FDA Lawyers Blog

by: Howard Rosenberg. Ph.D.

The FDA recently released a report on the 'Pathway to Global Product Safety and Quality', it highlights yet again its problems in safeguarding America's food and medical products particularly in reference to imported goods. The concern for pharmaceuticals imported from facilities which, in the main, have not been inspected by FDA staff is a key part of U.S. Sen. Sherrod Brown's (D-OH) letter to the FDA. Senator Brown is a leading voice on the need to protect Americans from unsafe food and drug products. In 2008, he introduced the Transparency in Drug Labeling Act (S. 3633), which would require country-of-origin labeling for both active and inactive ingredients on all pharmaceuticals.

FDA Pathway to Global Product Safety and Quality

This new FDA document discusses the difficulties it faces especially in resolving such safety problems on its own. The report is a follow up to last September's GAO reports, GAO-10-961 and GAO-10-960, which pointed out the need for better long term planning to ensure import safety and improving knowledge about foreign manufacture and the number of foreign inspections.

The FDA states its " new approach rests on four core building blocks:

1. FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.
2. With these coalitions, FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.
3. FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.
4. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

by Erin A. Lawrence

On June 15, the House of Representatives approved an Amendment to the agricultural appropriations bill that stated that none of the funds made available to FDA can be used for approval of genetically-engineered salmon. The Bill was co-sponsored by Lynn Woolsey (D-Calif.) and Don Young (R-Alaska).

The genetically altered salmon, dubbed "frankenfish" by its critics, was created by the Massachusetts company, AquaBounty in 1989. The salmon grows twice as fast and eats less than natural salmon. The increased growth is due to an added growth hormone that is found in a Chinook salmon which allows fish to produce their own growth hormone all year long. In other words, it acts as an on switch for the salmon's growth hormone. The growth hormones in natural salmon are only active for part of the year, hence their smaller size.

FDA is set to decide this year whether to approve the modified fish to be on consumers' dinner tables. Last September, FDA held a public meeting to discuss the issues potentially related to genetically-altered salmon (see our earlier blog). FDA concluded that the genetically-altered salmon was likely as safe as conventional salmon, but more studies were needed for a final decision. If the genetically-altered salmon is approved it would be the first time the government allowed such modified animals to be marketed for human consumption. FDA is also considering whether the fish needs to be labeled as genetically altered or not.

This Amendment would prohibit FDA from spending any money to approve the genetically-altered salmon. The House approved the Amendment based on concerns such as competition with wild salmon, adverse reaction to wild salmon that would decimate the natural population, unknown human allergies, etc. The Amendment is also supported by natural salmon farmers and Trout Unlimited, a group focused on conserving and protecting coldwater fisheries and their watersheds.

by Andrew S. Wasson

The Supreme Court granted Caraco's petition for a writ of certiorari to hear its appeal from the Federal Circuit's decision in Novo Nordisk A/S v. Caraco Pharm. Labs., Ltd., 615 F.3d 1374 (Fed. Cir. 2010). This case has been closely-watched by generic and brand-name companies alike. In March, the Supreme Court asked for the Solicitor General's view on whether it should take the case. The Solicitor General recommended that the Supreme Court grant Caraco's petition. The Solicitor General also took the position that the Federal Circuit's decision in April 2010 was incorrect. The Supreme Court's recent action makes sense looking back on the contentious and fractured opinions of the last year. For this blogger, the Supreme Court's action guarantees a steady stream of topics for the rest of the year.

We have been following this case closely, but for those of you still unfamiliar with the case, in Novo Nordisk, the Federal Circuit determined that Caraco could not compel Novo Nordisk to revert a patent use code narrative to its original form. The Federal Circuit's determination hinged on the statutory interpretation of 21 U.S.C. § 355(j)(5)(C)(ii), added to Hatch-Waxman Amendments in 2003, and authorizing a generic applicant to file a counterclaim to correct or delete patent information in certain situations. 21 U.S.C. § 355(j)(5)(C)(ii) provides in relevant part:

(ii) Counterclaim to infringement action.-- (I) In general.-- If an owner of the patent or the holder of the approved application under subsection (b) of this section for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) of this section on the ground that the patent does not claim either--

(aa) the drug for which the application was approved; or

(bb) an approved method of using the drug.

by Rachael P. McClure

On June 23, the Supreme Court ruled that generic drug manufacturers cannot be sued for failing to warn patients of adverse side effects of their products when the warning was not present in the referenced product's labeling. In a narrow 5-4 decision, the Court concluded that federal law, mandating that generic drugs carry label information identical to their brand-name counterparts, preempts "failure-to-warn" claims filed under state product liability law. We previously reported on generic drug preemption issues most recently here.

Thursday's ruling concluded a case in which two women alleged that their use of metoclopramide, the generic version of Reglan®, resulted in development of a serious neurological disorder known as tardive dyskinesia. The women sued generic drug manufacturers, including Pliva, under Louisiana and Minnesota state tort law for failing to include warnings about the potential effects from extended use of metoclopramide. Justice Clarence Thomas, writing for the majority, observed that the relevant state laws, requiring drug manufacturers to update product labels as they discover new risks of harm,"imposed a duty on the manufacturers to take a certain action, and federal law barred them from taking that action."

