Managing attorney departures at a law firm can be a daunting task, especially if a departing attorney has a book of business and takes clients along when leaving the firm. Although it can be difficult for the firm, a practice area and, often, the attorneys who remain, it has been a fairly rare occurrence in the past, particularly for equity partners.
That rarity is changing at an increasing rate as baby boomers have phased out of the workforce, leaving millennials to become the largest percentage of the U.S. employee pool. In fact, millenials are expected to make up 75 percent of our nation’s workers by 2030. They bring a different attitude regarding their careers and longevity with a particular company than we have become accustomed to, especially in a law firm culture.
As most business professionals are aware, it takes much more money to hire and train a new employee than to simply retain astute professionals. And, with millennials’ perceptions of how office life should be, law firms will need to pay much more attention to those ideals in order to keep excellent talent, which is imperative for a successful firm.
So, what do millennials expect in the way of work life? This is a frequently discussed topic in the media, at companies and within law firms throughout the world. I’ve read several good articles on the subject lately and will share from one in particular written by Jeff Fromm for Forbes magazine.
Fromm, who consults on the “Millennial Generation” or “Gen Y,” often speaks about the attributes these employees want from their companies, and it’s not all about salary and benefits.
Although there is no precisely defined birth date range for this segment of the population, it is often described as people reaching young adulthood around the year 2000. These individuals were raised with technology and gadgets at a time when developing a child’s self esteem and individuality was a predominant theme in educational and behavioral methodologies.
Other attributes discussed include:
- Millenials want to be a part of “the process.” They have strong entrepreneurial tendencies and desire growth. If they do not feel they are growing at a company or firm, they are much more likely to move to another than their older peers.
- Millenials prefer to be coached and mentored instead of “bossed” or just told what to do. Interestingly, this does not mean that they want to work independently with little supervision; it’s quite the opposite. They actually prefer more interaction and feedback than the typical baby boomer.
Conforming to the Millennial Way of Life
So, what does this mean for law firms and particularly law firm management, practice area leaders and the like? It means an almost 180-degree change in the way associates have been managed in the past.
Millennial attorneys will want to be part of the process from the beginning. They are not content to receive a directive such as, “Research a particular point of law and prepare an annotated brief on the subject.” Instead, they want to know about the case, why the research is important for the case and how it will be used to benefit the case.
Likewise, instead of just receiving a red-lined document back with few instructions regarding how to improve the work, millennials will prefer to discuss how the work product was perceived, why changes were made and how the changes make the information better in relation to the case. They want to learn and grow from the process; i.e., from performing their work.
These types of processes will, indeed, make for a better learning experience for associates, enhance their skills and grow more capable team members. However, this approach will also take more time and patience on the leader’s behalf. Just a “do as I say” directive, without an explanation of why to do it, doesn’t sit well with a millennial. Over time, such treatment will erode the associate’s desire to stay at the firm.
Remember, these younger attorneys need to feel included and that they are growing and making a difference to be motivated and engaged. Just receiving a good paycheck and the chance at equity ownership isn’t a long-term motivator for them. That really is a cultural change in how many, if not most, young associates used to be trained to be the future leaders of a law firm.
Also, consider that dramatic change in a firm’s processes can’t happen all at once, or else the culture will implode. Instead of instituting entirely new training and evaluation programs, try adding in or updating your firm’s processes. As a start, adding a strong associate mentoring program with real checks and balances will go a long way toward including associates in the process. And know that opening up the lines of communications top-down and bottom-up at any organization also will result in better operations and more-satisfied employees. If good communication isn’t standard at your firm, offer training across the board.
The impact the changing workforce has had on law firms isn’t just beginning … it is happening and must be addressed now to avoid major business operational issues for law firms. Take note of this growing trend and make the necessary changes to ensure your firm has the best talent today and in the future.
Last November, President Obama signed into law an amendment to the Federal Civil Penalties Inflation Adjustment Act (Sec. 701 of Public Law 114-74). The amendment requires federal agencies to adjust the maximum civil penalties for violations of the laws they enforce no later than July 1, 2016.
On June 29, 2016, the Federal Trade Commission revised its Rule 1.98 to reflect the new higher levels for maximum civil penalties. The new maximums will apply to civil penalties assessed by the FTC after August 1, 2016. They include civil penalties for violations that occurred prior to the effective date. (Going forward, the maximums will be adjusted for inflation each January.)
