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The FDA Regulatory Landscape for Covid-19 Treatments and Vaccine (Updated)

September 17, 2020 Update: The Trump administration is currently considering accelerating the approval of an experimental Covid-19 vaccine being developed by Oxford University and AstraZeneca.  In line with FDA’s June 2020 guidance on the development and licensure of Covid-19 vaccines, it appears that the administration is considering granting Emergency Use Authorization (EUA) for the vaccine.  However, Michael Caputo, a spokesperson for the U.S. Department of Health and Human Services, which includes FDA, has dismissed the idea that an EUA for the vaccine would issue before November 2020.  Phase 3 clinical trials for the vaccine were paused earlier this month after a participant became seriously ill, but have since resumed in the United Kingdom.  The vaccine is currently one of three in Phase 3 clinical trials.  See below for more information on EUA and FDA’s other tools for expediting the review and approval of promising Covid-19 biologic treatments or vaccines.

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FDA Releases Industry Guidance on Development and Licensure of COVID-19 Vaccines

The Food and Drug Administration (“FDA”) issued its Development and Licensure of Vaccines to Prevent COVID-19: Guidance for Industry on June 30, 2020.  This nonbinding guidance is intended to remain in effect for the duration of the COVID-19 public health emergency declared by the Secretary of Health and Human Services. 

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Federal Circuit Upholds Enbrel® Patents and Blocks Biosimilar

Earlier this month, in Immunex Corp. v. Sandoz Inc., the Federal Circuit upheld two patents covering Enbrel’s active protein and a process used to manufacture the drug, effectively blocking Sandoz’s Enbrel® biosimilar Erelzi from the U.S. market until 2029 and providing a major victory for Amgen.[1]  Enbrel is the brand name for the molecule etanercept, which is used to treat rheumatoid arthritis and several other inflammatory conditions.  A blockbuster drug, last year Enbrel generated over $5.2 billion in sales for Amgen, representing 22% of the company’s revenue.

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Federal Circuit Holds That Amendments to Biosimilar’s BLA Do Not Trigger Anew BPCIA’s Notice of Commercial Marketing Provision

Under Section 262(l)(8)(A) of the BPCIA, a biosimilar maker must provide notice to the reference product sponsor 180 days before the date of first commercial marketing of the biosimilar.  While the Supreme Court has held that such notice can be provided at any time, including before a biosimilar maker’s abbreviated biologics license application (aBLA) has been approved, the statute makes clear that a biosimilar cannot be launched without a notice of commercial marketing.  In Genentech, Inc. v. Immunex Rhode Island Corp., No. 2019-2155 (Fed. Cir. July 6, 2020), the Federal Circuit held that supplements to a biosimilar’s aBLA do not trigger a new Section 262(l)(8)(A) requirement.

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No Antitrust Violations for Creating and Enforcing Humira Patent Thicket

Last month, Judge Manish Shah of the United States District Court of the Northern District of Illinois dismissed an antitrust complaint brought by indirect purchasers of AbbVie’s blockbuster rheumatoid arthritis drug, Humira®.  The suit alleged antitrust violations under a novel “patent thicket” theory, citing § 2 of the Sherman Act, and “pay-for-delay” and “market allocation” theories under § 1 of the Sherman Act.  Mem. Op. and Order (Dkt. 170), In Re: Humira (Adalimumab)Antitrust Litigation, No. 19-cv-1873 (N.D. Ill. June 8, 2020).

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Q1 2020 Biosimilar IPR Update: Drop in New Filings

At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise.  This was followed by a dip in the number of new filings in FY 2018 and the first half of 2019.  Through Q1 2020, this downward trend has continued.  Specifically, there has been one new biosimilar IPR filing in the nine-month period from the beginning of Q3 2019 through the end of Q1 2020, leading to a total of 102 total biosimilar patent IPRs.  See Fresenius Kabi USA, LLC et al. v. Amgen, Inc. et al., IPR2020-00314 (December 20, 2019).