The practical result of this decision is that a brand-name company can be held liable for consumer harm resulting from deficient label warnings, while the exact same suit is barred as against a generic producer. Indeed, in 2009, the Court upheld a $6.75 million jury verdict against brand-name pharmaceutical firm Wyeth for a nearly identical cause of action. The difference, in the words of Justice Thomas, is that Wyeth was allowed "of its own volition to strengthen its label in compliance with its state tort duty."

Thomas noted that the suit would have been allowed had the women "taken Reglan, the brand-name drug prescribed by their doctors." Justice Sotomayor, joined in dissent by the more liberal fraction of the Court, countered that the majority dictates that a patient's ability to obtain relief will now be controlled by "the happenstance of whether her pharmacist filled her prescription with a brand-name or generic drug." Sotomayor further argued that a generic company has a duty to propose necessary label changes to the FDA, which can in turn call on the brand-name to update its label such that the generic can comply with both state and federal law.

This decision is a significant victory for generic drug companies, whose products account for seventy-five percent of prescriptions dispensed in the United States. They are now shielded from liability for failure to warn as long as their labels match those of corresponding brand-name drugs. John LaRocca, Vice President and chief legal officer of generic drug company Actavis, approved of the ruling as "accurately reflect[ing] the difficulties generic manufacturers faced in trying to comply with federal and state laws." The Pink Sheet (June 23, 2011). It may, on the other hand, result in more patients requesting that their prescriptions be filled with brand-name products.

Given the Court's admission that the discrepancy between generic and brand-name producers "makes little sense," and remark that Congress and FDA "retain the authority to change the law . . . if they so desire," generics should be on the look out for future regulatory change.

Frommer Lawrence & Haug LLP ("FLH") will attend the Biotechnology Industry Organization's ("BIO's") International Convention this year, to be held in Washington, D.C on June 27-30. Come visit FLH at Booth 2857, where FLH will feature information about Life Sciences at FLH, including a number of articles and presentations on biotechnology authored or presented by FLH and will answer questions of fellow participants and exhibitors about FLH, its Life Sciences practices, and its thoughts about biotechnology.

FLH's team at BIO 2011 includes FLH Partners Sandra Kuzmich, Charles Raubicheck, Brian J. Malkin, Elizabeth Leff, Associates Kathleen Ehrhard, Shelly Fujikawa, Brian McGuire, Ami Simunovich, and Scientific Advisors Ali Berkin, Russell Garman, and Blaine Hackman.

by Andrew M. Nason

On June 23, the United States House of Representatives voted 304-117 to pass H.R. 1249, their version of the "America Invents Act." As reported here, the Senate passed its own version by an even more lopsided margin of 95-5 in March. A House and Senate conference committee must now reconcile the two versions of the Bill before it heads to President Barack Obama's desk for his signature. Despite strong support for the Bill in both chambers and Obama's statements that he intends to sign what Congress puts before him, lawmakers could face significant hurdles in their reconciliation efforts.

While the two versions of the Bill are nearly identical in many respects, most notably the change from the current "first inventor" system to a "first-inventor-to-file" system, they still differ in key ways that could hamper the Bill's progress. For instance, while both versions allow the U.S. Patent and Trademark Office ("Patent Office") to set and collect its own fees, the House version would require that a certain dollar amount be appropriated to the Patent Office, and Congress would decide annually whether any fees collected would go to the Patent Office. The Senate version would simply let the Patent Office keep all the fees it collects. Critics of the House compromise on the Patent Office funding provisions note that it does not differ significantly from the current system, which they claim has led to the backlog of 1.2 million patent applications and associated three-year average pendency period for granted patents.

Congress has not set a timetable on when the bicameral conference will take place. With an important and contentious debt-ceiling debate ongoing, they will likely delay the reconciliation conference. Even so, supporters of the patent reform legislation are encouraged. "The effort to reform our nation's patent laws began a decade ago, and House passage . . . brings patent reform a significant step closer to becoming law," said David Kappos, Patent Office Director, in a written statement issued Thursday. "This bi-partisan legislation will transform our patent system, enhance our nation's competitiveness and promote economic growth and job creation."

If passed into law, the legislation would represent the first significant change to the U.S. patent system in almost 60 years.

by Leann M. Clymer

Earlier this week, the Boston Biotech Conference ("BBC") group held its chief executive officer ("CEO") conference, bringing together senior executives from both the biotech and pharmaceutical industries, in advance of next week's Biotechnology Industry Organization ("BIO") Convention in Washington, D.C. Representatives from Cubist, Genzyme, Allergan, Biogen, Targacept, and GlaxoSmithKline, among others, served as speakers and co-hosts at the BBC CEO Conference.

Also in attendance at this week's CEO Conference was Jim Greenwood, the BIO CEO, who presented an Introduction to the Role of Biotech in Drug Discovery and Development to the conference attendees. Greenwood also provided some insight on what BIO hopes to achieve during next week's international convention in the District of Columbia, June 27-30, at the Walter E. Washington Convention Center. He stated: "We want to change the formal legal mission statement of the FDA" to one that would place a greater focus on minimizing the time it takes to approve a new drug product. Specifically, BIO's CEO noted that the industry understands that FDA has failed when they approve a new product that is neither safe nor effective, but took issue with the fact that it is not considered an Agency failure when patients die because availability of a new therapy was delayed due to a slow approval process.

