Friday, 20 July 2018
The U.S. Secretary of the Department of Health and Human Services, Alex Azar, has recently directed the Food and Drug Administration (FDA) Commissioner Scott Gottlieb to establish a working group to explore importing “safe” pharmaceuticals from other countries in the case of a dramatic price hike by a pharmaceutical company. The Press Release is careful to note that this would not include pharmaceuticals covered by “patents or other exclusivities.” However, there is the recent U.S. Supreme Court case in Impression Products v. Lexmark International concerning an international exhaustion rule for U.S. patents. The Press Release states:
As part of the Trump administration’s efforts to lower drug prices and put American patients first, Health and Human Services Secretary Alex Azar requested today that FDA Commissioner Scott Gottlieb establish a working group to examine how to safely import prescription drugs from other countries in the event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.
“We look forward to working with Commissioner Gottlieb and the FDA to explore how importation could help address price hikes and supply disruptions that are harming American patients,” said Secretary Azar. “We have seen a number of both branded and generic examples in recent years where a single manufacturer dramatically hikes the price for a drug unprotected by patent or exclusivities. In the 2015 case of the drug Daraprim, we saw the list price of a drug approved by the FDA in 1953 increase by more than 5,000 percent.
“Safe, select avenues for importation could be one of the answers to these challenges. When HHS released the President’s Blueprint for putting American patients first, I said we are open to all potential solutions—assuming they are effective, safe for patients, and respect choice, innovation, and access.
“Importation may well fit that bill in some instances. We look forward to working with Commissioner Gottlieb on this issue, and appreciate the voluminous work FDA has done to increase competition in America’s drug markets.”
The U.S. Department of Energy (DOE) has released a new Lab Partnering Service that includes allows review of patents for licensing from 17 national DOE laboratories. The Lab Partnering Service website states:
The Laboratory Partnering Service ("LPS") is a suite of online applications enabling access to leading experts, projects, and patents from across the U.S. Department of Energy (DOE) and the national laboratories. It delivers a host of information to provide access to a portfolio of investment opportunities. The LPS enables rapid discovery of expertise and serves as a conduit between the investor and the innovator by providing multi-faceted search capability across numerous technology areas and across the national laboratories.
The Expert Search provides customers a direct conduit to experts from the DOE’s national laboratories. This categorized list is a selection of lab-identified leading experts across several "hot" technology areas with ability to further refine the list of the experts by sub-specialty.
The Technical Summaries provide information about the numerous technologies associated patents, patent applications, and publications from DOE’s national laboratories and other participating research institutions available for licensing.
This search tool enables a unique, visually-facilitated search of the patent content contained in the Lab Partnering Service. This patent content contains published US patent applications and issued US patents resulting from Department of Energy funded R&D.
The Visual Patent Search tool was created using two powerful technologies developed at the Pacific Northwest National Laboratory, the IN-SPIRE™ Visual Document Analysis and the Scalable Reasoning System (SRS). Using these analysis tools, a tiered patent categorization system was created from the "bottom up", enabling Lab Partnering Service to develop a unique way of searching DOE-patents beyond a simple key word search.
The DOE also offers the Energy Innovation Portal, which concerns access to energy efficient and renewable energy DOE funded patents for licensing. [Hat Tip to Technology Transfer Central.]
Thursday, 19 July 2018
The high cost of health care in the United States is a significant issue. Some research points to two causes of the high cost in the United States: 1) high pharmaceutical cost; and 2) high wages for health care workers.
Notably, two pharmaceutical companies, Novartis and Pfizer, recently announced that they would not implement pharmaceutical price increases on certain drugs. This is apparently from pressure from the Trump Administration.
The Commissioner of Trump's Food and Drug Administration, Scott Gottlieb, MD, recently released comments concerning pricing reform for a Brookings Institution discussion on pharmaceuticals. His comments define the problem with rising drug costs by placing a focus on biologics and the very slow movement in the United States for biosimilars to reach the marketplace. His comments further explain how improving competition can lead to decreased prices and savings for the United States. He details some solutions to the problems, including increased cooperation with regulators outside the United States to speed up biosimilar approval. He further points to how intellectual property tactics taken by biologic owners are slowing down the process for biosimilars to reach consumers and how the FDA plans to work with the Federal Trade Commission to address these tactics. Here is an excerpt of his comments:
While less than 2 percent of Americans use biologics, they represent 40 percent of total spending on prescription drugs.
