FDA Lawyers Blog

Over the past months, there has been a lot of speculation (see recent blogs here , here, and here) whether the White House's proposed budget would cause a sequester situation for FDA, resulting in potential layoffs or program cuts, in an era of new user fees for generic drugs and biosimilar biological products. While initial reports and temporary budget fixes (called continuing resolutions) appeared to keep FDA's user fees intact and available for use, FDA's Commissioner, Margaret A. Hamburg, M.D., recently reported to members of a biotechnology trade association, the Massachusetts Biotechnology Council ("MassBio"), that it was not clear what would happen with user fees in the new federal budget.

Released on April 10, the White House's proposed fiscal year 2014 budget is a mixed bag that has been called a "political document rather than a serious piece of legislation" with a "series of bargaining positions" that "would bleed pharma." On the one hand, the plan would appear to confirm that FDA's user fees would not be sequestered, given that it supported the $4.7 billion in total program budget requested by FDA, which included user fees that would help fund over 90 percent of the requested increases. On the other hand, the budget includes a myriad of proposals that would change the way the government pays for medical care and products. For example, Medicare (senior citizens' drug coverage) Part D manufacturer discounts for branded drugs would be increased from 50% to 75% in 2015 (rather than 2020) and low-income individuals would be pushed more to generic drugs by increasing certain copayments for branded drugs and lowering certain copayments for generic drugs.

Written by Brian J. Malkin

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Many of the more controversial proposals were nestled in a document called "Reducing the Deficit in a Smart and Balanced Way". Here, the White House proposes, among other things, several items to purportedly lower drug costs, including: 1) authorizing the Federal Trade Commission to stop companies from entering into certain "pay-for-delay" agreements (see below) and 2) beginning in 2014, to reduce biologic product exclusivity from 12 years to 7 years and prohibit additional periods of exclusivity for minor changes to product formulations. These two items could open up some unanticipated debate regarding the White House's budget.

Written by Rachael P. McClure

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With the $85 billion spending cuts now in effect, it is time for FDA and other agencies to adapt. The 2013 impact will be condensed into the next seven months because the federal fiscal year ends on October 1. While few details have been made available, FDA Commissioner Margaret A. Hamburg, M.D. said in an interview on Thursday that she did not anticipate FDA having to furlough workers and emphasized that the majority of the effects would not be felt in the short term. However, Hamburg estimated that the cuts will result in more than 2,000 fewer food safety inspections: "[C]learly we will be able to provide less of the oversight functions and we won't be able to broaden our reach to new facilities either, so inevitably that increases risk." FDA may renew efforts to implement a user fee program for the food industry to offset this hit.

President Barack Obama has vowed to continue to work with Congress to reach a compromise that would replace the cuts with a more balanced budget plan. Meanwhile, the House Appropriations Committee introduced a bill yesterday that would fund the government with $982 billion through the end of the fiscal year, assuming the sequester cuts would remain in effect. While largely focused on the Department of Defense ($518 billion) and military construction and Veterans Affairs ($71.9 billion), the general provisions maintain the funding level of the Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations Act, 2012. The bill is scheduled to reach the House floor tomorrow.

On January 28, The New York Times reported that biotechnology companies are actively lobbying state legislatures to limit access to biosimilar versions, i.e., "highly similar" versions of previously-approved, innovator biological products ("biologics"). According to the author, Andrew Pollack, Amgen and Genentech are proposing bills that would make it more difficult for pharmacists to substitute biosimilar versions for the innovator's products, unless FDA determines that a particular biosimilar version is "interchangeable" with the innovator's product.

For instance, the Virginia House of Delegates reportedly already passed such a bill last week by a 91-to-6 vote. Other bills in the works require patient consent for substitution, pharmacist notification of the patient's physician if a switch is made, and for both the pharmacist and patient's physician to maintain records of any such substitutions for years.