Senator Scott Brown (R-MA) provided a welcome and the opening remarks at this week's BBC CEO Convention. Sen. Brown was more verbose in his criticism of FDA's slow response to approve applications to market new drugs and medical devices in U.S., claiming that the Agency is "crushing businesses" in Massachusetts that seek to sell new and lifesaving technologies. Brown said FDA's slow response to approve new therapies, created by the "most innovative, intelligent workforce potential in the world," was "putting a wet-blanket" on the discovery and development of new drugs and medical devices. Furthermore, Sen. Brown proclaimed that "we're losing out to a lot of what's happening overseas" because FDA's slow response wastes money, time, and innovation.

FLH BIO 2011 Brochure

FLH Partners Sandra Kuzmich, Charles Raubicheck, Brian J. Malkin, Elizabeth Leff, Associates Kathleen Ehrhard, Shelly Fujikawa, Brian McGuire, Ami Simunovich, and Scientific Advisors Ali Berkin, Russell Garman, and Blaine Hackman will join the world's leading biotechnology companies at the Annual BIO International Convention this year, to be held in Washington, D.C. from June 27-30. The FLH team will be located at Booth 2857, where they will feature information about Life Sciences at FLH, including a number of articles and presentations on biotechnology authored by FLH and will answer questions of fellow participants and exhibitors.

by Andrew M. Nason

On June 20, the Intellectual Property Owners Association ("IPO") reported that the House has scheduled floor debate of its version of the "America Invents Act" (H.R. 1249) for "Wednesday or later in the week." The House Rules Committee delayed its meeting to discuss the parameters of the debate, originally scheduled for sometime last week, until 5:00 pm on June 21. The Committee delayed its meeting because of a now-resolved disagreement between some House members over the U.S. Patent and Trademark Office's ("Patent Office's" or "USPTO's") funding provisions of H.R. 1249. Specifically, Speaker John Boehner (R-OH) and several House Appropriations Committee chairmen agreed to amend the provisions of the Bill intended to end fee-diversion (section 22). With the amendments, the Bill's fee provisions essentially track current 35 U.S.C. § 42(b) and (c), which diverts fees the Patent Office receives in excess of their annual appropriation to a reserve fund. The inclusion of this amendment has cast doubt on whether patent reform can pass this year, and indeed has caused some groups to withdraw their support of the Bill's passage.

On July 20, the Innovation Alliance, a group representing innovators, patent owners, and stakeholders from various industries, issued a short statement, noting its disappointment with the removal of language to end fee diversion permanently. The group said the new language in the Bill "amounts to a promise to end fee diversion in the future, a promise that has repeatedly been broken in the past." The Innovation Alliance also noted its concern that "the USPTO will continue to earn . . . more fees than the funds it is allocated, and Congress will continue to impose the tax on innovation that fee diversion represents." With the removal of the anti-fee diversion provisions, the group said it had "no choice but to vigorously oppose" the Bill.

Similarly, the American Bar Association ("ABA") sent a letter to House Judiciary Chairman Lamar Smith (R-TX) stating its opinion that the end of fee diversion is an "indispensible component of any patent reform measure." The ABA called the provision "essential for the [Patent Office] to conduct effective and efficient financial planning and business operations." The National Association of REALTORS ("NAR") also sent a letter to House members indicating that its support for H.R. 1249 depends on the retention of anti-fee diversion provisions in the Bill. Without the funding provisions in place, the NAR expects that "delays in processing patent applications will continue to undermine American innovation and stymie the nation's economy."

The amendment and ensuing debate followed a letter on June 13 in which Representatives Joe Donnelly (D-IN) and Dan Boren (D-OK) urged their colleagues to support passage of the bill. In their letter--discussed in more detail here--Donnelly and Boren noted that the current backlog of over 700,000 patent applications is largely due to a lack of adequate resources and funding. The Representatives quoted estimates that "the U.S. could create as many as 2.25 million new jobs, over the next 3 years, simply by eliminating the patent backlog." Eliminating the backlog, however, would require adequate funding, which the now-stripped anti-fee diversion provisions would have provided.

by Rachael McClure

On June 13, Joe Donnelly (D-Ind.) and Dan Boren (D-Okla.) circulated an open letter to their colleagues in the House advocating passage of the America Invents Act (H.R. 1249). The Bill was introduced in the House on March 30 after the Senate version passed by an overwhelming majority of 95 to 5. In mid-April, it cleared the House Judiciary Committee by a 32-3 vote. The Bill is scheduled for debate on the House floor sometime this week.

The Act alters the current patent system's approach to priority of inventorship and effective filing date. Specifically, it awards a patent to the first person to file a patent application on an invention with the U.S. Patent and Trademark Office ("USPTO"), instead of the first person to invent. It also has provisions that allow for increased public feedback on patent applications, modify the rules for challenging patents and awarding damages for infringement, and ensure that the patent office can retain application fees for its own use.

Donnelly and Boren argue that the proposed changes will effectuate "a more reliable and efficient patent system" that will "encourage the development of new technologies that will create jobs across the country, grow businesses and help us better compete in the global economy." They criticize the current "first to invent" system as "cumbersome and inefficient" and commend the change to 'first to file' as an avenue to easier obtainment of patents by independent innovators as well as businesses. In addition, the Congressmen cite the USPTO's current backlog of over 700,000 patent applications as the result of insufficient funding, to which the provisions regarding diversion of application fees are directed.

