According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s sale of its biologic product Adynovate^® (Antihemophilic Factor (Recombinant), PEGylated).  In Bayer Healthcare LLC v. Baxalta Inc., et al., Nos. 2019-2418, 2020-1017 (Fed. Cir. 2021), the circuit court upheld an award to Bayer HealthCare LLC of $155 million in royalties and $18 million in pre-verdict supplemental damages, without enhancement, for infringement of U.S. Patent No. 9,364,520 (the “’520 Patent”), which is directed to recombinant forms of human factor VIII.

The Federal Circuit considered its 35 U.S.C. § 112 enablement case law and found that “the enablement inquiry for claims that include functional requirements”—in this case, claims to antibodies defined by their function—“can be particularly focused on the breadth of those requirements, especially where predictability and guidance fall short.”  Dkt. 132 at 10.  In Amgen Inc. et al. v. Sanofi, Aventisub LLC, et al., 20-1074 (Fed. Cir.), the Federal Circuit affirmed the district court’s finding of non-enablement for claims asserted by Amgen Inc., Amgen Manufacturing, Ltd., and Amgen USA, Inc. (collectively, “Amgen”). 

The last two years saw the launch of several biosimilars.  Looking ahead to 2021, several others may be on the horizon.  In 2019-2020, the FDA approved thirteen biosimilars directed to seven reference products.  Eight of the approved biosimilars have launched, while five are either embroiled in litigation or awaiting agreed-upon launch dates. 

Last week, Mylan filed a brief in opposition to Valeant’s petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402. In November, a Federal Circuit panel held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Valeant contends that rehearing is necessary because the panel’s decision conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement occurs” under Section 271(e)(2) of the Patent Act.  By contrast, Mylan contends that the petition for rehearing should be denied because the “panel correctly applied black-letter rules of statutory interpretation” in reaching its decision, and the precedents identified by Valeant are derived from “far-afield cases and ignore the governing venue precedents.” Dkt. 89 at 7-15.

Earlier this month, Valeant Pharmaceuticals North America LLC (“Valeant”) filed a petition for rehearing en banc in Valeant Pharms. N. Am. LLC v. Mylan Pharms. Inc., No. 2019-2402, arguing that the Federal Circuit panel’s decision limiting venue in Hatch-Waxman cases conflicts with precedent regarding “what the act of infringement is” and “where the act of infringement occurs” under Section 271(e)(2) of the Patent Act.  Dkt. 75 at 15, 20.  In its panel decision, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated."

On November 5, 2020, in Valeant Pharms. N. Am. LLC  v. Mylan Pharms. Inc., No. 2019-2402, the Federal Circuit held that venue in Hatch-Waxman cases brought under 35 U.S.C. § 271(e)(2)(A) is proper “only in districts where actions related to the submission of an Abbreviated New Drug Application (‘ANDA’) occur, not in all locations where future distribution of the generic products specified in the ANDA is contemplated.”  Slip op. at 3.  If the ruling stands, it will restrict venue available against domestic generic drug makers in ANDA cases, and may similarly impact venue in litigation under the Biologics Price Competition and Innovation Act (“BPCIA”).

On October 6, FDA issued updated guidance for industry concerning “Emergency Use Authorization for Vaccines to Prevent COVID-19,” updating the previous guidance issued in June.  The updated guidance, which is being “implemented immediately” and “without prior public comment,” is intended “to provide sponsors of requests for Emergency Use Authorization (EUA) for COVID-19 vaccines with recommendations regarding the data and information needed to support the issuance of an EUA . . . for an investigational vaccine to prevent COVID-19 for the duration of the COVID-19 public health emergency."

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.

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.

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).

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. 

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.” 

Last week, Mylan and Biocon announced the U.S. launch of Ogivri™ (trasuzumab-dkst), a biosimilar to Herceptin® (trasuzumab).  Genentech’s Herceptin, which was first approved in 1998, is a monoclonal antibody used to treat breast cancer and metastatic stomach cancer.

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.

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. 

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.

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.  

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.

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.   

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. 

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.

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.

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. 

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.

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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.