Written by Brian J. Malkin

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The Generic Pharmaceutical Association ("GPhA") and insurers generally accept that biosimilar substitution for a biologic should follow similar methods as with drugs only if deemed interchangeable by FDA but find that many of the bills go further to discourage use of biosimilars. "All of these things are put in there for a chilling effect on these biosimilars," commented Brynna M. Clark, Director of State Affairs for GPhA, adding that many of the limits "don't sound too onerous but undermine confidence in these drugs and are burdensome." GPhA and insurers would prefer that legislatures leave biosimilar regulation to FDA, which has been entrusted with using its regulatory prowess to determine the necessary requirements for biosimilars and "interchangeable" biosimilars, as well as when to waive those requirements based on what is know about a particular biosimilar product.

On January 2, 2013, barely three months after FDA's new user fee programs go into effect, certain mandated spending reductions, called sequestration, also may go into effect that could prevent FDA from using the user fees it collects from industry. A Congressional Super Committee failed to find the required $1.2 trillion in cuts over ten years by a November 2011 deadline. The combined effect of lost taxpayer and user fees projected by Maryland-based Alliance for a Stronger FDA, would be an initial $294 million out of a $3.65 billion budget.

The catch comes from a component of FDA's user fee programs known as the "trigger" that requires a certain baseline of taxpayer funds to go to FDA, so industry user fees supplement rather than fund FDA's operations. FDA's projected funding for fiscal year 2013, set at $2.5 billion, would be cut by an across-the-board, 8% cut in federal government, coined as a "fiscal cliff", imposed to help curb the ever-increasing government debt. While FDA's cut of about $200 million would not normally hit the trigger to prevent FDA's use of user fees, Steven Grossman, Deputy Executive Director of the Alliance for a Stronger FDA, told Anna Edney from Bloomberg that the Obama Administration may still sequester FDA's user fee funds to help with federal spending reduction goals. The exact trigger levels, moreover, are based on formulas that include consumer inflation and past spending, which so far FDA has declined to comment on.

Written by Brian Malkin

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According to Grossman, if this occurs, about $68 million in drug and device user fees and $40 million in tobacco-company payments would be diverted to a U.S. Treasury Department account that would "reduce government because it would reduce what they can do." Faced with the sudden loss of these funds, drug industry experts have speculated that FDA would be forced to lay off personnel and take other measures to reduce costs.

On August 27, FDA published a Federal Register notice announcing the availability of industry guidance for generic drug user fees entitled "Generic Drug User Fee Amendments of 2012: Questions and Answers" and "Self-Identification of Generic Drugs Facilities, Sites, and Organizations." Simultaneously with this notice, FDA also announced an upcoming public meeting on September 21, 2102 from 9 a.m. to 1 p.m. to discuss FDA's implementation of the Generic Drug User Fee Amendments of 2012 ("GDUFA"). Finally, on the same day, another related Federal Register Notice issued: "Notice of Opportunity to Withdraw Abbreviated New Drug Applications to Avoid Backlog Fee Obligations." Below is a snapshot of each of these items taken in turn.

GDUFA was signed into law on July 9, 2012 but the obligations arising therein begin on October 1, 2012. We have previously blogged on the genesis of GDUFA, when both the House and Senate passed GDUFA, for some background why and how we got here.

Written by Brian Malkin

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The GDUFA Q&A answers questions about the various types of fees (backlog fee, drug master file fee, generic drug submission fees (including a fee for active pharmaceutical ingredients ("APIs") not referenced in a drug master file), and facility fees for APIs and finished dosage forms ("FDFs")), self-identification of facilities, sites, and organizations, review of generic drug submissions, and inspections and compliance. For example, most immediately, backlog fees will be calculated based on the number of pending original abbreviated new drug applications ("ANDAs") at the start of October 1, 2012. As was mentioned in a recent conference discussing this topic, a recommendation was made for all generic applicants to "clean house" and make sure that they did not pay fees for any pending ANDAs that they were no longer pursuing. FDA explains in this Notice that in accordance with GDUFA, FDA will divide $50 million by the number of pending ANDAs pending on this day to arrive at an individual one-time backlog fee due for each pending ANDA. Applicants wishing to remove pending ANDAs from this list, however, must do so by written notification received by FDA on or before September 28, 2012. Failure to pay the backlog fee is further explained, including a public disclosure of the failure to pay, and FDA will not receive a new ANDA or supplement submitted by that applicant "or affiliate" until the fee is paid. The GDUFA Q&A also explains when the various fees will be collected and the effect of not paying those fees timely. For new ANDAs or supplements, feed need to be paid when due, e.g., for new ANDAs, within 20 calendar days of the date that FDA provides notification that failure to pay will result in the ANDA or supplement not being receive and, therefore, reviewed.

