It’s Apple Season: Federal Circuit Court Rules for Apple in Patent Dispute, Requiring Samsung to Change Some of Its Technology Features

September 24, 2015
Competition, Intellectual Property, Patents

Emily Harrison, MJLST Editor-in-Chief

This month, the United States Court of Appeals for the Federal Circuit gave Apple its latest victory against its biggest competitor, Samsung. In May 2014, the United States District Court for the Northern District of California denied Apple’s motion for a permanent injunction to bar Samsung from using software or code tending to infringe patented features in Apple’s products. However, on September 17, 2015, the court in Apple Inc. v. Samsung Electronics Co. Ltd., No. 2014-1802, 2015 WL 5449721 (Fed. Cir. Sept. 17, 2015), held that the lower court abused its discretion in failing to grant Apple the permanent injunction, and remanded the case to the lower court for reconsideration of the motion.

The current dispute between the competitors surrounds Apple’s patents covering its slide-to-unlock, autocorrect, and data detection features. The federal circuit notes that Apple has invested billions of dollars in introducing the iPhone. To decrease the risk associated with its large investments, Apple has applied for and received patents for much of the technology it has developed in the iPhone, including the features at issue. Furthermore, Apple filed a motion seeking permanent injunction that would bar Samsung from “making, using, selling, developing, advertising, or importing into the United States software or code capable of implementing the infringing features in its products.” The federal circuit found that Apple established a “causal nexus” between irreparable harm and Samsung’s infringement such that there was “some connection between infringing features and demand for competitor’s products,” Apple suffered irreparable harm, Apple lacked adequate remedy at law, and both the balance of hardships and public interest favored the injunction.

In determining the consequences of this decision, the court emphasizes the narrowness of this injunction: “This is not a case where the public would be deprived of Samsung’s product. Apple does not seek to enjoin the sale of lifesaving drugs, but to prevent Samsung from profiting from the unauthorized use of infringing features in its cellphones and tablets.” The court was also convinced that Samsung could remove the patented features without recalling products or disrupting customer use. Although the injunction is arguably narrow, the court’s decision may have a broad impact on product differentiation requirements with respect to complex technology. The federal circuit’s decision also signals a greater willingness to protect patent rights of inventors in the face of a key market rival.

An Injunction in the Des Moines Water Works Lawsuit Won’t Hurt Farmers, Here’s Why Not

September 15, 2015
Environmental Law, Food and Agriculture

James Meinert, MJLST Lead Managing Editor

Last spring, the public water utility for the Des Moines, Iowa metro area filed suit in federal court alleging that agricultural drainage districts are emitting nitrates to the Raccoon River in violation of the Clean Water Act (CWA). The utility’s remedy under the citizen suit provision of the CWA would be an injunction; and in the alternative, the utility’s associated common law claims could yield injunctive relief and damages (The utility’s private nuisance claim in particular seems likely to survive pre-trial dispositive motions, if not win outright at trial, as Iowa Code § 657.2(4) makes it a nuisance to “render[] unwholesome . . . the water of any river . . . to the injury or prejudice of others.”). Most commentators have focused on the novel CWA claim, that nitrate pollution flowing from tile drain outlets is point source pollution and thus subject to NPDES permitting just like a factory outfall. If successful, the CWA claim would categorize nitrate pollution from tile drains as a third type of flow off agricultural fields that is separate from otherwise exempt “agricultural stormwater” and “return flows from irrigated agriculture” (33 U.S.C. § 1362(14)).

The utility has been criticized by the Governor of Iowa, State senators, and farming associations, for not collaborating with the upstream farming communities, and for not waiting to see if they State’s two year old nutrient reduction strategy will lead to lower pollution over time. Is this a real dichotomy—suing versus working collaboratively?

The CWA has never had a strong regulatory regime for nonpoint source pollution. Section 303 says that “States shall” complete a number of planning activities: first, decide what uses each water should have (wildlife habitat, recreation, drinking water, etc.); then set water quality standards protective of those uses; then maintain lists of waters impaired under these standards; and finally calculate total maximum daily loads (TMDLs) the impaired waters could receive and still be clean enough for their use (33 U.S.C. § 1313(d)). There is no actual implementation or regulatory requirement for nonpoint sources. After the TMDL, there are federal grants to identify best management practices, and more grants for parties who volunteer to implement the identified activities. These are in addition to grant money farmers could receive from USDA to implement similar practices through EQIP or CRP contracts, but all of the implementation measures are voluntary.

