Patent trolls delay life-saving medical innovation ---- IPR is key to accessibility and innovation.

A number of organizations in the pharmaceutical and health industries submitted comments in opposition to the substance of the ANPRM proposals, including Mylan Pharmaceuticals, Fresenius Kabi, Association for Accessible Medicines, Edwards Lifesciences, I-MAK, and Generation Patient.

A core theme in these comments is that weak patents are frequently used to delay medical progress and competition – increasing costs for patients and reducing access to potentially life-saving medicines and technologies. These organizations all align on the importance of protecting existing PTAB processes, so that PTAB review can continue being used as a tool to challenge questionable patents and therefore promote medical innovation.

“...In the life sciences industry, weak patents that do not actually claim a novel, innovative invention, can nonetheless delay generic or biosimilar competition for many years. To combat those delays, Mylan has filed well over 100 inter partes reviews (“IPRs”), taking advantage of Patent Trial and Appeal Board’s (“PTAB”) efficient and streamlined process to challenge weak patents that would otherwise delay patient access to life-saving medicines. Those patent challenges have allowed patients to benefit from earlier access to competition for more than $35 billion in annual brand costs…” – Mylan Pharmaceuticals (A global healthcare company that provides critical access to quality lifesaving medicines)

“...Inter partes review (“IPR”) and post grant review (“PGR”) each play a critical role in tackling the root cause of inappropriate delays to low-cost competition in the pharmaceutical industry. Fresenius Kabi opposes the proposed ANPRM modifications because they would so significantly undermine such challenges as to actively discourage them. By extension, the ANPRM as currently proposed would delay access to more affordable generics and biosimilars. As a general matter, unfettered access to the PTAB is particularly important in the generic drug and biosimilar industries. Each generic or biosimilar manufacturer should be free to make its best invalidity case to the Office and not risk forfeiting its right to meaningful PTAB review or other remedies available under current law…” – Fresenius Kabi (Specializes in bringing affordable, off-patent medicines to patients with critical and chronic conditions)

“...When it is more difficult to challenge patents, especially in the pharmaceutical field, there is more potential harm to Americans when it comes to their ability to access lower cost generics/biosimilars. This leads to an overall impact on the health of Americans and the economy….” – I-Mak (Nonpartisan, not-for-profit, and non-governmental organization working to address structural inequities in how medicines are developed and distributed)

“...By creating heightened barriers, these rules stifle competition and unjustifiably drive up prices, particularly for crucial medical treatments we rely on as patients. Moreover, inter partes review fosters innovation by ensuring that patents do not impede future research and development. When invalid patents are challenged, it paves the way for others to build upon existing knowledge and create new, innovative treatments. This promotes a more dynamic and competitive pharmaceutical industry, leading to the development of new medicines and improved healthcare options...” – Generation Patient (A young adult patient led organization that increases the health literacy, confidence, self-management skills, public policy knowledge, and advocacy strategies of young adult patients)