Of particular significance to corporations that acquire, sell, or merge with other businesses, the penalties for violating the premerger reporting and waiting requirements under the Hart-Scott-Rodino Act have been increased from $16,000 per day to $40,000 per day, an increase of 150%.
As most businesspersons know, under the HSR Act, the parties to mergers and acquisitions that meet the dollar thresholds of the Act and are not otherwise exempt must file a premerger notification form, pay the appropriate fees, and wait 30 days (or possibly more) prior to closing the transaction. Failure to file the required notification or to observe the mandatory waiting period will subject the parties to civil penalties, which are now significantly higher.
Note that for continuing violations of the HSR Act, each day is a separate violation. As a result, the maximum civil penalty may be multiplied by the number of days for each violation of the applicable statute or order. (For example, a company or individual that is required to report but fails to do so for one year would be facing a fine of up to $14.6 million under the new levels.)
But statutory maximums are not automatically imposed. Before levying a civil fine, the Commission considers various factors in determining whether the maximum should be mitigated. Those factors include:
Harm to the public
Benefit to the violator
Good or bad faith of the violator
The violator’s ability to pay
Deterrence of future violations by this violator and others
Vindication of the FTC’s authority
Why does it happen that a company or individual fails to make the required HSR filing? The FTC reports that it frequently sees two specific scenarios:
Company executives who acquire company voting shares through exercising options or warrants may fail to aggregate the value of such shares with the value of the company shares they already hold and therefore do not realize that they have satisfied the HSR size of transaction threshold test.
Sometimes companies or individuals who have qualified for the “investment-only” exemption in the past may erroneously continue to rely on that exemption even though they have become active investors in the company or their holdings in the company have increased above 10%.
Other recurring scenarios can also trip up acquirers. For example, companies may not realize that patent and other IP licenses are in certain circumstances treated as the acquisition of an asset for HSR Act purposes.
© 2016 Schiff Hardin LLP
This week, Congress will vote on a short-term Federal Aviation Administration (FAA) authorization that will reauthorize FAA programs through September 30, 2017. The short-term authorization includes some policy changes, but avoids many significant changes the House and Senate had been pursuing. While the Senate passed a long-term FAA reauthorization bill this year, the FAA Reauthorization Act of 2016 (S. 2658), the House did not take up the bill reported out of the Transportation and Infrastructure Committee, the Aviation Innovation, Reform, and Reauthorization (AIRR) Act of 2016 (H.R. 4441). Both the House and Senate are expected to pass the highly-negotiated short-term extension, before FAA authorization expires on July 15.
The short-term extension does include provisions related to safety and security, as well as some unmanned aircraft systems (UAS) provisions. Among the policy changes, the bill will increase funding for bomb-sniffing dog teams, direct FAA to detect and mitigate UAS operation near airports, and require airlines to refund baggage fees if luggage is delayed or lost, among other provisions.
It appears that House Transportation and Infrastructure Committee Chairman Bill Shuster (R-PA) successfully kept many policy changes out of the short-term extension, in order to keep pressure up on Congress to pass a long-term extension next year that includes Chairman Shuster’s controversial air traffic control reform proposal.
This Week’s Hearings:
On Tuesday, July 12, the Senate Commerce, Science, and Transportation Subcommittee on Surface Transportation and Merchant Marine Infrastructure, Safety, and Security will hold a hearing titled “Intermodal and Interdependent: The FAST Act, the Economy, and Our Nation’s Transportation System.” The witnesses will be:
Patrick J. Ottensmeyer, Chief Executive Officer, Kansas City Southern Railway Company;
Major Jay Thompson, Arkansas Highway Police; President, Commercial Vehicle Safety Alliance;
David Eggermann, Supply Chain Manager, BASF; and
Stephen J. Gardner, Executive Vice President and Chief of NEC Business Development, Amtrak.
On Wednesday, July 13, the Senate Commerce, Science, and Transportation Subcommittee on Space, Science, and Competitiveness will hold a hearing titled “NASA at a Crossroads: Reasserting American Leadership in Space Exploration.” The witnesses will be:
William H. Gerstenmaier, Associate Administrator of Human Exploration and Operations, NASA;
Mary Lynne Dittmar, Executive Director, Coalition for Deep Space Exploration;
Mike Gold, Vice President of Washington Operations, SSL;
Mark Sirangelo, Vice President of Space Systems Group, Sierra Nevada Corporation; and
Professor Dan Dumbacher, Professor of Engineering Practice, Purdue University.
