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Posts Tagged: "bayer"

Delhi High Court Ruling Clarifies Requirements for Export Under India’s Bolar Exemption

In 2002, India’s Patent Act 1970 [“the Act”] was amended to include Section 107A. This provision says that any act of making, using, selling or importing a patented invention solely for uses reasonably related to the development and submission of information required under any law in India, or in a country other than India, shall not be considered as infringement of patent rights.  This provision also outlines India’s Bolar exemption. As per the “Bolar doctrine,” which arose out of the U.S. case of Roche Products v. Bolar Pharmaceuticals (1984), it is permissible for third parties to carry out research and development on patented products (especially drugs) for the purposes of submitting information as required by regulatory authorities. The purpose of this provision is to ensure that third parties can conduct research and development and obtain prior regulatory approvals, enabling them to launch the patented products on the market as soon as the patent term expires. This ensures that patent holders do not get a de facto monopoly on their inventions after expiration of their patent term. Further, it ensures that the public has access to cheaper generic versions of the drugs immediately after expiration of the patent term. In India, the scope of this provision has been controversial for some time now, leading to a slew of litigation between major international pharmaceutical companies and Indian generic manufacturers claiming the Bolar exemption. In the recent combined decision in the matters of Bayer Corporation v. Union of India & Ors. LPA No. 359/2017 and Bayer Intellectual Property GMBH & Anr. v. Alembic Pharmaceuticals Ltd. RFA(OS)(COMM) 6/2017 (March 22, 2019), the Division Bench of the Delhi High Court laid these controversies to rest by deciding the question of whether export is permissible under this provision.

Other Barks & Bites for Friday, February 15

This week in Other Barks & Bites: the USPTO appoints a new Chief Information Officer; Apple uses Qualcomm chips in Germany while American professors urge the ITC to deny exclusion of iPhones found to infringe Qualcomm patent claims; two important IP cases will be heard by the U.S. Supreme Court next week; the EU approves copyright reforms, including the hotly-debated Article 13; Fresh Prince of Bel-Air star Alfonso Ribeiro runs into issues at U.S. Copyright Office; Facebook could owe billions in fines for consumer data practices; a jury verdict dings Walmart for nearly $100 million in trademark infringement case; and Google announces multi-billion dollar plan to expand offices and data centers across the United States.

Other Barks & Bites for Friday, February 8

This week in Other Barks & Bites: the Federal Circuit affirms a Section 101 invalidation of patent claims in favor of Mayo Collaborative Services; Apple wins an order to limit damages in Qualcomm patent case; Google frets over proposed European Union copyright rules; India proposes jail time for film piracy; patent validity challenges drag down the stock of a major pharmaceutical firm; and a snag in the U.S.-China trade talks throws Wall Street for a loop.

International Trademark Lessons from the Bayer-Belmora FLANAX Trademark Fight

A closely watched cross-border trademark case finally has been resolved, and the results of the case have implications for global trademark holders. A  U.S. District Court Judge in the Eastern District of Virginia granted Bayer AG’s motion for summary judgment, dismissing rival Belmora’s claims to the trademark FLANAX. In Mexico, Bayer uses the FLANAX mark for the popular pain medication known elsewhere as Aleve (naproxen), and successfully blocked Belmora’s attempt to market its own naproxen product under the mark FLANAX in the United States. The ruling also affirms a U.S. Trial and Appeal Board ruling that cancelled Belmora’s U.S. trademark for FLANAX, which the company secured in 2005. The United States Court of Appeals for the Fourth Circuit had previously determined that the Lanham Act authorized Bayer’s claims against Belmora for unfair competition under §43(a) and its cancellation action under §14(3).

Myths about patent trolls prevent honest discussion about U.S. patent system

A $1 trillion a year industry not wanting to pay innovators less than a 1% royalty on the innovations they appropriate (i.e., steal) for their own profits seems like a terrible price to pay given the national security and economic consequences of forfeiting our world leadership to the Europeans and Chinese… Google and Uber are locked in a patent battle over self-driving automobiles, so does that make Google or Uber a patent troll? What about General Electric, Apple, Samsung, Microsoft, Cisco, Oracle, Whirlpool, Kraft Foods, Caterpillar, Seiko Epson, Amgen, Bayer, Genzyme, Sanofi-Aventis, and Honeywell, to name just a few?

The future of agricultural pest control is biopesticides, IoT insect monitoring systems

The Internet of Things has been lauded as a potential boon for crop production, including pest control. Automated IoT pest control systems have been developed by Spensa of West Lafayette, IN. Its Z-Trap unit is specifically designed for apple orchards to detect the levels of codling moths, one of the more common North American pests for apple trees. Z-Traps can be monitored remotely from a computer, Android or iPhone. This technology is also being developed to detect for Oriental fruit flies and obliquebanded leafrollers. Pest monitoring systems like this enable farmers to more effectively apply pesticides and hopefully reduce the amount of pesticide used on plants.

Ranbaxy Fined, J&J Tylenol Scandal, Bayer Sued Over Vitamins

Once again, a plethora of interesting events has occurred since the last time we stopped by. What was the biggest headline? That decision may be up for grabs, but certainly, the $500 million penalty paid by Ranbaxy Laboratories is high on the list. In other news, yet another Johnson & Johnson manufacturing scandal has erupted, this time in South Korea, where the authorities plan to bring criminal charges against its Janssen unit and ban production of five products – notably, a type of Children’s Tylenol. A non-profit group put Bayer on notice that a lawsuit will be filed charging the drugmaker with making “unsubstantiated and illegal claims” about the ability of its One-A-Day vitamin to prevent various disease, such as breast cancer, bolster physical energy and improve immunity, among other things.

Pharma Reverse Patent Payments Are Not An Antitrust Violation

The plaintiffs had argued that defendants had in fact violated Section 1 of the Sherman Act when they settled their dispute concerning the validity of Bayer’s Cipro patent by agreeing to a reverse exclusionary payment settlement. Bayer agreed to pay the generic challengers, and in exchange the generic firms conceded the validity of the Cipro patent. The Second Circuit panel affirmed the granting of summary judgment, finding themselves confined by the previous Second Circuit ruling in Tamoxifen. The panel did, however, make the extraordinary invitation to petition the Second Circuit for rehearing in banc, citing the exceptional importance of the antitrust implications, the fact that the primary authors of the Hatch-Waxman Act have stated reverse payments were never intended under the legislation and the fact that the Second Circuit in Tamoxifen simply got it wrong when they said that subsequent generic entrants could potentially obtain a 180 exclusive period even after the first would-be generic entrant had settled.