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Samsung Bioepis and Merck Launch Herceptin (trasuzumab) Biosimilar Ontruzant® in U.S.

This week, Samsung Bioepis announced the U.S. launch of Ontruzant® (trastuzumab-dttb), a biosimilar of Genentech’s Herceptin (trasuzumab).  Ontruzant® will be marketed and distributed in the U.S. by Merck.  This launch represents Samsung Bioepis’s first oncology biosimilar in the U.S. market. 

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FDA Finalizes New Definition of Biological Product

Last week, the U.S. Food and Drug Administration (“FDA”) issued a final rule to amend its regulation that defines the term “biological product” in line with the definition set by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), as amended by the Further Consolidated Appropriations Act, 2020, enacted on December 20, 2019 (“FCA Act”). 

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Hospira Seeks En Banc Review of the Federal Circuit’s “Safe Harbor” Ruling in Amgen v. Hospira

In December, in Amgen v. Hospira, 944 F.3d 1327 (Fed. Cir. 2019), a panel of the Federal Circuit issued the first decision applying the statutory Safe Harbor of 35 U.S.C. § 271(e)(1) to BPCIA patent litigation.  The Federal Circuit affirmed the jury’s finding that Hospira’s pre-approval manufacture of batches of its biosimilar was an act of infringement of Amgen’s manufacturing patents not protected by the Safe Harbor, even though data from those batches was used to support Hospira’s BLA.  The court held that the relevant Safe Harbor inquiry “is not how Hospira used each batch it manufactured, but whether each act of manufacture was for uses reasonably related to submitting information to the FDA.”  Hospira has now petitioned for rehearing en banc, arguing that the court’s holding “calls into question the continuing viability of the Safe Harbor, particularly in the context of BPCIA litigation.” 

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Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira

Recently, in Amgen Inc. v. Hospira, Inc., the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented manufacturing methods.

In a case brought in the District of Delaware, Amgen alleged that Hospira infringed several patent claims over methods of manufacturing erythropoietin (EPO), a biologic drug used to treat anemia. Following a trial, a jury issued a $70 million verdict for Amgen, which was based in part on the jury’s conclusion that fourteen batches of drug substance for Hospira’s EPO biosimilar product were not covered by the Safe Harbor provision of 35 U.S.C. § 271(e)(1). After the district court denied Hospira’s motion for judgment as a matter of law or alternatively for a new trial, Hospira appealed on a number of issues, including the jury instructions and jury findings on its Safe Harbor defense.

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2019 Year-End Biosimilar Litigation Roundup

As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts.  The current cases are listed below, in order from most-recently-filed to oldest:

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PTAB Denies Sigma-Aldrich’s Petition for Patent Interference on CRISPR-Cas9

On September 23, 2019, the Patent Trial and Appeal Board (“PTAB”) issued a decision dismissing Sigma-Aldrich’s interference petition related to the revolutionary CRISPR-Cas9 biotechnology.  The claims at issue in Sigma-Aldrich’s petition were directed to methods of genetically modifying a eukaryotic cell using a CRISPR-Cas9 system.  The petition was unusual because it sought an interference although none of Sigma-Aldrich’s claims had yet been allowed.  On this basis, PTAB denied the petition as premature (and on other procedural grounds) and dismissed it without prejudice to refiling.

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In Mayo, Federal Circuit Seeks to Head Off Disputes Over When Claims Are “Deemed Allowable” by Counting Continued Examination Time Until Notice of Allowance

Earlier this week, the Federal Circuit declined to further extend the patent term of an antibody patent held by the Mayo Foundation.  In Mayo Foundation v. Iancu, the court held that the time spent on a request for continued examination (“RCE”) following a declaration of interference did not count toward the three-year application pendency period for purposes of patent term extension.  As discussed below, the Mayo decision could have implications for the terms of biologics patents issued following a request for continued examination.

