FDA Lawyers Blog

The U.S. Court of Appeals for the Federal Circuit recently rendered a follow-up ruling on remand from the Supreme Court's April 2012 decision regarding Orange Book use codes for method-of-use patents Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S. The Federal Circuit held, in a July 30 ruling, that: (i) a district court can issue a mandatory injunction requiring the owner of the NDA for the brand product to correct a use code which inaccurately describes the FDA-approved, patented use, but (ii) the court must first give the NDA holder the opportunity to correct the use code, rather than direct the company to use precise language for the code.

Nevertheless, the Circuit went on to state: (i) the NDA holder does not have "unbounded discretion" in proposing a new use code, and (ii) the district court has the power to construe the scope of the patent claims and provide limits on the appropriate scope of the corresponding use code. If the court determines that the new code is inaccurate and/or overbroad, the judge at that point can correct the error.

This latest development comes in the wake of the U.S. Supreme Court's decision arising from Caraco's proposed section (viii) labeling carve-out for use of the diabetes drug repaglinide (on which we have previously reported here, for example). The patent at issue claimed use of repaglinide in combination with the drug metformin. Caraco wanted to omit the combination therapy, and label its generic version to treat diabetes with repaglinide only. Novo Nordisk admitted that the patent did not cover the use of repaglanide alone, but then changed its use code in the Orange Book to wording that was broad enough to cover repagalanide alone.

On August 3, a jury in the U.S. District Court for the District of Massachusetts found Genzyme's U.S. Patent Number 7,931,030 ("the '030 patent) was both not infringed by Seikagaku Corp. and its U.S. distributor, Zimmer Inc., and invalid as obvious in light of the prior art.

Genzyme obtained FDA approval in February 2009 to market Synvisc-One®, an injectable hyaluronic acid gel to treat osteoarthritic pain in the knee. According to Genzyme, Synvisc-One® was an improvement over prior treatments since only one injection of Synvisc-One® was required at least every six months compared to existing drugs that require three injections one week apart for similar pain relief. Synvisc-One® was the only single injection treatment until the FDA approved Gel-One®, a similar treatment also containing hyaluronic acid produced by Seikagaku, in March 2011. One month later, Genzyme filed a complaint alleging that Gel-One® infringed U.S. Patent Number 5,399,351 ("the '351 patent"). Genzyme then amended its complaint to add the '030 patent to the suit in June 2011 and agreed to drop claims concerning the '351 patent in February 2012.

Following this jury verdict, U.S. District Judge Douglas Woodlock vacated a preliminary injunction issued on December 30, 2012 barring Zimmer from providing free samples of Gel-One® and from selling Gel-One® at less than $547.60 per injection. Judge Woodlock also refused to grant a judgment as a matter of law after the jury verdict.

The use of a jury in this case as opposed to a bench trial in front of a judge is consistent with the significant increase in the use of juries in patent cases since the 1980s according to a 2011 Patent Litigation Study by PricewaterhouseCoppers. However, the outcome in this trial, favoring in the alleged infringer, is contrary to the general trend demonstrating that patent holders are more likely to win in front of a jury instead of a judge according to the same study.

There has been an increased effort to increase pediatric testing for adult medications, due to the expense of pediatric clinical trials and parent concerns about participation. For example, an alarming 70 percent of medications prescribed for children have never been tested on them, the National Institute of Health ("NIH") estimates.

In an effort to address the issue, on July 9, 2012, President Barack Obama reauthorized the "Best Pharmaceuticals for Children Act" and "Pediatric Research Equity Act" providing drug companies with a six month period of "pediatric exclusivity" if they perform studies approved by the FDA. This approval is a main proponent in easing parents' minds when allowing their own children to participate in clinical trials. In addition, such initiatives have helped incentivize sponsors to conduct more pediatric research with NIH funding for pediatric research rising by 18% "from $2.77 billion in 2008 to $3.28 billion in 2011.

Still, while improvements are on the horizon, there is much to be done to fully address the lack of pediatric clinical trials. A July 23 study in Pediatrics found a scarcity in pediatric drug trials as well. Dr. Florence T. Bourgeois, lead researcher on the new study, expressed concern that doctors have long been known to "extrapolate" findings from adult studies to then apply them to children. Bourgeois said that "children are not small adults." Due to children's developing bodies, they metabolize drugs differently than adults do. In fact, children encounter disease just as frequently, or more so, than adults, according to Bourgeois, yet "[c]hildren continue to be underrepresented in clinical trials compared with their burden of disease." Overall, just 12 percent of all clinical trials focused on children and teenagers. Yet children accounted for 60 percent of those suffering the conditions studied. Bourgeois said that more may need to be done to encourage not only drug company trials, but studies funded by non-commercial sources as well.