Iowa has largely completed the planning steps, the Raccoon River has TMDLs for nitrates, and specifically tailored best management practices for the watershed, but traditionally Iowa has not spent its federal grants directly at pollution on farm fields, but rather on broader projects like a K-12 state-wide education program to foster a “culture of conservation,” or creating wetlands areas upstream of lakes to mitigating silting and nutrient-based algae blooms.

There is an entire sector of Iowa’s economy surrounding the study and development of agricultural practices, however, there has been little governmental urgency in directing resources towards implementation of agricultural conservation practices for water quality improvement. In 2010, Iowa voters approved a constitutional amendment to create a 3/8ths of one percent state sales tax to fund water quality initiatives and to protect natural areas. However, the State legislature has yet to collect any revenue through the tax. Iowa even has its own grant funding program to pay farmers to implement water quality practices under the nutrient reduction strategy. But Governor Branstad has vetoed attempts by the legislature to fund those programs, last year vetoing the $22.4 million the Iowa house and Iowa senate agreed to appropriate for water quality initiatives.

In the world of Clean Water Act regulation of nonpoint source pollution, a lawsuit is the only way to get everyone to the table to get something done. In the 1980s and 1990s, most states completely ignored the impaired waters lists and TMDL requirements until citizens filed lawsuits in 35 states arguing progress was so slow that States and EPA had violated duties under the act. In general, courts held a duty was breeched only if the States and EPA truly did nothing, a low standard to meet, but nonetheless, EPA settled most of the suits and entered court-administered consent decrees to promulgate tens of thousands of TMDLs across the country. In the DMWW suit, the utility asks the court to “frame an injunction that permits sufficient flexibility for the Drainage Districts to comply with the injunction without undertaking an unreasonable burden.” Under such a request, the parties would be negotiating a binding timeline for farmers to take advantage of otherwise voluntary measures. If Governor Branstand doesn’t veto the State legislature’s appropriation for water quality grants this coming year farmers could implement best practices on the taxpayer’s dime, something Iowa voters asked for years ago. The utility could try for specific requirements like that all landowners physically abutting the Raccoon River make every effort to enroll in state and federal grant programs to conserve land and improve water quality. But whether the requirements are buffer strips funded by USDA Conservation Reserve Program contracts, or best practices from Iowa’s nutrient reduction strategy, that’s for the utility and farmers to negotiate in settlement conference.

Fourth Circuit Revives Circuit Split Over Cell Site Data

September 15, 2015
Constitutional Law

Mickey Stevens, MJLST Note & Comment Editor

In August, the United States Court of Appeals for the Fourth Circuit revived the dispute over whether the use of historical cell site location data constitutes a “search” under the Fourth Amendment, and whether obtaining that cell site data requires a warrant. That court’s decision in United States v. Graham, Nos. 12-4659, 12-4825, 2015 WL 4637931 (4th Cir. 2015), now conflicts with the Third, Fifth, and Eleventh Circuits on how to treat the use of cell site data in criminal investigations.

A September 2014 MJLST blog post discussed the then-existing circuit split between the Eleventh Circuit holding that a warrant was required to obtain cell site data and the Fifth and Third Circuits holding that a warrant was not necessary to do so. Since the time of that post, the legal landscape regarding cell site data has undergone significant changes.

First, the Eleventh Circuit vacated their initial decision in United States v. Davis, 754 F.3d 1205 (11th Cir. 2014), and granted a rehearing. Upon rehearing, the Eleventh Circuit came to the exact opposite conclusion, holding that the government did not conduct a “search” by obtaining cell site data, and that no warrant was necessary even if that conduct did constitute a search. United States v. Davis, 785 F.3d 498 (11th Cir. 2015). The Eleventh Circuit’s decision upon rehearing agreed with previous decisions from the Third and Fifth Circuits and eliminated the circuit split that was created by the initial decision.

Then, the Fourth Circuit decided Graham. The Graham opinion closely mirrors the Eleventh Circuit’s initial Davis decision, holding that the government conducts a “search” when it obtains and inspects cell site data and that a warrant is necessary to obtain cell site data. The court reasoned that the third-party doctrine, which says that information provided to third-parties such as cell phone service providers is no longer protected by a reasonable expectation of privacy, should not be applied to cell site data because cell phone users do not voluntarily share their location. This is the same approach that the initial Davis court took, thus renewing the debate over how to apply this doctrine to modern cell site data.

