Facing unprecedented innovation and explosive growth in the life sciences industry, many leading biotechnology and pharmaceutical companies turn to Perkins Coie lawyers for strategic advice and practical counsel on expanding their business and protecting their intellectual property.
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Publications
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08.29.2023FDA Finalizes Guidance for IRBs, Clinical Investigators, and Sponsors on Informed ConsentArticlesThe U.S. Food and Drug Administration (FDA) released a new set of guidelines on August 15, 2023, concerning informed consent (Final Guidance).
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06.26.2023Washington State’s New My Health My Data Act Will Likely Result in Insurance Coverage DisputesUpdatesWashington state recently passed the My Health My Data Act, which will almost certainly lead to an explosion of consumer lawsuits and follow-on insurance coverage disputes.
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06.07.2023The Wide Reach of the New Washington Privacy LegislationUpdatesThis Update is the third installment of the ongoing series covering Washington state’s new My Health My Data Act. The original impetus for the Act was the protection of reproductive rights, and it was signed into law alongside several other pieces of legislation focused on providing abortion and gender-affirming protections. However, because of the broad and vague definition of “consumer health data” covered by the legislation and because it applies to a wide range of entities, the Act may reach much further than might be justified by its original purpose.
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06.01.2023Consumer Rights and Business ObligationsUpdatesAs detailed in Part 1 of this ongoing series, Washington Governor Jay Inslee signed the state’s My Health My Data Act into law on April 27, 2023. In this installment, we provide an overview of the consumer rights bestowed by the Act and the obligations it imposes upon regulated entities and small businesses.
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2022California Consumer Privacy Act Litigation Year in Review 2022Lawyer PublicationsPerkins Coie is pleased to announce the launch of our second annual report California Consumer Privacy Act Litigation Year in Review. The California Consumer Privacy Act (CCPA) became effective on January 1, 2020, and regulates any “business” that does business in California.
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02.27.2020Federal Circuit Decides Country of Origin Test for Drugs Under Trade Agreements ActUpdatesWhat is a thing? On February 10, 2020, the U.S. Court of Appeals for the Federal Circuit gave us a new answer to this old philosophical question.
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12.15.2017Federal Circuit Rules Out State-Law Remedies for Failure to Participate in the Biosimilars "Patent Dance"UpdatesOn December 14, the Federal Circuit issued a decision that further clarifies the ground rules for disclosures of product information by manufacturers of biosimilar pharmaceutical products. In particular, the Federal Circuit ruled in Amgen Inc. v. Sandoz Inc. that the original sponsors of biologics products cannot invoke state laws to compel applicants that are seeking to market biosimilar products to disclose information about those products under the Biologics Price Competition and Innovation Act (BPCIA).
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09.22.2015Pharma and Medical Device Industry Victory in Off-Label Marketing DecisionUpdatesThe U.S. District Court for the Southern District of New York recently held that the FDA may not constitutionally bring a misbranding action based on truthful and non-misleading off-label promotion of an FDA-approved drug, thereby helping to clarify lingering uncertainty over the scope of First Amendment protection afforded statements by drug representatives, at least in states located in the Second Circuit.
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03.31.2015OIG Warns Lab “Pull-Through” Arrangements May Be IllegalUpdatesIn an important advisory opinion, the U.S. Department of Health and Human Services Office of Inspector General (OIG) gave a thumbs-down to a proposed clinical laboratory “pull-through” arrangement even though the patients in question were not federal healthcare program beneficiaries and the physician practices derived no direct financial benefit from the arrangement.
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04.30.2014Theft of Unencrypted Laptops Leads to Two HHS Settlements Totaling Nearly $2 MillionUpdatesOn April 22, the U.S. Department of Health and Human Services (HHS) announced settlements with both Concentra Health Services (Concentra) and QCA Health Plan, Inc. (QCA). Through these latest settlements, HHS is reiterating its message to covered entities and business associates that laptops and similar devices containing electronic protected health information (ePHI) should be encrypted.
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01.03.2014New Rules Amend Regulatory Exceptions for Donation of Electronic Health Records Items and ServicesUpdatesOn December 27, 2013, the Department of Health and Human Services published two final rules, one amending the Office of Inspector General’s (OIG) Anti-Kickback safe harbor related to electronic health records (EHR) items and services (42 C.F.R. § 1001.952(y)), and the other amending the Centers for Medicare & Medicaid Services’ (CMS) parallel Stark law exception.
