IP Issues

Roadmaps for Ensuring Patient Access to Generic and Biosimilar Medicines: Securing Sustainable Markets

eklinger — Mon, 22 Feb 2021 18:47:02 +0000

Roadmaps for Ensuring Patient Access to Generic and Biosimilar Medicines: Securing Sustainable Marketseklinger Mon, 02/22/2021 - 13:47

This paper examines the challenges to market sustainability for generic and biosimilar medicines that have cleared the regulatory and patent hurdles to obtain FDA approval and launch into the U.S. market. It is the first in a series of AAM papers that will highlight challenges to the overall sustainability of the generics and biosimilars industry. Future papers will examine threats to the balance between innovation and competition that drives generic and biosimilar development, including maintaining incentives to challenge brand-name drug patents and eliminating abuses of the patent system, as well as regulatory challenges relating to generics and biosimilars approval.

Issues

AAM’s Recommendations to #SecureOurMeds

kmurphy — Fri, 29 Jan 2021 17:00:00 +0000

AAM’s Recommendations to #SecureOurMedskmurphy Fri, 01/29/2021 - 12:00

Karin Hessler Joins AAM as Assistant General Counsel

rschwartz — Mon, 18 Mar 2019 13:00:00 +0000

Karin Hessler Joins AAM as Assistant General Counsel

WASHINGTON, DC (March 18, 2019) – Karin Hessler joins the Association for Accessible Medicines as Assistant General Counsel, effective today.

“Through her extensive legal representation of manufacturers of generic and biosimilar medicines, Karin will bring valuable insights into the intellectual property barriers that our companies face in trying to deliver safe, more affordable treatment options to patients,” said Jeff Francer, AAM’s Senior Vice President and General Counsel.

Hessler will focus primarily on Hatch-Waxman, biosimilar and pharmaceutical patent issues.

Before joining AAM in March 2019, Hessler was a partner at Wiley Rein LLP, where she represented clients on intellectual property matters, with a special focus on patent litigation in the biotechnology and medical device industries. She has played a lead role in all phases of numerous Hatch-Waxman litigations, including expert discovery, fact discovery, claim construction, trials, regulatory analysis and settlement negotiations.

Hessler received her J.D. from NYU School of Law, an M.A. in biochemistry from Duke and her B.S. in biochemistry from Lafayette College.

View Bio

MEDIA CONTACT:
Rachel Schwartz
202.249.7147

About AAM

AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 23 percent of total drug spending.

About the Biosimilars Council

The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available at www.biosimilarscouncil.org.

rschwartz Mon, 03/18/2019 - 09:00

Issues

IP Issues

AAM Welcomes Re-Introduction of the PACED Act

rschwartz — Wed, 13 Feb 2019 18:49:07 +0000

AAM Welcomes Re-Introduction of the PACED Act

WASHINGTON, DC (February 13, 2019) — With everyone from patients to the President demanding action on drug pricing, AAM welcomes the re-introduction of the Preserving Access to Cost Effective Drugs (PACED) Act.

As pharmaceutical companies continue to find novel ways to game the system to keep their monopolies intact long past their expiration date, the PACED Act addresses this particularly onerous practice that keeps drug costs artificially high. The scheme is so egregious that everyone said, ‘there ought to be a law.’ Thank you to Senators Tom Cotton (R-Arkansas), Pat Toomey (R-Pennsylvania) and Joni Ernst (R-Iowa) for taking the first step toward that objective. Congress should give the PACED Act its full consideration and enact this law.”

Attribution: Association for Accessible Medicines

MEDIA CONTACT:
Rachel Schwartz
202.249.7147

About AAM

About the Biosimilars Council

rschwartz Wed, 02/13/2019 - 13:49

Issues

Drug Prices

IP Issues

Patent Reform

AAM Files Amicus Brief in Helsinn v Teva

rschwartz — Wed, 17 Oct 2018 15:00:54 +0000

AAM Files Amicus Brief in Helsinn v Teva

WASHINGTON, DC (October 17, 2018)–Yesterday the Association for Accessible Medicines (AAM) filed an amicus brief in the Supreme Court case Helsinn v. Teva calling on the court to reject one form of patent system manipulation attempted by a brand-name drug company. The case will be heard on December 4.

For nearly two hundred years, the “on-sale bar” has funneled inventors into the patent system by preventing inventors from commercializing their inventions indefinitely before filing a patent application. Congress incorporated a prohibition on patenting “on sale” inventions into the Patent Act in 1836, and this prohibition remains unchanged. Yet Helsinn, a brand-name drug company has argued that a drug is not “on sale” if at least one “term” of the sale is not disclosed to the public.

AAM’s brief emphasizes the extent to which Helsinn’s interpretation of the on-sale bar would invite manipulation and foster confusion in the pharmaceutical market, with deleterious consequences for patients, taxpayers, and others who seek more affordable medicines.

Jeff Francer, AAM’s Senior Vice President and General Counsel stated, “Helsinn’s position reflects a variation on patent evergreening. It seeks to obtain monopoly profits for a period exceeding the statutorily prescribed monopoly period. Helsinn’s position is inconsistent with the national policy of fostering generic and biosimilar competition after that period has expired to ensure affordable patient access to prescription drugs.”

