draft LDT Guidance Documents; Provides 120-Day Comment Period and will Host October Public Meeting (link) – October 2, 2014
  • CDRH Holds Webinar on Draft LDT Guidances – Highlights that Guidances Hold More Questions than Answers (link) – October 28, 2014
  • OIR Head Alberto Gutierrez Discusses Draft LDT Framework at Federal Laboratory Advisory Committee Meeting; Provides Additional Insights on Agency Plans to Regulate LDTs (link) – November 11, 2014
  • LDT Battle Lines Drawn: FDA Announces Jan. 8-9 Public Meeting on LDT Framework; Lab and Medical Groups Send Letter to FDA Commissioner Urging Notice-and-Comment Rulemaking; FDA and Patient Groups Advocate for LDT Framework on Hill (link) – November 25, 2014
  • As Part of Effort to Prepare 21st Century Cures Legislative Discussion Draft, House Committee Seeks Comment on FDA Proposed Framework to Regulate LDTs (link) – December 12, 2014
  • As Snow Falls, We See a Flurry of Developments Related to FDA Efforts to Actively Regulate LDTs (link) – February 22, 2015
  • Diagnostic Test Working Group Proposes Alternative to FDA’s LDT Framework (link) – April 16, 2015
  • Molecular Pathologist Group Proposes Legislative Solution to Modernize CLIA, Including CMS/Third-Party Premarket Review, as Substitute for FDA’s LDT Framework (link) – August 14, 2015
  • Back from Break: FDA Issues Letter to Pathway Genomics for Cancer Screening LDT; Proposed Legislative Alternatives to FDA Framework Continue to Emerge (link) – September 29, 2015
  • FDA Plans to Issue Final LDT Framework in 2016; Subcommittee Members, CMS and FDA Officials Critique Proposed Legislative Approach that Would Give CMS LDT Premarket Review Authority (link) – December 20, 2015
  • FDA Will Not Finalize Draft LDT Guidances in 2016 – But That’s Not the End of LDT Regulation (link) – November 21, 2016
  • No Final LDT Guidance, But FDA Provides Insight into What a Future Guidance Might Contain (link) – January 26, 2017
  • LDTs: The Saga Continues (link) – May 14, 2017

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ACI’s 32nd FDA Boot Camp – Boston Edition

ACI’s 32nd FDA Boot Camp – Boston Edition

By Hyman, Phelps & McNamara, P.C.

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 32nd iteration – is scheduled to take place from September 26-28, 2018, at the Omni Parker House, in Boston, Massachusetts. The conference is billed as the premier event to provide folks with a roadmap to navigate the difficult terrain of FDA regulatory law.

ACI’s FDA Boot Camp will provide you not only with the essential background in FDA regulatory law to help you in your practice, but also key sessions that show you how this regulatory knowledge can be applied to situations you encounter in real life. A distinguished cast of presenters will share their knowledge and provide critical insights on a host of topics, including:

  • The organization, jurisdiction, functions, and operations of FDA
  • The essentials of the approval process for drugs and biologics, including: INDs, NDAs, BLAs, OTC Approval, the PMA process and the Expedited Approval Process
  • Clinical trials for drugs and biologics
  • Unique Considerations in the approval of combination products, companion diagnostics, and stem cell therapies
  • The role of the Hatch-Waxman Amendments in the patenting of drugs and biologics
  • Labeling in the drug and biologics approval process
  • Off-Label use and a New World Order
  • cGMPs, adverse events monitoring, risk management and recalls

Highlights from this year’s program include an up-to-the-minute “Ripped from the Headlines” section covering recent hot issues such as the FDA Reauthorization Act, states attempts to affect drug pricing, and the potential effects of the mid-term elections on federal legislation and FDA regulations.

Hyman, Phelps & McNamara, P.C.’s Kurt R. Karst and Axinn, Veltrop & Harkrider LLP’s Suchira Ghosh will present in a session titled “Navigating the Approval Process for Drugs and Biologics.”

