Steve Auten

J&J affiliate Janssen has asked the district court to bar the ANDA defendants from asserting at trial the invalidity arguments that were found in parallel IPR proceedings to render the asserted claims unpatentable. Does the estoppel provision of 35 USC 315(e)(2) bar successful IPR defenses?

The forthcoming inter partes review (IPR) decision on one of the patents listed in the Orange Book for ALIMITA (pemetrexed) may conflict with the Federal Circuit decision already issued in Eli Lilly's favor on the same patent.

The Federal Circuit held that the function-way-result test for equivalents may not apply in chemical cases, which may be a useful argument for generic sponsors looking to avoid infringement. The court modified a preliminary injunction that had been entered against Aurobindo, but did not dissolve the injunction because at least one more patent proved to be an obstacle at that juncture. The case was eventually settled.

The Federal Circuit reversed the trial court's finding that the main prodrug patent for Velcade was obvious, including the lower court's finding of inherency when the applicant combined elements (the API, mannitol, and lyophilization) known in the prior art. The case presents an obstacle for generic sponsors looking to assert an inherency defense, as the court may reject that as impermissible using an inventor's own conduct against them contrary to the express language of section 103.

Reversing the trial court, the Federal Circuit found invalid four patents listed for ALOXI (palonosetron) based on a prior sale before the critical date. That the formulation needed further testing and FDA approval did not negate the invalidating sale, and the court drew no distinction between the pre- and post-America Invents Act versions of the on-sale bar (based on these facts).

On March 6, 2017, the First Circuit reversed the trial court’s dismissal of Amphastar’s antitrust complaint against Sandoz and Momenta concerning enoxaparin. According to Amphastar, Sandoz and Momenta knowingly failed to disclose to the U.S. Pharmacopeial Convention (“USP”) that a proposed method for testing generic enoxaparin might be covered by Momenta’s then-pending (later issued and asserted against Amphastar) patent application.

Thinking of converting from a P-IV to a P-III and having your case easily dismissed. Not so fast. Judge Andrews denied Sandoz's motion to dismiss after such a certification change, noting the case was not moot as Sandoz claimed to be able to freely reconvert anytime.

Forward Pharma and Biogen settled at least part of their dispute on TECFIDERA (dimethyl fumarate). Biogen will pay Forward a non-refundable sum of $1.25B and conditional royalties in the future. The agreement does not affect ongoing interference and opposition proceedings. Moreover, there is a separate IPR involving the last-expiring, listed patent and which has a deadline for a final written decision only days before the NCE-1 date of March 27, 2017. G

Teva successfully petitioned FDA to withdraw the final approval of TWI's ANDA referencing AMRIX (cyclobenzaprine hydrochloride) ER capsules due to Teva's sNDA to include an applesauce study. Teva regained market exclusivity without any three-year data protection or related patent plus use code, thereby preventing a carve-out that would have enabled generic competition.

In October 2016, the Federal Circuit heard oral argument concerning Teva's challenge to Helsinn's ALOXI (palonosetron) product. At issue is whether a clinical formulation, which showed promise in Phase II, was a formulation "ready for patenting" under Pfaff parlance, as well as whether a licensing and distribution agreement continent on future FDA approval was a commercial sale.

Several generics won their trial against Eli Lilly for their generic versions of AXIRON (testosterone), while another generic was found to infringe based in part on statements made in the ANDA comparing the product to the RLD. The case serves as a reminder to review ANDA statements with litigation counsel before submitting them to FDA.

Can an out-of-specification batch, which cannot legally be marketed, nevertheless support a finding of infringement in an ANDA case? A recent decision from Judge Chesler may support that position.

Two decisions issued a week apart in June 2016, upholding all the asserted patents for TREANDA (bendamustine) and three of four for SUBOXONE (buprenorphine + naloxone), thus delaying near-term generic competition.

Following its win at the preliminary injunction phase, Hikma won dismissal of Takeda's amended complaint concerning alleged induced infringement of its colchicine 505(b)(2) product, which did not reference Takeda's Colcrys but instead an earlier combination product. Judge Robinson found no infringement where the carved out labeling only "could" lead to infringement but did not actively encourage same.

Judge Stark scheduled oral argument on Ezra Venture's challenge to Novartis' patent term extension on the main compound patent for GILENYA (fingolimod) capsules. Ezra argues the PTE impermissibly extends the patent, as it blocks the public from practicing an earlier-expiring patent directed to a method of use. If granted, Ezra's motion would change the fingolimod market dramatically and provide a new weapon for ANDA sponsors.