"One of FDA's top priorities is giving pediatricians and parents the same level of tested and researched information on drugs used to treat children that is required for drugs used to treat adults," FDA spokesperson Sandy Walsh reportedly said. "Congress has helped increase studies for children by passing legislation that gives companies financial incentives to conduct pediatric studies and to require them to study a product they are developing for adults if the disease also occurs in children," Walsh added.

The impact and influence of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act will be discussed by FDA's Pediatric Advisory Committee this upcoming September. The meeting agenda includes the discussion of pediatric-focused safety reviews as mandated by both of the recently authorized Acts.

Yesterday, FLH Partner Brian J. Malkin was quoted in a MedPage Today article by Washington Correspondent David Pittman on a GPhA Study that also published yesterday entitled: "Savings $1 Trillion Over 10 Years: Generic Drug Savings in the U.S. (Fourth Annual Edition: 2012)". According to the Report, generic drug use has saved the U.S. health care system approximately $1.07 trillion over the past decade (2002 through 2011) with $198.8 billion in savings in 2011 alone. The GPhA Report in turn referenced a number of recent positive analyses of the generic industry, asking Congress not to change the innovator-generic incentives or restrict the use of generics, with a promise for delivering generic biologicals in the future.

Along these lines, MedPage Today attributed Malkin with the following statements:

Changing the 5-year exclusivity period for traditional small-molecule drugs or the 12-year exclusivity for biologics is unlikely, Brian Malkin, drug industry attorney and partner with Frommer Lawrence & Haug in Washington, told MedPage Today in an interview.

"It's an election year; maybe they're trying to position themselves for the future," Malkin said of Thursday's GPhA report. The savings analysis seemed to be mostly about creating awareness and generating good will for future policy decisions, he said.

For instance, seeking to dissuade a Health Affairs article in November 2011 that stated generic drug usage has increased at a rate that has discouraged the development of new drugs, the GPhA Report highlighted a recent IMS report in April 2012 that found: "...[A]though generic utilization has reached new levels, more new medicines were launched in 2011 that in any other year of the past decade ... since the implementation of Hatch-Waxman, there has been a multiple-fold increase in the innovation of new medicines." The GPhA Report observed: "By creating a fair balance between innovation of new medicines and accessibility to lower cost generic medicines, federal law has established a win-win for providers and American consumers."

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On July 23, 2012, FDA approved Tudorza™ Pressair™ (aclidinium bromide inhalation powder) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease ("COPD"). COPD, which is most often caused by smoking, includes chronic bronchitis and emphysema, and affects close to 24 million people in the United States. While quitting smoking is the best option for reducing the progression of COPD, the damage caused by the disease is irreversible, and there is currently no cure.

Chronic bronchitis is a chronic inflammation and tightening of the airways, characterized by a phlegm-producing or mucus-producing cough which lasts for at least three months in at least two consecutive years. Emphysema is a long-term lung disease where the walls of the air sacs become damaged, preventing a person from fully exhaling used air, and from inhaling enough fresh air. Individuals with COPD suffer from difficulty breathing, shortness of breath, wheezing, reductions in energy, as well as other symptoms. Many individuals dismiss these symptoms as age-related or as nothing more than a "smoker's cough." Consequently, only about one half of COPD cases are actually diagnosed.

Tudorza™ Pressair™ is a non-steroidal, long-term-maintenance treatment that loosens the muscles around the lungs in order to open constricted airways and to increase airflow in COPD patients. Tudorza™ Pressair™ is a long-acting muscarinic antagonist ("LAMA," or "anticholinergic"), which blocks the muscarinic receptors in the airways, leading to airway relaxation and improved lung function. Since 2004, the Pfizer Inc./Boehringer Ingelheim Spiriva® Handihaler® has been the only approved LAMA available to COPD patients.