FDA Law Blog is a conference media partner. As such, we can offer our readers a special 10% discount. The discount code is: P10-999-FDAB18.  You can access the conference brochure and sign up for the event here.  We look forward to seeing you at the conference.

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The Center for Food Safety Pushes AMS to Finalize BE Labeling Rule; Sues Seeking to Force AMS to Act

The Center for Food Safety Pushes AMS to Finalize BE Labeling Rule; Sues Seeking to Force AMS to Act

By Riëtte van Laack

As readers of this blog know, the Agricultural Marketing Service of the USDA (AMS) is mandated to implement the 2016 National Bioengineered Food Disclosure Standard (“NBFDS” or the “Standard”). Congress set a time line for AMS to take certain actions toward implementing the Standard.  AMS, however, has had trouble staying on schedule.  Although the Agency was required to issue the final regulation and standard for disclosure statements on bioengineered (BE) foods by July 2018, in fact it issued the proposed rule barely three months before that deadline.  It is, therefore, no surprise that AMS did not meet its statutory deadline.  And it is questionable whether AMS will be able to complete the rulemaking any time soon.  According to the latest count, it received more than 14,000 comments to the proposed NBFDS rule.

Meanwhile, the Center for Food Safety (CFS) has consistently acted to keep pressure on AMS, and move the rulemaking along. In September, 2017, CFS sued AMS for failing to release in a timely manner the results of a study on possible technical challenges to obtaining BE information through electronic or digital disclosure methods mandated by NBFDS.  Shortly after CFS filed its complaint, AMS did release the study results.

On July 3, 2018, CFS again sued the government in connection with the NBFDS. This time it sued the Office of Budget Management’s (OMB’s) for its alleged failure to produce records in response to CFS’s FOIA request.  As described in the complaint, CFS submitted a FOIA request to OMB on May 3, 2018 and as of early July, a mere two months later, had not received the requested documents.

Now, a week ago, two days after the statutory deadline, CFS (together with the Center for Environmental Health) has again sued AMS. This most recent suit alleges that AMS has unreasonably delayed the BE labeling rulemaking and has failed to meet the mandatory deadline set by Congress, in violation of the Administrative Procedures Act (APA) § 702.  In their complaint, Plaintiffs take the position that AMS’s “failure to implement a national disclosure standard is withholding information from the public, a practice that is inimical to the democratic process. U.S. consumers have already waited decades for mandatory GE labeling, and further delay of the final rule has caused still more harm to the public and the stakeholders.”

Plaintiffs ask that the Court order AMS “to finalize and issue the regulations implementing the statute as soon as reasonably practicable, according to a Court-ordered timeline.” They further ask that the Court retain jurisdiction to ensure compliance with the ordered time line.

We will be monitoring further developments.

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It Feels Like the First Time: FDA’s First Competitive Generic Therapy Approval

It Feels Like the First Time: FDA’s First Competitive Generic Therapy Approval

By Sara W. Koblitz & Kurt R. Karst

Well, we haven’t quite waited the lifetime that Foreigner did, but it’s exciting nonetheless. Only about one year after signing the provisions into law, FDA announced the approval of the first generic drug with a Competitive Generic Therapy (“CGT”) designation: ANDA 211067 for potassium chloride oral solution in 20 and 40 MEQ/15 mL strengths. Created to expedite the development and approval of generic drugs for reference products that lack significant competition, a CGT designation offers applicants benefits, like enhanced communications with FDA officials, expedited ANDA review, and potential eligibility for CGT exclusivity. A reference product that lacks significant competition is one for which there is no more than one approved ANDA for a specific reference product listed in the Orange Book.

In announcing the approval of Apotex ANDA 211067, FDA Commissioner Gottlieb touted the effectiveness of the Agency’s new Drug Competition Action Plan, explaining that the product was approved in its first cycle of review. Potassium chloride oral solution is intended for the treatment and prevention of hypokalemia (low potassium blood levels) in patients on diuretics when dietary management with potassium-rich foods is insufficient or diuretic dose reduction is not possible.