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Federal Circuit Walks Back Its “Exceptional” Stance on the Doctrine of Equivalents in the Latest Amgen v. Sandoz Decision

In Amgen’s long-running dispute with biosimilar-maker Sandoz over biosimilar versions of Amgen’s filgrastim (Neupogen®) and pegfilgrastim (Neulasta®) biologics, the Federal Circuit earlier this year affirmed summary judgment of no literal infringement and no infringement under the doctrine of equivalents.  Amgen Inc. v. Sandoz Inc., 923 F.3d 1023 (Fed. Cir. May 8, 2019).  In so holding, the panel stated that “the doctrine of equivalents applies only in exceptional cases.”  Amgen petitioned for rehearing en banc, arguing that the Federal Circuit had overstated the law.  According to Amgen’s petition, “[s]uch a rule is contrary to Supreme Court precedent and [Federal Circuit] precedent.”  This week, the Federal Circuit course-corrected, granting Amgen’s petition without explanation for the limited purposes of removing the “exceptional” language from its prior decision. 

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Federal Circuit Rebuffs Fifth Amendment Challenge to IPR Proceedings

In Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, the Supreme Court suggested that whether inter partes reviews (“IPRs”) apply to pre-AIA patents is an open constitutional question.  But following the Federal Circuit’s recent decision in Celgene Corp. v. Peter, it appears that retroactive IPRs are here to stay, at least for now.

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Amgen Files New Patent Infringement Suit Over Neupogen Biosimilar

On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of California against Tanvex Biopharma over Tanvex’s proposed filgrastim biosimilar.  See Amgen Inc. v. Tanvex BioPharma USA, Inc., 3:19-cv-01374-BEN-MSB.  Amgen asserts a patent that claims methods of refolding recombinant proteins used in the manufacture of Neupogen.

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Prosecution History Estoppel Bars Amgen’s Doctrine-of-Equivalents Infringement Claim Against Neulasta (Pegfilgrastim) Biosimilar Maker Coherus

Amgen Inc. v. Coherus Biosciences Inc., No. 2018-1993, Slip op. at 6 (Fed. Cir. July 29, 2019) stems from a Biologics Price Competition and Innovation Act action brought by Amgen against Coherus seeking FDA approval to market a biosimilar version of Amgen’s pegfilgrastim product Neulasta.

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Sigma-Aldrich Files “Urgent” Petition for Patent Interference on CRISPR-Cas9

On July 19, 2019, Sigma-Aldrich filed a petition with the Director of the U.S. Patent and Trademark Office (“USPTO”) and the Chief Administrative Patent Judge (“CAPJ”) of the Patent Trial and Appeal Board (“PTAB”) seeking an interference between itself and the Regents of the University of California (“UC”) that would parallel an interference that was recently declared between UC and the Broad Institute (“Broad”).  The claims at issue are directed to methods of genetically modifying a eukaryotic cell using a CRISPR-Cas9 system.  The petition is unusual because it seeks to provoke an interference although Sigma-Aldrich’s pending claims have not been allowed, contrary to 37 C.F.R. § 41.102 and MPEP § 2303.  Sigma-Aldrich argues that the circumstances here are extraordinary and warrant an exception to the rule.  

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Q2 2019 Review: Biosimilar IPRs See a Drop in New Filings and Mixed Results

At the end of 2017, inter partes review (IPR) proceedings for biosimilar products were on the rise.  2018 and the first half of 2019, however, have seen a dip in the number of new filings.  And looking back at biosimilar IPRs that have been decided, results have been mixed.  The Patent Trial and Appeal Board has denied institution in about half (47%) of its institution decisions on petitions challenging biologics-related patents.  For those petitions actually reaching a Final Written Decision, the patentability of at least one claim has been upheld in just over half (53%) of the Board’s decisions.  Notwithstanding the mixed results for petitioners and the recent dip in new filings discussed here, IPR remains a key battlefield for biologic innovators and biosimilar makers.