This case presents a new twist with one brand suing another brand company over a prodrug patent, thus forcing a pioneering company to argue invalidity. That surely is something you don't see every day. The stakes are high, as Merck claims Gilead's SOVALDI (sofosbuvir) infringes its patents. As this drug is atop Medicare Part D's list in terms of cost, that is a lot of revenue at risk!

The Federal Circuit affirmed the invalidity of four of Purdue's OxyContin patents, including a tablet patent on the basis of inherent anticipation. Such a defense is rarely successful, particularly in Hatch-Waxman cases, as the standard is very high. Notably, Teva presented test results on several hundred tablets, while Purdue offered no counter testing.

Judges Moore and Dyk reversed their earlier position, now finding that the safe harbor does not protect Amphastar's quality control activities from Momenta's enoxaparin patent. Moreover, with a decision to surely impact the biotechnology/biosimilar industries, the court found that such activities do not constitute "making" the product under 35 USC 271(g), thereby potentially freeing the world from the reaches of related U.S. patents.

Personal jurisdiction is one of the hottest topics in Hatch-Waxman, with many ANDA/(b)(2) sponsors moving to dismiss complaints with little success. Until now. Score one for Collegium who persuaded Judge Robinson to dismiss Purdue's complaint for lack of personal jurisdiction. Complicating matters for Purdue is that it, in reliance of Collegium's concession on jurisdiction, dismissed its protective complaint in another forum, thereby losing its 30-month stay.

In a case of first impression, the Federal Circuit issued its split decision in the Amgen v. Sandoz litigation regarding the latter's biosimilar to NEUPOGEN (filgrastim). The court held that the BPCIA's “patent dance” is optional and that the 180-days’ notice prior to commercial marketing can be given only upon final FDA approval.

Amending invalidity contentions in New Jersey is already difficult. In this decision, Magistrate Judge Bongiovanni denied Mylan's request to amend its contentions in its Lo Loestrin Fe litigation, finding that Mylan could not credibly explain its lack of diligence in seeking to amend particularly where Mylan had filed an inter partes review petition a few months earlier with the same art.

In Hatch-Waxman litigation, a common issue is for what purposes may the ANDA be used. Brands would prefer to evaluate any other patents it may want to add to the current litigation. Generic sponsors want any such use limited to the patents being asserted. In an issue of first impression, Magistrate Judge Schneider says use outside the patents-in-suit is permitted, provided that any other patent is "sufficiently related" and leaves open the possibility for the parties to address that issue.

The Supreme Court has limited patentable subject matter with its rulings in the Myriad and Mayo cases. Most would agree one cannot patent what is naturally-occurring, even if isolated. This article suggest a similar approach to isolated enantiomer or isomers from the racemate, as the same principle--merely isolating a product from what is already know--is involved.

On March 31, 2015, the Federal Circuit reversed in the BENICAR (olmesartan) litigation, allowing Apotex to proceed with its declaratory judgment claim on a disclaimed patent and thwarting Daiichi's attempt to keep Mylan's exclusivity from being forfeited. The court also finds that while the failure to market forfeiture provisions requires a sponsor to have tentative approval, that can be secured after filing and is not a prerequisite to suit.

IPR decisions are getting published at a rapid clip. One concern is the requirement to name all real "parties-in-interest." This note examines the Board's two related decisions to dismiss petitions for failure to comply with that requirement where the corporate parent ostensibly had control over the matter, including a corporate executive being both the president and CEO of a named and unnamed party, and the overlapping board of directors. As such, the parent with power had to be named.

Our annual summary of the top case decisions and events affecting the generic drug and biosimilar industries in the United States. It was another landmark year for firsts in both sectors.

The third case involving a declaratory judgment plaintiff who is also a putative biosimilar applicant was dismissed on December 1, 2014, when Judge Crotty granted The Kennedy Trust's motion to dismiss against Celltrion. Celltrion had earlier voluntarily dismissed another case against Janssen. This was also the second time such a dismissal was for a lack of subject matter jurisdiction; Sandoz's DJ case on entanercept being the first, and whose appeal was argued in September and remains pending.

In the first Hatch-Waxman case interpreting the effect of the Supreme Court decision in Daimler v. Bauman, Judge Sleet in Delaware finds against Mylan, ruling that its ANDA and notice letter sent to Astra Zeneca in Delaware were sufficient to find specific jurisdiction. May ANDA sponsors now be sued wherever the notice letter goes?

