Justia Drugs & Biotech Opinion Summaries

First introduced in 1960, combined oral contraceptive (COC) “birth control pills,” deliver synthetic hormones that regulate the natural ovarian cycle and prevent pregnancy. Bayer filed an application directed to a low-dose, extended-regimen COC in 1993, which eventually led to the 564 patent. Bayer received final approval to market YAZ in the U.S. in 2006. Defendants filed Abbreviated New Drug Applications with the U.S. Food and Drug Administration seeking approval to market generic versions of YAZ, with certifications asserting that the 564 patent is invalid (21 U.S.C. 355(j)(2)(A)(vii)(IV). Bayer responded with patent infringement actions. The district court entered summary judgment that the patent’s claims are not invalid for obviousness in view of numerous cited prior art references. The Federal Circuit reversed, finding that Bayer did not present evidence that overcomes the plain disclosures and express motivation to combine those disclosures in the prior art. View "Bayer Healthcare Pharma, Inc. v. Watson Pharma, Inc." on Justia Law

Saffran is the owner and sole named inventor of the 760 patent, entitled “Method and Apparatus for Managing Macromolecular Distribution,” which concerns “treatment of injured tissues within human or animal bodies, specifically ... the way injured tissues are joined and the way macromolecules are directed to promote healing.” The patent discloses methods and devices for treating injured tissues by sequestering particles and macromolecules in a defined space using a selectively permeable barrier. The specification primarily describes the invention in terms of a strategy for treating serious bone fractures, known as complex or comminuted fractures, where the bone has been shattered into numerous fragments. The district court held Cordis liable for infringing multiple claims of the patent. The Federal Circuit reversed, holding that the district court erroneously construed the “device” and “release means” limitations of the asserted claims. View "Saffran v. Johnson & Johnson" on Justia Law

1999, Drs. Dawson and Bowman submitted the patent application that led to the issuance of the two patents at issue, which concern a method for topically treating and preventing infections of the eye. They claim to overcome difficulties in existing methods through a process for topically applying an azalide antibiotic to the eye. Both patents are entitled “Topical Treatment or Prevention of Ocular Infections.” In 2007, in order to provoke an interference, UCSF filed a patent application that named Dr. Dawson as the sole inventor and generally copied the specification and claims from the patents. Dr. Dawson declined to join UCSF’s submission. The Patent and Trademark Office’s Board of Patent Appeals and Interferences found that Dr. Dawson did not conceive of the claimed inventions by himself prior to his collaboration with Dr. Bowman. The Federal Circuit affirmed, noting that, apart from reduction to practice, conception requires that the inventor know how his “definite and permanent idea of the complete and operative invention ... is hereafter to be applied in practice.” View "Dawson v. Dawson & Bowman" on Justia Law

This case involved a confidential document called the Project Tulip Financial Analysis (Tulip FA), which projected profits, as well as discussed the appropriate terms and benefits from a settlement, involving Solvay's highly lucrative patent on AndroGel, a topical testosterone gel. Solvay subsequently appealed the district court's decision to modify an earlier protective order and unseal the Tulip FA. The court affirmed the district court's judgment, concluding that the district court did not abuse its considerable discretion to modify its own protective order. The district court found that the passage of time had altered the balance enough so that the value of public access to the Tulip FA exceeded the value of confidentiality to Solvay. The court also vacated the stay entered by a panel of the court. View "Federal Trade Commission v. AbbVie Products LLC" on Justia Law

The patent examiner rejected all of the inventors’ pending claims in an application entitled “Enzyme-Mediated Modification of Fibrin for Tissue Engineering,” filed in 2003, relating generally to the field of tissue repair and regeneration, and more specifically to matrices containing bidomain peptides or proteins. The examiner found obviousness-type double patenting over several patents. The Board of Patent Appeals and Interferences affirmed. The Federal Circuit affirmed; tO'Mahe Board did not err in concluding that the pending claims were barred under the doctrine of obviousness-type double patenting. View "In re Hubbell" on Justia Law

The patents relate to a method of drug delivery via the mucous membrane lining or mucosa in the oral cavity. The oral mucosal route provides direct access to the bloodstream without having to travel through the gastrointestinal tract, which allows the drug to avoid the “first pass effect,” the percentage of drug lost to metabolization in the liver. Drug delivery across the oral mucosa potentially provides patients with rapid onset of action at a lower dosage. The patents disclose use of effervescent agents used as penetration enhancers, which influence drug absorption across the buccal, sublingual and gingival mucosae and use of an additional pH adjusting substance in combination with an effervescent agent for promoting the absorption. Watson filed an Abbreviated New Drug Application for a generic version of FENTORA®. In response, Cephalon instituted a patent infringement suit. The district court found that Watson’s ANDA products did not infringe and held the asserted patents invalid for lack of enablement. The Federal Circuit reversed on the issue of enablement, holding that Watson failed as a matter of law to show with clear and convincing evidence that Cephalon’s patents require undue experimentation to practice the invention. The court upheld the noninfringement finding. View "Cephalon, Inc. v. Watson Pharm., Inc. " on Justia Law

