U.S. Supreme Court, picture taken by Gene Quinn 11/9/2009
One of the most debated issues in patent and antitrust law today involves pharmaceutical patent settlements. Brand-name drug manufacturers pay generic firms to settle patent litigation and delay entering the market. How should the antitrust laws respond?
Recent appellate courts have upheld the settlements with an analysis bordering on per se legality. The Second Circuit recently offered such analysis in upholding Bayer’s $398 million payment to Barr to delay entering the market with a generic version of antibiotic ciprofloxacin hydrochloride (Cipro). I (along with David Balto) recently filed an amicus brief on behalf of several consumer organizations recommending that the Supreme Court grant certiorari. I made three arguments for why the Court should take the case.
Earlier today, in In re Ciprofloxacin Hydrochloride Antitrust Litigation, the United States Court of Appeals for the Second Circuit issued a ruling addressing whether so-called reverse payments, payments made under a negotiated settlement by a pharmaceutical patent owner to a would-be generic entrant in exchange for not entering the market, are a violation of U.S. Antitrust Law. The appeal came from a judgment of the United States District Court for the Eastern District of New York (Trager, J.) granting summary judgment for defendants, manufacturers of the antibiotic ciprofloxacin hydrochloride (“Cipro”) or generic bioequivalents of Cipro. In a per curiam decision the Second Circuit panel (Judges Newman, Pooler and Parker) affirmed, determining in accordance with Second Circuit precedent (see In re Tamoxifen Citrate Antitrust Litig.) that reverse payments stemming from a patent settlement do not violate U.S. Antitrust Laws.
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.
In this release, the authors (Kaye Scholer LLP’s Patent Group) update and expand Pharmaceutical and Biotech Patent Law with new discussion of many topics, including double patenting, inequitable conduct, product by process claims, attorneys fees under Hatch-Waxman and more.
Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York. Mylan’s filing of an ANDA for what they are calling a generic version of COPAXONE® was not unexpected, as the company announced its intention to do so over a year ago. Teva received Mylan’s Paragraph IV certification notice referring to Teva’s U.S. Patents, which cover the chemical composition of COPAXONE®, pharmaceutical compositions containing it, and methods of using it. These patents are listed in the U.S. Food and Drug Administration’s (FDA) Orange Book and extend through May 24, 2014. While the press release and news accounts have not identified the patents in question, the prescribing information flyer available on copaxone.com lists the following patents as covering the drug — U.S. Patent Nos. 5981589, 6054430, 6342476, 6362161, 6620847, 6939539 and 7199098.
Earlier today, Judge Garrett Brown of the United States Federal District Court for the District of New Jersey, issued an Order and Findings of Fact and Conclusions of Law in the dispute between between Merck and Teva Pharmaceuticals. Judge Brown found that the patent in question, US Patent No. 5,565,473, was valid and enforceable, and that the Teva’s Abbreviated New Drug Application (“ANDA”) filing infringed the patent. The ’473 patent specifically relates to montelukast sodium, which is the active ingredient in the Singulair® tablets, Merck’s pharmaceutical product used for treating certain ailments, including asthma and allergic rhinitis. Those familiar with patent law will realize that it is technically not appropriate for a district court to find that a patent is valid, and rather should have declared the patent not invalid, but the point remains that as a result of his 100+ page ruling Judge Brown has handed Merck a large victory and Teva Pharmaceuticals a significant setback.
On Tuesday, March 10, 2009, Dr. Reddy’s Laboratories (NYSE:RDY) prevailed in a patent dispute with Astra Zeneca, receiving a summary judgment victory in the ongoing dispute before the United States Federal District Court for the Southern District of New York. U.S. District Court Judge Colleen McMahon ruled that the Omeprazole Magnesium OTC Abbreviated New Drug Application (ANDA) filed by Dr. Reddy’s does not infringe the patents in suit related to AstraZeneca’s Prilosec OTC®.
The Patent Docs are reporting that on February 3, 2009, Senator Herb Kohl (D-WI) introduced legislation into the Senate titled the Preserve Access to Affordable Generics Act, which would prohibit brand name drug companies from compensating generic drug makers for delaying the entry of generic drugs into the market. This bill is in response to a lawsuit initiated by the FTC in which Solvay Pharmaceuticals, Inc. paid generic drug makers Watson Pharmaceuticals, Inc. and Par Pharmaceutical Companies, Inc. to delay generic competition to Solvay’s branded testosterone-replacement drug AndroGel, a prescription pharmaceutical with annual sales of more than $400 million.
Despite the fact that an official announcement is not due until sometime later this morning, it seems likely that everyone already knows that President Barack Obama has selected Judd Gregg, the Senior United States Senator from New Hampshire, to be his Secretary of Commerce. All the political pundits have offered expert commentary on why President Obama might choose a Republican Senator to be his Secretary of Commerce, but maybe it is as simple as he actually paid his federal income taxes on time and in full, who knows? One thing is for certain though, Judd Gregg does not have a long history to review on patent matters, but the man who will be the boss of the next Director of the United States Patent and Trademark Office does have one thorny patent issue in his past, namely the misguided attempts by Columbia University to extend its patent protection on a multi-million dollar process. If failure to pay federal income taxes does not disqualify a nominee from serving in the President’s Cabinet I doubt this issue will present any problems for Gregg, although it certainly deserves to be an interesting footnote in his political career. This is particularly true given that he will head the Agency under which the US Patent Office falls.
How to Write a Patent Application is a must own for patent attorneys, patent agents and law students alike. A crucial hands-on resource that walks you through every aspect of preparing and filing a patent application, from working with an inventor to patent searches, preparing the patent application, drafting claims and more. The treatise is continuously updated to address relevant Federal Circuit and Supreme Court decision impacting patent drafting.
Earlier today, in 
Teva Pharmaceutical Industries Ltd. issued a press release last week discussing the abbreviated new drug application (ANDA) containing a Paragraph IV certification for COPAXONE® (glatiramer acetate injection), filed by Mylan Pharmaceuticals Inc. Teva announced that it has filed a lawsuit against Mylan Pharmaceuticals, Inc., Mylan Inc. and Natco Pharma Ltd. for patent infringement in the U.S. District Court for the Southern District of New York. Mylan’s filing of an ANDA for what they are calling a generic version of COPAXONE® was not unexpected, as the company announced its intention to do so over a year ago. Teva received Mylan’s Paragraph IV certification notice referring to Teva’s U.S. Patents, which cover the chemical composition of COPAXONE®, pharmaceutical compositions containing it, and methods of using it. These patents are listed in the U.S. Food and Drug Administration’s (FDA) Orange Book and extend through May 24, 2014. While the press release and news accounts have not identified the patents in question, the 
Earlier today, Judge Garrett Brown of the United States Federal District Court for the District of New Jersey, issued an 
On Tuesday, March 10, 2009, Dr. Reddy’s Laboratories (NYSE:RDY) prevailed in a patent dispute with Astra Zeneca, receiving a summary judgment victory in the ongoing dispute before the United States Federal District Court for the Southern District of New York. U.S. District Court 
The 
Despite the fact that an official announcement is not due until sometime later this morning, it seems likely that everyone already knows that 
