District of Massachusetts IP Blog

Generic Pharma Sued In Advance On Method Patent

Momenta Pharm. (Cambridge, MA) and its exclusive licensee Sandoz Inc. (Princeton, NJ) have sued Amphastar Pharm. (Rancho Cucamonga, CA), International Medication Systems, Ltd. (Rancho Cucamonga, CA), and Watson Pharm. (Boston, MA) for infringement of Patent Nos. 7,575,886 and 7,790,466 directed to ways of manufacturing generic enoxaparin.  

Like similar complaints filed by Momenta, this complaint is based on an announcement by the defendants that the FDA had approved Amphastar’s ANDA for generic enoxaparin.  To cover their bases, the plaintiffs include in the complaint not only counts for infringement but also counts for declarations of infringement. 

Momenta Pharm., Inc. v. Amphastar Pharm., Inc., 11-11681-NMG (D. Mass. Sep. 21, 2011)

Fresenius Files ANDA Case Against InvaGen

Fresenius Medical Care Holdings, Inc. (Waltham, MA) has sued InvaGen Pharm., Inc. (Hauppauge, NY) for infringement of Patent No. 6,576,665 following an ANDA submitted by InvaGen. 

Fresenius Medical Care Holdings, Inc. v. InvaGen Pharm., Inc., 11-11645-RGS (D. Mass. Sep. 16, 2011)

Designer Smashes Infringing Barware

Designs By Lolita (Providence, RI) and its owner have sued CKK Home Decor Ltd. Partnership d/b/a Top Shelf Glasses (Frisco, TX) for copyright infringement relating to designs for painted drinkware.  The complaint alleges that at least nine of the defendant’s glasses infringe particular designs of the plaintiff.  They even feature similar names with similar designs (e.g., “Walking on Sunshine” infringes “Sun Glass Cooler” and “Naughty or Nice” infringes “Wild Child”.  You get the idea.)  Here’s an example:

Fresenius Files Another ANDA Infringement Case

In its latest ANDA case Fresenius Medical Care Holdings, Inc. (Waltham, MA) has sued Zydus Pharm., Inc. (Pennington, NJ) for infringement of Patent No. 6,576,665 as a result of Zydus’ ANDA application to sell a generic version of Fresenius’ PhosLo® GelCaps calcium acetate drug product.  Similar cases are pending against Lupin Ltd., Amneal Pharm., and Paddock Labs.  The latter two cases have been consolidated in a case which has already reached claim construction. 

Fresenius Medical Care Holdings, Inc. v. Zydus Pharm., Inc., 11-10110-RGS (D. Mass. Jan. 21, 2011)

Fresenius Sues Generic Drug Manufacturer to Prevent Generic PhosLo GelCaps

Fresenius Medical Care Holdings, Inc. (Waltham, MA) has sued Lupin Ltd. (Maharashta, India) and its U.S. subsidiary for infringement of Patent No. 6,576,665 as a result of Lupin’s ANDA application to sell a generic version of Fresenius’ PhosLo® GelCaps calcium acetate drug product.  A similar case against Amneal Pharm. was filed in August was also assigned to Judge Stearns and was consolidated with an earlier case against Paddock Labs.  Judge Stearns recently construed claim terms in that case.

Fresenius Medical Care Holdings, Inc. v. Lupin Ltd., 10-11856-RGS (D. Mass. Oct. 29, 2010)

Capsule Claims Construed

Judge Stearns construed claims in two patents owned by Fresenius Medical Care Holdings, Patent Nos. 6,576,665 and 6,875,445, directed to a calcium acetate drug product for containing hyperphosphatemia in patients suffering from chronic renal failure.  The claim construction applies to two consolidated ANDA cases brought by Fresenius against generic drug manufacturers. 

The most noteworthy of the claim construction disputes centers around the term “capsule” and whether “capsule” should necessarily mean a capsule of a certain numerical size category. 

The plaintiff argued that the independent claims place no restrictions on a capsule’s size and supported its argument through claim differentiation between the independent claim and size category limiting dependent claims.  The defendant argued that the language in the specification touting the size benefits of the invention (allowing smaller pills swallowable by renal failure patients) ought to be included in the claim construction.  

The court declined to assign a numerical size range to the term “capsule,” noting no clear disavowal of claim scope (and relying on the generic “other variations and modifications may be made” language ubiquitous in patent applications).  The court did, however, note that the plaintiff argued size benefits to the Examiner, which appeared to affect the Examiner’s decision to allow the claims.  Thus the court ruled that “capsule” was limited to having “a size range consistent with what a human patient with chronic renal failure can manipulate and swallow.”  The court left the application of that construction to the jury based on medical evidence presented at trial. 

Fresenius Medical Care Holdings, Inc. v. Paddock Labs, Inc., 09-11130-RGS (D. Mass. Oct. 6, 2010)Fresenius Medical Care Holdings, Inc. v. Amneal Pharmaceuticals, LLC., 10-11429-RGS 

ANDA Results in Fresenius Patent Case

Fresenius Medical (Waltham, MA) has sued Amneal Pharm. (Patterson, NJ) for infringement of Patent Nos. 6,576,665 and 6,875,445.  Under the Hatch-Waxman Act Amneal submitted an Abbreviated New Drug Application (ANDA) indicating that the ‘665 patent was either invalid or would not be infringed by Amneal’s proposed sales of generic versions of Fresenius’ PhosLo® GelCaps calcium acetate drug product.  By statute this was an act of infringement, and Fresenius sued.  It also tacked on an infringement claim for the ‘445 patent which would be infringed by Amneal making and selling the product in question.

 

Fresenius Medical Care Holdings, Inc. v. Amneal Pharmaceuticals, LLC., 10-11429-RGS (D. Mass. Aug. 19, 2010)