This blog serves the purpose of providing information and happenings in the Pharma IP milieu.
Wednesday, January 20, 2010
Impax confirms Patent Challenge against Colesevelam HCl tablets, 625 mg
Endo receives para IV certification notice from Watson for lidocaine topical patch
Tuesday, January 12, 2010
Watson files ANDA for generic LoSeasonique® [(levonorgestrel and ethinyl estradiol (0.10 mg/0.02 mg)]
Saturday, January 9, 2010
Pros and Cons of US Reissue patent and reexamination system
The reissue and reexamination procedures of the U.S. Patent and Trademark Office (USPTO) are valuable tools for businesses that want to strengthen their patent portfolio or weaken that of their competitors. Reissue allows patent owners to correct errors in
Benefits of Reissue
1. Reissue allows a patentee to correct a wide variety of errors in a patent wherein the error may include inadvertently obtaining a patent that does not cover all of the disclosed inventions the patentee intended to protect.
2. By Reissue patent a patentee can help to correct errors wherein the patentee inadvertently covers too much subject matter, such as an invention already known in the prior art which if not corrected would render the patent invalid.
3. In reissue, patentability issues may be submitted based on any type of prior arts (patents, printed publications, and prior knowledge, use, or sale of the claimed invention). Reissue applications are handled by examiners in the same patent-examining group that issued the original patent; thus, they are likely to have technical expertise relevant to the claimed invention.
4. In reissue, a patent owner can request automatic extensions of time for a fee, file additional continuation applications, and request continued examination (RCE) of a patent, each providing the patentee additional time and opportunity to address any problems in the patent.
5. Besides the abovesaid points, reissue can correct typographical errors in a patent's specification and drawings, incorrect listings of inventors, or inadvertent procedural errors made by the patentee during the patent-application process.
Limitations of Reissue
To be eligible for reissue, the patent owner must acknowledge and identify an error in the patent. But there are limits to the types of errors correctable through reissue.
1. A patentee gets a limited period (two years post issue of the patent) to correct the errors.
2. Second, even if a patentee requests a broadening reissue within the two-year time limit, the patentee may not broaden the original patent to recapture disclaimed subject matter.
3. Third, if a patentee made misrepresentations or intentionally failed to submit relevant prior art to the USPTO during the patent-application process, the patentee may not use reissue to correct such inequitable conduct.
4. Only a patent owner can request a reissue of the patent, but once the reissue process has begun, a third party may file a protest arguing why a patent claim is not patentable. Other than the protest, a third party cannot participate in the reissue process.
Benefits of Reexamination
In the
1. First, reexaminations are much cheaper than patent lawsuits, which can cost millions of dollars. One of the main reasons for the high litigation costs is the extensive discovery permitted in
2. Second, in federal court, an issued patent is automatically presumed valid. Judges and juries in federal court can declare the patent invalid only if there is "clear and convincing" evidence. But in reexaminations, there is no such presumption; thus, it can be easier to invalidate a patent at the USPTO.
3. Third, most reexaminations can be requested anonymously. If a requester fears the patent owner is targeting the requester for a patent-infringement suit, then he can file a reexamination request anonymously through a third party, such as a patent attorney. In contrast, lawsuits in federal court require identification of the real party in interest.
4. Fourth, reexamination can be requested during litigation. Judges will often stay a patent litigation pending the outcome of a reexamination. The stay benefits a defendant because it gives the defendant time to prepare the case and search for additional prior art to use in an invalidity defense. The likelihood that a judge will grant a stay depends greatly on each judge's preference. Judges in the district courts of
5. Fifth, even if a patent is not completely invalidated during reexamination, the USPTO will often reduce the scope of patent claims. Thus, a device or process that might have infringed a patent before reexamination might not infringe the same patent after reexamination.
Limitations of Reexamination
Reexamination poses some risks. Before the USPTO grants a reexamination request, it reviews the request and the prior art submitted with the request to determine whether the request raises a substantial new question of patentability. If the USPTO denies the request, it has, in effect, determined that the prior art submitted with the request would not invalidate the patent. The USPTO, however, rarely denies a reexamination request—only about eight percent of the time. Alternatively, the USPTO may grant the reexamination request but confirm the validity of the patent during reexamination. In both cases, the reexamination strengthens the patent, making it harder to assert invalidity later on. Thus, reexamination can backfire on a requester who intended to invalidate the patent but must instead deal with a stronger patent that survives reexamination. This is why patent owners often file reexamination requests for their own patents after learning of prior art that may affect validity. Indeed, approximately 40% of ex parte reexaminations—one type of reexamination at the USPTO—are filed by patent owners. Only patentability issues based on prior patents or printed publications may be submitted for reexamination. The central reexamination unit at the USPTO handles reexaminations. It deals with a broad variety of technologies, so examiners working on a reexamination may not always have the technical expertise most relevant to the claimed invention. Lastly, like reissue, reexamination cannot be used to correct inequitable conduct.
It can take from less than a year to several years for the USPTO to complete a reexamination, which can cause much uncertainty for companies waiting to make business decisions based on the outcome. The USPTO is charged to handle all reexaminations with special dispatch, especially for patents already in litigation. But if the reexamination unit is busy or if the patent under reexamination is in a popular technology area, the reexamination process can often be slow. Further, if the patent owner disagrees with the outcome of the reexamination, he can appeal to the USPTO's Board of Patent Appeals and Interferences, then later to the U.S. Court of Appeals for the Federal Circuit, each of which may take several years to resolve.
