Lexmark and International Patent exhaustion on sale: its implications on affordable medicines in The US and India
Bibliographic record
Abstract
The role of intellectual property in the pharmaceutical industry has been controversial for decades. On one hand, evidence suggests that patents and monopolies on drug sales for limited periods are necessary to fund costly R&D required to produce life-saving therapies. On the other, there is concern that patent rights have gone too far in favour of innovation, limiting access to lower-income populations who cannot afford exorbitant drug prices. This tension plays out at a grander scale in the international context, as drug prices can vary drastically between countries, as has happened in the COVID-19 pandemic. In 2017, the United States Supreme Court held in Lexmark that a patentee’s rights are exhausted after international sale. This decision has immense implications for the U.S. pharmaceutical industry and the affordability of medicines worldwide. Legislators such as Senator Bernie Sanders have proposed bills in light of the decision to lower American drug prices by permitting importation from countries like Canada. Though FDA and other regulatory barriers may still be present, American innovator companies can no longer sue reimports on the grounds of patent infringement. However, while the results may be favourable to U.S. consumers, international impacts remain to be seen. Some suggest that prices in countries like India could increase to reduce opportunities for arbitrage. In this article, we suggest methods for branded pharmaceutical companies to address issues arising from Lexmark while simultaneously providing affordable access—from voluntary licensing to avoid the risk of compulsory licenses and creative forms of contracting. Finally, we conclude regarding India’s newfound consumer protection laws to note that American pharmaceutical players may not simply be able to lower product standards to prevent parallel importation back to the US
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.005 | 0.016 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.002 |
| Bibliometrics | 0.003 | 0.004 |
| Science and technology studies | 0.006 | 0.015 |
| Scholarly communication | 0.017 | 0.009 |
| Open science | 0.002 | 0.007 |
| Research integrity | 0.009 | 0.011 |
| Insufficient payload (model declined to judge) | 0.016 | 0.001 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".