On July 26, FLH Partner Brian J. Malkin was interviewed and quoted in FDAnews' article: "Jazz Petitions FDA, Alleges Agency Wrongly Accepted Xyrem ANDA" available here (subscription required for full story). Malkin and another FDA attorney, David Rosen, were both quoted in the article to provide some color surrounding Jazz's latest Citizen Petition regarding generic Xyrem® (sodium oxybate):

Despite Jazz's arguments, David Rosen, an attorney at Foley & Lardner, questions whether the FDA actually accepted an incomplete application. The FDA, including the Office of Generic Drugs, is well aware of REMS requirements and wouldn't accept an ANDA application if it was deficient on its face, Rosen told DID, noting there is more than one way to put appropriate controls in place for drugs. "The FDA has been taking [ANDA] filings seriously," he said, adding he is confident the FDA is good at judging completed applications.

And Brian Malkin, an attorney at Frommer Lawrence & Haug, explained that because Jazz's Xyrem REMS is still pending and not yet accepted by the agency, generic filers would typically only be required to include the "same essential elements" of a risk management plan in their ANDA application, a flexible approach that could have been satisfied by Roxane. ANDA filers for companies with approved REMS are held to a different standard, Malkin explained.

As FDA Lawyers Blog previously reported here, Jazz's latest Citizen Petition focuses on FDA's same labeling requirement for generic drugs and argues that risk management programs are included in that same labeling.

Jazz's Xyrem Citizen Petition

While Xyrem® has been designated by FDA as a product that has been deemed to have a Risk Evaluation and Mitigation Strategy ("REMS"), FDA does not list Xyrem® as a product with an approved REMS. To some extent, Xyrem® 's risk management program called the Xyrem® Success Program has been described on its website and in FDA's review package and public documents for Xyrem®.

On July 25, Corindus Vascular Robotics announced that FDA has granted a 510(k) premarket clearance for its CorPath® 200 System for use in performing percutaneous coronary interventions ("PCI"), otherwise known as angioplasty. David M. Handler, President and CEO of Corindus, calls it "the world's first system designed for robotic assisted PCI procedures." The newly-approved system is designed to assist interventional cardiologists in performing PCI more accurately and with reduced health concerns for surgeons.

PCI procedures are relatively common, but they pose risks to the operating cardiologists. The procedure involves a surgical technique in which blood flow is restored to a blocked coronary artery by inserting a balloon catheter into the artery, inflating it, and then implanting a stent to keep the artery open. While undergoing the procedure, the patients are x-rayed, and the surgeon is also exposed to the radiation. Generally surgeons wear a protective lead apron to minimize exposure to the radiation, but recent data has demonstrated that daily exposure can lead to health risks such as cancer and cataracts. The aprons are often heavy and the procedure can last for several hours. Over time, this can lead to orthopedic problems. Additionally, Corindus points to data published in the American Journal of Cardiology in 2008 showing that nearly 47% of stents are not optimally placed due to difficulties in visualization, measurement, and imprecise stent deployment.

The CorPath® 200 System offers a solution to these problems by robotically-assisting the cardiologist in the controlled placement of coronary guidewires and stent/balloon catheters while the physician resides safely inside lead-lined cockpit. The cockpit protects the cardiologist from radiation exposure and allows the procedure to be done in a seated position in front of monitors which provide an enhanced view of the angiography screen. The system includes a robotic drive and a single-use cassette, which contains the guidewire, balloon, and stent, mounted to an arm on the cathether lab table. The cardiologist controls the robotic drive from the cockpit by using two joysticks and a touch screen monitor, which allow the surgeon to be incredibly precise while minimizing radiation exposure and fatigue. The CorPath PRECISE trial, a study involving 164 patients at nine locations, which served as the basis for the 510(k) application, showed a reduced radiation exposure rate of 95% for physicians. The cockpit is located at the foot of the cathether lab table and the operator can easily switch from a remote procedure to a manual procedure if necessary.

On July 17, 2012, FLH Partner Brian J. Malkin joined other experts in the field of clinical trials to discuss methods for ensuring safe and compliant domestic and international clinical trials. New to the ACI's Clinical Trials Conference running for more than seven years was Malkin's presentation "Safely Conducting Biosimilars Clinical Trials: Understanding FDA's Requirements for Biosimilar Clinical Trials". The audience was comprised of many individuals seasoned in traditional clinical trials, who came to the conference in Boston to learn about the newest trends in clinical trials.