A question often asked is what exactly is an impermissible reverse payment in view of last year’s Supreme Court decision in FTC v. Actavis? Like most answers to legal questions, this one too is “it depends.” Base on numbers only, there are more courts finding that a reverse payment does not have to be just cash. But that’s an incomplete conclusion. The courts are applying a high burden for antitrust plaintiffs to establish the value of the payment and whether it was impermissibly "large."

Two Federal Circuit decisions published the same day regarding the P-IV challenges to Ferring’s LYSTEDA (tranexamic acid). That is not surprising given that the cases were tried together and heard by the same panel. The Federal Circuit held that neither Watson nor Apotex infringed the asserted patents, which are generally directed to the drug product’s dissolution profile. While short, the decisions are very useful to ANDA sponsors by supporting the following concepts/tactics: (1) no sample… Show more

Two Federal Circuit decisions published the same day regarding the P-IV challenges to Ferring’s LYSTEDA (tranexamic acid). That is not surprising given that the cases were tried together and heard by the same panel. The Federal Circuit held that neither Watson nor Apotex infringed the asserted patents, which are generally directed to the drug product’s dissolution profile. While short, the decisions are very useful to ANDA sponsors by supporting the following concepts/tactics: (1) no sample production if the ANDA answers infringement, (2) advisory opinions on infringement are permissible, (3) post-trial ANDA amendments to evade infringement, and (4) a few outlier samples do not necessarily mean infringement, which could have larger implications in polymorph and impurity cases. Show less

Patentees in ANDA litigation will often assert declaratory judgment infringement claims in addition to those under section 271(e)(4). They will also assert both types of claims as to unlisted patents, or for which no Paragraph IV certification was filed. This note examines the authority for ANDA sponsors to move to dismiss all such claims.

The district court in Nevada recently granted in part Watson's motion to dismiss Ferring's 271(a) claims for damages relating to three patents listed for LYSTEDA (tranexamic acid) tablets. The court ruled after trial earlier this year that Watson infringed those three patents, but awarded no damages as Ferring failed to ask for them. The court, however, denied Watson's motion as to a newly-asserted fourth patent, though clearly invited Watson to move for summary judgment based on issue… Show more

The district court in Nevada recently granted in part Watson's motion to dismiss Ferring's 271(a) claims for damages relating to three patents listed for LYSTEDA (tranexamic acid) tablets. The court ruled after trial earlier this year that Watson infringed those three patents, but awarded no damages as Ferring failed to ask for them. The court, however, denied Watson's motion as to a newly-asserted fourth patent, though clearly invited Watson to move for summary judgment based on issue preclusion. If Ferring is unable to assert a damages claim, then will it ever recover its damages for Watson's at-risk launch? Show less

In a decision published June 27, 2014, the Patent Trial and Appeal Board reasons that a putative petitioner for an Inter Partes Review must be obligated to defend in a litigation regarding a proposed amended complaint to trigger the one-year statutory bar to file its petition. Merely receiving the motion for leave, even with the proposed complaint attached, is insufficient.

Mylan and Endo tried the ANDA litigation over FROVA (frovatriptan) to Judge Bumb, who was sitting by designation in Delaware. Mere minutes before she released her trial opinion, finding in Endo's favor, the parties reached an oral settlement. Naturally, Endo tried to undo the settlement, but Mylan successfully sought enforcement of the oral agreement. Judge Bumb granted Mylan's requested relief, highlighting the need for clear communications during settlement negotiations.

In April 2014, the U.S. Supreme Court decided the Octane Fitness case, lowering the showing required and related burden of proof to establish an exceptional case under 35 U.S.C. 285. Mere weeks later, the U.S. District Court in Maryland sanctioned Classen in the ongoing, seminal safe-harbor case for filing an objectively baseless suit against Biogen Idec. The decision may very well mark the beginning of a new "plague" in patent cases, replacing inequitable conduct with an exceptional case.

In April 2014, a district court found an exception to the general rule of preemption as to state-law based tort claims regarding a generic drug. The United States District Court for the Southern District of Illinois denied Teva's motion for judgment on the pleadings regarding tort claims based on allegedly defective generic Yaz, relying on a footnote in the Bartlett decision from the U.S. Supreme Court.

In view of the Supreme Court's decision in FTC v. Actavis in the ANDROGEL (testosterone) reverse payment case, Par, Paddock, and Solvay moved to dismiss FTC's complaint. They argued that their settlement was protected under Noerr-Pennington largely due to a consent judgment in the underlying litigation. The district court in Georgia disagreed, denying the motion on April 21, 2014.