On June 13 in a separate letter, twenty law professors wrote to Rep. Lamar Smith (Rep.-TX), sponsor of H.R. 1249 and chairman of the Judiciary panel, defending the bill against claims that the 'first-to-file' provision violates Article I, Section 8, Clause 8 (the IP clause) of the Constitution. Parties asserting such claims argue that only the first person to actually invent something can constitutionally qualify as an "inventor" and thus be granted patent rights. The professors counter that the IP clause is not limited to first inventors and "Congress has discretion in defining the term 'inventor' and is able to specify conditions that true inventors must satisfy in order to be awarded a patent." The letter further approves the Act as worthy of "Congress' attention and debate."

If approved in the House, the America Invents Act will soon become law. Following Senate approval, President Obama praised the Act as "the most significant patent reform in over half a century." The President continued, "I look forward to working with the House of Representatives to pass patent reform legislation I can sign into law."

H.R. 1249 has also received strong support from members of the biopharmaceutical industry, including Proctor & Gamble, Eli Lilly, and the Pharmaceutical Research & Manufacturers of America. Susan Kling Finston, CEO of Amrita Therapeutics Ltd., sees the bill as an important stepping stone to shift from "a litigation culture to an innovation culture." She contends that the bill "will help to level the playing field for small- and medium-sized biotechnology companies with limited resources to cross the 'valley of death' that stands between invention and FDA approval of a new therapy or medical device."

by Michael W. Harkness

The first major change to FDA's food safety procedures since 1938 was dealt a blow last Thursday, as a majority of House Republicans voted to cut over $200 million from FDA's food safety budget for the 2012 fiscal year. The House also voted to cut FDA's overall discretionary funding for fiscal year 2012 as well, by $284 million, or 11.5 percent. No Democrats voted in favor of the reduced appropriations bill, and nineteen Republicans joined the Democrats in opposing the legislation.

The deep cuts in FDA's budget leaves the Food Safety Modernization Act -- passed with bipartisan support last December -- without adequate funding to implement FDA reforms called for in the bill. The cuts also come in the wake of an E. coli outbreak in Germany that has left 25 dead and over 2,500 sick.

The White House released a letter to Rep. Mike Rogers (R-KY), chairman of the House Appropriations Committee, objecting to the budget cuts, saying that the cuts will result in staff reductions and "severely limit the FDA's ability to protect the public's health, assure the American consumer that food and medical products are safe, and improve American's access to safe and less costly generic drugs and biologics."

Congressman John Dingell (D-MI) introduced an amendment afterwards to restore the full amount of funding requested by FDA, but the amendment was voted down by a vote of 178-241. Rep. Dingell said later, "FDA has the responsibility and tools to prevent and detect food-borne illnesses without the money to back it up. The audacity and arrogance to play political games with the safety of our food is sickening."

House Republicans defended the cuts, with Rep. Jack Kingston (R-GA), chairman of the subcommittee that oversees FDA, arguing that the nation's food supply was "99.99 percent safe." Rep. Kingston reasoned that the private sector keeps the American food supply very safe because "they don't want to be sued, they don't want to go broke. They want their customers to be healthy and happy."

The Food Safety Modernization Act called for a $955 million food safety budget for FDA. The House voted to cut the budget to $750 million, a 21 percent reduction. However, the controversy over FDA's funding may be unnecessary, as the Senate has the power and the Democratic majority to restore FDA's funding and pass an amended bill in the upcoming weeks.

FLH Partner Brian J. Malkin will attend the Drug Information Association's ("DIA's") 47th Annual Meeting in Chicao, IL from June 20-23, 2011. DIA's Annual Meetings are considered one of the pharmaceutical industry's premier events for education and networking. More information about the conference may be found here.

by Erin A. Lawrence

After 33 years of consideration, FDA finally plans to reduce consumer confusion related to the ample types of sunscreens available on the market. On Tuesday, June 14, FDA published new guidance that will specify which lotions provide the best protection against the sun.

The new rules require sunscreens that claim protection against skin cancer to prove that they filter out UVB and UVA rays. Currently, FDA only requires testing for UVB rays--the ultraviolet rays responsible for sunburn and cancer. UVA rays are responsible for wrinkles and cancer.

Next summer, sunscreens that do not protect against UVA and UVB rays or if they are below a protection factor of 15 are required to carry the warning: "This product has been shown only to help prevent sunburn, not skin cancer or early skin aging." Consumers should be on the look out for sunscreens that state protection against a "broad spectrum." By next summer, this will mean that the lotion does an acceptable job at protecting against UVA and UVB rays. Lotions that protect against "broad spectrum" and are above SPF 15 will be allowed to state that they reduce the risks of cancer and signs of early aging if used as directed.

The new rules also propose several other changes. Sunscreen marketing claims like "waterproof" or "sweat proof" are prohibited, as the agency believes that these "are exaggerations of performance." The new rules required that a lotion past a water resistance test to maintain a water claim on their label. Additionally, FDA also proposes capping the highest SPF value at 50, unless the company can provide results of testing to support better protection. FDA reasoned that there is currently no data that shows that SPF above 50 adds any value. SPF stands for sun protection factor. The SPF number relates to protection against UVB rays.