We haven’t yet seen the ANDA Approval Letter or any approval materials, and there are several Potassium Chloride products listed in the Orange Book. Only one of the Potassium Chloride products is included on the current List of Off-Patent, Off-Exclusivity Drugs, FDA’s “hit list” for generic manufacturers, published in December 2017 (another Potassium Chloride product was included on the original June 2017 list, but because an ANDA referencing the NDA has been approved since the previous list publication, it was moved to the Appendix). By deductive reasoning, the Reference Listed Drug (“RLD”) for Apotex’s ANDA is Potassium Chloride approved under NDA 206814 in December 2014. Apotex’s version is the second approved generic drug referencing NDA 206814, with another generic drug manufacturer receiving approval of ANDA 210041 without CGT status on July 19, 2018.

Apotex’s CGT-designated ANDA additionally received CGT exclusivity, which provides a “first approved applicant” for a product with “inadequate generic competition” with 180 days of exclusivity. A “first approved applicant” is defined in the statute as (1) any applicant with an ANDA approved on the first day that any ANDA for a designated CGT is approved; (2) that is not eligible for Paragraph IV 180-day exclusivity; and (3) is not a drug for which all drug versions have forfeited eligibility for 180-day exclusivity. 21 U.S.C. § 355(j)(5)(B)(v)(III)(bb). “Inadequate generic competition” is defined as a drug for which there is no more than one approved ANDA for the corresponding reference product. 21 U.S.C. § 356h(e)(2). Assuming Apotex starts commercially marketing within 75 days of approval, a subsequent generic will not be approved to market for 180 days after launch. However, this exclusivity will not preclude the marketing under ANDA 210041, which received approval prior to the Apotex even though Apotex is technically the “first approved applicant.” This is because “first approved applicant” applies only to CGT-designated applicants.

Apotex has only 75 days to start commercially marketing to block the approval of other applicants for 180 days, but nothing in the statutory language precludes FDA from approving other applicants prior to Apotex’s commercial launch (and the triggering of CGT 180-day exclusivity). The statute prohibits FDA from approving subsequent applicants only if the first approved applicant has commenced commercial marketing. And applicants approved prior to Apotex’s commercial launch wouldn’t be blocked from marketing during Apotex’s 180- day exclusivity period because the statute blocks only the approval of a subsequent applicant for 180 days after commercial launch – not the marketing. Contrast this with Paragraph IV 180-day exclusivity, which blocks the approval of a subsequent applicant after a first applicant has submitted an application containing a Paragraph IV certification thereby preserving the first applicant’s exclusivity until commercial launch or forfeiture.

Once Apotex actually starts commercially marketing, the CGT exclusivity will block the approval of all applications for the RLD. This too differs from 180-day exclusivity for Paragraph IV filers, which blocks approval of only ANDAs containing Paragraph IV certifications.

Apotex has significant incentive to start commercial marketing as soon as possible, but it will be interesting to see how all of these potential scenarios play out if Apotex delays.

We talked to our friend, Terri Stewart of Abraxeolus Consulting (and former VP of Global Regulatory Policy, Intelligence & Compliance at Teva Pharmaceuticals) about how the CGT program came about. Terri is credited with developing the CGT pathway (and therefore, we’ll say she’s the Mother of the CGT Program). Here’s what Terri had to say:

In 2015, Congress began paying very close attention to rising prices of several older medicines. After oversight hearings to examine the steep price increases of medicines such as Daraprim, Epipen, Nitropress, and Isuprel, they passed legislation that would impose an additional rebate or consumer price index (CPI) penalty on generic medicines that increase their prices beyond the rate of inflation. However, this did little to solve the underlying problem, due in large part to the fact that these medicines, while on the market for decades, were brand drugs. Generic manufactures had either not targeted or not successfully gotten approval for these medicines, the step the health system relies upon to decrease prices. When the FDARA legislation presented an opportunity to once again address the issue and create a way to insert competition into the market it was the Schrader and Bilirakis offices that sought the advice of the pharmaceutical industry to find a new policy. I worked closely with their staff to develop what is today the Competitive Generic Therapy exclusivity, an incentive not for the filing of an ANDA for one of these older medicines but a benefit that is bestowed upon approval. Since passage of the legislation, I have discussed with many in the industry the impact that this has had on product selection and in may ways the return for these medicines of the promise of generic drugs – to insert competition into the market.  We often take for granted the impact that generics have for patients until we see these instances where they are not present within the life cycle of a medicine. With today’s first approval under the new pathway, I am hopeful that our efforts to solve one of the key drug pricing issues of today will continue to be successful.