In July, a petition for writ of certiorari was filed with the Supreme Court of the United States asking for review of the Eleventh Circuit’s rehearing decision in Davis. The Eleventh Circuit’s own flip-flopping on these issues, combined with Graham’s revival of a circuit split, provides good reason for the Supreme Court to resolve these open questions regarding the gathering and use of cell site data in criminal investigations.

The BPCIA Patent Dance: A Patent Law Cliffhanger

September 5, 2015
Intellectual Property, Patents

Will Orlady, MJLST Lead Articles Editor

In 2009, Congress enacted the Biologics Price Competition and Innovation Act (“BPCIA”), found at 42 U.S.C. § 262(k) and § 262(l). The BPCIA created an abbreviated pathway to FDA approval for biologic products that the agency found to be sufficiently similar to biologic products already approved for market sale (“biosimilars”). The BPCIA also created mechanisms for resolving patent disputes related to biosimilars. Colloquially known as the “patent dance,” the BPCIA’s patent dispute resolution mechanisms allows participants to go through a series of negotiations and disclosures—all in place to limit the complexity and cost of patent litigation. Parties complying with the “patent dance’s” requirements can enjoy safe harbor from costly patent litigation. The underlying policy of the BPCIA’s “patent dance” is to narrow the scope and reduce the costs associated with patent disputes.

Congress enacted the BPCIA. Time passed, and its “patent dance” flew under the radar—until this year. In 2014, Sandoz became the first company to file a Biologic License Application pursuant to the BPCIA’s abbreviated procedure. Despite availing itself of the BPCIA’s abbreviated approval procedures, Sandoz snubbed the “patent dance.” In its litigation against competitor Amgen, Sandoz argued that the BPCIA’s “patent dance” was not compulsory. The matter made its way to Judge Richard Seeborg in the Northern District of California. In a detailed opinion, Judge Seeborg outlined both Amgen’s and Sandoz’s positions and ultimately sided with Sandoz, ruling that the “patent dance” is optional (the abbreviated statutory biosimilar FDA approval scheme notwithstanding). The parties appealed the matter to the Federal Circuit. The Court heard the matter on June 3, 2015.

On July 21, 2015, the Federal Circuit handed down its decision in Amgen v. Sandoz, answering whether the BPCIA’s “patent dance” is compulsory for those manufacturers availing themselves of the BPCIA’s abbreviated FDA approval scheme. A fractured panel (led by J. Lourie) held that the “patent dance” is optional. Conceding that the statutory provisions involved are immensely complex, the Court stated that the provisions involved must be read in the context of the entire statute. The relevant provisions in light of the entire statute lead Judge Lourie to the conclusion that Congress intended the “patent dance” to be optional.

“We therefore conclude that, even though under paragraph (l)(2)(A), when read in isolation, a subsection (k) applicant would be required to disclose its aBLA and the manufacturing information to the RPS by the statutory deadline, we ultimately conclude that when a subsection (k) applicant fails the disclosure requirement, 42 U.S.C. § 262(l)(9)(C) and 35 U.S.C. § 271(e) expressly provide the only remedies as those being based on a claim of patent infringement. Because Sandoz took a path expressly contemplated by the BPCIA, it did not violate the BPCIA by not disclosing its aBLA and the manufacturing information by the statutory deadline.”

Judge Newman dissented on this point.

Though the Federal Circuit has answered whether the “patent dance” is compulsory for the time being, the parties have petitioned the court to hear the matter en banc. This is not surprising given the divided tone of the deciding panel’s opinion. Practitioners and scholars alike are now waiting to see whether the Court uses this matter to affirm or re-decide the “patent dance” question. Even if the Federal Circuit denies the en banc petition, a petition for certiorari would not be out of the question. The instant issue may just be juicy enough to grab SCOTUS’s attention.

Regulating the Sharing Economy: Fostering Innovation and Safety

September 5, 2015
Competition, Economy

Steven Groschen, MJLST Managing Editor

The sharing economy is a marketplace for individuals to exchange goods and services directly with one another. In the past, sharing economy participants, whom wished to lend their property and time directly to others, had the challenge of finding a way to connect with individuals seeking to borrow property and services. The internet and other modern communication systems have provided opportunities for overcoming this barrier. Consequently, the cost of matching a particular individual’s demand with another individual’s supply (i.e. transaction costs) within the sharing economy has been greatly reduced. As a result, sharing is quickly becoming a cost-effective and environmentally friendly option for ordinary consumers.