So, enabling a path to competition for biologics from biosimilars is a key to reducing costs and to facilitating more innovation.
By enabling a path for competition from biosimilars, we also give innovators an added incentive to invest in further research that’ll lead to the discovery of even better drugs that deliver additional benefits for patients.
At the FDA, we’re focused on advancing policies that make the process for developing biosimilars more efficient.
To achieve these goals, I’m pleased to announce today that we’re releasing our Biosimilars Action Plan. This plan is an important piece of the Administration’s bold Blueprint to Lower Drug Prices and demonstrates the progress being made against the deliverables the President laid out.
Our plan is aimed at promoting competition and affordability across the market for biologics and biosimilar products. Before I focus on some of the details, I’d like to talk about some of the broader goals we’re focused on.
. . .
Biologics represent 70 percent of the growth in drug spending from 2010 to 2015. And they’re forecasted to be the fastest growing segment of drug spending in the coming years.
To make sure that the next generation of breakthroughs remains affordable, it requires vibrant competition from biosimilars. But it also means that we must consider new payment approaches. Models that allow us to take advantage of the competition that biosimilars offer.
Our current payment system, which reimburses drugs based on their average sales price, was designed in a single-source world. It was a market of biologics where there was typically only one drug in a category. And there wasn’t a lot of therapeutic variety or competition.
At the time, there was only one EGFR inhibitor on the market, and just one VEG-F inhibitor. I was there when this system was designed and implemented. And I can tell you many of us didn’t envision a world where there’d be so much competition in these therapeutic categories.
So a system was designed that accepted the fact that government programs, like Medicare, would be price takers.
We didn’t have the advantage of drug competition to enable the development of formularies, bidding and market-based negotiations like we have under Part D prescription drug plans.
So the system we designed—using the average sales price as a benchmark for reimbursement—was designed to help make sure that drug makers wouldn’t be able to take big price increases once the drugs reached the market. But it wasn’t a system designed to take advantage of price competition. Because we didn’t foresee that there would be multiple drugs in these different categories.
. . .
While the FDA has approved 11 biosimilars through 2018, only three are now marketed in the U.S.
Competition is, for the most part, anemic.
It’s anemic because consolidation across the supply chain has made it more attractive for manufacturers, Pharmacy Benefit Managers, Group Purchasing Organizations and distributors to split monopoly profits through lucrative volume-based rebates on reference biologics—or on bundles of biologics and other products—rather than embrace biosimilar competition and lower prices.
It’s anemic because litigation has delayed market access for biosimilar products that are, or shortly will be, available in markets outside the U.S. several years before they’ll be available to patients here. These delays can come with enormous costs for patients and payors.
Let me give you one measure of those costs.
At the FDA, we did an analysis of biosimilar competition across all Organisation for Economic Co-operation and Development (OECD) markets. We looked at what would have happened if all the biosimilars that the FDA approved in the U.S. were successfully marketed here in a timely fashion.
We’ll release the full details on this analysis soon. But I want to give you a sense today of what we found.
To measure the potential impact of this biosimilar competition, we assumed that the savings achieved in the U.S., in terms of price discounts, would have been on par with the experience enjoyed in the other OECD nations.
Based on these assumptions, our analysis showed that if Americans had the opportunity to purchase successfully marketed, FDA-approved biosimilar prescription drugs, they could have saved more than $4.5 billion in 2017.
These are large savings. They’re about half of the nearly $9 billion in total savings in 2017 from all of the 2017 generic drug approvals, according to earlier FDA work.
This analysis assumes that all of the biosimilars that the FDA approved were successfully marketed.
But we know that’s not the case. We know that litigation blocked a lot of these launches. Yet our study found that entry of a single biosimilar product in non-U.S. OECD markets lowers prices relative to the reference product by 30 percent; markets with three to four biosimilar entrants have prices 35 to 43 percent lower than their reference biologics.
Our savings estimate doesn’t include additional potential savings from biosimilars approved in 2018. Estimated savings would therefore be significantly greater than $4.5 billion if these additional FDA-approved biosimilars were also marketed at or near the time of their approval.