Some of the featured government speakers included Karena Cooper, J.S., M.S.W., Acting Associate Director of Policy and Communications and Regulatory Counsel, Office of Scientific Investigations ("OSI"), Center for Drug Evaluation and Research, FDA, and Mary E. Crawley, Assistant U.S. Attorney, Eastern District of Pennsylvania. Other featured speakers included former government enforcers and top in-house counsel from sponsor biopharmaceutical and medical device companies, contract research organizations ("CROs"), hospitals, universities, and research institutions.

Cooper described FDA's new inspection platform, where FDA does not need to inspect a facility to issue a warning letter, and the reorganization of the Office of Compliance. In terms of postmarket studies, sponsors are now provided with milestone timetables where failure to complete a milestone by a certain time will result in a violation. While a sponsor may show "good cause" for failure to meet a milestone, FDA has a very limited high bar, essentially for items completely outside the sponsor's control. Examples where FDA did not find good cause included difficult recruitment, costly studies, or development of data in lieu of the data that the sponsor agreed to provide. Regarding postmarket studies, however, FDA has already issued its first warning letter dated February 17, 2012 that utilized the no-inspection format. In this letter, FDA provided the sponsor with 30 calendar days to respond. FDA's Office of Compliance also has new civil money penalties to enforce its provisions that Cooper said FDA is "actively considering" but has not utilized yet. Cooper also described how FDA is working with the European Medicines Agency ("EMA") for joint and observed inspections, where there is a "robust" confidentiality agreement in place.

Earlier this month, Jazz Pharmaceuticals ("Jazz") submitted a Citizen Petition requesting that the FDA rescind its acceptance of Roxane's abbreviated new drug application ("ANDA") referencing Xyrem®, an oral solution indicated for the treatment of patients with narcolepsy. In its petition, Jazz argues that Roxane's ANDA did not have the same labeling and conditions of use as Xyrem®, because it did not contain a risk management system when it was submitted. Jazz asks that the FDA require Roxane to file a new ANDA, which would result in a new thirty-month stay of the associated New Jersey Hatch-Waxman litigation.

Jazz's Xyrem Citizen Petition

Xyrem® is the sodium salt of gamma-hydoxybutyric acid ("GHB"), a notorious "date-rape" drug. In 2000, Congress passed the Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act, defining GHB as a Schedule I controlled substance but creating an exception for FDA-approved drugs containing GHB. FDA approved Xyrem® in 2002, requiring extraordinary restrictions on the drug product's use under 21 C.F.R. § 314, Subpart H, including a restricted distribution program, an education program, restrictions on the distribution of prescriptions, and a registry system. To meet these demands, Jazz implemented and patented the "Xyrem® Success Program," and listed the patents claiming methods of using its program in FDA's Orange Book.

Jazz claims that Roxane's ANDA did not include a proposed risk management system when it was submitted. Instead, Jazz explains that Roxane submitted a six-page document describing a partial proposed risk management program for generic Xyrem® ten months after its initial ANDA submission and did not submit a full proposal until more than a year after the initial ANDA submission.

On July 20, the United States Court of Appeals for the Federal Circuit heard re-argument in Association for Molecular Pathology et al. v. United States Patent and Trademark Office et al. On the panel were Judges Alan Lourie, William Bryson, and Kimberly Moore. The Federal Circuit decided in 2011 that certain claims to isolated DNA were patent-eligible under 35 U.S.C. § 101, but the United States Supreme Court vacated the Federal Circuit's judgment and remanded for further consideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) ("Prometheus"). Association for Molecular Pathology v. Myriad Genetics, Inc., 132 S. Ct. 1794, 1794 (2012) (granting certiorari, vacating, and remanding). (For a previous discussion on Myriad supplemental briefing for the Federal Circuit see our blog here.)

Myriad Genetics ("Myriad") argued that nothing in Prometheus should change the conclusion that isolated genes are patent-eligible. More specifically, Myriad addressed the Prometheus Court's concern that access to products of nature should not be "preempted." In response to this concern, Myriad explained that nothing in Prometheus altered the Supreme Court's earlier decision in Diamond v. Chakrabarty, 100 S. Ct. 2204 (1980), which held that a genetically-engineered bacterium constituted patentable subject matter, and placed great importance on the fact that the bacterium was human-made. Additionally, Myriad addressed the effect of Prometheus on Claim 20 of U.S. Pat. No. 5,747,282 ("Claim 20"), which recites:

A method for screening potential cancer therapeutics which comprises: growing a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer in the presence of a compound suspected of being a cancer therapeutic, growing said transformed eukaryotic host cell in the absence of said compound, determining the rate of growth of said host cell in the presence of said compound and the rate of growth of said host cell in the absence of said compound and comparing the growth rate of said host cells, wherein a slower rate of growth of said host cell in the presence of said compound is indicative of a cancer therapeutic.