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Federal Circuit Invalidates Polynucleotide-Labeling Claims for Lack of Enablement

In Enzo Life Sciences v. Roche Molecular Systems, No. 2017-2498, 2017-2499, 2017-2545, 2017-2546, Slip op. (Fed. Cir. July 5, 2019), the Federal Circuit affirmed summary judgment of invalidity for lack of enablement of Enzo’s two patents relating to non-radioactive labeling of polynucleotides.  The decision highlights non-enablement issues that may arise with respect to broad functional claims in an unpredictable field.

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Lawmakers Release Framework for Section 101 Reform

On April 17, 2019, several lawmakers from the Senate and House of Representatives released a bipartisan, bicameral framework for statutory reform of 35 U.S.C. § 101.  The framework was released about two months after the revival of the Senate Judiciary Subcommittee on Intellectual Property.  For the past several years, innovators, the Patent Office, and even judges on the Federal Circuit have raised concerns that Section 101 has become a runaway law for invalidating patents that reflect genuine advances in science and technology.  The revival of the Senate subcommittee and the release of this framework indicate that Capitol Hill has heard, and is moving towards a response to, these concerns. 

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Federal Circuit Strikes Down Diagnostic Patent in Latest § 101 Decision

On February 6, 2019, the Federal Circuit issued its latest opinion on patentable subject matter under 35 U.S.C. § 101 in Athena Diagnostics, Inc. v. Mayo Collaborative Servs., LLC, No. 2017-2508, slip. Op. (Fed. Cir. Feb. 6, 2019).  Judge Lourie wrote for the majority in this split decision, expressing some regret but affirming an order invalidating a diagnostic patent involving proteins.  Judge Newman dissented, voicing a concern that § 101 jurisprudence has become counterproductive to the goals of patent law.  Though unsurprising, the decision further narrows an already shrinking space for patents to diagnostic methods.  It is unclear from this decision what diagnostic methods, if any, are safe from future § 101 challenges.   

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Federal Circuit Dismisses Momenta IPR Appeal for Lack of Standing and Mootness After Momenta Abandons Orencia® Biosimilar

Last week, the Federal Circuit issued its long-awaited opinion in Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 2017-1694, slip op. (Fed. Cir. Feb. 7, 2019).  While many had hoped the decision would provide clarity on whether a biosimilar maker who has not yet filed an aBLA has standing to appeal a PTAB decision upholding an innovator patent, the Federal Circuit instead dismissed the appeal for lack of standing and mootness based on post-appeal developments making it clear that Momenta had abandoned its efforts to develop the biosimilar in question.  Nevertheless, Momenta is important in that it illustrates the continued risk to biosimilar makers of unappealable IPR decisions when they bring IPRs years before filing an aBLA.

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Republicans, Democrats, and Pharma Debate Trump Drug Pricing Proposal

Last October, the Trump Administration announced its plan to lower prescription drug prices by adopting foreign price controls on certain drugs covered by Medicare Part B.  Many Medicare Part B drugs treat serious illnesses such as cancer. Over the months that have followed, the announcement has stirred debate and led to competing proposals. 

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USPTO’s Revised Patent Eligibility Guidance Aims for Greater Clarity and Consistency

On January 7, 2019, the United States Patent and Trademark Office (USPTO) published new guidance for patent examiners intended to address concerns expressed by Federal Circuit judges, industry stakeholders, and others about the perceived lack of predictability and clarity in determining subject matter eligibility under 35 U.S.C. § 101.  See 2019 Revised Patent Subject Matter Eligibility Guidance, 84 Fed. Reg. 50 (Jan. 7, 2019).  The guidance, which is intended for use by USPTO personnel in evaluating subject matter eligibility, “revises the procedures for determining whether a patent claim or patent application claim is directed to a judicial exception (laws of nature, natural phenomena, and abstract ideas).”  Id.  This new guidance represents an attempt by the USPTO to address “the legal uncertainty surrounding Section 101,” recognizing that “[m]any stakeholders, judges, inventors, and practitioners across the spectrum have argued that something needs to be done to increase clarity and consistency in how Section 101 is currently applied.”  Id.