Biologic manufacturers have a right to defend their legitimate intellectual property interests. And we want them to continue to offer the benefits of improved versions of originator biologics. These benefits might include biologics that target disease in new ways, such as delivering a toxic payload directly to cancer cells, or biologics that target multiple targets of disease at the same time.
. . .
But rebating schemes or patent thickets that are purely designed to deter the entry of approved biosimilars are spoiling this sort of competition. Long-dated contracts are another toxin. The branded drug makers thwart competition by dangling big rebates to lock up payors in multi-year contracts right on the eve of biosimilar entry.
We’re also concerned that volume-based rebates may encourage dysfunctional clinical treatment pathways. We’ve heard from multiple sources that some payors are requiring step-therapy or prior authorization on the reference biologic before patients can access a biosimilar. We see no clinical rationale for these practices, since a biosimilar must demonstrate, among other things, that it has no clinically meaningful differences from the reference product as a part of demonstrating biosimilarity.
The branded drug industry didn’t build its success by being business naïve. They are smart competitors.
But that doesn’t mean we need to embrace all of these business tactics, or agree that they’re appropriate.
Some of these tactics should be unacceptable to every member of the drug supply chain.
Biosimilars may be relatively new, but manufacturers’ tactics to delay and frustrate Congress’ legislative intent to promote competition in drug pricing date back decades.
These tactics were first honed in battles between branded companies and manufacturers of small molecule generics after the passage of the Hatch Waxman Act in 1984.
And these battles played out for a time. But ultimately competition prevailed, and so did the benefits of generics.
In 1983, generic drugs accounted for only 13 percent of U.S. prescriptions. Today, in 2018, it’s 90 percent. And generics can cost 75 to 90 percent less than their branded competitors.
Robust competition has led to generic drug prices that are often less expensive here in the U.S. than in other developed markets in Europe and Asia. The Association for Accessible Medicines, a trade group that represents generic drug makers, estimates that generic medicines have saved the U.S. well over $1 trillion over the last decade.
The generics market that we see today, while not perfect, is robust in most respects. But it took about two decades to develop. It took a long time for providers to grow comfortable prescribing generics and patients to be confident in taking them. It took a long time to work through legal tactics that were put in the way of competition. It took a long time for the coverage systems to be changed to take brisk advantage of generic entry.
Sometimes it feels as if we’re seeing the biosimilars version of “Groundhog Day,” with brand drug makers replaying many of the same tactics, and all of us being too susceptible to many of the same misconceptions about biosimilars’ safety and efficacy relative to originator biologics.
We’re falling into some of the same doubts and policy constraints that were used to deter competition from generics in the years after the Hatch Waxman Act.
But we’re not going to play regulatory whack-a-mole with companies trying to unfairly delay or derail the entry of biosimilar competitors. We’re not going to wait a decade or more for robust biosimilar competition to emerge.
Expanding access to affordable biosimilars, and slowing the rise of health care inflation, is an even more critical issue today than it was in 1984. The higher costs, and longer timelines, required to develop biosimilars relative to generics means that these delaying tactics can make it uneconomical for biosimilar sponsors to postpone entry for extended periods of time. I’m worried that the biosimilar manufacturers may pull out of these endeavors altogether if the brand drug makers are able to lock up markets even in cases where there’s a fully interchangeable competitor.
Ultimately, this behavior is also putting innovative drug development at risk by eroding public confidence in market-based pricing mechanisms. Too many people now are shooting at the branded drug makers. And the shrapnel isn’t just going to tear apart the gaming tactics that we might agree are gratuitous and ill conceived.
I’m worried that the shrapnel could also fray the fragile market-based rewards that support new innovation.
Our Biosimilars Action Plan applies many of the lessons learned from our experience with generic drugs to accelerate biosimilar competition with four key strategies.
First, improving the efficiency of the biosimilar and interchangeable product development and approval process.
Second, maximizing scientific and regulatory clarity for the biosimilar product development community.
Third, developing effective communications to improve understanding of biosimilars among patients, providers and payors.
And fourth, supporting market competition by reducing gaming of FDA requirements or other attempts to unfairly delay market competition to follow-on products.
I don’t want to get into the details of the entire plan in my remarks today. We’ve issued a plan that lays out all of the discrete elements of our approach.
But I want to highlight a few key actions that we’re taking.
