Pharma / ANDA

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Pills flowing out of a bottle of prescription medicine with information of their possible serious side effects.

The PTAB recently addressed the limits on strategies to patent drug labeling, canceling claims directed to a method of supplying a pharmaceutical product where the method includes a step of providing certain “information” to the medical provider. According to the PTAB, the claimed step of providing the information is entitled to no patentable weight under the “printed matter” doctrine where it is not functionally related to other elements of the claimed method.  Specifically, even if the claim says that the information is “sufficient to” cause some effect (e.g., for a medical provider to avoid treating a patient) there is no functional relationship with the claim if the claim doesn’t recite that effect.   Praxair Distribution Inc. v. Mallinckrodt Hospital Prods. IP Ltd., IPR2015-00529.
Continue Reading “Providing . . . information” Step Given No Patentable Weight

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In Cuozzo Speed Technologies, LLC v. Lee, the Supreme Court recognized that a “district court may find a patent claim to be valid, and the agency may later cancel that claim in its own review.”  The Court also recognized that because of the different evidentiary burdens in court versus before the agency—the Patent Office—“the possibility of inconsistent results is inherent to Congress’[s] regulatory design.” Is that inconsistency sensible? As good a case as any to consider that question involves a global pharmaceutical company, one of its top-selling drug products, and a patent it owns that covers the administration of that drug product.
Continue Reading The Possibility of Inconsistent Results Inherent to Congress’s Design of AIA Trial Reviews

US Patent and Trademark Office in Alexandria, VA.

On June 30, 2016, lead APJ Jacqueline Wright Bonilla provided a status report on Inter Partes Review/Post Grant Review in the Biotechnology and Chemical Technology Center 1600 during the Biotechnology/Chemical/Pharmaceutical Customer Partnership (BCP) Conference.  The statistics discussed during this BCP Conference are current as of May 31, 2016. 
Continue Reading Status Report on IPR Statistics for the Biotech/Pharma Technology Center

The Board initially denied institution of Mylan Pharmaceuticals’ petition for inter partes review of U.S. Patent No. RE44,186, owned by AstraZeneca.  After a rare grant of Mylan’s request for rehearing, the Board reconsidered the record and decided to institute the IPR.  The decision to institute focused on the content of Mylan’s expert testimony; and although not mentioned in the decision, the replacement of one APJ in the PTAB panel for the decision on rehearing might have played a role in the grant of the request for rehearing and the decision to institute the IPR on rehearing even though both decisions were unanimous.
Continue Reading Rare Grant of Rehearing of Denial of Petition for Inter Partes Review

Bumble beeIn a recent order by the magistrate judge in Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC (NJD, Jan. 22, 2016), defendants Amneal Pharmaceuticals and Par Pharmaceuticals were reprimanded and threatened with sanctions and monetary fines for trying to use confidential information from the litigation to move for additional discovery in a related IPR proceedings.  The judge ruled this behavior violated a Discovery Confidentiality Order (DCO) in place in the litigation.  
Continue Reading Cross-Pollination of Information From Litigation to IPR Can Lead to Trouble for Parties

Pen poised to sign a declaration. Classic silver and gold ballpoint, shallow depth of field.

If you rely in an IPR on a declaration submitted during prosecution, the PTAB may give it little or no weight if your opponent cannot cross-examine the declarant.

In Praxair Distribution, Inc. v. INO Therapeutics LLC, the PTAB instituted inter partes review of U.S. Patent No. 8,846,112, directed to methods of providing nitric oxide gas for treating newborn children suffering from hypoxia.

In response, the Patent Owner relied not only on a supporting expert declaration, but also on three declarations submitted during prosecution of the ’112 patent.
Continue Reading PTAB Warns Again That Prosecution Declarations Without Depositions May Be Given Little or No Weight

Outstretched ArmsTwo recent PTAB final written decisions highlight the benefits that the “broadest reasonable interpretation” standard for claim construction provides to Petitioners, as well as the difficulty Petitioners face in proving inherent anticipation.  The PTAB instituted two IPRs on the same patent: one on an anticipation ground, and another on an obviousness ground.  The Petitioner failed to prove anticipation, but prevailed on obviousness of all claims of the patent.
Continue Reading Broader is Better for the Petitioner, but Inherency is Intrinsically Difficult

The pharmaceutical industry continues its efforts to exempt pharmaceutical and biotechnology patents from inter partes reviewBalance Scale (IPR). Neither the House’s Innovation Act nor the Senate’s PATENT Act currently contain any provisions that would exempt particular patents from these proceedings. But as we reported in June, some members of the Senate judiciary committee appear sympathetic to addressing the pharmaceutical industry’s concerns with an exemption for pharmaceutical and biotechnology patents.
Continue Reading Pharma industry continues efforts to exempt patents from IPR

Mind the GapPetitioners should beware gaps in their evidence and reasoning.  Two DepoMed patents recently survived their second IPR challenge because the petitioner failed to meet its burden of proof.  The PTAB rejected petitioner’s obviousness arguments as “overly vague and nonspecific,” concluding that petitioner failed to “explain persuasively why or how a person of ordinary skill in the art would modify the drug formulation” of the prior art to develop the claimed formulation, and failed to show a reasonable expectation of success. 
Continue Reading Mind The Gap: The PTAB Will Not Bridge It For You

Score another win for pharma against investment funds-turned-IPR petitioners. On September 21, 2015, the PTAB denied institution of Ferrum Ferro Capital, LLC’s (“FFC”) petition for IPR of an Allergan patent claim related to its Combigan® eye-drop product for treating glaucoma. This dispute has attracted publicity for having bled into the courts, where Allergan has sued FFC for extortion, unfair competition, and malicious prosecution. The PTAB’s non-appealable denial of FFC’s petition is obviously a significant victory for Allergan, and follows the PTAB’s recent denials of two IPR petitions filed by the Coalition For Affordable Drugs.  
Continue Reading PTAB Denies Institution of Another Investment Fund IPR Petition, Refusing to Ignore Claim Limitation Under BRI Standard

Resources & Info

Arthrex and the Supreme Court Resource Center

In United States v. Arthrex, Inc., the Supreme Court has heard whether 125+ PTAB decisions rendered through October 2019 must be remanded for new decisions. Read about how that issue developed through our post.

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Our Team

PTABWatch, provided by Marshall, Gerstein & Borun LLP, analyzes and reports recent developments concerning Post-Grant Proceedings at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent and Trademark Office (USPTO), including Inter Partes Review (IPR), Post Grant Review (PGR), and Covered Business Method (CBM) proceedings.