Myriad argued that unlike the claim in Prometheus, which claimed a method based on a routine idea, Claim 20 applies routine steps to a new composition of matter (i.e., the transformed eukaryotic host cell containing an altered BRCA1 gene).

The Association for Molecular Pathology ("AMP") argued that the breath of the claims at issue is "stunning." It argued that because of this breadth, the claims preempt the use of products of nature, and therefore must therefore are invalid under section 101 as interpreted by Prometheus. Judge Moore was not persuaded by this argument and recited a quote from Prometheus that explained that patent eligibility has never been decided based upon whether a law of nature is "sufficiently narrow." Therefore, Judge Moore said that AMP's preemption argument was "a waste of time and space." Regarding Claim 20, AMP argued that this claim was invalid under Prometheus because it simply recited "putting the stuff all together in the cell and seeing what happens." Especially interesting was AMP's response to a question from Judge Lourie, who inquired whether a method of using penicillin would be patent-eligible. Although the argument was not entirely clear, it appears that AMP was arguing that a method for using penicillin's anti-bacterial properties is "clearly not patentable."

The promise of gene therapy as a commercially-available tool for treating genetic disorders may finally be inching closer to reality. On July 20, 2012 the European Medicines Agency ("EMA") Committee for Medicinal Products for Human Use ("CHMP") took the first step towards making gene therapy treatment a reality by recommending the gene therapy, Glybera® (alipogene tiparvovec), for marketing approval in the European Union ("EU"). Glybera®, which is indicated for the treatment of lipoprotein lipase ("LPL") deficiency, was developed by Netherlands-based, uniQure.

Patients lacking LPL enzymes are unable to break down fats. The CHMP press release states that:

So far, management of patients with the disorder consists of strict reduction of dietary fat to less than 20% of the daily caloric intake. It is very difficult to comply with such a dietary regimen and as a consequence many patients experience life-threatening pancreatitis attacks requiring admission to hospital.

Due to the difficult circumstances faced by individuals suffering from LPL deficiencies that trigger severe or multiple pancreatitis attacks, the CHMP has deemed the treatment benefits afforded by this gene therapy to be worth its risks.

Fundamentally, gene therapy is a method by which exogenous "functioning" or "normal" DNA replaces "abnormal" DNA that is responsible for a particular genetic disorder. Gene therapy was originally touted in the 1970s as a potential way to treat genetic disorders.

On Monday, July 16, FDA approved the first drug to be used for preventing Human Immunodeficiency Virus ("HIV") infection, in what reporters are calling "a milestone in the 30-year battle against the virus that causes AIDS," a "huge step toward controlling the spread of HIV," and a contributing factor to "the turning point in the AIDS epidemic." Truvada®, a pill owned by Gilead Sciences, is a drug used to treat HIV and Acquired Immunodeficiency Syndrome ("AIDS") since 2004. However, Monday's approval permits Gilead Sciences to market the drug for preventative use, potentially dramatically increasing the number of doctors prescribing the drug for that use. Using Truvada® as a preventative measure could help slow the spread of HIV, which currently infects about 50,000 new Americans per year.

Truvada® is a combination of two anti-HIV medications: Emtriva® (emtricitabine) and Viread® (tenofovir disoproxil fumarate). The two medications are combined into a single pill that is taken once a day with or without food. The drug works by lowering the amount of virus circulating in infected people's blood. Truvada® blocks the activity of the enzyme (HIV-1 reverse transcriptase) the virus needs to replicate and consequently slows down the progression of HIV by limiting its ability to take hold and start an infection.

The drug is approved for use by healthy, uninfected individuals who are at high risk of contracting HIV. Individuals considered "high-risk" include sex workers and people with HIV-positive partners. Additionally, people who engage in high-risk behaviors such as using intravenous drugs fall into the "high-risk" category. To prevent HIV infection, or at least reduce the risk of HIV infection, uninfected individuals at a high-risk of acquiring the virus must take the drug daily before and after exposure. Prevention, however, comes at a steep cost. A Truvada® prescription ranges from about $11,000 to $14,000 annually.

