FORUM: Paragraph IV filings and patent protection


Financier Worldwide Magazine

January 2019 Issue

FW moderates a discussion on paragraph IV filings and patent protection between Christopher L. McArdle at Alston & Bird LLP, Sanya Sukduang at Finnegan and Jeanna M. Wacker at Kirkland & Ellis LLP.

FW: What are the key factors that companies need to consider in terms of protecting their patents in today’s business world? How would you characterise the growing risks and threats in this regard?

Sukduang: There are several key factors to consider when protecting Orange Book-listed patents. First, obtaining well-prosecuted patents with claims that can withstand validity attacks beyond those presented during prosecution and can still be infringed is of primary importance. Often, companies take a short-sighted look at prosecution, only to face issues during litigation. Second, companies must retain highly qualified and personable experts early in the process. More often than not, outcomes are dictated by expert credibility in conveying issues of infringement and validity. Finally, do not sweat the small stuff. If companies have hired experienced Hatch-Waxman counsel, they will know what scheduling, discovery and expert issues to contest and those to concede. Follow their advice. The growing risk to companies trying to defend their Orange Book-listed patents from attack is from inter partes review proceedings. Generic companies have tried to tip the balance in their favour by taking two bites at the apple through Hatch-Waxman litigation and at the Patent Trial and Appeal Board (PTAB). There are attempts, however, to curb these activities through recent legislation proposed by Senator Hatch, namely, the Hatch-Waxman Integrity Act of 2018.

McArdle: Pharmaceutical companies need to take intellectual property (IP) seriously. That means hiring an experienced in-house attorney with a solid IP background. On too many occasions, companies mismanage their valuable IP assets by failing to timely file patent applications or inadequately covering their innovations. One of the risks to patents that I have seen make a real impact over the past several years is the patent office’s inter partes review programme, which makes it much easier and less expensive to challenge a patent’s validity at the patent office instead of in court. As a result of inter partes review, many patents that would otherwise have their validity decided by a judge or a jury are being invalidated by the patent office. This system is emboldening accused patent infringers to take their chances with an inter partes petition, when in prior years they might have been more willing to settle their dispute with the patent owner.

Wacker: One of the most important aspects of protecting a company’s products is to plan the patent portfolio early in the product development process. When an applicant files a Paragraph IV (PIV) certification for patents listed in the Orange Book in their initial Abbreviated New Drug Application (ANDA) filing, the patent owner can trigger a 30-month stay preventing the Food and Drug Administration (FDA) from approving the ANDA by filing a lawsuit within 45 days of receiving notice of the PIV filing. This 30-month stay is unavailable for patents listed in the Orange Book after the original ANDA was filed. Absent the stay, the FDA may approve the ANDA as soon as regulatory requirements are satisfied, and the ANDA filer may choose to launch the generic product ‘at risk’ but before the patent issues are resolved. Therefore, it is important for patent owners to understand the regulatory exclusivities that are likely to attach to the product and when an ANDA challenge may first be filed, so that patent applications are filed early enough to ensure that patents are issued and listed in the Orange Book prior to an ANDA challenge. Advance planning of the patent portfolio is also important in order to ensure that patent claims are drafted to allow for maximum protection for a product.

In most instances, it is fairly routine for a patent holder to receive a PIV challenge because generic companies need to file a PIV certification in order to qualify as a ‘first filer’ under the statute.
— Jeanna M. Wacker

FW: In your opinion, how much of an Achilles’ heel is the Abbreviated New Drug Application (ANDA) process and its subset, a Paragraph IV (PIV) certification, for companies looking to protect their patents? How should a patent holder respond when an ANDA is filed?

McArdle: The ANDA process strikes a careful balance between protecting drug development and encouraging lower-cost generic drugs. One of the first things a patent holder needs to consider after receiving a PIV certification is the venue for its suit against the ANDA filer. Patent venue challenges are increasingly common in the wake of last year’s TC Heartland decision, so it is vital for the patent holder to choose an appropriate venue for its suit. Some patent holders will even file so-called ‘protective’ suits in a separate venue – typically where the generic company is incorporated – in order to ensure that at least one of their lawsuits will survive a venue challenge, and preserve an automatic 30-month stay of the FDA approval for the generic drug. Once a patent holder has chosen an appropriate venue, it should start investigating leading experts in the field and meeting with key witnesses to gather relevant facts that will help shape a successful litigation strategy.