All in all, consumers will have a much easier time deciding what lotion will keep their skin safe and healthy next summer. The must only look for sunscreen that claims "broad spectrum" and then the SPF that is over 15 of their choice.

by Erin A. Lawrence

On June 9, FDA issued a draft guidance titled, "Considering Whether an FDA-Regulated Product Involves the Application of Nanotechnology." Nanotechnology is the science of particles that are less than 100nm in size. Nanomaterials can have different chemical, physical, or biological properties than conventionally-manufactured products. FDA acknowledges the need to learn more about the potential role and importance of dimensions in the characteristics exhibited by engineered nanomaterials. The guidance is FDA's current thinking on whether FDA-regulated products contain nanomaterials or otherwise involve nanotechnology.

FDA will determine whether a product contains nanomaterials by considering whether the engineered material or final product has at least one dimension in the nanoscale range and whether the product contains physical or chemical properties that are attributable to its dimensions. These considerations apply to new products and when manufacturing changes alter the dimensions, properties, or effects of an FDA regulated product or any of its components.

FDA has yet to establish regulatory definitions of "nanotechnology," "nanoscale" or related terms. Currently, FDA addresses nanomaterials on a case-by-case basis using existing review processes. The National Nanotechnology Initiative Program defines nanotechnology as the "understanding and control of matter at dimensions between approximately 1 and 100 nanometers, where unique phenomena enable novel applications."

Nanotechnology has various potential applications. It can increase the bioavailability, decrease dosage, increase potency, and/or decrease toxicity of drugs. Additionally, nanotechnology can lead to better detection of pathogens, improve food packaging, and can be used cosmetics.

On June 20-23 Frommer Lawrence & Haug LLP Partner Brian J. Malkin will be attending the Drug Information Association's ("DIA's") 47th Annual Meeting in Chicago. This year's meeting features the theme "Convergence"--the convergence of science, medicine, and health; of scientific and operating functions and technology solutions; of internal and contract service personal; of research professionals, health care providers, patients, and the public.

DIA 2011 features a rich opportunity for education and networking opportunities to share information, collaborate, and build new relationships. Speakers from a wide range of stakeholder groups from around the world including industry, government, academia, associations, foundations, and patient organizations will lead tutorials, sessions, forums, workshops, and symposia on a variety of topics related to the discovery, development, and life cycle management of pharmaceuticals, biopharmaceuticals, medical devices, and other health treatments. DIA 2011 features as its keynote speaker David D. Ho, M.D., Founding Scientific Director and Chief Executive Officer of the Aaron Diamond AIDS Research Center, Irene Diamond Professor at The Rockefeller University. Dr. Ho has been at the forefront of AIDS research for 29 years.

If you are interested in meeting with Mr. Malkin at DIA 2011, please send him an e-mail at bmalkin@flhlaw.com. Mr. Malkin looks forward to the educational and networking opportunities and hopes to see you there!

by Erin A. Lawrence

On June 8, 2011, FDA announced a new guidance for industry entitled "Citizen Petitions and Petitions for Stay of Action Subject to Section 505(q) of the Federal Food, Drug, and Cosmetic Act". The draft guidance issued in January 2009 and clarifies verification requirements in final citizen petitions. The guidance provides FDA's current thinking on interpreting Section 914 of Title IX of the Food and Drug Administration Amendments Act ("FDAAA") which was enacted on September 27, 2007. Section 914 of Title IX of the adds new Section 505(q) which governs prevention of the citizen petition process from being used to delay approval of ANDAs and 505(b)(2) new drug applications ("NDAs"). The guidance contains recommendations, not legally enforceable responsibilities.

Section 505(q) provides that FDA must not stay approval unless it "determines, upon reviewing the petition, that a delay is necessary to protect the public health." A delay is caused if the petition would be ready for approval "but for" the issues raised in the petition. If FDA determines that a delay is necessary, FDA is required to provide the applicant notification that a determination has been made, any additional information or clarification, and a brief summary of the specific substantive issues within 30 days. Section 505(q)(1)(E) describes the factors that will be used to determine whether a petition is submitted with the primary purpose of delaying the approval of an application.

FDA also stated that, under Section 505(q), FDA may not consider a petition for review unless the petition is in writing, signed and contains a certification that is specified in that section. The petition must be self-encompassing and cannot incorporate by reference information that is not included in the petition. All information must be submitted in full. Additionally, FDA must take action on a petition not later than 180 days after submission. This time period cannot be extended for any reason.

Section 505(q) does not apply to all petitions. Petitions relating to timing of approval (the 180-day exclusivity) and petitions that are submitted by a sponsor to have FDA take or refrain from taking action with respect to that application. Section 505(q) only applies to petitions that are submitted on or after September 27, 2007, submitted in writing, and ANDA or Section 505(b)(2) NDA is pending at the time the petition is submitted, petitioner requests an action that could delay approval, and does not fall within any exceptions. If a petition is submitted, and there is no related ANDA or Section 505(b)(2) NDA pending, then such petition will not be subject to Section 505(q). Furthermore, the status of the petition will not be subject to Section 505(q) even if a related ANDA or Section 505(b)(2) NDA is filed after the citizen petition is submitted.

by Andrew S. Wasson

The Supreme Court recently held that the University and Small Business Patent Procedures Act of 1980 (known colloquially as the "Bayh-Dole Act") does not automatically vest title to federally-funded invention in a federal contractor. In so holding, the Supreme Court resisted Stanford's call to vest title from a federally-funded invention in an inventor's employer. The Supreme Court held "[t]he Bayh-Dole Act does not confer title to federally funded inventions on contractors or authorize contractors to unilaterally take title to those inventions; it simply assures contractors that they may keep title to whatever it is they already have."