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The 2019 U.S. Federal Government Shutdown and its Potential Impact on Biologics

On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day.  If the shutdown continues through the weekend, it will be the longest federal government shutdown in U.S. history.  While many federal offices and services are completely closed, agencies that impact biologics—including the FDA, the USPTO, and the Federal Judiciary—remain open in various capacities, at least for now.  Nevertheless, if the shutdown continues, the biotech/pharmaceutical industry could begin to feel its effects.

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The Patent-Eligibility Question: Aatrix, Berkheimer and Beyond

Two cases decided by the Federal Circuit in 2018, Aatrix Software, Inc. v. Green Shades Software, Inc., 882 F.3d 1121, en banc rehearing denied, 890 F.3d 1354 and Berkheimer v. HP Inc., 881 F.3d 1360, en banc rehearing denied, 890 F.3d 1369, address what qualifies as patent-eligible subject matter under 35 U.S.C. § 101 and how courts should resolve that question.  These cases expose divisions within the court on § 101 issues, however, and leave uncertainty in their wake.  Many stakeholders, including judges, are therefore calling for guidance from the Supreme Court as to how to resolve such issues or seeking the aid of Congress.

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Federal Circuit Clarifies Law of Obviousness-Type Double Patenting: Patent Term Extension and Patent Term Due to URAA Are Safe from Gilead v. Natco

In a pair of decisions on Friday, the Federal Circuit clarified the law of obviousness-type double patenting (ODP).  In Novartis AG v. Ezra Ventures LLC, the court held that ODP does not invalidate an otherwise valid patent term extension (PTE) granted under 35 U.S.C. § 156 (extending the term of a pharmaceutical patent to compensate for regulatory delays).  And in Novartis Pharmaceuticals Corp. v. Breckenridge Pharmaceutical Inc., the court clarified that its holding in Gilead Sciences, Inc. v. Natco Pharma Ltd., 753 F.3d 1208 (Fed. Cir. 2014), i.e., that a later-issuing, earlier-expiring patent can invalidate an earlier-issuing, later-expiring patent for ODP, applies only to post-URAA (Uruguay Round Agreements Act) patents.  Under Breckenridge, where a later patent expires earlier only because of URAA’s change in patent term, the post-URAA patent is not an ODP reference against the pre-URAA patent.  The two decisions provide certainty for the biopharma industry and put an end to post-Gilead ODP challenges to pre-URAA patents and patents with PTE based on term granted by Congress.

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Bill Requiring Disclosure of Biosimilar Settlement Agreements to the FTC and DOJ Becomes Law

Earlier this month, the President signed into law the Patient Right to Know Drug Prices Act (Public Law 115-263). The Act mainly focuses on eliminating so-called “gag clauses” that prevent pharmacists from telling patients when paying for a drug out of pocket is cheaper than paying through insurance.  In addition, the Act amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law 108-173) to require branded drug companies and biosimilar applicants to disclose settlement agreements relating to the “manufacture, marketing, or sale” of biosimilar products to the Federal Trade Commission (“FTC”) and U.S. Department of Justice (“DOJ”) for evaluation under the antitrust laws. The new legislation brings biosimilar litigation in line with ANDA litigation, for which the same disclosure requirements were already in place. 

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New Arguments in Momenta On Standing to Appeal IPR Loss Before Filing a Biosimilar Application

In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co., No. 17-1694 (Fed. Cir. argued Dec. 5, 2017), BMS challenges Momenta’s standing to appeal a PTAB decision upholding the validity of BMS’s patent relating to a formulation of Orencia® (abatacept) in an IPR brought by Momenta before having filed a biosimilar marketing application.  The Federal Circuit is expected to decide whether a petitioner must have filed a marketing application in order to have Article III standing to appeal from an unfavorable PTAB decision.  As months have passed without a decision, Momenta and BMS have both used the time to further press their case. 