Not everyone is fond of the sharing economy movement. Long-established institutions and industries are experiencing increased competition by competitors whom are not always required to play by the same rules. For instance, the increasingly popular ride sharing system, Uber, has received scrutiny from players in the current taxi system. They argue that Uber is unfairly competing because it is not subject to the same regulations as traditional taxi drivers.

Regulators are challenged to find the optimal method of regulating the emerging sharing economy. Enacting regulations that are too strict will impede the innovation generated by sharing economy startup companies. On the other hand, regulations that are too lenient may threaten another core value: protecting the safety of consumers. Unregulated and non-centrally controlled systems of transportation run the risk of having a wide variance in outcomes. One Uber taxi driver may be perfectly safe, whereas another creates a hazard on the streets. Some are concerned there should be more government oversight and regulation addressing these risky drivers.

Professor Sofia Ranchordás suggests “establishing, broader, principle-based regulation[s]” is the answer to the legal problems created by the sharing economy. The use of principles rather than specific regulations acknowledges that technology is constantly changing. Broad regulations are designed to be more adaptable to changes in technology. As a result, this method of regulation protects two of the important goals of the sharing economy. First, bottom-up innovation is not stifled by rigid regulations that prohibit experimentation. Startup companies in the sharing economy are free to experiment so long as they stay within the boundaries of the broad principles. Second, there is more flexibility to create regulations addressing concerns for safety and general consumer protection. Regulators are not restricted to a narrow definition of what is “safe,” thus technology changes affecting safety are more easily managed.

Awaiting an Important Decision on the Gulf of New Mexico “Dead Zone” Lawsuit

September 5, 2015
Environment, Environmental Law, EPA

Allison Kvien, MJLST Managing Editor

In 2013, the U.S. Environmental Protection Agency was ordered to set limits on nitrogen and phosphorous levels in U.S. waterways. These nutrients contribute to the loss of oxygen and cause what is called hypoxia to occur in the water, killing marine life. This year, the “dead zone” in the Gulf is larger than Connecticut and Rhode Island combined. While this is larger than average, it is not a record. The oxygen levels are so low in this zone that it was reported that even starfish are suffocating.

An appeals court recently decided that the district court should determine, based on the Clean Water Act (CWA), whether the EPA gave adequate reasons for its refusal to set limits on the nutrients in U.S. waterways. Environmental groups, such as the NRDC, are optimistic that the original ruling requiring the EPA to set nutrient limits will be reaffirmed by the district court.

This CWA ruling is analogous to the 2007 Supreme Court Clean Air Act (CAA) case, Massachusetts v. EPA, which ruled that the EPA must have good reasons, based on the CAA, for refusing to regulate greenhouse gases (GHGs). The Supreme Court found that the EPA’s rationale for not regulating GHGs was inadequate and required the EPA to come back with a reasonable basis for not regulating GHGs in order to avoid being forced to regulate GHGs.

If the outcome of this CWA lawsuit is that the EPA is required to regulate nutrients causing the enormous hypoxia zone, the EPA will embark on a hugely collaborative journey to set appropriate limits for these nutrients all over the country. For instance, the NRDC reports that Chicago, over one thousand miles away from the Gulf, was found to be the single largest contributor to the “dead zone” in the Gulf.

Bitcoin Regulation: Lifeline or Kiss of Death?

August 24, 2015
Economics, Internet

Ethan Mobley, MJLST Articles Editor

Bitcoin’s ever-increasing popularity has sparked fierce debate over the extent to which the alternative currency should be regulated, if at all. Bitcoin, a “cryptocurrency,” is the leading digital currency used today. The cryptocurrency can be used to buy and sell goods online or in traditional brick-and-mortar stores but is also used for speculative currency trading. As Bitcoin is adopted by more and more users, numerous businesses have sprouted geared toward facilitating Bitcoin transactions. One such company is Coinbase, which serves as a currency exchange allowing users to buy and sell Bitcoin (XBT) for USD and other currencies. Coinbase also acts as a “wallet” for Bitcoin, allowing users purchase Bitcoin at the market exchange rate, store that Bitcoin on their phone, and then pay for items using their phone’s “wallet.”

Bitcoin proponents claim the cryptocurrency is superior to traditional fiat for several reasons: 1) Bitcoin supply is self-regulating, and hence not susceptible to changes in government policy; 2) Bitcoin eliminates transaction costs between the buyer and seller of goods, which is especially helpful for small merchants; and 3) buyers using Bitcoin are not vulnerable to identity theft if the merchant incurs a security breach. Bitcoin opponents argue the cryptocurrency is problematic because it can be used for illicit purposes (e.g. transactions on Silk Road) while protecting its users due to relative transaction anonymity. Whatever the advantages and disadvantages, Bitcoin’s success is ultimately dependent upon wide-spread use by buyers and sellers and government regulation that permits free-use of the currency.