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06.14.2013Supreme Court Rules That Isolated Genes Are Unpatentable Products of NatureUpdatesYesterday, the Supreme Court issued its highly anticipated decision in Association for Molecular Pathology v. Myriad Genetics, Inc. The Court unanimously held that isolated genomic DNA is a product of nature and therefore is not patent-eligible under 35 U.S.C. §101. The Court also held that complementary DNA (cDNA) molecules excluding “intron” portions of the natural DNA sequence are patent eligible.
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02.12.2013CMS Issues Final Physician Payment Sunshine Act RegulationsUpdatesOn February 1, 2013, the Centers for Medicare and Medicaid Services (CMS) published the long-awaited final regulations implementing the Physician Payment Sunshine Act (Act or Sunshine Act). The Sunshine Act requires drug, medical device, biological and medical supply manufacturers to track and report, for publication by CMS, payments made to physicians and teaching hospitals.
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02.05.2013The Madrid System Is Expanding: Is Your Trademark Portfolio Covered?UpdatesAs more countries join the Madrid Protocol System for the International Registration of Marks (Madrid System), trademark owners should be sure to take full advantage of this trademark registration option. There are now 89 members of the Madrid System. Significantly lower application and maintenance costs, as well as streamlined portfolio management options, are just a few of the reasons why the Madrid System is advantageous for trademark owners.
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12.12.2012New Rules Will Be “Taxing” on Medical Device ManufacturersUpdatesThe U.S. Department of the Treasury and the Internal Revenue Service (IRS) recently issued much-anticipated final regulations under Section 4191 of the Internal Revenue Code (Code), which imposes a 2.3% tax on sales of any “taxable medical device” by a manufacturer, producer or importer (collectively referred to as “manufacturers”). The IRS simultaneously issued Notice 2012-77, providing interim guidance to manufacturers while it continues to study certain issues that are not addressed by the final regulations.
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10.15.2012Sixth Circuit Rebukes Government’s Reliance on Profit Motive to Prove False ClaimUpdatesOn October 5, 2012, the Sixth Circuit reversed an $82.6 million award in a False Claims Act (FCA) lawsuit against Fresenius Medical Care Holdings (Fresenius) and granted partial summary judgment in favor of the defendants.
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09.10.2012FTC Seeks Comments on Proposed HSR Rule Amendments Related to the Transfer of Exclusive Patent Rights in the Pharmaceutical IndustryUpdatesThe Federal Trade Commission (“FTC”) recently announced and asked for comments on proposed changes to the premerger notification rules under the Hart-Scott-Rodino Act (“HSR Act”). The proposed rules would require pharmaceutical companies to report to the FTC and the Department of Justice ("DOJ") acquisitions of exclusive patent licenses in which the licensor retains the right to manufacture patented products for the licensee.
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07.11.2012$3B GlaxoSmithKline Settlement: Is the Government Changing the Way Drug and Device Companies Do Business?UpdatesOn July 2, 2012, the Department of Justice announced the largest health care fraud settlement in U.S. history: GlaxoSmithKline LLC (“GSK”) will pay $3 billion to resolve criminal and civil allegations of unlawfully promoting prescription drugs, failing to report safety data and engaging in allegedly false price reporting practices. This resolution includes a criminal fine and forfeiture totaling $1 billion and $2 billion in civil payments.
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07.02.2012Affordable Care Act Withstands Constitutional Scrutiny But Providers Face Uncertain FutureUpdatesIn National Federation of Independent Business v. Sebelius, a divided U.S. Supreme Court upheld the vast bulk of the Patient Protection and Affordable Care Act (“ACA” or the “Act”) against a number of challenges.
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05.14.2012Abbott’s Settlements and Criminal Conviction Illustrate the Government's Continuing Interest in Off-Label MarketingUpdatesOn May 7, 2012, the Justice Department announced that Abbott Laboratories Inc. (“Abbott”) has agreed to pay $1.5 billion to resolve criminal and civil investigations into the company’s promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration (“FDA”). The resolution, which is the second-largest settlement ever for a drug company, includes a criminal fine and forfeiture totaling $700 million and civil payments with the federal government and states totaling $800 million. Whistleblowers will receive $84 million from the federal share of the settlement amount. With this settlement, the Justice Department has recovered over $10.2 billion in False Claims Act cases and has secured $3.9 billion in criminal fines, forfeitures, disgorgements and restitution relating to violations of the Food, Drug and Cosmetic Act (“FDCA”) since January 2009.
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05.09.2012Physician Payment Sunshine Act Data Collection Deferred to 2013UpdatesOn May 4, 2012, the Centers for Medicare and Medicaid Services (“CMS”) announced that it will not require applicable manufacturers and group purchasing organizations (“GPOs”) to begin collecting data on relevant payments under the Physician Payment Sunshine Act (“Act” or “Sunshine Act”) until January 1, 2013. Under the Sunshine Act, data collection was set to begin January 1, 2012.