On Tuesday, July 12, the Senate Foreign Relations Subcommittee on Department and USAID Management, International Operations, and Bilateral International Development will hold a hearing titled “Public-Private Partnerships in Foreign Aid: Leveraging U.S. Assistance for Greater Impact and Sustainability.” The witnesses will be:
Eric G. Postel, Associate Administrator, U.S. Agency for International Development; and
Daniel F. Runde, William A. Schreyer Chair and Director, Project on Prosperity and Development, Center for Strategic and International Studies.
© Copyright 2016 Squire Patton Boggs (US) LLP
It’s no surprise when laid-off lawyers or law school grads who can’t find a job hang out their own shingles, but there are even more attorneys heeding the siren call to start up their own firm in order to achieve a better work-life balance (if that even exists).
You may feel at times that starting a law firm is counterintuitive when it comes to finding balance in your life. However, if you build it right, running your own firm can be a highly satisfying way to employ yourself and serve clients the way you’ve always wanted.
I have personally trained over 18,000 lawyers on how to manage and market their firms more efficiently and effectively. I have probably helped more attorneys break the seven-figure barrier in revenues than anyone else. I’m not telling you this to brag, but to share with you the keys to breaking the seven-figure barrier based on my experiences.
Key #1: Run your law firm like a business.
You studied the law as a noble profession, but to break the seven-figure barrier, you must run your law firm like a business. As a solo practitioner or the owner of a small law firm, your primary focus – after gaining competency as an attorney – is to understand and apply the key principles of business development, operations, management and law firm marketing every single day. There are 10 major parts every successful law firm owner must focus on – in this order:
Marketing: The purpose of marketing is to generate leads. There are a wide variety of ways to do this. All of them work, but they are not always suited for all situations, practice areas or attorneys. Find three-five different ways that work for you and use them frequently. Not every attorney will be a top Rainmaker, but everyone can do something to grow and market his or her practice.
Sales: The purpose of sales is to close the deal or sign up the client. Once you start generating leads, you must become better at getting prospects to become paying clients.
Services: Once you have become proficient at generating leads and closing the deal, you must perform the services for the client. When you fix your marketing, then you have a sales problem. When you fix your sales problem, then you have a services problem. See how this works?
Staff: When you become successful at marketing and sales, eventually you will also need more staff to do the work. You cannot hire just any staff; they must be the right staff for you. What kind of culture do you want your firm to have? Who will best fit that culture? Develop a list of qualities and characteristics you need your team members to have.
Systems: Policies, procedures and systems allow you to scale to the next level. Without written systems you cannot scale your business. You will hit a breaking point. It may be at half a million or more, but eventually you will experience a lot of unnecessary pain and suffering because you didn’t invest in creating written policies, procedures and systems for your law firm. You need written systems for every major part of your business. From marketing and intake to money and metrics, it all must be logically written down so even a brand new team member who knows nothing about your business can follow it.
Space: After you start hiring the right staff because you have more clients to serve, eventually you will need more office space to house them. Far too many attorneys get caught up in renting a much bigger or nicer space than they can afford in an attempt to “keep up with the Joneses” or give off the appearance of being more successful than they are. The pleasure you may gain from a fancy office is nothing compared with the worry of making those big payments every month. Don’t strap yourself with too many financial obligations and be careful about signing longterm agreements, especially when you’re just starting off.
Money: Very few attorneys went to school to become a bookkeeper or an accountant, but to manage a growing business you must know how to manage your money. You need to know the basics of finances for small business, from reading a profit and loss statement to analyzing your cash flow. Being an owner means other people are depending on you to manage the money wisely.
Metrics: To consistently break a million dollars per year in revenues, there are over a dozen numbers you must be monitoring and measuring consistently. Here are a few of them – unique website visitors each month, leads per month, average cost per lead by marketing channel (PPC, SEO, TV, radio, print, etc), appointments your team sets per month, show up rate to your appointments, conversion rate for initial consultation by attorney, average cost per client acquisition by marketing channel, cost of goods sold (COGS) per practice area and profit margin per practice area. This is not a comprehensive list, but if you know, measure and track each of those metrics every month, you’re on your way to comprehensively monitoring your business.
Strategy: While having a great strategy is necessary, most attorneys spend too much time developing a strategy and too little time implementing the strategy! Get some leads in the door. Make the sale. Collect the money. Do great work. Obtain some referrals. Wash, rinse and repeat! Then work on your next level strategy.