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Sandoz Uses Patent Dance to Limit Humira® Biosimilar Lawsuit to Two Patents For Now

Earlier this month, AbbVie filed suit against Sandoz’s proposed biosimilar to AbbVie’s HUMIRA® (adalimumab).  Invoking the Biosimilar Price Competition and Innovation Act (“BPCIA”), AbbVie asserts two patents protecting Humira, a fraction of the 84 patents AbbVie wished to litigate.  Taking full advantage of the pre-litigation “patent dance,” Sandoz limited the number of patents-in-suit to just two.  As this case illustrates, following the patent dance affords biosimilar makers considerable control and power over the scope of biosimilar lawsuits.

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Beyond the Presumption Against Extraterritoriality

The Supreme Court of the US handed patent owners a significant victory in WesternGeco v ION  by overturning the Federal Circuit’s bright-line rule prohibiting recovery of lost profits accrued overseas as a result of domestic patent infringement under § 271(f)(2) of the Patent Act.§ 271(f)(2) prohibits supplying components of a patented invention from the US with the intent that they be combined abroad.

To continue reading Irena Royzman and Jordan Engelhardt's article from Intellectual Property Magazine, please click here.

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FDA Approves First-Ever siRNA Therapy

Today FDA approved the first-ever “small interfering RNA” (siRNA) product, marking a significant milestone in the story of RNA interference (RNAi) technology and clearing the way for a new type of therapeutic.  Alnylam® secured approval and Orphan Drug Designation for its siRNA product Onpattro (patisiran), a therapy for the rare hereditary disease transthyretin-mediated amyloidosis in adult patients.  The disease is caused by mutations in a protein called “transthyretin” which leads to symptoms of neuropathic pain, loss of sensation in the hands and feet, and wheel-chair confinement.  In Alnylam’s Phase III clinical trial, Onpattro improved multiple clinical manifestations of the disease and demonstrated safe administration of a siRNA product.

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FDA Approves Pfizer’s Biosimilar of Neupogen® as Amgen and Pfizer Litigate Patent Infringement

On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen® (filgrastim).  Pfizer’s product, Nivestym™, is the second biosimilar of Neupogen to be approved after Sandoz’s Zarxio®, the first approved biosimilar in the United States.  Pfizer’s Nivestym gained approval for all eligible Neupogen indications.

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Amgen Brings Third BPCIA Lawsuit Against Apotex After Losing Two Others

Amgen has sued Apotex in connection with Apotex’s efforts to market biosimilar versions of Amgen’s cancer drugs Neupogen (filgrastim) and Neulasta (pegfilgrastim). In a complaint filed on August 7 in the Southern District of Florida, Amgen alleges infringement of U.S. Patent No. 9,856,287. This is the third time that Amgen has filed a BPCIA lawsuit against Apotex in connection with its filgrastim and pegfilgrastim biosimilars.

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FDA Issues Final Guidance on Biosimilar Labeling, Sticking with Generic Model

Earlier this month, FDA issued final guidance on the labeling of biosimilar products. The final guidance continues the approach adopted in FDA’s March 2016 draft guidance. That approach largely treats biosimilars like generic drugs for purposes of labeling, even though biosimilars, unlike generic drugs, are not exact copies of innovator products.

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FDA Announces Biosimilars Action Plan with Surprising Rhetoric

On July 18, FDA released its long-awaited Biosimilars Action Plan (“BAP”).  In prepared remarks to the Brookings Institution the same day, FDA Commissioner Scott Gottlieb described the BAP as “enabling a path to competition for biologics from biosimilars” in order to “reduc[e] costs and to facilitat[e] more innovation.”  While the BAP is straightforward, the Commissioner’s remarks included unexpected jabs at innovator drug makers for what FDA believes is anticompetitive conduct.  The speech was likely driven by the Trump Administration’s American Patients First plan, which sets as a top FDA priority the reduction of prescription drug prices, including by reducing “gaming” of regulatory requirements, but what the speech achieves given the role of FDA remains unclear.