Wacker: The ANDA process has been in place for over 30 years, so most of the kinks with the statute have been worked out. For example, 180-day exclusivity periods for first filers used to be patent-specific, so one party could end up with multiple exclusivity periods or multiple filers could obtain exclusivity for different patents. The Medicare Prescription Drug, Improvement, and Modernisation Act (MMA) of 2003 corrected this issue and made the 180-day exclusivity period product specific, so there is only one exclusivity period, regardless of which patents have been challenged and how many filers there are. A patent holder should respond to a PIV certification by asserting the patents it has a good faith belief are valid and infringed within the statutory 45-day period. One consideration for a patent holder is whether to assert all available patents in litigation. For example, a patent holder may choose not to assert secondary patents, such as patents to polymorphs or formulation patents, in order to decrease litigation costs.

Sukduang: The ANDA and PIV process, set forth in the Hatch-Waxman Act, is not an Achilles’ heel, but instead a necessary part of the careful balance between protecting innovative efforts in the pharma space and the entry of generic drugs. When a company receives a PIV notice letter from an ANDA applicant, it should not panic. Assuming it has already hired outside counsel, a plan of action should already be in place for issuing litigation hold notices to inform the appropriate in-house and corporate representatives. Then, companies and their outside counsel should carefully review the letter and accompanying Offer of Confidential Access (OCA), assess the generic’s non-infringement and invalidity positions, determine whether the parties can agree on terms for the OCA so that the ANDA can be produced and, if appropriate, file suit within 45 days of receiving the notice letter to obtain the 30-month stay of regulatory approval of the ANDA.

FW: What factors may determine whether or not a brand will receive a PIV challenge? To what extent is filing a PIV certification now a routine part of how generic companies conduct their business?

Sukduang: Every company holding a new drug application (NDA) should expect to receive a PIV notice letter and so should plan accordingly. With the limited number of NDAs available for challenge each year and the incredibly crowded generic market, NDA holders should expect to receive multiple PIV challenges.

Wacker: In most instances, it is fairly routine for a patent holder to receive a PIV challenge because generic companies need to file a PIV certification in order to qualify as a ‘first filer’ under the statute. Under the Hatch-Waxman Act, the first company to file an ANDA containing a PIV certification receives 180 days of exclusivity from first commercial marketing of the drug. This exclusivity prevents the FDA from approving other ANDAs, absent a forfeiture event. Companies that file an ANDA without a PIV certification do not get the benefit of the 180-day exclusivity, and therefore run the risk of entering the market later than their competitors. However, there are some instances where products are difficult to formulate, where generic companies do not file at all, or take a while to file a PIV certification. Additionally, for products protected by compound patents as well as secondary patents that expire later, many generic companies elect not to challenge compound patents and only certify with respect to the secondary patents or even a subset of the secondary patents.

McArdle: Typically, generic companies carefully analyse whether a PIV challenge has a high enough likelihood of success, or of prompting a favourable settlement before filing. In making this determination, generic companies often weigh the strength of the brand’s patents, potential design-around options, if any, for the generic drug, the expiration dates of the brand’s patents, the costs of litigating the patent challenge in court and the potential value of the drug as a generic. PIV challenges are entirely routine and brands expect them as a part of their business.

Companies should also not overlook the importance of pre-trial findings and conclusions because, if done well, they can set the stage for the judge and his or her clerk to understand the case in a more favourable light.
— Sanya Sukduang

FW: In terms of the PIV and ANDA process, what steps do both patent holders and generic applicants need to take to present the relevant facts and issues surrounding the enforceability of a patent?

Wacker: Finding a patent unenforceable is generally very difficult, but there are some recent instances where unenforceability arguments have been successful. Inequitable conduct is subject to the more stringent pleading standard of Federal Rule of Civil Procedure nine and must be pleaded with particularity. Often, upon the initial filing of a complaint, enough information is not available to meet this pleading standard. If inequitable conduct is pleaded in the original complaint, patent holders should pay attention to whether the heightened pleading standard is met, and should consider moving to dismiss the count. Generic applicants, on the other hand, should consider whether they have sufficient factual bases to plead inequitable conduct in an original complaint or whether the allegations should be presented in an amended pleading filed after obtaining discovery on the issue. In either case, generic applicants should pursue discovery on the topic diligently, and should consider amending the complaint to include facts that were unavailable at the time of the original filing. Both parties should also be mindful of the obligation to amend discovery responses and contentions to preserve the ability to present information obtained during discovery in their case. Patent holders should also consider the strategy they will employ in defending against inequitable conduct allegations and how that impacts any privilege assertions they may make throughout the case.