In the Stanford case, Dr. Mark Holodniy arrived at Stanford as a research fellow to develop a method to quantify levels of HIV using PCR technology. The problem was that Dr. Holodniy had little PCR experience. Therefore, his supervisor arranged for him to learn PCR technology at Cetus Corporation. While Dr. Holodniy signed a Copyright and Patent Agreement purporting to assign his rights in inventions resulting from employment at Stanford, he also signed a Visitor's Confidentiality Agreement ("VCA") with Cetus assigning all right in inventions conceived as a result of his time at Cetus. Dr. Holodniy thereafter successfully developed PCR technology quantifying HIV virus and obtained patents on the same, each assigned to Stanford. Years pass and Roche acquired Cetus's PCR assets and commercialized an HIV kit using a PCR procedure. Stanford sued Roche for patent infringement and Roche argued that Stanford lacked standing because Roche was a co-owner due to the VCA.

Stanford, in turn, argued that the Bayh-Dole Act vested rights in Stanford, regardless of the language of the VCA. Against the backdrop of increased economic competition from foreign countries, Congress passed Bayh-Dole to promote the commercialization of inventions from federally-funded research. According to the Supreme Court, "the [Bayh-Dole] Act allocates rights in federally funded 'subject invention[s]' between the Federal Government and federal contractors." The Act defines a "subject invention" as "any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding arrangement."

by Michael W. Harkness

Rep. Erik Paulsen (Minn.) announced his plan to propose new legislation before Congress's August recess aimed at reforming the FDA's approval procedure for medical devices. Testifying at an Oversight and Government Reform Health Care subcommittee hearing on June 2, Paulsen said he plans to simplify the approval process used by the FDA's Center for Devices and Radiological Health ("CDRH") in order to compete with regulatory agencies in Europe. Paulsen pointed out that European regulatory agencies are approving medical devices two years faster, on average, than FDA.

Paulsen further testified that FDA's long approval process and "lack of consistency, predictability, and transparency" have allowed European countries to lure away successful new biotech startup companies. Once the unopposed leader in the device market industry, the United States is losing its competitive advantage "not by cheap overseas labor or countries with more competitive tax structures, but by the bureaucracy within our own borders," Paulsen testified.

Paulsen, who serves as the co-chair of the bipartisan House Medical Technology Caucus, said that he hopes to make the approval process more predictable for biotech companies who feel "frustrated with what appear to be FDA stalling techniques." Observers are speculating that Paulsen will propose a change to the European standard of review for medical devices. The European standard demands a demonstration of safety and performance, compared to FDA's standard of safety and effectiveness.

by Brian Malkin

On June 7-8, the American Conference Institute ("ACI") hosted its second annual Biosimilars Conference in New York City, previously known as its Follow-On Biologics Conference. Over 100 attendees actively participated in the debate concerning unresolved litigation-oriented and regulatory issues that have yet to play out with an FDA-filed biosimilars application.

Building upon last year's program, where it seemed many of the presenters and attendees were just trying to wrap themselves around the then, three-month-old Biologics Price Competition and Innovation Act of 2009 (BPCI Act) enacted on March 23, 2010, this year's program matured with more information concerning the world view of biosimilars, including possible economic implications for a new biosimilars market in the U.S. Still missing from the program, or even the attendee list, however, was FDA, though speculation about when FDA was going to offer guidance or what type of guidance FDA would offer continued to abound.

Despite expectations that at least some of the industry speakers, such as Sandoz and Teva likely have been involved in the 8-13 reported pre-IND meetings about prospective biosimilar applications, it appeared that those with knowledge about those meetings were not willing to explicitly share their pre-IND meeting insight publicly just yet. To the extent that speakers are affiliated with organizations or companies, it should be appreciated that any statements made by the speakers at meetings such as this are speaking based on their own opinion and generally does not represent an official organization/company position.

by Julie E. Kurzrok

On June 3, Judge Roger Couch of the Circuit Court of Spartanburg, South Carolina ordered Ortho-McNeil-Janssen Pharmaceuticals ("Janssen"), a division of Johnson & Johnson, to pay $327 million for deceptive marketing of its drug Risperdal® (risperidone), an atypical antipsychotic drug. The South Carolina Attorney General sued Janssen in 2007 alleging that Janssen made misleading claims about Risperdal® through its marketing and labeling activities. On March 22, 2011, the jury returned a verdict of $360 million, which Judge Couch later lowered to $327 million.

The State's case centered on a Dear Health Care Provider ("DHCP") letter that Janssen sent on November 10, 2003 to approximately 7,200 South Carolina physicians. The State alleged that in the letter Janssen falsely claimed that Risperdal® was safer and more effective than its competitors. The State further alleged that the Risperdal® package label violated South Carolina's Unfair Trade Practices Act, which allows for a penalty of up to $5,000 per violation.