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Supreme Court Reverses Federal Circuit, Holds Patent Owners May Recover Lost Foreign Profits

On Friday, June 22, 2018, the Supreme Court issued its decision in WesternGeco LLC v. ION Geophysical Corporation, 585 U.S. ___, Slip. Op.  No. 16-1011 (June 22, 2018), reversing the Federal Circuit and holding that WesternGeco’s award for lost foreign profits was a permissible application of the damages provision of the Patent Act, 35 U.S.C. § 284.[1]  Justice Thomas wrote the opinion for a seven-justice majority while Justice Gorsuch wrote a dissent joined by Justice Breyer.

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FDA Withdraws Draft Guidance on Evaluating Analytical Similarity Following Industry Criticism

Analytical studies to demonstrate that a biosimilar is highly similar to its reference product are central to the biosimilar development and approval process.  For this reason, there have been calls from industry for more guidance from FDA on its expectations for evaluating and demonstrating analytical similarity.

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Senator Hatch’s New Legislation Would Eliminate IPR Challenges by Generics and Biosimilar Makers

Generics and biosimilar makers have increasingly used inter partes reviews, proceedings made possible by the America Invents Act, to challenge patents protecting innovator small-molecule drugs and biologic medicines.  Senator Orrin Hatch, co-author of the Hatch-Waxman Act, has introduced an amendment that would require these manufacturers either to take advantage of the abbreviated regulatory approval pathways provided by the Hatch-Waxman Act and BPCIA and challenge innovator patents in district court or to challenge innovator patents in IPRs before the PTAB, but not both.  Senator Hatch explains that while he strongly supports IPRs and the America Invents Act and that IPRs are of particular importance to the tech community to fight “patent trolls,” they are also “producing unintended consequences in the Hatch-Waxman context” and “threaten[] to upend the careful Hatch-Waxman balance by enabling two separate paths to attack a brand patent.”  If enacted, generics and biosimilar makers that choose to take advantage of the abbreviated regulatory process will challenge innovator patents in court rather than in IPRs before the PTAB.

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First Decision on Label Carve-Outs for Biosimilars Expected in Enbrel Litigation

As biosimilar litigation between Amgen, the maker of Enbrel® (etanercept), and Sandoz, the maker of biosimilar ErelziTM (etanercept-szzs) heads toward trial before Judge Claire Cecchi in the District of New Jersey, Sandoz is seeking to stave off Amgen’s infringement claims for three of the patents in suit by pointing to its recent amendment to the Erelzi label, which “carves out” certain treatment indications listed on the Enbrel reference label and, Sandoz argues, moots any claim that Erelzi infringes Amgen’s patents covering the use of etanercept to treat those conditions.

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Federal Circuit Issues Two Decisions Impacting Standing to Challenge Validity of Pharma Patents

Two recent Federal Circuit decisions address when a party has standing to challenge the validity of a patent. Though the cases arose in different contexts, they both center on the question of what it means for a party to be facing an imminent and cognizable injury. In Altaire Pharmaceuticals, Inc. v. Paragon Bioteck, Inc., 17-1487, the Federal Circuit upheld a party’s standing to appeal from a post-grant review where it was at risk of an infringement suit. In AIDS Healthcare Foundation v. Gilead Sciences, Inc. et al., 16-2475,[1] however, the court reached the opposite conclusion and determined that the immediacy requirement to bring a declaratory judgment action was not met for a party that had an interest in purchasing generic drugs, but did not itself produce them.

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Fourth Circuit Rules that Maryland’s Anti-Price Gouging Act for Off-Patent or Generic Drugs is Unconstitutional

The U.S. Court of Appeals for the Fourth Circuit last month handed manufacturers and wholesalers of off-patent drugs a victory by ruling that Maryland’s anti-price gouging act violates the U.S. Constitution’s dormant commerce clause.  The legislation, like many others, was enacted in the wake of the Martin Shkreli case, where the former Turing Pharmaceutical CEO raised the price of a vital and old prescription drug by 5,000 percent. Although the Circuit sympathized with consumers affected by this type of conduct, it held, in a majority opinion written by Judge Stephanie Thacker, that Maryland overstepped its constitutional limits in seeking to compel manufacturers of off-patent or generic drugs to act in accordance with Maryland law outside of Maryland.