Thanks Terri! We look forward to seeing additional CGT approvals and what new and interesting 180-day exclusivity issues might arise.

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Can FDA’s Drug Shortage Task Force Devise New Solutions to an Old Problem?

Can FDA’s Drug Shortage Task Force Devise New Solutions to an Old Problem?

By Jennifer M. Thomas

Last month, FDA announced the creation of a new Drug Shortage Task Force, intended to address continuing shortages of medically necessary drug products. The Task Force expands FDA’s existing group focused on drug shortages and, according to Commissioner Scott Gottlieb, will “delve more deeply into the reasons why some shortages remain a persistent challenge.” Indeed, drug shortages have been a critical issue for years, yet some shortages linger despite FDA’s regulatory focus and the serious impacts on healthcare.  It is unclear whether the new Drug Shortage Task Force will uncover any new causes of shortages, as these have been the subject of considerable investigation and scholarship already – a more important goal is the Task Force’s aim of seeking new solutions to address those causes.

The Agency’s recent announcement came on the heels of its Annual Drug Shortages Report to Congress, which reported 39 new drug shortages in 2017. It also responds to a June 15, 2018 letter from a bipartisan group of U.S. Senators requesting FDA to:

[D]evelop a report and recommendations to Congress regarding the root causes of drug shortages and the authorities FDA and other agencies need to address these causes and ensure that appropriate supplies of essential medications are always available.

In comments discussing the creation of the Drug Shortage Task Force, Commissioner Gottlieb implied that new strategies may be in the works relating to federal reimbursement policies, which would attempt to address the economics that often contribute to or perpetuate drug shortages. Namely, Commissioner Gottlieb said that FDA, the Center for Medicare and Medicaid Services, and the Department of Veteran’s Affairs, would be investigating how they could adjust reimbursement policies to increase investment in manufacturing for certain drugs prone to shortage.

Even before its recent announcements on the establishment of the Drug Shortage Task Force, FDA had renewed its focus on manufacturing quality metrics programs, announcing a Quality Metrics Feedback Program after a lengthy hiatus. One of the primary goals of quality metrics programs is to predict and prevent supply disruptions that can cause drug shortages.  However, as we noted earlier this year, the Agency’s most recent guidance on such programs seemed to take a step back from the goal of requiring drug manufacturers to establish a quality metrics program.  The Feedback Program seeks information from applicants and manufacturers who have voluntarily implemented quality metrics programs.  Industry initially objected to a mandatory quality metrics requirement as overly burdensome, at least as proposed by the Agency in 2015, and the Agency’s current statutory authority to implement such a requirement is ambiguous. The Senators’ recent bipartisan request, specifically seeking information on “authorities FDA and other federal agencies need” may encourage FDA to seek a legislative fix to the latter problem, at least.

Of course, FDA cannot prevent or resolve every problem that leads to a critical drug shortage – at least not within its current statutory authority. CDER Deputy Director for Regulatory Affairs, Dr. Douglas Throckmorton, made that clear in his recent detailed description of three ongoing drug shortages. We would welcome the thoughts of our readers as to the feasibility of FDA’s current ideas to combat critical drug shortages, and any new strategies to address shortages that have not been discussed here.

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Americans for Homeopathy Choice Petitions FDA to Establish a Homeopathic Advisory Committee and Regulations

Americans for Homeopathy Choice Petitions FDA to Establish a Homeopathic Advisory Committee and Regulations

By Riëtte van Laack

As readers of this blog may recall, last year, FDA issued a draft guidance describing how FDA would prioritize enforcement and regulatory actions regarding homeopathic drug products marketed in the United States. This new guidance document, once finalized, would replace the compliance policy guide, CPG 400.400, which had been in use for approximately three decades.