On September 11, 2003, FDA notified Janssen that in response to post-marketing reports of diabetes, and after evaluating the risks, FDA now required the addition of warning language regarding diabetes and hyperglycemia in the package insert for all atypical antipsychotics. On November 6, 2003, Janssen filed supplemental new drug applications ("sNDAs") with the additional information. FDA approved the sNDAs, and requested that Janssen send a DHCP letter including the new risk information.

Janssen sent its DHCP letter on November 10, 2003. On April 19, 2004, FDA issued a warning letter to Janssen stating that its DHCP letter was false or misleading and violated the Federal Food, Drug, and Cosmetic Act.

In the warning letter, FDA stated that Janssen's DHCP letter failed to disclose the additional risks added to the product label, minimized the risk of hyperglycemia-related adverse events, failed to recommend glucose control monitoring, and claimed that Risperdal® was safer than other atypical antipsychotic drugs.

The South Carolina jurors ruled that Janssen's DHCP letter was misleading and violated South Carolina's Unfair Trade Practices Act. The South Carolina Attorney General argued that Janssen's failure to include the risk information in the DHCP letter affected more than 700,000 prescriptions for Risperdal® in South Carolina. Further, the attorneys argued that the deceptive information was presented in approximately 185,000 sales calls and close to 500,000 sample boxes of Risperdal®.

Judge Couch held that Janssen was liable for violating South Carolina's Unfair Trade Practices Act for 7,180 DHCP letters and 36,372 instances of in-person marketing. Based on these violations, the Judge applied a $4,000 per violation penalty for a total of $174.2 million. Judge Couch also found that 509,499 sample boxes of Risperdal® had labels with deceptive information, and imposed a $300 per violation penalty for an additional $152.8 million. Janssen argued that the Judge's separate calculation based on prescriptions, letters, and calls was "triple counting," and was unfair.

This case is the third of ten related cases involving the marketing of Risperdal®. Janssen sent its DHCP letter to approximately 700,000 doctors across the United States. In June 2010, Janssen won dismissal of a suit in Pennsylvania where it was accused of hiding Risperdal®'s diabetes risk. In October 2010, a jury in Louisiana ordered Janssen to pay $257.7 million for making misleading claims regarding Risperdal®'s safety. In 2009, a judge in West Virginia ordered Janssen to pay $3.95 million for making misleading claims about the risks and benefits of Risperdal®, however the state dropped the case after Janssen won an appeal.

Janssen intends to appeal Judge Couch's decision.

by Julie E. Kurzrok

On May 31, ReGen Biologics, Inc. ("ReGen") filed suit against FDA for an alleged improper reclassification of ReGen's Collagen Meniscus Implant ("CMI") device. ReGen requests that this FDA action be set aside, and that such act is a nullity and without any legal effect. ReGen further requests an injunction enjoining FDA from rescinding CMI's class II classification and from challenging such classification except as authorized by law.

Section 513 of the Food, Drug, and Cosmetic Act ("FD&C Act") mandates that, prior to marketing, FDA must classify all medical devices into one of three classes depending on the intended use, indications for use, and level of control necessary to ensure the safety and effectiveness of the device. Class I requires the least control, followed by class II, and class III requires the most control. Section 513(i) of the FD&C Act essentially states that if a new device is substantially equivalent to an already-marketed device or "predicate" device, the new device is given the same classification as the device already in the market and may be submitted as a 510(k) submission. If the new device is not substantially equivalent to any such device, the new device is placed in class III and requires a premarket approval application ("PMA") under Section 515 of the FD&C Act.

According to ReGen, its CMI device is a collagen-based mesh used only to support damaged or weakened meniscus tissue in the knee. The CMI device has been marketed in Europe since 2000, and on July 22, 2008, ReGen applied to FDA as a 510(k) submission to market the CMI in the United States as the ReGen Menaflex® Collagen Scaffold ("CS") device. An FDA Orthopedic Advisory Panel met in November 2008 and agreed to classify the CMI device into class II, because it was substantially equivalent to a prior-marketed surgical mesh device with the same indication. ReGen then began preparing to market and sell the CMI device, and the device was first distributed on April 10, 2009.

Frommer Lawrence & Haug LLP Partner Brian J. Malkin will speak on a hot issue concerning biosimilars, "Ascertaining the Type and Volume of Clinical Data Necessary to Establish Biosimilarity"at the American Conference Institute's Biosimilars Conference in New York City, held from June 7-8, 2011 The Biologics Price Competition & Innovation Act ("BPCIA") left FDA with considerable discretion to design a regulatory pathway for biosimilars, and the industry hopes that FDA will have issued guidance by mid-2011.

ACIBiosimilars2011

by Howard E. Rosenberg, Ph.D.

In response to the Court of Justice of the European Union's ("CJEU's") rejection of the original proposal for a unified specialized patent jurisdiction, the European Commission has published a "non-paper" taking into account the CJEU's objections. The CJEU's concerns related to the lack of sufficient guarantees to ensure that the European and EU Patents Court ("EEUPC") would respect the primacy of Union law and apply Union law in conformity with the interpretation of the CJEU.