Friday, January 8, 2010
Medicines Company files additional Patent Infringement Lawsuits
The Medicines Company has filed lawsuits against Teva Parenteral Medicines, Inc., Pliva Hrvatska d.o.o. and related entities in the United States District Court for the District of Delaware alleging patent infringement based on ANDA seeking USFDA approval to market and sell generic versions of The Medicines Company's Angiomax(R) product prior to expiration of U.S. Patent No. 7,598,343 ("the '343 patent"). Each lawsuit alleges infringement of the '343 patent which was issued on October 6, 2009. As per an earlier announcement, The Medicines Company has patent infringement lawsuits pending against the same parties in the United States District Court for the District of Delaware for infringement of its U.S. Patent No. 7,502,727.
Strides Arcolab to market 40 off-patent sterile injectable & oral products in US
Tentative approval of Lamivudine, Nevirapine, and Zidovudine FDC Tablets
USFDA has granted tentative approval for a FDC product containing lamivudine, nevirapine, and zidovudine, 150mg/200mg/300mg, indicated for use alone as a complete regimen, or in combination with other antiretrovirals, for the treatment of HIV-1 infection. This new FDC is manufactured by Strides Arcolab Limited
Watson filed ANDA for generic armodafinil
Watson's subsidiary, Watson Laboratories, Inc. has filed an ANDA with the USFDA seeking approval to market its 50 mg, 100 mg, 150mg, 200 mg, and 250mg strength armodafinil tablets prior to the expiration of patents owned by Cephalon France. Watson's 50 mg, 100 mg, 150mg, 200 mg and 250mg armodafinil tablet products are generic versions of Cephalon, Inc.'s Nuvigil(R), which is indicated for the improvement of wakefulness in adults who experience excessive sleepiness (ES) associated with treated obstructive sleep apnea (OSA), shift work sleep disorder, also known as shift work disorder (SWD), or narcolepsy.
Cephalon, Inc. and Cephalon France filed suit against Watson on January 5, 2010 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 7,132,570. Cephalon's suit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months or until final resolution of the matter before the court, whichever occurs sooner. Watson claims to be a "first applicant" to file an ANDA for the 100 mg and 200 mg strengths of a generic version of Nuvigil(R) and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity for those strengths.
Teva entered into agreement with AstraZeneca regarding Prilosec® (omeprazole) and Nexium® (esomeprazole) generics
TA-CD (Cocaine conjugate vaccine)
Cocaine’s primary sites of action in the brain include monoamine neurotransmitter transporters for dopamine (DAT), serotonin (SERT) and norepinephrine (NET). DAT, SERT and NET regulate the amount of dopamine, serotonin and norepinephrine available for signal transduction by removing excess monoamine from the synapse back to the presynaptic neuron. Cocaine is able to bind to these transporters and causes a blockade in neurotransmitter reuptake by the presynaptic neuron, thus prolonging neurotransmitter availability in the synaptic cleft. This leads to excessive activation of the postsynaptic neuron, as a consequence of increased binding of the neurotransmitters to their respective receptors, which is manifested as cocaine-induced reward/reinforcement.
The current lack of approved pharmacotherapies in Europe and the
EU probes Lundbeck for generic citalopram delay
EU regulators suspect Danish Company Lundbeck may have delayed the launch of a cheaper, generic version of its antidepressant drug (citalopram) in Europe. The European Commission said it had opened a formal antitrust investigation to check whether H. Lundbeck A/S made deals with other pharmaceutical companies to delay them selling citalopram after Lundbeck's exclusive right to the drug it developed ran out in 2003. Citalopram is one of the most widely used drugs to treat depression and anxiety and is sold under the name Celexa in the U.S. and Canada and Cipramil in most of Europe. It acts by altering serotonin levels which can raise a person's mood. Lundbeck has expressed cooperation with the EU regulators and was "confident that the group has complied with all relevant national and EU competition legislation." The company recently patented escitalopram, which is chemically similar to citalopram. Three generics companies tried to challenge that patent in the British courts, claiming it was not significantly different to the original drug. In 2008, Lundbeck won on appeal, protecting its patent.
Investigations are in the pipeline to be carried out by EU regulators who would monitor the allegations on Lundeback as a matter of priority. The EU says generic drugs are on average 40 percent cheaper than their branded rivals two years after they launch. It warned that it knew of at least 200 settlement agreements - some including payments to delay drug launches - between generic and brand-name drug makers that could restrict the rollout of generic versions.
Abbott and Fournier agree to pay $22.5 million for blocking generic fenofibrate
Makers of the popular cholesterol-lowering drug TriCor have agreed to pay $22.5 million to resolve allegations that they illegally kept generic versions off the market. As a result of these practices, consumers and state governments paid higher prices for the cholesterol drug.
Under the agreement, Abbott and Fournier will pay $22.5 million to the states. North Carolina's share of nearly $800,000 will go to the state's Medicaid program, a joint federal-state program that provides health insurance for the poor. TriCor is a brand-name prescription drug that uses the active ingredient fenofibrate to regulate trigyliceride and cholesterol levels.
Cooper and the other attorneys general allege that since 1998, Abbott and Fournier have successfully monopolized sales of fenofibrate drugs by blocking generics from the market. The companies crafted elaborate schemes like filing multiple patents with the Federal Drug Administration and then filing patent infringement lawsuits to delay generic versions of TriCor. The attorneys general also contend that Abbott and Fournier thwarted competition by making various clinically insignificant changes to the dosage and form of TriCor and manipulating the drug codes used to create generic substitutions. Under the settlement, Abbot and Fournier have agreed not to delete the drug codes for the latest version of TriCor in the event a generic manufacturer seeks FDA approval of a generic version of the drug.