Self: Upgrading yourself is the last, but most important step. You need to read business growth books or take classes or seminars if that fits your style of learning better. Hang around other successful business owners. Join a mastermind group of successful attorneys. Push yourself outside of your comfort zone. You will never build a multimillion-dollar law firm by staying inside your comfort zone.
Key #2: Focus on a Niche
When you’re in the startup phase (from $0 to about $250,000), you face a never-ending challenge of taking whatever business comes in through the door in order to pay the bills or concentrating on one area to build a niche practice. It becomes a question of short-term focus versus longterm survival – and I realize that most solos need to balance both in order to make it.
However, the faster you can start focusing on one to two practice area niches, the faster you will go from having a job ($0 to $500,000) to creating a practice ($500,000 to $1M). When people see you as a jack of all trades (the generalist approach), they also perceive you as the master of none. People will pay more for a specialist because they see you as an expert. People will refer more to a specialist because they aren’t afraid of you stealing their clients or competing with them. Contrary to popular belief, this approach does not limit you. It helps to focus your marketing and business development efforts.
There are many ways to select a niche, but it must be small enough to be realistic, yet big enough to have enough potential clients in it. For example, being No. 1 divorce attorney in all of the Phoenix metro area is not realistic. There are far too many entrenched and successful competitors to ever achieve this. However, you could be the No. 1 divorce attorney for entrepreneurs and small business owners in the East Valley. Here are a few other ways to select a niche:
ServiceNiche: DUI attorney for licensed health care professionals; estate planning and asset protection for doctors and dentists; tax attorney for the self-employed; business transactional lawyer for real estate investors; business immigration law for the hi-tech industry; business law for health care providers; and IP and trademark lawyer for small business owners.
Industry Niche: Technology, agriculture, doctors, transportation, restaurant owners, manufacturing, construction, energy, or real estate development.
Geographic Niche: Phoenix, Gilbert, Tempe, Chandler, Scottsdale, or the East Valley.
Specialty Market Niche: Privately held companies, Fortune 500, physicians, white collar executives, blue collar construction workers, franchise owners, bicycle accidents, fitness centers, Spanish-speaking clients, developers, or commercial lenders.
Review your top 10 client list (either by amount of revenue/fees generated or in terms of how much you enjoy working with them). Then, look for any similarities. It may not be apparent at first, but keep asking questions and you will find it. Building a niche around a solid client base is one of the fastest ways to differentiate yourself.
Federal courts correct bad litigation behavior, eventually.
People take being sued personally, and lawsuits can take an emotional toll on defendants, whether as an individual or as a representative of an employer. Anger and frustration always lead to the same questions: Can we sanction them for lying? Can I get my fees (or my insurance deductible) back? Won’t the court do something?
Federal courts can and do sanction attorneys for lying, failing to investigate claims and “posturing” a case to get a settlement. But sanctions are reserved for the worst offenders, and it often takes multiple violations before attorneys’ fees, costs or other monetary fines are imposed.
A Case in Point
In Keister v. PPL Corp., U.S. District Court Judge Matthew W. Brann of the Middle District of Pennsylvania directed Attorney X to pay opposing counsel’s fees and costs in excess of $103,000.
What did Attorney X, a solo practitioner in a rural Pennsylvania county, do to potentially warrant more than $100,000 in sanctions? In a 55-page Opinion (which supplemented a 48-page summary judgment opinion), the court explained that Attorney X:
Engaged in “litigious necromancy” by “conjuring” facts to support the age discrimination claim of his client, Ernest Keister, a 34-year employee of PPL and a union member, who worked in a unique position (i.e., his job could not be compared with others) and who was neither fired nor replaced by a younger worker.
Proceeded with the claim, in the absence of any evidence that Keister’s age was a factor in (1) his employer’s 2011 denial of a request to reevaluate his job title, duties, salary and management role or (2) the union’s decision not to support moving Keister’s position from the collective bargaining unit.
Alleged that Keister faced “ongoing” discrimination in order to avoid dismissal of his client’s lawsuit, despite the complete absence of evidence that anyone insulted or otherwise mistreated Keister.
Intentionally asserted claims that were directly contradicted by Keister’s testimony, failed to comply with local motion practice by failing to admit undisputed facts, and submitted documents that were “calculated” to confuse the court and opposing counsel.
Failed to investigate the facts and observe procedural requirements, including following the union’s grievance process and filing the federal action within the applicable limitations period (as established by the EEOC’s denial of a claim filed by Attorney X).