On August 2, four members of the House of Representatives, led by Congressman Edward Markey, introduced, H.R. 6272, "The Trial and Experimental Studies Transparency (TEST) Act of 2012." The TEST Act will amend Section 402(j) of the Public Health Service Act, tightening the reporting requirements for the Internet site designed to better inform the public about ongoing and completed clinical trials in the United States, ClinicalTrials.gov. The main goal of the TEST Act is to prevent clinical-trial sponsors from withholding negative study data and safety concerns while emphasizing the positive results of their clinical trials.

Prior to the proposed TEST Act, under the Food and Drug Administration Amendments Act of 2007 ("FDAAA"), most United States-conducted interventional clinical trials were registered at ClinicalTrials.gov, and most of the results of those clinical studies were eventually published. However, loopholes in the requirements of the FDAAA resulted in clinical studies that were either not registered, that failed to report results, or both. There are a number of clinical trials, therefore, that are not registered in the publically-accessible database.

Written by Julie E. Kurzrok

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The TEST Act will require all interventional biomedical studies conducted on humans to be registered on ClinicalTrials.gov prior to enrolling any patients. In addition, sponsors of these clinical trials will be required to post the study results and other required information on ClinicalTrials.gov within one year of the completion date of the trial. According to the proposed legislation, interventional studies include all human studies where patients are assigned, via protocol, by an investigator to receive specific intervention where the effects of such intervention on biomedical or health-related outcomes are evaluated. For clinical trials involving drugs or medical devices that have never been approved for any use, the TEST Act permits a delayed results submission of up to two years from the date of completion of the clinical trial.

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.

Written by Brian Malkin

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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.

The Food and Drug Administration Safety and Innovation Act, otherwise known as the User Fee Bill, has passed through Congress and awaits the President's signature. This Bill, mostly known for implementing user fees for generic drug applications, also provides new programs to foster the study of nanomaterials in products regulated by FDA. Section 1126 of Title XI, Subsection C calls for the Secretary to "intensify and expand activities related to enhancing scientific knowledge regarding nanomaterials, ... to address issues relevant to the regulation of those products, including potential toxicology, the potential benefit of new therapies derived from nanotechnology, the effects of nanomaterials on biological systems, and the interaction of such nanomaterials with biological systems." This provision mirrors the Nanotechnology Regulatory Science Act of 2011 introduced by Sens. Ben Cardin (D-MD) and Mark Pryor (D-AR) last year, which stalled after its introduction in the Senate.

Nanomaterials utilize nanotechnology--manipulation of matter on the atomic and molecular scale. Nanomaterials, measured in billionths of a meter, range from 1- 100 nanometers (nm) and are used in a range of products, from paint and sunscreen to drugs and cosmetics. In 2010, the National Science Foundation estimated that nanotechnology-based products and manufacturing would add 2 million jobs and $1 trillion dollars in revenue to the world economy by 2015. These nanoproducts have different physical, chemical, and biological properties than conventionally-scaled materials, and some speculate that these properties may involve unknown risks to humans and our environment.

The importance of nanomaterials has been recognized for some time. President Clinton advocated nanotechnology research, and President George W. Bush increased funding for nanotechnology development in 2003 with the passage of The 21st Century Nanotechnology Research and Development Act. However, this will be the first time that Congress has mandated that FDA study nanotechnology to evaluate the safety and toxicity of nanomaterials in consumer goods and products.

