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Your search for ‘Upadhye Tang’ returned 33 results

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  • Article

    Data Falsification/Data Integrity - You Can Run But You Cannot Hide

    Why is it so hard to do the right thing? Why do companies insist on falsifying data on drug development and manufacture.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Upadhye Tang
    Upadhye Tang
  • Article

    Does Drug Quality Matter? Do Lives Matter?

    In a recent FDA warning letter, the FDA upheld the import alert that banned a certain Indian drug company's products from the US market.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Upadhye Tang
    Upadhye Tang
Article

The Patent Eligibility Restoration Act: Revisions To Section 101 Moving Closer To The Finish Line

PERA is hardly new; substantially similar laws were proposed in each year since 2022. But momentum may be growing
United StatesIntellectual Property
Upadhye Tang
Upadhye Tang
  • Article

    Inducement To Infringe Is Not A Strict Liability Test

    In the pharmaceutical world, often times a method of use patent is used to sue competitors, such as generic drug companies, for patent infringement. The standard that is supposed...
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    The Culture Of CGMP Compliance - More Falsified Data

    We see here yet another example, unfortunately, of a drug company potentially falsifying data to support pharma manufacturing. In this warning letter, the FDA noted that the data falsification was admitted.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Upadhye Tang
    Upadhye Tang
  • Article

    Why Patent? Ways To Monetize Patents

    Patents, as one part of intellectual property protection, provides a valuable tool for protecting ideas, R&D, and business growth. It is a political policy decision of how patents are obtained, maintained, enforced, etc.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Ophthalmic, Parenteral, & Otic Drug Development: Does FDA's Draft Guidance Provide A Vehicle To Avoid Patent Problems?

    In April 2022, FDA released a proposed draft guidance (FDA Dock. No. 2022-D-0108) involving pH adjusters in drug development relating to ophthalmic, parenteral, or otic drug products.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Recent Developments In Medical Device Patent And FDA Law

    Patent litigation in the medical device area continues. Along with pharmaceutical patent litigation, medical device patent litigation continues to provide important rulings and case law precedent.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    On The Use Of Generative AI In Patent Litigation

    Back in 2021, I (Yixin) wrote down some thoughts on how the emerging "age of artificial intelligence" can change legal work and make lawyers more efficient.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Navigating Administrative Law: Understanding The Basics Of Challenging Federal Agency Decisions

    In the complex landscape of governance, federal agencies wield significant authority in executing and enforcing laws enacted by Congress.
    United StatesFood, Drugs, Healthcare, Life Sciences
    Upadhye Tang
    Upadhye Tang
  • Article

    FDA's Move To Streamline Biosimilar Approval: What In-House Counsel Must Prepare For Now

    On 29 Oct. 2025, FDA released a new draft guidance (on the need for demonstrating comparative clinical efficacy studies) signaling a major shift in biosimilar regulation.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Proving Patent Infringement – Double Counting Pharmaceutical Ingredients When One Element Satisfies Two Claim Limitations

    Typically, patentinfringement requires comparing the patent claims to the accused device or process. Patent claims are stylized differently but the import is the same...
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Conception & Inventorship Under Pharmaceutical Patent Law: Lessons And Best Practices

    In patent law, conception is the cornerstone of inventorship. For pharmaceutical companies, where billions in revenue hinge on patents for molecules, formulations...
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    The Supreme Court's "Skinny Label" Showdown: What Hikma v. Amarin Means For Generic Drug Companies

    On April 29, the Supreme Court will hear argument in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc., a case that may determine whether the Section...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Upadhye Tang
    Upadhye Tang
  • Article

    Your Rights If FDA Agreed To Your Proposed Q1/Q2 ANDA Formulation But Sends A Refuse To Receive (RTR) Instead?

    The pharmaceutical industry is complex and expensive. Companies and investors deserve certainty. Imagine asking an agency what to do, the agency tells you to do X...
    United StatesFood, Drugs, Healthcare, Life Sciences
    Upadhye Tang
    Upadhye Tang
  • Article

    The Right To Repair Versus Reconstruction Under U.S. Patent Law: An In-Depth Analysis

    The right to repair emerged as a crucial issue in U.S. patent law, as manufacturers increasingly leverage patents to control post-sale repairs. This analysis delves into the legal framework, examining key court decisions.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Five (5) & Ten (10) Year Data Exclusivity For New Drugs – When To File Generic Drug Applications

    Brand pharma companies invest valuable resources, time, and money in moving drugs from development to FDA approval. The new drug approval may also enjoy some type of FDA exclusivity.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Billion Dollar Verdicts Wiped Out Due To Patent Law's Written Description

    Imagine your billion dollar win wiped out later. You'd be mad. You'd wonder how that happened. You'd ask if you did anything wrong to deserve that wipe out.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Standards Of Review In Patent Appeals To The Federal Circuit Court Of Appeals

    By statute, the Court of Appeals for the Federal Circuit has appellate jurisdiction over appeals from the administrative boards of the Patent & Trademark Office and the various district courts.
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
  • Article

    Ice Hockey Referee And Patent Litigator – What On Earth Do These Have In Common?

    The closest comparator for the ice hockey referee is the federal trial court judge. I am not a judge but I thought this would be a fun little article about what being an ice hockey referee...
    United StatesIntellectual Property
    Upadhye Tang
    Upadhye Tang
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