FDA’s new draft guidance was not well-received by the homeopathic community. Comments submitted show a concern about the loss of the CPG 400.400 which provided clear guidance about the manufacturing and marketing of homeopathic drug products. In contrast, the new guidance was considered vague and created uncertainty.

Concerned that the new guidance would reduce the access to homeopathic products, Americans for Homeopathy Choice submitted a Petition to FDA requesting that FDA convert the existing CPG to regulations and establish an advisory committee.

Americans for Homeopathy Choice is a non-profit advocacy organization that “exist[s] to ensure consumer access to homeopathic medicines that meet the standards for strength, quality, and purity set forth in the Homeopathic Pharmacopoeia of the United States.”  The organization previously met with FDA and submitted detailed comments to the draft guidance. Their Petition is the organization’s response to FDA’s invitation for alternatives to its approach in the draft guidance.

The three main requests by the organization are 1.) Withdrawal of the 2017 draft guidance; 2.) the establishment of an advisory committee consisting of licensed or certified homeopathic practitioners and academicians and consumers of homeopathic medicines; and 3.) The establishment of regulations for homeopathic products by converting a slightly modified CPG. In the interim, the current version of the CPG would continue to be the guiding document.

Comments may be submitted through Jan. 28, 2019.

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FDA Holds Nutrition Innovation Strategy Public Meeting

FDA Holds Nutrition Innovation Strategy Public Meeting

By Riëtte van Laack

On June 26, FDA announced a public meeting to discuss the implementation of the Nutrition Innovation Strategy (NIS), a broad initiative intended to promote public health through efforts to empower consumers to make better and more informed decisions about their diets and health, foster the development of healthier food options, and expand the opportunities to use nutrition to reduce morbidity and mortality due to chronic disease. The public meeting took place on July 26.  Agenda items included updating standards of identity (SOIs), ingredient statements (naming of ingredients) and consumer education.

FDA Commissioner Scott Gottlieb’s opening remarks focused on standards of identity and were consistent with his written statement released immediately after the remarks. Dr. Gottlieb repeated and elaborated on his concerns regarding plant-based products using dairy related terms.

During the remaining presentations, discussions, and comments, SOIs were by far the most frequently mentioned topic. Besides the issue of using defined terms from SOI regulations in naming of products that do not meet the SOI, discussions addressed a need for a revision of SOIs to allow innovation of healthier options (e.g., some standards do not allow salt replacement by salt substitutes); questions as to the purpose of SOIs (is it related to nutrition or to assure authenticity of the food, or both); and consumer understanding, including how on-line purchasing will affect the need for, and understanding of, SOIs.  A recurrent suggestion was for FDA to consider amendments that applied to all SOIs (horizontal regulations) instead of reviewing and revising the more than 300 SOI regulations one by one.

Comments related to ingredient statements were limited and included vitamin naming (last year, DSM petitioned FDA to permit declaration of vitamins by letter and number rather than by chemical name), and use of all caps (which presumably makes the ingredient statement difficult to read).

The breakout sessions titled Claims and Statements Used on Food Labels / Icon for “Healthy” highlighted the need for a reconsideration of the “healthy” claim, as well as the wide diversity of opinion on what constitutes “healthy” and how the term should be defined. Concerns about the icon related to competition with other icons and potential overconsumption of foods carrying the icon.  Several individuals expressed a need to do consumer research as well as consumer education.

Discussions regarding claims generally suggested that FDA needs to consider moving away from a focus on nutrients to a focus on food groups and positive claims because consumers foods rather than nutrients as such.

Opinions on consumer education also greatly varied as to how FDA can promote healthy eating in general. Again, there appeared to be support for a focus on food groups rather than on nutrients. The role of influencers via social media was also brought up.

The 40 plus public comments included comments encouraging FDA to enforce the SOIs for milk and other dairy products, comments opposing the strict interpretation of dairy and other terms, and comments about medical foods.