On July 2, the much heralded new European Pharmacovigilance legislation came into operation. This new piece of legislation is aimed at promoting and protecting public health by strengthening the existing Europe-wide system for monitoring the safety and benefit-risk balance of medicines and provides regulators with a range of new or improved tools to ensure that patients are not exposed to unnecessary risks when taking medicines.

Highlights of the new legislation include:

• The establishment of a new scientific committee, the Pharmacovigilance Risk Assessment Committee ("PRAC").


• A clarification of the roles and responsibilities leading to more robust and rapid European Union ("EU") decision-making.


• The engagement of patients and healthcare professionals in the regulatory process.


• An improved collection of key information on medicines, e.g., through risk-proportionate, mandatory post-authorization safety and efficacy studies.


• More transparency and better communication.

Written by Howard E. Rosenberg, Ph.D.

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The first meeting of the new key committee, PRAC, will be on July 19 and 20, 2012. PRAC's mandate includes, among other things, "All aspects of the risk management of the use of medicinal products including the detection, assessment, minimization and communication relating to the risk of adverse reactions, having due regard to the therapeutic effect of the medicinal product, the design and evaluation of post-authorization safety studies and pharmacovigilance audit".

In a June 11, 2012 letter, Representative Elijah Cummings of Maryland and Senator John Rockefeller of West Virginia summarized growing concerns about the "gray market" for prescription pharmaceuticals. The pharmaceutical gray market consists of the sale of prescription drugs through distribution channels that, although legal, are unofficial and generally not intended by the products' original manufacturers. The recipients of the letter included Senators Tom Harkin and Michael Enzi as well as Representatives Fred Upton and Henry Waxman. All four Congressmen are working on legislation that would reauthorize the FDA's user-fee programs. That same legislation also addresses pharmaceutical supply chain security, which was the focus of the June 11 letter. It provided the four Congressmen with information obtained from a recent investigation, launched by Representative Cummings and later joined by Senators Rockefeller and Harkin, into the pharmaceutical gray market and its impact on the cost and safety of high-demand but short-supply drugs.

Representative Cummings began his investigation in October 2011 in response to claims by hospitals and health care organizations that some pharmaceutical companies were taking advantage of drug shortages. "Hospitals and patient groups reported numerous examples in which patient care was compromised because hospitals could not obtain adequate supplies [at reasonable prices] of ... [critical] drugs through their normal distribution networks." The investigation initially consisted of information request letters sent by Representative Cummings to five companies that marketed drugs to hospitals. He sought information about the cost and source "of five injectable drugs that were at the time facing national shortages, according to FDA." The study later expanded to include information requests from more than 50 prescription drug manufacturers, distributors, and pharmacies. At least one company refused to disclose its source and price information voluntarily.

Written by Dario A. Machleidt

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The investigation uncovered substantial evidence that many pharmaceutical companies engaged in questionable practices with respect to drugs in short supply. Rather than travel from manufacturer to distributor and then to dispenser, which is the intended distribution chain for prescription pharmaceuticals, short-supply drugs move through much longer gray market distribution channels. Such channels consist of numerous companies that purchase pharmaceuticals and then resell them at inflated prices. This process can happen several times, and on each occasion, the price of the pharmaceuticals increases. "The markups ... bear little or no relation to the companies' cost of purchasing, shipping, or storing the drugs."

Senate Update: On June 26, the Senate Okayed the reconciled user-fee reauthorization bill that had passed the House last week. Again, there was significant bipartisan support for the legislation, which bill passed by a 92-4 margin. All that remains is President Barack Obama's signature, which looks certain to occur before the July 4 goal that Congress had set for the passage of this legislation. While the President's signature will finalize a bill that has been over a year in the making, Thursday's Supreme Court ruling on the constitutionality of the Patient Protection and Affordable Care Act could have an immediate effect on the user fee bill. Most notably, if the Supreme Court strikes the entire healthcare bill, the status of the biosimilar approval pathway would be in question. This, in turn, could lead to some questions about the $128 million dollars the biosimilars companies are scheduled to pay FDA over the next five years.