Amended the complaint for the sole purpose of forcing a mediation to settle a valueless case.
Engaged in this conduct after receiving two (non-monetary) Rule 11 sanctions in other cases as well as a public reprimand by the Pennsylvania Disciplinary Board.
Judge Brann repeatedly stated that Rule 11 sanctions are not a “general fee-shifting device” and are not available merely because one side was successful. Sanctions were imposed because Attorney X “is simply not getting the message,” despite prior federal court and state bar disciplinary reprimands. The court held that the “least severe sanctions adequate to serve the purpose” of punishing Attorney X’s conduct and deterring it in the future was to award all costs and fees to the defendants.
The Keister ruling suggests that a Rule 11 motion should only be filed when it can be proven that opposing counsel did not have the facts to back up a client’s claims and made an effort to hide the absence of a factual dispute. However, even when such proof can be found, federal courts will first award non-monetary sanctions for an attorney’s first and even second offense, as happened here with Attorney X.
When facing a litigation opponent who lies to the court, it is best to prove the lie, document it, and then decide the most appropriate way to bring it to the attention of opposing counsel and, if appropriate, the court or disciplinary authorities. The work might not yield monetary sanctions in the first instance, but the federal courts may not act to stop abusive litigators until presented with multiple examples of bad conduct.
In the short run, it may seem more cost-effective to ignore an opponent’s abusive actions because a judicial reprimand does not return money to the client. But in the long run, the federal courts will not protect a client from future bad acts or additional lawsuits until an attorney’s repeated pattern of deception is established.
© 2016 Wilson Elser
Will Brexit Undermine U.K. Participation in the General Data Protection Regulation and the U.S./E.U. Privacy Shield?
The June 23, 2016 Brexit referendum outcome in the U.K. does create uncertainty about whether the U.K. will continue to follow EU data protection laws, including implementation of the E.U.’s new General Data Protection Regulation (“GDPR”), scheduled to become effective on May 25, 2018. Furthermore, the recently negotiated new U.S./E.U. Privacy Shield, intended to replace the E.U.-invalidated Safe Harbor, faces an uncertain future in the U.K. as well if it is not an available framework for multinational businesses to do business in the U.K. For example, Microsoft stated in an open letter in May, 2016 to its 5000 U.K. employees before the Brexit vote that the U.K.’s EU membership was one of the factors that attracted Microsoft to make investments in the U.K., including in a new data center. One important future signal will be whether the U.K. opts to join the European Economic Area, or otherwise maintains significant trade with the EU, in which case the U.K. would necessarily need to comply with EU privacy regulations. If not, the U.K. would still need to develop its own data protection network. However, because at least two years must elapse before the U.K. can formally exit the EU under Article 50 of the Treaty of Lisbon, and even that two year period does not commence until formal notice is given, both the GDPR (in May 2018) and the Privacy Shield are likely to be in place in the U.K. before any actual exit from the EU occurs. And many observers believe that any law that Britain adopts will likely be similar to the GDPR, since a non-member country’s data protection regime must be deemed “adequate” by the EU for businesses in that non-member country to exchange data and to do business within the EU. In short, nothing is going to change immediately, and because Brexit won’t likely be completed for years, the Privacy Shield could well be implemented in the U.K. for personal data transfers from the U.K. to the U.S. well before actual withdrawal is completed. It also may take years to negotiate and complete agreements, and enactment of alternative U.K. data privacy laws.
In Amgen v. Apotex, the Federal Circuit rejected Apotex’s arguments that the 180-day pre-marketing notice requirement does not apply to biosimilar applicants who participated in the “patent dance” process of the Biologics Price Competition and Innovation Act (“BPCIA”), expanding on its decision in Amgen v. Sandoz that 42 USC § 262(l)(8)(A) is a mandatory, stand-alone requirement. The Supreme Court has asked the Solicitor General to weigh in on whether it should grant certiorari in Amgen v. Sandoz. Will this decision make the Court more or less likely to review the Federal Circuit’s interpretation of this important biosimilar statute?