Ethypharm, a French corporation, contracted with Reliant, an American company. Ethypharm would manufacture and provide its drug (Antara®); Reliant would obtain approval and market the drug. Reliant sought FDA approval under 21 U.S.C. 505(b)(2), using data from an approved, fenofibrate drug, TriCor®, developed by Fournier and distributed in the U.S. by Abbott. Antara received approval. Reliant began marketing and sought a declaration of non-infringement or unenforceability of Abbott’s patents. Abbott counterclaimed. In 2006, the companies settled: Abbott and Fournier would license the patents to Reliant and Reliant would pay royaltys. The agreement prohibited Reliant from assigning its rights to or partnering with specific companies. Reliant sold its rights to Oscient, which was not a prohibited purchaser. Losing market share to generic fenofibrate, Oscient discontinued promotion of Antara and filed for bankruptcy. Ethypharm sued Abbott, alleging antitrust and sham litigation under 15 U.S.C. 1, asserting that the settlement agreement was designed to ensure that Antara would be marketed by a company with “limited resources and a relatively small sales force,” so that it could not effectively compete with TriCor and that the royalty payment weakened Antara’s profitability. The district court granted Abbott summary judgment. The Third Circuit vacated, holding that Ethypharm lacked standing under the Sherman Act. View "Ethypharm SA France v. Abbott Labs" on Justia Law

The 314 patent, a reissue of the 440 patent, covers the “statin” drug with the brand name Crestor®, which is approved for use in control of cholesterol and for treatment of atherosclerosis. The active ingredient of Crestor® is the calcium salt of a chemical compound whose common name is rosuvastatin, one of several statin products that lower cholesterol production in the liver by inhibiting the enzyme HMG-CoA reductase. Several generic producers initiated a challenge to the 314 patent by filing an Abbreviated New Drug Application (ANDA) accompanied by a Paragraph IV certification, 21 U.S.C. 355(j)(2)(A)(vii)(IV). An ANDA permits a generic producer to market a drug product based on the federal approval obtained by the original registrant. Submission of an ANDA constitutes a statutory act of infringement pursuant to 35 U.S.C. 271(e)(2)(A). If the challenge to the patent fails, the ANDA cannot be approved until expiration of the patent. The generic producers argued that the 314 patent was invalid on the ground of obviousness and improper reissue, and that the patent is unenforceable for inequitable conduct in the Patent and Trademark Office. The district court ruled that the patent is valid, enforceable, and infringed. The Federal Circuit affirmed. View "Astrazeneca UK, Ltd. v. Aurobindo Pharma, Ltd." on Justia Law

The patent, issued in 1995, entitled “Valve Prosthesis for Implantation in the Body and a Catheter for Implanting Such Valve Prosthesis,” describes a prosthetic heart valve, mounted on a stent and implanted by catheter to avoid open heart surgery. The district court found the patent valid and infringed by and that the infringement was willful. The jury awarded damages of $72,645,555 in lost profits and $1,284,861 as a reasonable royalty. The district court entered judgment on the verdict, but declined to enhance damages for the willful infringement. The court also declined to issue an injunction against future infringement, apparently on defendant’s representation that, if enjoined, it would move its manufacturing operations to Mexico. The court also denied a request to modify the litigation-agreed protective order and to permit patent counsel and technical expert to participate in ongoing reexamination proceedings of the patent in suit and related patents. The Federal Circuit affirmed, but remanded reconsideration of the denial of an injunction in view of the representation of changed circumstances, and for reconsideration of the ruling on the protective order as applied to patents not in suit, to the extent that this issue has not become moot. View "Edwards Lifesciences AG v. Corevalve, Inc." on Justia Law

A jury found that Demant and Widex infringed the 749 and 850 patents. The court entered judgment finding noninfringement of the 749 patent, finding that prosecution history estoppel barred the finding of infringement under the doctrine of equivalents. The patents relate to technology for reducing acoustic feedback in a programmable digital hearing aid. All hearing aids have: a microphone that picks up sound and converts it to an electrical signal, a speaker (receiver) that converts the signal back into sound waves, and sound processing circuitry that adjusts received sound to compensate for any hearing impairment. Some of the amplified sound from the speaker may also travel back to the microphone via an “acoustic feedback path” and is amplified along with all other sound arriving at the input microphone. The resulting cycle of amplification causes the whistling sound known as “feedback.” The common specification. with a 1986 priority date, describes a method of reducing feedback by creating an electrical feedback path and inserting a programmable filter in that path to mimic the effects of acoustic feedback on the phase and amplitude of a sound signal in the transmission channel. This electrical feedback signal then cancels the acoustic feedback signal. The Federal Circuit affirmed. View "Energy Transp. Group, Inc. v. Wm. Demant Holding A/S WDH, Inc." on Justia Law