On June 20, the House passed a reconciled user-fee reauthorization bill by a more-than-two-thirds-voice vote. Earlier in the week, members from the House and Senate ironed out the details of a reconciled user-fee reauthorization bill for FDA. The House passed its version, the Food and Drug Administration Reform Act (H.R. 5651), earlier this month (last discussed here), and the Senate approved its version (S. 3187) in late May (last discussed here). Both versions contained near identical reauthorized the user fee programs for brand-name drugs and medical devices and created new user-fee programs for biosimilars and generic drugs. There were, however, a number of differences that had to be addressed.

Written by Scot B. Pittman

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Among the casualties from the reconciled version was an effort to impose stricter controls for potentially abusive prescription drugs. Congress rejected the Senate's proposal that would have: (1) required patients seeking refills for hydrocodone-combination products to obtain new prescriptions; (2) required a higher level of security for transportation and storage of the drugs; and (3) increased penalties for misusing the drugs. Pharmacists and drug stores opposed these measures, claiming they would make it more difficult from those in pain to get access to their medications and that pharmacies would face expensive administrative obligations under the proposal.

Last Wednesday, the House of Representatives passed the Food and Drug Administration Reform Act (H.R. 5651), which reauthorizes the user fee programs for brand-name drugs and medical devices and creates new user-fee programs for biosimilars and generic drugs. Like its counterpart in the Senate (previously discussed here), the Bill has significant bipartisan support, which is evidenced by the 387-5 vote.

The user fee provisions of the House version are almost identical to those on the Senate Version. Drug and devices makers will have to pay FDA $6.4 billion over five years to help finance the evaluation and review of their products. Again, brand-name drug companies will pay $4.1 billion, generic drug companies will pay $1.6 billion, device makers will pay $609 million, and biotechnology companies will pay $128 million. In exchange for the user fees, FDA will be required to meet certain performance goals throughout the five years. These performance goals are intended to decrease the average review time for FDA approvals of drugs, devices, and biosimilars.

Written by Scot B. Pittman

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The House's Bill also has provisions outside the user-fee arena. Of particular importance, the bill:

• Provides for increased oversight of medical devices by pushing FDA to institute an electronic monitoring system and requiring post-market studies of certain medical devices.


• Removes the requirement that every U.S. drug manufacturing facility be inspected every two years and increases FDA's discretion to inspect more foreign manufacturers.


• Requires mandatory reporting of potential drug shortages.


• Increases the maximum penalty for drug counterfeiting from 3 to 20 years in prison.


• Allows FDA to relax the clinical trial standards for new medicines that address life-threatening diseases.


• Requires that FDA provide reasons for denying medical implants within thirty days of issuing a rejection.

In a recent 43-54 vote, the U.S. Senate defeated a proposed amendment to the FDA Safety and Innovation Act (S.3187), which we previously reported on here, that would have allowed Americans to purchase drugs from Canadian pharmacies. The Amendment, proposed by Sen. John McCain (R-Ariz.) sought to lower the cost of prescription drugs for Americans.

In the days leading up to the vote, McCain had been critical of the pharmaceutical industry for lobbying the Senate to defeat the Amendment. "In a normal world, this would probably require a voice vote, but what we're about to see is the incredible influence of the special interests, particularly pharma, here in Washington, that keeps people who cannot--that have to make a choice between eating and medicine," McCain said. "So what you're about to see is the reason for the cynicism that people have for the way we do things in Washington. Pharma, one of the most powerful lobbies in Washington, will exert its influence again at the expense of average, low income Americans who, again, will have to choose between medication and eating."

Written by Kenneth J. Szeto

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While the Amendment was defeated, several fellow Republicans voiced support for McCain's proposal. Sen. Charles Grassley (R-Iowa), a proponent of importation of Canadian pharmaceuticals, reasoned that allowing importation would provide economic incentives. "I have always considered drug importation a free-trade issue," Grassley said. "Imports create competition and keep domestic industry more responsive to consumers. If Americans could legally and safely access prescription drugs outside the United States, then drug companies will be forced to re-evaluate their pricing strategies."