I believe some of these actions can be transformative for sponsors’ ability to bring high quality biosimilars to market.
As part of this effort, the FDA is seeking to strengthen its partnerships with regulatory authorities in Europe, Japan and Canada. Such partnerships can enable greater efficiency in developing safe and effective biosimilars.
For example, we’re actively exploring whether data sharing agreements could give us better insights into biosimilars’ real-world safety and efficacy and, in some circumstances, facilitate the increased use of non-U.S.-licensed comparator products in certain studies to support an application under Section 351(k).
We know that when those developing biosimilars use biologics sourced ex-U.S. as their comparator product, it can lower the cost of clinical studies since many of these products can be procured more easily, and cheaply, in European and Asian markets.
We’ll also be updating the Purple Book and evaluate how we can incorporate additional information into that resource to give product developers more transparency.
And we’re also taking new steps to make the biosimilar development process more efficient.
. . .
Today, the FDA issued its final guidance on biosimilar labeling. The FDA wants to make sure that biosimilar products have labeling that allows health care practitioners to make informed prescribing decisions for their patients. Our guidance gives recommendations to applicants on how to prepare this labeling for review by the FDA.
We’re also going to be updating guidance to provide additional clarity on how biosimilar manufacturers can carve out indications from their labels where a branded drug maker might still maintain some IP. And we’re going to describe how these indications can be efficiently added into a biosimilar label once that IP on the branded alternative has lapsed.
We are also currently developing and implementing new FDA review tools, such as standardized review templates, that are tailored to applications for biosimilar and interchangeable products. We’ve already adopted similar approaches when it comes to generic drugs. These templates will improve the efficiency of the FDA’s review.
We’re also developing an index of biosimilars’ critical quality attributes relative to their reference products.
Such an index can allow sponsors to better understand how the FDA evaluates data from comparative analytical studies performed to support a demonstration of biosimilarity, and how to use suitable analytical methods.
And we’re going to be taking new steps to challenge some of the gaming tactics I talked about earlier. This includes new efforts to coordinate with the Federal Trade Commission (FTC) to address anti-competitive behavior.
A video of the Brookings Institution talk along with panelist responses can be found, here.
Wednesday, 18 July 2018
Professor Raymond T. Nimmer of the University of Houston Law Center, a leader in intellectual property law in the United States, sadly passed away in January of 2018. Before passing, he authored, “Revised Article 9 and Intellectual Property Asset Financing.” The abstract states:
Commercial asset value today often resides primarily in information assets, rather than in the physical assets that dominated the industrial age (goods and real estate). While tangible assets continue to have value, of course, the shift toward intangibles as value is significant and has been occurring for some time. We have not yet seen its end. More important, we have not yet come to grips with its meaning, either for commercial contract law or for commercial asset-based financing. Attitudes and approaches from the commercial world before intangible assets took center stage continue to influence how modern law treats information assets. Intangible assets take a variety of forms. Some involve contract rights to receive payment from third parties. This type of intangible property has provided a basis for commercial financing arrangements for several generations. But, in the modern economy, sources of intangible asset value go beyond contracts. Information has value. Rights to use or to prevent others' use of information have value. These values do not depend on a contract right to payment. Rather, the value depends on both the situational value of the information itself (e.g., how important is it in light of other sources of similar or the same information) and on a statutory or contractual right to use or to exclude others' use of the information. It is in dealing with this type of asset that modern commercial asset financing law must be judged because it is here that the major share of economic growth in this country will continue to focus. My purpose in this Article is to explore the relationship between information assets and commercial asset-based financing under proposed revisions of U.C.C. Article 9. This relationship entails a structural and philosophical conflict that engenders uncertainty at various levels. Revised Article 9 represents a massive and largely successful effort to solve many previously uncertain issues in asset-based financing. In information financing, however, many questions are left unanswered or the answers are structured in a manner that exacerbates conflict. We have not reached an effective accommodation between information property rights law and state law of secured financing under Article 9.
A tribute to Professor Nimmer may be found, here.
Saturday, 30 June 2018
Major innovations in cellular technologies arise largely from the substantial Research and Development (R&D) investments and inventions of relatively few companies, followed by widespread collaborations including many more in the process of standard setting.