On April 22, 2014, the Federal Circuit released it much-anticipated decision in Sanofi v. Glenmark, regarding the latter's at-risk launch of generic TARKA. The case is especially noteworthy because it involves the first jury award of damages in a Hatch-Waxman case. All prior cases have either had damages settled or controlled by contract. As the damages award itself was not appealed, industry remains unclear whether the appropriate metric is a reasonable royalty or lost profits.

The Federal Circuit decision of March 18, 2014, affirmed the trial court that Barr's ANDA product for generic TRAVATAN Z (travoprost) did not infringe two of Alcon's patents. This is because Alcon's evidence was limited to test data in its own patents as extrapolated to Barr's product, which the parties conceded was substantially different. With no data as to Barr's product, the Federal Circuit affirmed that there was no infringement. On validity, the Federal Circuit reversed the trial… Show more

The Federal Circuit decision of March 18, 2014, affirmed the trial court that Barr's ANDA product for generic TRAVATAN Z (travoprost) did not infringe two of Alcon's patents. This is because Alcon's evidence was limited to test data in its own patents as extrapolated to Barr's product, which the parties conceded was substantially different. With no data as to Barr's product, the Federal Circuit affirmed that there was no infringement. On validity, the Federal Circuit reversed the trial court's rulings on enablement and written description, reasoning that the trial court did not apply the correct standards. Thus, while Alcon loses this battle against Barr, its patents are resurrected for another day. Show less

On March 28, 2014, the Federal Circuit reversed the claim construction in Actavis' case regarding its challenge to Shire's LIALDA (mesalamine). The court found the trial court's construction too broad, particularly in view of the prosecution history. The construction and related infringement finding were thus reversed and the case remanded. What remains unknown is whether first-filer Zydus will hold onto its presumed 180-day exclusivity in view of FDA's bioequivalence guidance having issued… Show more

On March 28, 2014, the Federal Circuit reversed the claim construction in Actavis' case regarding its challenge to Shire's LIALDA (mesalamine). The court found the trial court's construction too broad, particularly in view of the prosecution history. The construction and related infringement finding were thus reversed and the case remanded. What remains unknown is whether first-filer Zydus will hold onto its presumed 180-day exclusivity in view of FDA's bioequivalence guidance having issued after Zydus' ANDA had been filed. Show less

Given the high stakes in ANDA litigation, branded pharmaceutical sponsors will exhaust all routes to protect their patents. One relatively untested route is that of the reissue patent application, which Pfizer filed after losing one of its patents on CELEBREX (celecoxib). Teva has recently tried the same route, seeking to reissue one of its COPAXONE (glatiramer acetate) patents, which the Federal Circuit held invalid in July 2013.

On February 25, 2014, the Federal Circuit dismissed an appeal between Teva and Alcon, docket no. 10-1097. This was an appeal from a 2006 (yes, that's right) case that had been pending before Judge Robinson in Delaware. At first glance, the dismissal may seem uneventful. But no, no, no -- the dismissal signals the end of what I had been calling the Moxifloxacin Mess.

Nearly nine months after losing at trial in New Jersey, Zydus wins the appeal against Takeda regarding its Paragraph IV challenge to PREVACID SOLUTAB (lansoprazole). The Federal Circuit found that the trial court erroneously included a 10% margin in its construction of the particle size requirement, which was not supported by the plain language of the claim or the specification. Without that margin, Zydus's proposed ANDA product did not literally infringe the claim.

Prosecution laches and unclean hands remain viable defenses for Roxane Laboratories in its Paragraph IV challenge to Jazz Pharmaceuticals' XYREM (sodium oxybate). In granting Roxane's motion to amend its pleadings and add these defenses, the court found Jazz arguing too much on the merits rather than the legal sufficiency. Naturally, this decision is limited to the ability to plead the defenses with the merits next to be tested. In ANDA cases involving serial patent complaints against the… Show more

Prosecution laches and unclean hands remain viable defenses for Roxane Laboratories in its Paragraph IV challenge to Jazz Pharmaceuticals' XYREM (sodium oxybate). In granting Roxane's motion to amend its pleadings and add these defenses, the court found Jazz arguing too much on the merits rather than the legal sufficiency. Naturally, this decision is limited to the ability to plead the defenses with the merits next to be tested. In ANDA cases involving serial patent complaints against the same generic sponsor, this case could prove even more interesting! Show less