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FDA Approves Pfizer’s EPO Biosimilar

Yesterday, Pfizer announced that FDA had approved Retacrit® (epoetin alfa-epbx), a biosimilar of Amgen’s Epogen® and Johnson & Johnson’s Procrit® (epoetin alfa).  Epoetin alfa (EPO) is a blockbuster treatment for anemia.  Retacrit is the first EPO biosimilar approved in the United States. EPO biosimilars have been marketed in the EU for over a decade.   Hospira (now a Pfizer company) initially filed an application for approval of its EPO biosimilar in 2014.  FDA rejected that application in a complete response later and Hospira later resubmitted it after addressing FDA's concerns.  While Retacrit received a favorable FDA advisory committee recommendation in May 2017, it was rejected again in a second complete response letter due to concerns with the proposed manufacturing site for the biosimilar.  Nearly a year later, FDA approved Retacrit.  Pfizer plans to launch Retacrit this year.

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PTAB and Bar Prepare for Aftermath of Supreme Court’s SAS Decision

Last week, the Supreme Court upheld the constitutionality of inter partes review (IPR), as expected by most observers.  However, it was the Court’s decision in a second IPR-related case that will have an immediate impact on patent practitioners.  In SAS Institute Inc. v. Iancu, the Supreme Court, in a 5-4 decision, held that the PTO’s practice of “partial review”—instituting an IPR on some but not all claims challenged in a petition for IPR—is inconsistent with the text of the AIA.  The decision will lead to immediate consequences, not the least of which is a major increase in the number of claims tried before the PTAB.

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Supreme Court Holds IPRs Are Constitutional

In a highly anticipated ruling, the Supreme Court upheld the constitutionality of inter partes review proceedings.  Justice Thomas, writing for the seven-member majority in Oil States Energy Services, LLC v. Greene’s Energy Group, LLC, held that the Patent Trial and Appeal Board could reconsider and cancel patent claims through inter partes review without violating Article III or the Seventh Amendment of the Constitution.

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In WesternGeco v. ION Geophysical Corp., the Supreme Court Weighs the Availability of Foreign Damages for U.S. Patent Infringement

On Monday, April 16, 2018, the Supreme Court heard oral argument in WesternGeco LLC, v. ION Geophysical Corporation, No. 16-1011, a case with broad implications for patent holders that sell products abroad.  The case addresses whether lost profits accrued outside of the United States can be recovered for patent infringement occurring domestically.  In the decision below, 791 F.3d 1340 (Fed. Cir. 2015), the Federal Circuit adopted a per se bar to recovery of such foreign damages, even when domestic patent infringement is established and proximately caused.  Although WesternGeco involves infringement under 35 U.S.C.§ 271(f) – which prohibits the supply of components of a patented invention in the U.S. with the intent that they be combined abroad – in its argument in support of the petitioner, the Solicitor General framed the question more broadly as whether lost profits accrued outside of the United States can be recovered for any domestic act of patent infringement under § 271.[1]  Four key takeaways from the oral argument are discussed below.

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Amgen v. Adello: A Blind Biosimilar Infringement Lawsuit

Last month, Amgen sued Adello for patent infringement under the Biologics Price Competition and Innovation Act of 2009 (BPCIA) in connection with Adello’s proposed biosimilar of Amgen’s Neupogen.  Adello elected to bypass the pre-suit procedures of the BPCIA and did not provide any information regarding its biosimilar or how it is manufactured to Amgen.  In its lawsuit, Amgen asserts 17 patents against Adello blind.  The lawsuit illustrates the consequences of the Supreme Court’s and Federal Circuit’s recent decisions holding that provisions of the BPCIA requiring production of information to the innovator company are not enforceable under federal or state law and that information needed to assess infringement can only be obtained by filing a patent infringement lawsuit.

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