The Commission reiterates that any future unified patent system needs to be based on two pillars that come into effect at the same time: the creation of unitary patent protection and the setting up of a unified and specialized patent jurisdiction. The recent agreement between 25 of the European Union's ("EU's") 27 member states for the Enhanced Cooperation Procedure, which is aimed at delivering plans for a single patent, cannot realistically go ahead without having a specialized patent court in place as well.

The Commission has decided that the only practical solution is for an international agreement between the Member States to set up a unified patent court with jurisdiction for the Member States only. The Commission document states: "The Member States participating in the enhanced cooperation have signaled their commitment to create a unified patent court; therefore they would have to be party to the agreement creating such a jurisdiction. The Member States who have decided not to take part in the enhanced cooperation may seek to participate in the creation of the unified court for disputes related to 'classical' European patents valid on their territories." The restriction to include only Member States means that the participation of third states will be excluded and that the EU itself would not be a party.

by Andrew M. Nason

On May 31, the U.S. Supreme Court ruled 8-1 that induced patent infringement requires actual knowledge that the induced acts constitute infringement and that "willful blindness" can constitute actual knowledge.

The case, Global-Tech Appliances, Inc. v. SEB S.A. came to the high court on writ of certiorari, with petitioner Pentalpha Enterprises Ltd. arguing the Federal Circuit used the wrong standard in determining that fryers made by Pentalpha induced infringement of a deep fryer patent held by SEB SA. Although the Justices rejected the appellate court's finding that deliberate indifference would support a finding of induced infringement, the court affirmed the judgment of the court of appeals, because the evidence supported a finding of inducement even under the higher willful blindness standard.

The willful blindness doctrine, commonly applied in criminal law, dictates that defendants cannot escape the law by deliberately shielding themselves from clear evidence that their conduct is wrong. Given the doctrine's wide acceptance in criminal law, the high court held that it should apply in civil patent law as well. The court found the willful blindness standard more appropriate than the deliberate indifference standard, because it permits a finding of knowledge, when defendants only know of a risk their acts may infringe, and requires active efforts by an inducer to avoid knowing about the infringing nature of the acts.

FLH's Scientific Advisor Howard E. Rosenberg, Ph.D will be speaking on Patentability of Pharmaceutical Solids at the Pharmaceutical Solids at the Thirteenth International Workshop in Indianapolis, Indiana on June 21, 2011. The series of workshops will be held June 20 - June 23, 2011. Event details may be found here.

by Rachael McClure

In March, California-based Second Sight Medical Products announced approval of its Argus II prosthetic retinal system for sale in Europe. The device is designed to treat degenerative diseases, such as retinis pigmentosa, which prevent retinal photoreceptors from properly converting light into electrochemical impulses that are needed for the brain to decipher images. Retinis pigmentosa is an incurable genetic disease affecting about one in 4,000 individuals.

The Argus II replaces the role of the damaged photoreceptors with a system combining an implant placed on top of the retina, special glasses equipped with a tiny camera, and a video processing unit. The processing unit converts video recordings of the user's surroundings into instructions that are sent to the implant. The implant then produces electrochemical impulses similar to those produced by a healthy retina. The optic nerve transfers these impulses to the brain, allowing patients to perceive patterns of light. Ultimately, patients are trained to interpret those patterns to make out visual forms.

European approval follows more than three years of clinical trials on thirty patients from around the world, and the results appear promising. Nearly a third of participants attained a visual acuity of 20/1260, and most subjects were able to identify large numerals and locate objects. The highest performers could read short words and perceive certain colors on a lit screen. Further, participants reported improvement in everyday tasks such as using utensils, navigating through doorways, and crossing streets with curbed sidewalks. While the state of the new technology has been compared to that of cochlear implants for deafness 26 years ago, the Argus II offers hope for individuals who have lost their sight to advanced degenerative diseases.

by Brian Malkin

On May 26, the Congressional Budget Office ("CBO") released an Economic and Budget Issue Brief entitled, "Potential Effects of a Ban on Direct-to Consumer Advertising of New Prescription Drugs". The Brief aims to draw on data documenting direct-to-consumer ("DTC") advertising and other promotional materials activities for pharmaceutical products and how this affects the market for drugs. For the Brief, CBO analyzed data from SDI and IMS Health--two companies that collect and sell information on the pharmaceutical industry and sales--academic research on advertising prescription drugs, focusing on the 1999-2008 timeframe.

SInce FDA issued new guidelines in 1999 for DTC advertising, concern has raised in Congress and elsewhere that DTC advertising drives consumers to seek new medical therapies before they are well proven or their risks are fully discovered. The concerns have led to recent proposals for a moratorium on DTC advertising during the first two years of FDA approval. Others have questioned whether a ban would be contrary to the public health by making consumers unaware of new medical therapies as they become available for commercial use. Congress has considered but never adopted bills in recent years that would have limited DTC advertising in the first two to three years or otherwise limited DTC advertising.

The Brief concludes that a two-year moratorium would cause:

1. Drug manufacturers to expand marketing to physicians for at least some of the banned advertising to consumers.
2. The number of prescription drugs filled for some products would decrease for some drugs but others would stay the same due to substitution for other types of promotion and other factors that affect new prescription drug use.
3. The change in price for new drugs would likely be minimal given that the effects on prescription drugs prescribed would be expected to be limited.