The Biosimilar Patent Dance
The biologic product at issue is Amgen’s Neulasta® (pegfilgrastim) product. Amgen describes pegfilgrastim as “a recombinantly expressed, 175-amino acid form of … human granulocyte-colony stimulating factor (‘G-CSF’) conjugated to a 20 kD monomethoxypolyethylene glycol (m-PEG) at the N-terminus.” After Apotex filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Neulasta® (pegfilgrastim), the parties followed several steps of the patent dance procedures, which resulted in Amgen asserting U.S. Patent Nos. 8,952,138 and 5,824,784 in the U.S. District Court for the Southern District of Florida. Those infringement claims are being litigated, although the ‘784 patent has been dropped since it expired.
The Biosimilar 180-Day Notice Dispute
As noted in the Federal Circuit decision, Apotex sent Amgen a letter on April 17, 2015, stating that it was “providing notice of future commercial marketing pursuant to 21 USC § 262(l)(8)(A), though Apotex lacked (as it still lacks) an FDA license.” Amgen sought a preliminary injunction to “require Apotex to provide … notice if and when it receives a license and to delay any commercial marketing for 180 days from that notice.” The district court granted that motion, citing the Federal Circuit decision in Amgen v. Sandoz that notice cannot be given before the biosimilar product is approved. Apotex appealed.
The Federal Circuit Decision
The Federal Circuit decision was authored by Judge Taranto and joined by Judge Wallach and Judge Bryson. The bottom line of the court’s decision is this:
The [§ 262(l)](8)(A) requirement of 180 days’ post-licensure notice before commercial marketing … is a mandatory one enforceable by injunction whether or not [the biosimilar applicant provided a copy of its biosimilar application to the reference product sponsor in accordance with § 262(l)(2)(A)].
As it had in Amgen v. Sandoz, the court emphasized the “categorical” language used in the statute:
The subsection (k) applicant shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the biological product licensed under subsection (k).
The court noted that § 262(l)(8)(A) “contains no words that make the applicability of its notice rule turn on whether the applicant took the earlier step of giving the [§ 262(l)](2)(A) notice that begins the § 262(l) information-exchange process,” and stood by its holding in Amgen v. Sandoz that the statute is “‘a standalone notice provision’ not dependent on the information-exchange processes that begin with [§ 262](l)(2)(A).”
Further justifying its decision, the court emphasized that the BPCIA created a “two stage” patent litigation process, and found that the 180-day pre-marketing notice is essential to the second stage. In that regard, it explained that the 180 day period “gives the reference product sponsor time to assess its infringement position for the final FDA-approved product as to yet-to-be-litigated patents,” and “gives the parties and the district court the time for adjudicating such matters without the reliability-reducing rush that would attend actions for requests for relief against immediate market entry that could cause irreparable injury.”
The court also considered and rejected Apotex’s arguments based on the relationship between § 262(l)(8)(A) and other sections of the BPCIA, such as § 262(l)(9)(B) and § 262(l)(9)(C), which give the reference product sponsor the right to bring delcaratory judgment actions when the biosimilar applicant fails to follow some or all of the patent dance procedures.
Requiring 180-Days Notice Does Not Extend The 12-Year Exclusivity Period
Perhaps Apotex’s most compelling argument was that the court’s interpretation of 262(l)(8)(A) effectively gives original biologic products 12.5 years of exclusivity rather than the 12 years provided by Congress in § 262(k)(7). The court dealt with this argument in two ways. First, the court noted that “§ 262(k)(7) by its terms establishes the 12-year date only as an earliest date, not a latest date, on which a biosimilar license can take effect” (emphasis added). Second the court hypothesized that the FDA could implement the 12-year exclusivity period by “issu[ing] a license before the 11.5-year mark and deem[ing] the license to take effect on the 12-year date.” In that case, the 180-days notice could be given in time to expire when the 12-year exclusivity period expires.
(The FDA has not yet issued guidance or regulations on this issue, and is not bound by the Federal Circuit decision. Indeed, the U.S. Court of Appeals for the District of Columbia is the appellate court most likely to review the FDA’s interpretation of § 262(k)(7).)
What Will the Supreme Court Do?
As noted above, the Supreme Court has asked the Solicitor General to weigh in on whether it should grant certiorariin Amgen v. Sandoz. Since this decision is consistent with that one, it is not clear that it will make the Court more or less likely to hear the case. The opinion here provides a detailed summary of the patent litigation procedures of the BPCIA and the related sections of the patent infringement statute, 35 USC § 271. That analysis may make the Court more comfortable with the Federal Circuit’s interpretation, or could lead the Court to try its own hand at deciphering a statutory scheme that Judge Lourie characterized as deserving of “a Pulitzer Prize for complexity.”
© 2016 Foley & Lardner LLP