The disproportionately large amounts of value created by those with most of the inspiration and perspiration in technology development are not reflected in simplistic and often-inflated metrics that are increasingly being used in patent-licensing rate apportionments, including by the courts in Fair, Reasonable and Non-Discriminatory (FRAND) licensing disputes. These metrics include the numbers of contributions to the standards and the numbers of patents declared-essential or cursorily judged to be essential to the standards. Thousands of negotiated and executed licensing agreements, including cross-licenses, with various terms in addition to royalty rates—all underpinned by billions of dollars paid annually over many years—much better reflect how patent-protected value is generated and exchanged.
|Inventor inspiration triggers avalanche of activities|
Standard-essential technology development lifecycle
|SSO work at 3GPP is the tip of the iceberg|
Non-linearities in apportioning rates
Outstanding technology value in cellular standards
Friday, 22 June 2018
Making Patents Great Again: U.S. Supreme Court Allows Foreign Lost Profits for Infringement Under 271(f)(2)
The U.S. Supreme Court (Justice Thomas) issued the opinion in WesternGenco v. Ion concerning the availability of foreign profits as part of damages under section 284 of the Patent Act. The U.S. Supreme Court basically holds that section 284 includes lost foreign profits—at least as a remedy to an infringement under 271(f)(2). Essentially, WesternGenco owns patents directed “to a system that it developed for surveying the ocean floor” and does not license the patents. ION “manufactured the components for [a] competing system and then shipped them to companies abroad.” Western Genco sued for patent infringement under 271(f)(1) and (2). The jury “awarded WesternGenco damages of $12.5 million in royalties and $93.4 million in lost profits.” ION asserted that the lost profits are unavailable to WesternGenco because “271(f) does not apply extraterritorially.” The Federal Circuit reversed and “had previously held that 271(a), the general infringement provision, does not allow patent owners to recover for lost foreign sales.” The U.S. Supreme Court reverses the Federal Circuit.
In deciding whether section 284 (in conjunction with 271(f)(2)) applies extraterritorially, the Court examined the focus of the statute(s):
“If the conduct relevant to the statute’s focus occurred in the United States, then the case involves a permissible domestic application” of the statute, “even if other conduct occurred abroad.” RJR Nabisco, 579 U. S., at ___ (slip op., at 9). But if the relevant conduct occurred in another country, “then the case involves an impermissible extraterritorial application regardless of any other conduct that occurred in U. S. territory.” Ibid.
When determining the focus of a statute, we do not analyze the provision at issue in a vacuum. See Morrison, supra, at 267–269. If the statutory provision at issue works in tandem with other provisions, it must be assessed in concert with those other provisions. Otherwise, it would be impossible to accurately determine whether the application of the statute in the case is a “domestic application.” RJR Nabisco, 579 U. S., at ___ (slip op., at 9). And determining how the statute has actually been applied is the whole point of the focus test. See ibid.
Applying these principles here, we conclude that the conduct relevant to the statutory focus in this case is domestic. We begin with §284. It provides a general damages remedy for the various types of patent infringement identified in the Patent Act. The portion of §284 at issue here states that “the court shall award the claimant damages adequate to compensate for the infringement.” We conclude that “the infringement” is the focus of this statute. As this Court has explained, the “overriding purpose” of §284 is to “affor[d] patent owners complete compensation” for infringements. General Motors Corp. v. Devex Corp., 461 U. S. 648, 655 (1983). “The question” posed by the statute is “‘how much ha[s] the Patent Holder . . . suffered by the infringement.’” Aro Mfg. Co. v. Convertible Top Replacement Co., 377 U. S. 476, 507 (1964). Accordingly, the infringement is plainly the focus of §284. But that observation does not fully resolve this case, as the Patent Act identifies several ways that a patent can be infringed. See §271. To determine the focus of §284 in a given case, we must look to the type of infringement that occurred. We thus turn to §271(f)(2), which was the basis for WesternGeco’s infringement claim and the lost-profits damages that it received.