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04.17.2012Supreme Court Sides With Generic Drug Manufacturers, Closes Loophole in Hatch-Waxman ActUpdatesIn Caraco Pharmaceutical Laboratories, Ltd. v. Novo Nordisk A/S, the Supreme Court has unanimously held that generic drug manufacturers may invoke the counterclaim provision of the Hatch-Waxman Act.
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03.13.2012FDA Releases Draft Guidelines for Biosimilar Development ApprovalUpdatesOn February 9, 2012, the Food and Drug Administration ("FDA") released draft biosimilar development approval pathway guidelines.
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02.13.2012Medical Device Company Smith & Nephew Resolves FCPA Charges for Unlawful Incentive Payments to Greek PhysiciansUpdatesThe U.S. Department of Justice announced on February 6, 2012 that medical device company Smith & Nephew Inc. has agreed to pay over $22 million to settle Foreign Corrupt Practices Act allegations that it paid government-employed doctors in Greece to use its products.
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12.19.2011CMS Issues Proposed Physician Payment Sunshine Act RegulationsUpdatesThe Centers for Medicare and Medicaid Services published proposed regulations today under the Physician Payment Sunshine Act.
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10.14.2011New Peer Reviewed Edition of Reference Manual on Scientific Evidence for Judges ReleasedUpdatesOn September 28, the Federal Judicial Center and the National Academies jointly released the third edition of the Reference Manual on Scientific Evidence (the "Manual"), containing tools for use by judges to manage cases involving complex scientific and technical evidence as part of their responsibilities under Daubert.
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08.23.2011Protecting Your Brand in the New .XXX DomainUpdatesThere have been many recent changes in the world of domain names. This is the fourth in a series of updates on these issues. It is intended to keep you informed about issues that are important to brand owners and any others with a significant web presence.
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06.30.2011.Pepsi and .Soda: Are You Ready for the Coming Expansion of Domain Name Space? Legal and Practical Issues for In-House Counsel and Brand ManagersUpdatesIn a matter of months, the amount of "Internet real estate"—which has been static for the past several years—will expand dramatically. Companies, organizations, cities and others will be able to apply to ICANN to launch new domain spaces using brand names (for example, .nike), generic terms (such as .shoes) and locations (such as .nyc).
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06.16.2011The Supreme Court Clarifies Invention Ownership Under Bayh-DoleUpdatesThe U.S. Supreme Court in Board of Trustees of Leland Stanford Junior University v. Roche Molecular Systems, Inc., ruled that the Bayh-Dole Act does not automatically vest title to inventions resulting from research funded by the federal government in federal contractors such as universities.
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06.07.2011Sunshine Act Mandates Public Reporting of Payments by Drug, Medical Device and Medical Supply Manufacturers to PhysiciansUpdatesThe Physician Payment Sunshine Act, enacted into law as part of the Health Care Reform package in 2010, will require the tracking and reporting to the government of payments made on or after January 1, 2012 by drug, medical device and medical supply manufacturers to physicians and teaching hospitals.
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05.18.2011Health Care Fraud Enforcement Trends Highlighted at American Bar Association ConferenceUpdatesThe American Bar Association held a Health Care Fraud Conference on May 11-13, 2011 in which high level officials from both the Department of Justice (“DOJ”) and Health and Human Services (“HHS”) described the new tools and tactics the government is utilizing to combat health care fraud. The government's new campaign will increase the amount of scrutiny that hospitals, pharmaceutical manufacturers, medical device companies and individual providers face.
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05.05.2011Government to Exclude Pharma CEO from Federal Health Programs Based on Corporation's ConvictionUpdatesThe Department of Health and Human Services (HHS) recently announced that it will seek to exclude Howard Solomon, CEO of pharmaceutical company Forest Laboratories Inc., from participation in federal health programs (such as Medicare and Medicaid) based solely on the corporation’s criminal conviction.
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04.22.2011Federal Circuit Alters Test for Contempt in Patent Cases and Imposes Greater Burden on Adjudged Infringers to Seek Clarification of Ambiguous InjunctionsUpdatesOn April 20, the Federal Circuit issued its long-awaited en banc decision in TiVo Inc. v. EchoStar Corp.,[1] vacating one ground for a contempt citation but affirming the other and upholding a $90 million sanction. Along the way, the court significantly revised its approach to contempt proceedings in ways that may both help and hurt patentees in future cases.