On May 24, the Senate passed the FDA Safety and Innovation Act (S.3187), which reauthorizes the user fee programs for brand-name drugs and medical devices and creates new user-fee programs for biosimilars and generic drugs. The Bill (previously discussed here), sponsored by Sens. Mike Enzi (R-Wyo.) and Tom Harkin (D-Iowa), passed by a 96-1 vote. The sole dissent came from Sen. Bernard Sanders (I-Ver.), who said that the Bill did "far too little" to address the high prices Americans pay for prescription drugs."

In terms of user fees, the Bill will require drug and devices makers to pay FDA $6.4 billion over five years to help finance the evaluation and review of their products. Specifically, brand-name drug companies will pay $4.1 billion, generic drug companies will pay $1.6 billion, device makers will pay $609 million, and biotechnology companies will pay $128 million. In exchange for the user fees, FDA will be required to meet certain performance goals throughout the five years. These performance goals are intended to decrease the average review time for FDA approvals of drugs, devices, and biosimilars.

Written by Scot B. Pittman

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User fee agreements are not the only topic addressed in the now-passed Bill. The Bill contains provisions addressing:

• Increased inspection of foreign drug manufacturing facilities and the ability for U.S. border agents to turn away drugs from companies that have denied or delayed FDA inspections.


• Mandatory reporting of potential drug shortages.


• Protection of confidential information received from foreign government agencies relating to drug inspections.


• Independent assessment and evaluation of FDA's review of drug and biologic applications.

Patent challenges prior to product marketing are part of the landscape for applicants filing generic drug applications (Abbreviated New Drug Applications or "ANDAs"), new drug applications under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act ("505(b)(2) NDAs"), and now biosimilar applications. As with all other products, patent challenges also can be made subsequent to market entry of an allegedly infringing item. On September 16, 2011, President Obama signed into law the Leahy-Smith America Invents Act ("AIA"). The AIA makes significant changes to United States patent law, such as creating new post-grant procedures in the United States Patent and Trademark Office ("USPTO"). Leahy-Smith America Invents Act, Pub. L. No. 112-29, §19(b ), 125 Stat. 284, 331-32 (2011). Congress is now reportedly considering making additional changes to the AIA that could impact how applicants pursue their options to challenge patents.

Relevant here, the AIA creates a new post-grant review procedure whereby within nine months of a patent's issuance, a person other than the patent owner may challenge the validity of the patent. 35 U.S.C. §§ 321-329. The Director of the USPTO may authorize the initiation of post-grant review if the Director is satisfied that the information set forth by the petitioner, if not rebutted, demonstrates that it is more likely than not that at least one of the claims challenged in the petition is unpatentable. Id. § 324. Through this procedure, Congress seeks to encourage early resolution of patent validity challenges.

Written by Jonathan Herstoff

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However, of concern to some is an estoppel provision in the post-grant-review statute. Specifically, if the USPTO reaches a final written decision with regard to the patent's validity, the petitioner is thereafter estopped from raising invalidity arguments in litigation "that the petitioner raised or reasonably could have raised during that post-grant review." Id. § 325(e)(2). In a recent Congressional hearing, Robert Armitage, General Counsel for Eli Lilly & Co., expressed the concern that the "reasonably could have been raised" language could potentially cause the post-grant review provision to become a "dead letter." Mr. Armitage explained that this estoppel is "so draconian in character that it would be highly problematic for a patent challenger to use." This is because a post-grant review proceeding, unlike an inter partes reexamination, is not limited merely to issues of novelty and non-obviousness based upon published materials, but instead can be used to challenge the patent's validity on any ground. By way of example, the post-grant review procedure can be used to challenge lack of utility or patentable subject matter under section 101, public use under section 102, or sufficiency of the specification under section 112. By estopping petitioners from later asserting invalidity on grounds that "reasonably could have been raised," rather than limiting the estoppel to grounds that were actually raised during the post-grant review, Mr. Armitage expressed concern that challengers would find the post-grant review procedure too risky. Therefore, Mr. Armitage argued, accused infringers would choose to mount its validity challenges in court rather than in the USPTO.