Section 271(f)(2) focuses on domestic conduct. It provides that a company “shall be liable as an infringer” if it “supplies” certain components of a patented invention “in or from the United States” with the intent that they “will be combined outside of the United States in a manner that would infringe the patent if such combination occurred within the United States.” The conduct that §271(f)(2) regulates—i.e., its focus—is the domestic act of “suppl[ying] in or from the United States.” As this Court has acknowledged, §271(f) vindicates domestic interests: It “was a direct response to a gap in our patent law,” Microsoft Corp., 550 U. S., at 457, and “reach[es] components that are manufactured in the United States but assembled overseas,” Life Technologies, 580 U. S., at ___ (slip op., at 11). As the Federal Circuit explained, §271(f)(2) protects against “domestic entities who export components . . . from the United States.” 791 F. 3d, at 1351.
In sum, the focus of §284, in a case involving infringement under §271(f)(2), is on the act of exporting components from the United States. In other words, the domestic infringement is “the objec[t] of the statute’s solicitude” in this context. Morrison, 561 U. S., at 267. The conduct in this case that is relevant to that focus clearly occurred in the United States, as it was ION’s domestic act of supplying the components that infringed WesternGeco’s patents. Thus, the lost-profits damages that were awarded to WesternGeco were a domestic application of §284.
Interestingly, the Court notes that it specifically does not address whether other doctrines such as proximate cause may limit damages under its decision. Justice Gorsuch authored a dissent which was joined by Justice Breyer. Justice Thomas addresses their dissent by stating:
Two of our colleagues contend that the Patent Act does not permit damages awards for lost foreign profits. Post, at 1 (GORSUCH, J., joined by BREYER, J., dissenting). Their position wrongly conflates legal injury with the damages arising from that injury. See post, at 2–3. And it is not the better reading of “the plain text of the Patent Act.” Post, at 9. Taken together, §271(f)(2) and §284 allow the patent owner to recover for lost foreign profits. Under §284, damages are “adequate” to compensate for infringement when they “plac[e] [the patent owner] in as good a position as he would have been in” if the patent had not been infringed. General Motors Corp., supra, at 655. Specifically, a patent owner is entitled to recover “‘the difference between [its] pecuniary condition after the infringement, and what [its] condition would have been if the infringement had not occurred.’” Aro Mfg. Co., supra, at 507. This recovery can include lost profits. See Yale Lock Mfg. Co. v. Sargent, 117 U. S. 536, 552–553 (1886). And, as we hold today, it can include lost foreign profits when the patent owner proves infringement under §271(f)(2).
The opinion is available, here.
Thursday, 21 June 2018
Senator Orrin Hatch has introduced legislation designed to curb the use of IPRs and PGRs against pharmaceutical and biologic patents by essentially denying the benefits to generic/biosimilar companies of the Hatch-Waxman Act and the Biologics Price Competition and Innovation Act. Allowing the usage of IPRs against pharmaceutical and biologic patents was a serious oversight in enacting the America Invents Act. Senator Hatch’s Office has released the following information concerning the new Hatch-Waxman Integrity Act of 2018 (which includes a section by section analysis):
In 2012, Congress enacted the America Invents Act to fix a problem unrelated to drug/biologic innovation and drug/biologic affordability; it created the inter partes review (“IPR”) and post-grant review (“PGR”) processes to combat the growing problem of patent trolls.
Even though Congress did not intend to upset its drug/biologic-specific Hatch-Waxman and BPCIA procedures with the enactment of the IPR and PGR processes, generic drug and biosimilars manufacturers have increasingly used the IPR process to circumvent the Hatch-Waxman Act and BPCIA patent challenge processes while nonetheless taking advantage of their abbreviated processes for drug entry.1 Moreover, hedge funds with no interest in manufacturing or marketing drugs have filed IPR challenges against drug patents with the goal of profiting from stock market declines triggered by the IPR filings—a type of market manipulation.
The Hatch-Waxman Integrity Act of 2018 would close the loophole unintentionally created by the America Invents Act. To restore the careful balance of the Hatch-Waxman Act and the BPCIA, and to prevent the IPR or PGR processes from undercutting them, the FD&C Act and the PHS Act would be amended to prevent using IPR (or PGR) challenges to circumvent the specific patent challenge processes for drugs and biologics painstakingly created by Congress. In addition, the federal securities rules would be clarified to indicate that filing IPR patent challenges and profiting from resulting stock price changes is a form of prohibited market manipulation.
The Press Release is available, here. The text of the proposed legislation is available, here. [Hat Tip to Professor Dennis Crouch’s Patently Obvious Blog]