McArdle: It is important for both patent holders and generic applicants to have clear and direct trial presentations, especially when dealing with the complex technical issues that routinely arise in pharmaceutical patent litigations. That starts early in the case by hiring experts that can explain complicated subject matter in a simple, easy-to-understand manner. If the expert’s presentation is too complex, it may be lost on a judge or jury. It is also important to design effective opening and closing arguments that remind the court what are the key issues and what is just a side show.

Sukduang: An effective trial strategy is critical for Orange Book patent holders, as they need to prevail on infringement and every validity attack, likely from multiple defendants. This planning starts well before a complaint is even filed, with the development of the basis for the invention and engagement of competent experts. Throughout the case, the trial strategy needs to be consulted, and potentially revised, based on case development. And as trial approaches, positions need to be harmonised and concepts simplified, to the extent possible, in order to present a clear and compelling case to the judge. Companies should also not overlook the importance of pre-trial findings and conclusions because, if done well, they can set the stage for the judge and his or her clerk to understand the case in a more favourable light.

FW: Have any recent patent infringement cases caught your eye? What lessons can companies draw from how these cases were conducted and resolved?

McArdle: There have been a number of recent cases on the issue of induced infringement of method of treatment patents, including Sanofi v. Watson and Vanda v. West-Ward. The main takeaway from these cases is that courts have been willing to find that a generic company induced physicians to infringe a brand company’s patents based on an inference of specific intent from the generic’s proposed drug label – even in cases where the generic drug label merely describes an infringing use as an option among other, non-infringing uses. Outside of the Hatch-Waxman context, however, courts have been more reluctant to infer specific intent based on product instructions that describe both infringing and non-infringing product uses.

Sukduang: Two recent Hatch-Waxman cases have become particularly important as they attempt to erode the use of long-felt need and failure of others as objective indicia of non-obviousness – ‘secondary considerations’. In particular, the Federal Circuit in Acorda Therapeutics, Inc. v. Roxane Laboratories, Inc. et al and the district court in Allergan, Inc. v. Teva Pharmaceuticals USA, Inc., have used the concept of ‘blocking patents’ to minimise the factual value of a long-felt need and failure of others. Patent holders should keep these cases in mind when developing their position on objection indicia of non-obviousness.

Wacker: A few recent cases have dealt with parties’ unsuccessful attempts to skirt courts’ rules. For example, in Shire LLC et al. v. Abhai, LLC, the court sanctioned Abhai for failing to alert its attorneys, in a timely manner, that some data included in the original ANDA was incorrect and to produce the corrected data or correct the testimony of corporate representatives after discovering the error. The court did not grant Shire’s request for an adverse inference of infringement, but awarded attorneys’ fees for time spent dealing with the incorrect data and the revised data, as well as discovering and dealing with the litigation misconduct. Similarly, in Regeneron Pharmaceuticals, Inc. v. Merus N.V., the court sanctioned the plaintiff for failing to comply with the court’s local rules regarding claim construction, improperly withholding non-privileged documents, and attempting an eve-of-trial privilege waiver that would have required the wholesale reopening of discovery.

I think we will continue to see uncertainty in the area of patent-eligible subject matter, an issue that for decades was a relatively straightforward matter.
— Christopher L. McArdle

FW: What essential advice would you offer to patent holders on strengthening their patent protection strategies?

Wacker: It is important for patent holders to plan the patent portfolio early in the development process. Patent holders should work with the regulatory and research teams to discuss the regulatory and patent protection available to a product and how best to harmonise the two. Patent holders should consider seeking patents that are difficult to design around or carve out from a label. It is also important to coordinate with the regulatory team in drafting a label, so that patent protection can be sought for appropriate indications and the label includes sufficient information to establish that the brand product is covered by the patents and any generic filer copying the label would infringe the claims.