Recently, California legislators introduced a bill to regulate digital currencies. California isn’t the first state to consider such legislation, but it is arguably the most important considering California is home to more Bitcoin users than any other US state. Specifically, California AB-1326 would establish a regulatory framework for entities engaged in the “virtual currency business,” which would impose licensure and fee requirements on those entities. As defined, a “virtual currency business” is one that maintains “full custody or control of virtual currency in this state on behalf of others.” Specifically excluded from the bill are entities primarily engaged in buying and selling goods or services. Thus AB-1236 would not impose any burden on retailers–only quasi-banking entities like Coinbase would be subject to the regulation. Such regulation would ideally reduce Bitcoin market risk and volatility, thereby making the cryptocurrency a more viable alternative to traditional fiat. Nevertheless, Bitcoin advocacy groups disagree over whether the bill will ultimately encourage or inhibit widespread adoption of Bitcoin. After all, Bitcoin’s government-independence is one of its most beloved features. Agree or disagree with policies advanced by AB-1236, but one thing is clear—Bitcoin’s ubiquitous influence makes widespread regulation inevitable, and early legislation such as AB-1236 will serve as a model for other states to follow.

Popular Perceptions May Hold Automated Vehicles Back

April 25, 2015
Uncategorized

Alex Vilisides, MJLST Symposium Editor

Last October, when the Minnesota Journal of Law, Science and Technology (MJLST) co-sponsored a symposium entitled “Automated Vehicles: The Legal and Policy Road Ahead,” experts from a broad range of areas came together to discuss the challenges of self-driving cars. There was excitement that the technology was closer than ever, but also sober discussions of the many legal, ethical, and practical challenges that lay ahead. Recent media reaction to a new academic study emphasizes a very basic challenge: autonomous cars must overcome the challenge of being weird.

On April 9, 2015, University of Michigan announced in a press release the findings of a new study concluding that use of automated vehicles could increase the incidence of motion sickness. The study asked 3,200 adults what activities they would do in a car that drove itself. From the responses, such as reading, texting or watching television, the study concluded that “6-12 percent of Americans adults riding in fully self-driving vehicles” could expect to “suffer moderate or severe motion sickness.” Of course, the “frequency and severity of motion sickness is influenced” not by the inherent nature of an automated vehicle, but “by the activity that one would be involved in instead of driving.”

Outlets from NBC News to Popular Mechanics to The Guardian picked up the story. “Self-Driving Cars Might Make You Vomit,” declared a headline about the study on the Huffington Post. The cost-benefit imbalance is staggering. If people are able to implement technology that may be capable of making travel safer, cheaper, more accessible and less destructive to our environment it may come at a cost. That cost, these articles point out, is that if people choose to read or watch television in a self-driving car, some fraction of the population may be at greater risk to experience motion sickness. Despite this stark contrast, the dominant media narrative is served by focusing more on the weird, uncomfortable experience of riding in a self-driving car.

It is unlikely that any of the extraordinary articles published in MJLST’s upcoming symposium issue, focusing on automated vehicles, will receive this type of media attention. This is because an article about these vehicles making people vomit fits the dominant narrative: automated vehicles are weird. They a strange new technology and a harbinger of the robot-controlled dystopian future. Information that fits this narrative is far more affecting for an average reader than a rational cost-benefit analysis. And this weirdness has consequences. If the benefits are as great as advocates claim, the delay in adoption caused by social pressures and popularity has real consequences. The adoption of mass technologies is not pre-ordained. The weirdness battle is one that advocates of automated cars must fight if society is going to adopt this potentially transcendent technology.

USDA Heightened Country of Origin Labelling Laws: Good Start, Can Be Tightened

April 25, 2015
FDA, Food and Agriculture

Vinita Banthia, MJLST Staff Member

The Country of Origin Labeling (COOL) laws have long been debated and amended in the Unites States. COOL regulation dictates the degree to which a product’s label must indicate which countries were involved in the production of the product. Currently, a product’s countries of origin must be labelled for the all of its ingredients, with the exception of where the product has been processed. These standards apply to food such as meat that had been born and raised in the United States but contains elements that have been produced in other countries like China. Hence, all raw foods and its ingredients must be labelled, including “raw muscle cuts, ground commingled meat, or live imported animals are not excluded.”