FDA Lawyers Blog is pleased to report that Andrew S. Wasson, Partner, in our New York office was a presenter at the Food and Drug Law Institute's ("FDLI's") "Intellectual Property Throughout the Drug Development Lifecycle: Opportunities and Challenges" Conference in Washington, D.C. on July 17. This Conference addressed intellectual property ("IP") issues important to patent litigators and in-house counsel in the pharmaceutical and generic industries, as well as critical regulatory issues affecting those industries.

The early-morning session began with presentations about The Role of IP During Drug Discovery and Pre-Clinical Drug Development. In this session, the speakers addressed various issues including:

• Whether and when to publish scientific findings and studies


• Transactional due diligence and informational sharing concerns regarding intellectual property


• Differences between patenting process for drugs versus biosimilars


• AIA alterations and effects on inventorship, prior art, and trade secrecy.


• The late-morning session covered Brand Development Through IP in the Clinical Testing Phase. The issues in that session addressed:


• Regulatory considerations for patent listing and labeling


• Non-traditional IP protection strategies for pharmaceutical companies and their products.


• Trademark and social media issues on the internet.

The afternoon session kicked off with presentations about Post-Marketing IP Protection and Enforcement. These presentations focused on:

• FDA and patent exclusivities


• A generic side perspective of post-marketing IP protection and enforcement


• The AIA's invalidation procedures


• Compulsory licensing and the TRIPS Agreement.

The program concluded with a roundtable discussion, which included Wasson, about Third Party IP: Preserving Freedom to Operate ("FTO"). Key issues addressed were:

• Surveying the landscape


• How to conduct an FTO search


• Obtaining competent clearance opinions


• Overcoming or working around blocking patents


• Taking advantage of the 271(e)(1) "safe harbor"


• Off shoring strategies and issues

Wasson spoke on the topic: Third Party IP: Preserving Freedom to Operate. He was joined by Andrea Kamage of Johnson & Johnson and Vincent Capuano of Duane Morris LLP. The group focused on rights required to ensure freedom to operate for third parties. Key issues addressed were:

• Surveying the landscape


• Mechanics of Conducting the FTO Search


• Obtaining competent clearance opinions


• Overcoming or working around blocking patents


• Taking advantage of the 271(e)(1) "safe harbor"


• Off shoring strategies and issues.

Unlike similar conferences frequently attended by patent attorneys, FDLI's conference focused on educating food and drug attorneys about some essential related patent concepts.

In February 2012, FDA Lawyers Blog wrote regarding FDA's secret e-mail monitoring of whistle-blowers in the Center for Devices and Radiological Health ("CDRH"). Now it appears that FDA's surveillance program, which began as an effort to determine whether five FDA scientists were leaking trade secret information, may have been much broader than previously known. According to a New York Times article published on July 15, an FDA contractor inadvertently posted a database containing more than 80,000 surveillance-related documents onto a public website. These documents revealed the extent of the surveillance program that tracked communications between the scientists and Congressional officials, journalists, and others. The surveillance software utilized by FDA allegedly tracked keystrokes, intercepted personal e-mails, and took screen shots of letters being drafted to members of Congress, the Office of the President, and the Office of Special Counsel ("OSC"), an independent federal agency which investigates whistle-blower retaliation claims.

Federal agencies have broad power to monitor employees' computer usage. In fact, FDA computers warn employees when logging on that they have "no reasonable expectation of privacy," and that the Agency may intercept data for any lawful government purposes. However, it is still possible that FDA acted unlawfully when intercepting certain legally protected communications, such as, attorney-client communications, whistle-blower complaints, and workplace grievance filings. The OSC sent a memorandum to all government agencies in June identifying the legal restrictions and guidelines that agencies should consider with regard to monitoring employee communications. Members of Congress have demanded an investigation into the legality of the FDA's program.

FDA defended the program, saying it restricted surveillance to the five scientists suspected of leaking trade secret information. The Agency established the operation after the Inspector General at the Department of Health and Human Services refused to launch a criminal investigation into the scientists' alleged wrongdoing. FDA officials acknowledge that the operation intercepted communications that the scientists had with Congressional officials, journalists, and others, but FDA maintained that the e-mails "were collected without regard to the identity of the individuals with whom the user may have been corresponding." Additionally, FDA claimed that they did not intend to prevent employees from making these communications, and that individuals outside of the agency were not targets of the operation.