View AAM’s brief in the case, Helsinn v Teva.

View Brief

CONTACT:
Rachel Schwartz
202.249.7147 (o)
202.251.8881 (c)

About AAM

About the Biosimilars Council

rschwartz Wed, 10/17/2018 - 11:00

Issues

Patent Reform

IP Issues

Pharmaceutical Patent Abuse: To Infinity and Beyond!

ekomendant — Tue, 07 Aug 2018 14:25:44 +0000

Pharmaceutical Patent Abuse: To Infinity and Beyond!ekomendant Tue, 08/07/2018 - 10:25

AAM Statement on Importation Task Force

agoldberg — Thu, 19 Jul 2018 17:36:25 +0000

AAM Statement on Importation Task Force

WASHINGTON DC (July 19, 2018) – Secretary Azar testified on June 26 before the Senate Finance Committee, policy makers should examine whether the U.S. is "underpaying for and under-reimbursing for generics. We need a strong, robust generic market. We may be driving those prices so low that we're creating manufacturing anomalies that lead to sole-source products with others exiting. We need to look at that and be open minded about whether we've actually made it too low."

With Secretary Azar testifying that generic prices are being forced too low, the most important goal of the new HHS task force should be to address why there are sole source off-patent drugs in the first place. While AAM appreciates the Administration's efforts through its Blueprint to increase generic and biosimilar competition to bring down high brand name drug prices, importation of prescription drugs manufactured overseas will not solve the underlying under-reimbursement issues that Secretary Azar identified.

The task force must ensure that any initiatives do not further harm generic drug markets to the detriment of patient access. And given its mission to "address price hikes ... that are harming American patients," the most significant impact the task force could have is to look closely at drugs whose monopolies and price increases are enabled by well-documented abuses of the patent system.

MEDIA CONTACT:
Allen Goldberg
202.249.7110 (o)
202.251.8881 (c)

About AAM

About the Biosimilars Council

agoldberg Thu, 07/19/2018 - 13:36

Issues

Drug Prices

IP Issues

AAM Files Brief to Oppose Pharmaceutical Company Abuse of the Patent System

jfrancer — Fri, 18 May 2018 18:37:30 +0000

AAM Files Brief to Oppose Pharmaceutical Company Abuse of the Patent System

WASHINGTON, DC (May 18, 2018) –AAM filed an amicus brief in the U.S. Court of Appeals for the Federal Circuit calling on the court to reject gamesmanship of the patent system which keeps prescription drug prices high for patients. In this case, Allergan Inc. has transferred its patents to the St. Regis Mohawk Native American Tribe with the intent to use the tribe’s sovereign immunity to evade review of the drug company’s patents. AAM is joining with a diverse range of groups, including America’s Health Insurance Plans, in opposing this abuse of the patent system.

"If all pharmaceutical companies are allowed to shield their patents from the congressionally authorized processes for patent review under the America Invents Act, then patients seeking more affordable medicines lose," says AAM Senior Vice President and General Counsel Jeff Francer. “Such monetization of Native American tribal sovereign immunity would deal an extraordinary blow not only to the U.S. patent system, but to our health care system as well.”

View AAM’s brief in the case, Saint Regis Mohawk Tribe v. Mylan Pharmaceuticals Inc.

View Brief

CONTACT:
Rachel Schwartz
202.249.7147 (o)
202.251.8881 (c)

jfrancer Fri, 05/18/2018 - 14:37

Issues

Patent Reform

IP Issues

AAM Statement on Oil States Energy Services v. Greene's Energy Group

rschwartz — Tue, 24 Apr 2018 18:50:54 +0000

AAM Statement on Oil States Energy Services v. Greene's Energy Group

AAM commends the Supreme Court for upholding the constitutionality of the Inter Partes Review (IPR) process. This is a win for patients who depend on continued access to safe, effective and affordable generic and biosimilar medicines. IPR helps enhance patient access to generic and biosimilar medicines by providing a more efficient mechanism for determining whether the patents of brand-name drug manufacturers are valid.

ATTRIBUTE TO: Jeff Francer, Senior Vice President & General Counsel

View Amicus Brief

CONTACT:
Rachel Schwartz
202.249.7147 (o)
202.251.8881 (c)

rschwartz Tue, 04/24/2018 - 14:50

Issues

IP Issues

Skyrocketing Drug Prices Are a Threat to Everyone

eklinger — Mon, 26 Mar 2018 17:21:44 +0000

Skyrocketing Drug Prices Are a Threat to Everyoneeklinger Mon, 03/26/2018 - 13:21

The Average Annual Price of Specialty Drugs Has Tripled Over the Last Ten Years.

Prescription drugs treat conditions and improve patient health. But when drug prices are too high, access to medicines becomes out of reach for far too many patients.

Share the infographic below to help educate lawmakers on how generic and biosimilar medicines are the remedy to high drug costs.

Download a PDF of the "Skyrocketing Drug Prices Are a Threat to Everyone" Infographic

Read more about this infographic on our blog
Watch the video on YouTube
Share this page to raise awareness about this issue
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Learn more through AAM's 2020 Access and Savings Report

Issues

Patent Reform

Drug Prices

REMS/Sample Acquisition Remedies

IP Issues