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03.31.2011Supreme Court Addresses Materiality in Securities Fraud CasesUpdatesIn Matrixx Initiatives, Inc. v. Siracusano, No. 09-1156 (U.S. Mar. 22, 2011), the U.S. Supreme Court unanimously held that a plaintiff can establish the materiality (for purposes of claims under Section 10(b) of the Securities Exchange Act of 1934 and SEC Rule 10b-5) of adverse events experienced by users of pharmaceutical products without showing that the incidence of harm from those adverse events was statistically significant.
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06.28.2010Business Methods Patents Survive, But Not Bilski’s PatentUpdatesBy a 5-4 vote, the United States Supreme Court has rejected the notion that business methods are categorically unpatentable. By a unanimous vote, however, the Court has affirmed the PTO and Federal Circuit’s rulings rejecting Bilski’s patent claims on methods of hedging commodity risks. The Court also unanimously agreed that while the "machine or transformation" test adopted by the Federal Circuit is a useful indicator of patentability, it is not the sole test for patentability under Section 101 of the Patent Act. Although many had feared--and some had hoped--that all software patents were in jeopardy, the Court’s relatively narrow decision should allay those fears and dash those hopes.
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05.28.2010Treasury Releases New Guidance for Tax Credit in Affordable Care Act to Support Groundbreaking Biomedical ResearchUpdatesThe Patient Protection and Affordable Care Act, signed into law on March 23, 2010, provides an opportunity for biotech and biopharma companies to recover certified investments in qualifying therapeutic discovery projects as a cash grant or a tax credit.
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04.02.2010Cash Grants and Tax Credits Now Available for Certain Biotech/Biopharma R&D ExpensesUpdatesBiotech and biopharma companies now have an opportunity to recover up to 50% of their qualified investments in qualifying therapeutic discovery projects as a cash grant or tax credit.
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09.2009Safety Versus Savings: Congressional Biosimilar LegislationArticles
Intellectual Property Today
Presentations
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05.18.2023 – 05.19.2023International Forum on Consciousness – Nature, Earth, and Humanity: Evolution of ConnectionSpeaking EngagementsPerkins Coie sponsored the BioPharmaceutical Technology Center Institute’s (BTC Institute) International Forum on Consciousness, “Nature, Earth, and Humanity: Evolution of Connection,” on May 18 – 19, 2023.
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04.19.202317th Wisconsin Stem Cell SymposiumSpeaking EngagementsPerkins Coie sponsored the 17th Wisconsin Stem Cell Symposium “Stem Cell Innovations in Building and Rebuilding the Nervous System” coordinated by the University of Wisconsin–Madison Stem Cell & Regenerative Medicine Center and the BioPharmaceutical Technology Center Institute (BTC Institute).
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10.20102010 Product Liability WorkshopSeminarsIn the past 19 years, more than 750 companies have sent employees to a Perkins Coie Product Liability Workshop.
Blog
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USPTO Requests Comments on PTAB-Decision Review by October 18, 2022
On July 22, 2022, the USPTO released a Request for Comments (RFC) seeking public input on Director review, Precedential Opinion Panel (POP) review, and internal circulation and review of Patent Trial and Appeal Board (PTAB) decisions. As set out in the RFC, “[t]he USPTO has implemented a number of processes that promote the accuracy, consistency,... Continue Reading…
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On February 28, 2022, the Patent Trial and Appeal Board (“PTAB”) issued a decision on priority in an interference proceeding between the Broad Institute, Inc., Massachusetts Institute of Technology, and President and Fellows of Harvard College (collectively, “Broad”) and the Regents of the University of California, University of Vienna, and Emmanuelle Charpentier (collectively, “CVC”), and... Continue Reading…
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Federal Circuit Confirms the Broad Reach of IPR Estoppel
Under 35 U.S.C. § 315(e), inter partes review (IPR) estoppel applies to “any ground that the petitioner raised or reasonably could have raised during that inter partes review.” In 2018, the Federal Circuit held in Shaw Industries Group, Inc. v. Automated Creel Systems, Inc., 817 F.3d 1293 (Fed. Cir. 2016), that IPR estoppel does not apply... Continue Reading…
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Real Parties-In-Interest: Guidance On Who Is An RPI-And Who Is Not-In Post-Grant Proceedings
In a recent article, Real Parties In Interest Guidance On Who Is An RPI-And Who Is Not-In Post Grant Proceedings, linked here, Emily Greb and Maria Stubbing offer practical guidance and examine caselaw to clear some of the confusion and frustration practitioners encounter when real parties-in-interest in post-grant review proceedings before the U.S. Patent and Trademark... Continue Reading…