However, if meat has been born and raised in the United States, and then shipped to China for processing, then shipped back to the United States for consumption, it does not need to be labelled as being processed in China. Except for locations of processing, meat must be labelled for the countries where the animal lived during its life, and where it was subsequently “raised, slaughtered, butchered, and prepared for sale.” These laws have become increasingly strict since changes in the U.S. Department of Agriculture (USDA) consumer information policies in 2009 and 2013.

The recent Note, Country of Origin Labeling Revisited: Processed Chicken from China and the USDA Processed Foods Exception published in the Minnesota Journal of Law, Science, and Technology, by Daniel Schueppert highlights the stringent COOL requirements for raw and live foods. The Note discusses the recent change in the USDA funding and regulation policies that allowed the United States to export chicken to China for processing, and then import it back in to the US for commercialization without labelling the meat’s journey. The agricultural industry and grocery stores have been largely opposed to the laws as requiring excessive labelling for non-processed meats. Canada and Mexico have challenged the U.S. COOL laws at the WTO, stating that the COOL requirements for non-processed meat are overly burdensome on Canadian and Mexican beef exporters, thereby creating an unfair advantage for U.S. domestic beef. In October 2014, the WTO ruled in favor of Canada and Mexico. Canada has threatened retaliatory actions if the U.S. does not relax its COOL laws.

In contrast, Schueppert argues that some, limited COOL standards should also be applied to meat processed in China. This position supports greater restrictions not only for non-processed and raw foods, but also for processed meats. In addition, Schueppert argues that the current definition of processed foods is too broad and over-inclusive, leading to potential safety concerns in non-processed products. This argument holds more ground that the views of industries and countries unwilling to invest greater resources in ensuring the safety and disclosure of products. The USDA should continue to take measures to ensure that meat products are increasingly safe and well-labelled for consumers.

The FDA’s Role in Innovative Change

April 11, 2015
Administrative Law, FDA

Paul Overbee, Articles Editor

In Volume Six, Issue Two of the Minnesota Journal of Law, Science and Technology, Susan B. Foote and Robert Berlin penned a piece titled “Can Regulation be as Innovative as Science and Technology? The FDA’s Regulation of Combination Products.” Published in 2005, this piece set out to explore whether an agency as slow as the FDA could keep pace with ongoing technological innovations and respond in an appropriate and timely manner. Ultimately the authors concluded that the FDA is an agency that progresses in an iterative and incremental manner, and that both politics and administrative law were likely to prevent the FDA from being a force for innovation. The authors tried to justify the potential block to innovation by arguing that innovators and manufacturers benefit from the predictability and certainty and that a slow regulatory is the essential cost of these benefits. As such, the authors offered that regulation would come after innovations occurred rather than predicting upcoming innovation and issuing preliminary regulation.

Since the time of the author’s predictions, they have been proven correct in many ways. For instance, nanotechnology is an emerging technology with many predicting how it will be implemented in the future, and it has already has appeared in products such as sunscreens and spray paints. Despite its current presence in society, the FDA has failed to issue a formal definition of what nanotechnology is and what it is not. As such the predictability and certainty that is desired by innovators is lacking. One of the most recent developments that continue to show that the FDA is ill-equipped to deal with fast paced innovation is their recent draft guidance on combination products. A full 10 years after Foote and Berlin criticized the FDA’s ability to act swiftly, the FDA has finally issued a draft guidance to clarify and explain the current good manufacturing practices for combination products. This guidance has been made available by the FDA

The FDA defines a combination product as any combination of a drug, device, or biological products, taken individually as constituent parts of the combination product. Additionally, a combination may be two or more separate products that have been packaged together in a single package such as pre-filled syringes. The new FDA guidance gives multiple options for combination products to meet current good manufacturing practices. First, the producer may demonstrate compliance under the current drug manufacturing practices or by meeting qualify system regulations; this option is available where the combination is both a drug and device. The other option is that the manufacturer may demonstrate compliance will all good manufacturing practices that are applicable to each constituent part that makes up the whole combination product.

Both Berlin and Foote justified the slow moving nature of the FDA by stating that it may provide the type of predictability and certainty that is desired by innovators. Since that date, actions by the FDA have put that predictability and certainty in question. Instead of having a clear practice in place, the FDA may leave manufacturers guessing for years before the agency comments on their appropriateness. Berlin and Foote both agreed that perhaps the FDA wasn’t properly tooled to deal with ongoing innovation, but ongoing developments continue to drive that point home.

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