Why It Matters
The Pharmaceutical Research and Manufacturers of America (PhRMA) retained Covington & Burling LLP to lobby on drug patents, biosimilars, and Medicare pricing legislation during the third quarter, according to federal lobbying disclosures.
The filing covers the Medication Affordability and Patent Integrity Act (S. 2658), which would require drug and biologic manufacturers to share certain patent-relevant information between the Food and Drug Administration (FDA) and the U.S. Patent and Trademark Office (USPTO), and the Skinny Labels, Big Savings Act (S. 43/H.R. 6485), which would establish protections against certain patent infringement claims involving generic drugs and biosimilars. The lobbying reflects the pharmaceutical industry's interest in legislation that could affect patent protections, competition from lower-cost medicines, and federal drug pricing policy.
By the Numbers
Covington & Burling reported $340,000 in lobbying income from PhRMA during the third quarter, an increase of $120,000, or approximately 54.5%, from $220,000 in the second quarter. No corresponding third-quarter filing from the previous year was identified in the supplied records, preventing a direct year-over-year comparison.
Across 38 reported registrants, PhRMA's combined lobbying expenditures totaled approximately $9.53 million, down $301,250 from $9.83 million in the second quarter. PhRMA's in-house operation accounted for most of the decrease, reporting $7.04 million, compared with $7.36 million previously. LMH Strategic Solutions LLC and AEGIS LLC appeared in the third-quarter records but not the second-quarter records.
The six lobbyists listed on Covington's filing were:
- Krista Carver, partner
- Richard Kingham, senior counsel
- Natalie Derzko, of counsel
- Tom Cosgrove, partner, Food, Drug and Device Group
- Michael Stern, partner
- Jennifer Plitsch, partner
Broader Context
S. 2658 — Medication Affordability and Patent Integrity Act
Sponsored by Sen. Maggie Hassan (D-NH), S. 2658 would require manufacturers to certify the consistency of certain information submitted to the FDA and USPTO and share information material to patentability. The bill was introduced and referred to the Senate Health, Education, Labor and Pensions Committee. A March 19 hearing was reported in the supplied legislative record, but its connection to formal action on S. 2658 requires confirmation.
The U.S. Chamber of Commerce and Council for Innovation Promotion oppose the proposal, arguing that its disclosure requirements and patent defenses could penalize manufacturers for inadvertent errors. The Pharmaceutical Industry Labor-Management Association (PILMA) also urged the committee to reject it, citing a study attributing more than 136 million labor hours across 18 states to pharmaceutical construction investment.
H.R. 6485/S. 43 — Skinny Labels, Big Savings Act
The legislation would establish a statutory safe harbor for certain activities involving generic drugs and biosimilars marketed without approval for patented uses. The proposal responds in part to litigation including GlaxoSmithKline LLC v. Teva Pharmaceuticals USA Inc., which addressed potential infringement liability associated with skinny-label generics.
Rep. Ben Cline (R-VA) sponsors H.R. 6485, while Sen. Amy Klobuchar (D-MN) introduced S. 43. The Association for Accessible Medicines supports the legislation, while the Intellectual Property Owners Association has opposed its proposed safe harbor as overly broad.
Biosimilar bills and the Medicare proposed rule
The Expedited Access to Biosimilars Act (S. 1414), sponsored by Sen. Rand Paul (R-KY), would restrict when the FDA may require additional studies for biosimilar approval.
The Biosimilar Red Tape Elimination Act (S. 1954), sponsored by Sen. Mike Lee (R-UT), would generally deem FDA-licensed biosimilars interchangeable with their reference products.
The Centers for Medicare and Medicaid Services also published a proposed Medicare Drug Price Negotiation Program rule in June at 91 Fed. Reg. 36236. Its final status requires confirmation.
The Bottom Line
PhRMA increased its use of Covington & Burling as Congress considered proposals affecting drug patent disclosures, skinny-label generics and biosimilar competition. The legislation could reshape how manufacturers defend patents and how competing medicines reach patients, making the outcome consequential for pharmaceutical companies, generic manufacturers and consumers.
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