The safe harbor continues to confuse those in the Hatch Waxman space. In the latest episode, the District Court of Maryland dismissed Classen's allegations of infringement, even where commercial activity was implicated, because of the Federal Circuit's decision in the Momenta case and despite that same court's earlier decision to the contrary with respect to the consideration of commercial timing. The decision is dated January 29, 2014, and will surely be appealed, giving the Federal Circuit… Show more

The safe harbor continues to confuse those in the Hatch Waxman space. In the latest episode, the District Court of Maryland dismissed Classen's allegations of infringement, even where commercial activity was implicated, because of the Federal Circuit's decision in the Momenta case and despite that same court's earlier decision to the contrary with respect to the consideration of commercial timing. The decision is dated January 29, 2014, and will surely be appealed, giving the Federal Circuit another chance to clarify its position. Show less

2013 was a landmark year for those in the pharmaceutical and biosimilars industries. We saw our first Inter Partes Review patent challenges, several U.S. Supreme Court cases, the first monoclonal antibody biosimilar approved in Europe, and the first ever compound patent in the U.S. invalidated for structural obviousness. Count down the top events with us!

Tolmar won its appeal against Galderma regarding the Paragraph IV challenge to Differin Gel 0.3% (adapalene). The panel was divided 2-1 with Judge Newman providing a blistering dissent, stating that the majority panel makes new law and eviscerates all incremental patents. One may read the majority decision as shifting the burden of production to the patentee in a scenario where the claimed invention recites a specific percentage of the active and the prior art discloses an overlapping range.

Astra Zeneca scores a win on appeal over ANDA sponsors Apotex, Breath and Sandoz. A key issue on appeal was whether the trial court properly included a limitation not explicitly found in the patent claims, by which the sponsors avoided infringement at trial. The Federal Circuit also examined the validity of a second patent directed to once-daily usage of nebulized budesonide.

An examination of the trial decision from October 4, 2013, Hatch-Waxman patent litigation between Bristol Myers Squibb and Mylan Pharmaceuticals regarding the latter's Paragraph IV challenge to SUSTIVA (efavirenz). The asserted patent claims a polymorph, yet is not listed in the Orange Book. The article examines the state of the inherent anticipation doctrine as well as the scenario where a non-listed patent may block generic competition.

On August 9, 2013, Judge Andrews issued his decision in the AVODART (dutasteride) trial on the compound patent (Del. docket 11-046). Trial was held in January 2013, and this article examines that decision. Like most compound patent trials, the court upheld the patent in favor of the innovator (GSK) and against the P-IV ANDA sponsors (Banner, Roxane, Mylan and Impax). Several defenses were asserted with utility among the most interesting.

A review of the summary judgment decision in the PRILOSEC (omeprazole) litigation, denying Andrx's request for summary judgment that it was not liable to Astra Zeneca for damages related to its production of validation batches. Andrx would later secure a favorable judgment at the trial level when the court excluded a key witness for Astra Zeneca.

The Biologics Price Competition and Innovation Act provides a pathway for regulatory approval of generic drugs and the associated patent challenge. This article reviews strategic considerations during the patent litigation and injunction phases. Considerations during the initial patent litigation phase include when and whether to exchange a paragraph k application and the listing and exchange of patent information during the volley phase.

Four recent decisions shine some light on document retention policies. Case law has not been particularly precise as to when inside counsel should advise clients to begin the tedious—and costly—task of preserving documents for patent litigation. However, the twin 2011 rulings by the Federal Circuit (Micron II and Hynix II) followed by their respective 2013 remand decisions provide a solid primer.

Health care reform brought about sweeping changes to our nation's health-care system. Much of the commentary has been focused on the medicaid expansion and the individual coverage mandate, punctuated by the U.S. Supreme Court finding the law constitutional in a 5-4 decision last June. The general public has not concerned itself with most of the act, particularly its establishment of a regulatory pathway for biosimilar versions of biologic medicines. The act created the Biologics Price… Show more

Health care reform brought about sweeping changes to our nation's health-care system. Much of the commentary has been focused on the medicaid expansion and the individual coverage mandate, punctuated by the U.S. Supreme Court finding the law constitutional in a 5-4 decision last June. The general public has not concerned itself with most of the act, particularly its establishment of a regulatory pathway for biosimilar versions of biologic medicines. The act created the Biologics Price Competition and Innovation Act (BPCIA), thereby starting the multibillion-dollar, biosimilar drug market of tomorrow and enhancing our future health-care savings. Show less