During the wrap-up, FDA mentioned that it will try to summarize the breakout sessions’ discussions and will place the summary in the docket. Meanwhile, the Agency encouraged submission of comments and suggestions to the docket. The deadline for submissions is Aug. 27, 2018.

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District Court Takes Another Logical Step to Expand the Safe Harbor

District Court Takes Another Logical Step to Expand the Safe Harbor

By Sara W. Koblitz

With one paragraph in a Summary Judgment Order issued last week, the Northern District of California further expanded the patent safe harbor under 37 U.S.C. § 271(e)(1). Though not a huge leap from previous safe harbor decisions, the Order in Nevro Corp. v. Boston Scientific Corp. held that use of a patented invention in clinical trials falls within the safe harbor provision “even after the patients have completed their participation in the trial.”  Docket No. 16-cv-06830 (N.D. Cal. July 2018).

In this case, Nevro sued Boston Scientific alleging infringement of its patents relating to Nevro’s Senza and HF10 spinal cord stimulation systems.  The Senza is a spinal cord stimulator using high-frequency pulses rather than low-frequency, approved for marketing by FDA in May 2015 with labeling stating that the device is superior to conventional spinal cord stimulators using low-frequency therapy.  Boston Scientific manufactures a competing spinal cord stimulator, the Spectra WaveWriter, as well as the Precise with Multiwave system.  Nevro sued Boston Scientific for patent infringement in 2016 asserting that Boston Scientific infringed its patents covering methods for delivering spinal cord stimulation therapy at frequencies between 1.5 kHz and 100 kHz in its use of high-frequency therapy with Boston Scientific’s spinal cord stimulation devices.  Both parties filed cross-motions for summary judgement with respect to these patents.

Because Boston Scientific used high-frequency spinal cord systems only in a clinical trial, the Court determined that its use of Nevro’s patented technology was protected by the patent safe harbor codified in 35 U.S.C. § 271(e). The safe harbor protects the use of patented technology in the development and approval of a drug:

It shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.

In Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990), the Supreme Court read the safe harbor to include all inventions rather than only drug-related inventions because the safe harbor must be read in conjunction with the patent term restoration provisions in 35 U.S.C. § 156.  In time, the standard for the applicability of the safe harbor extended to any use of the patented technology as long as it is “reasonably related” to FDA approval. Abtox v. Exitron Corp., 122 F.3d 1019, 1029 (Fed. Cir. 1997).

Use of information obtained under the exemption – even if not related to regulatory approval – is also protected under the safe harbor as long as the initial use is related to regulatory approval. See Telectronics Pacing Sys. v. Ventritex, Inc., 982 F.2d 1520, 1523-24 (Fed. Cir. 1992).  In 2012, the Federal Circuit explained that the safe harbor will still protect use even if a non-infringing alternative exists.  Momenta Pharms., Inc. v. Amphastar Pharms., Inc., 686 F.3d 1348 (Fed. Cir. Aug. 3, 2012), the Federal Circuit explained that the safe harbor will still apply even if a non-infringing alternative exists.

Building from this safe harbor framework, Nevro v. Boston Scientific explained that use of the patented invention in a clinical trial is clearly reasonably related to the development and submission of information to FDA for device approval.  Continued use of the invention after the clinical trial ends is necessarily included in the safe harbor because FDA “specifically approved a trial plan” that allowed patients to continue using the treatment protected by the safe harbor even after the relevant data for FDA submission was obtained and the trial concluded.  Further, international standards for medical research require trial sponsors to allow participants to access the studied treatment even after the trial’s conclusion.

The Court here marginally extends the safe harbor to include the continued use of a patented invention even after the trial has ended and no further data will be submitted to FDA since it is still “reasonably related” to an FDA submission. This makes sense: the safe harbor is clearly intended to protect research and encourage innovation; denying clinical trials protection from a safe harbor is therefore nonsensical.  While continued use after the clinical trial may seem like more of a reach, denying such protection would preclude the continued treatment of the studied population – a consequence that would inherently deter other patients from participating in clinical trials down the line.  Given the congressional intent to encourage innovation and the safe harbor cases preceding Nevro v. Boston Scientific, this result is only logical.

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