Sukduang: In-house counsel prosecuting patent applications are highly skilled patent attorneys, competent in navigating the challenges faced during prosecution. But even the most skilled attorneys benefit from a second set of eyes. For these critically few patents protecting your innovative new drug, we would recommend enlisting the help of outside counsel, either prosecution or litigation, to review the claims, prior art and file history to ensure the strongest claims come out of prosecution as well as to explore additional claiming options. This initial investment will be well worth it once litigation begins.

McArdle: It is vitally important to understand the rules concerning prior art and what patent holder actions may create statutory bars to patenting. For example, some brand companies have lost valuable patents because they waited too long to file applications after conducting a clinical trial. Likewise, certain commercial offers or other sales activities can create statutory bars that could invalidate a patent. In fact, the Supreme Court is currently deciding whether confidential sales activities qualify as prior art under the America Invents Act, an issue that is being closely watched in the legal community.

FW: How do you envisage the patent protection landscape evolving over the months ahead? Are there any trends and developments relating to PIV or ANDA that you expect to see?

Sukduang: Unless changed through legislative intervention, we expect to see an increase in the use of post-grant proceedings by generic drug manufacturers to attack Orange Book-listed patents. This strategy is used to open another avenue of attack under a lower burden of proof. IPR attacks of Orange Book-listed patents have not been as successful as IPR proceedings overall. Only 66 percent of petitions challenging Orange Book-listed patents were instituted from September 2012 to September 2017, compared to 68 percent overall. Fortunately, however, the survival rate of instituted claims is much higher than other technologies during the same time period. For instance, 51 percent of final written decisions involving Orange Book-listed patents found all claims patentable, compared to only 17 percent of all other technologies and 54 percent of final written decisions involving Orange Book-listed patents found all or some claims patentable, compared to only 34 percent for all other technologies. Additionally, the impact the Supreme Court’s decision in TC Heartland had on venue for patent cases will likely result in multijurisdictional Hatch-Waxman cases, despite involving the same set of patents. Consequently, parties will need to negotiate consolidation into a single jurisdiction, which some generic companies might agree to and others may not, or explore using the multi-district litigation (MDL) process.

McArdle: I think we will continue to see uncertainty in the area of patent-eligible subject matter, an issue that for decades was a relatively straightforward matter. Despite recently addressing patent eligibility in its Bilski, Mayo, Myriad and Alice decisions, the Supreme Court’s guidance on this threshold consideration has led to conflicting decisions at the Federal Circuit and district court levels. Unfortunately, Congress is unlikely to take action to address the current confusion, and courts will continue to struggle with these issues going forward.

Wacker: One issue that has played a significant role in Hatch-Waxman litigation and will likewise continue to do so is patent eligibility. After many years as a rarely asserted defence, patent eligibility challenges have made a strong comeback following Mayo Collaborative Services v. Prometheus Labs, Inc and Association for Molecular Pathology v. Myriad Genetics, where the Supreme Court found certain claims directed to diagnostic products invalid as directed to patent ineligible laws of nature under Section 101 of the patent laws. District courts have struggled to consistently apply the framework articulated in Mayo and Myriad and their progeny, and have increasingly found claims of biomedical and pharmaceutical patents invalid under Section 101.


Chris McArdle is a member of Alston & Bird’s intellectual property (IP) litigation team. His practice includes all areas of intellectual property litigation and counselling, with a particular emphasis on patent litigation and appellate advocacy. He has represented clients in patent infringement lawsuits and appeals in federal courts across the US, including cases involving generic pharmaceuticals, medical devices, computer software and electrical transmission. He can be contacted on +1 (212) 210 9542 or by email:

Sanya Sukduang has a dynamic practice litigating matters concerning Abbreviated New Drug Applications (ANDA) challenges for brand drug manufacturers, diagnostic methods, biological products and medical devices. He has been the recipient of various awards and nominations, including being repeatedly recognised by LMG Life Sciences as an ‘intellectual property: life sciences star’. He can be contacted on +1 (202) 408 4377 or by email:

Jeanna Wacker is an experienced intellectual property litigation partner in the New York office of Kirkland & Ellis LLP. Her practice focuses on patent litigation in the life sciences field and she has extensive experience representing clients in the pharmaceutical, biotechnology, chemical and medical device industries. She has represented both plaintiffs and defendants at all stages of litigation, including trial and appeal. She can be contacted on +1 (212) 446 4773 or by email:

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